Pfizer

Eyes, mouth & ears symptom reports

Female, 40 - 59 years

Age Reported Symptoms Notes
40 2020-12-31 eye twitching CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC... Read more
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
40 2021-01-01 ear itchiness Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benad... Read more
Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.
40 2021-01-03 vision blurred Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ... Read more
Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ER. BP noted to be 163/100. After one hour and a half, BP in the 120's systolic and 90's diastolic. Continued to have blurred vision. Blood pressure became labile and continued to be in the range of 160's over 100's to 130/90's. After 48 hours, vision no longer blurred, Blood pressure returned to normal baseline and maintained. Took BP for over one week after, morning, noon, and night on the Left arm and Right arm. My BP stayed in the 117/70-120/80 range. Wanted to make sure I had no underlying hypertension. No other adverse issues.
40 2021-01-04 loss of smell, loss of taste Headache congestion clear nasal discharge throat pain and inflamation no smell no taste
40 2021-01-04 taste impairment Headache, nausea, metalic taste, general malaise, low back pain
40 2021-01-04 ear discomfort Severe headache, bilateral ear pressure, intense vomiting, chills, dizziness, fatigue, nausea
40 2021-01-04 mouth numbness, mouth tingling Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left h... Read more
Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
40 2021-01-04 mouth numbness Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then ... Read more
Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.
40 2021-01-04 mouth tingling Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and join... Read more
Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2
40 2021-01-04 swelling around the eyes Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 4... Read more
Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-01-04 sensitivity to light, eye pain eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report fr... Read more
eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 on 29Dec2020 12:30 at left arm at single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included labetalol, lisinopril, tolvaptan (JYNARQUE), calcium, and ascorbic acid/ferrous fumarate (VITRON C). Patient experienced headache the night on 29Dec2020 21:00 after took the vaccine. Slept the night without much trouble. Headache worsened in the morning, almost felt like a migraine attack with sensitivity to light and eye pain etc. on 30Dec2020. Treatment was not received for these events. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-04 ringing in ears bilateral tinnitus; This is a spontaneous report from a contactable physician (patient). A 40-year-o... Read more
bilateral tinnitus; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, intramuscular in the arm left, first dose on 19Dec2020 09:30 at a single dose for Covid-19 immunization. Medical history included hypothyroidism. The patient previously took penicillin and had allergy with hives. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid 19 nor was she tested for Covid 19. Concomitant medication included levothyroxine. The patient noticed onset of bilateral tinnitus that was constant and new since the injection. She doesn't know that it was related but it was very new in onset about 24 hrs after the vaccine and quite an obvious change. She mentioned that she is only 40 and has no known hearing loss and an ENT physician so can pinpoint no other triggers. The event resulted to a doctor or other healthcare professional office/clinic visit. No treatment received for the event. The outcome of the event bilateral tinnitus was not recovered. Information on the lot/batch number has been requested.
40 2021-01-04 tongue itchiness, lip swelling Patient with very mild swelling lip and itchy feeling of tongue. Given 37.5 mg Benadryl, all sympt... Read more
Patient with very mild swelling lip and itchy feeling of tongue. Given 37.5 mg Benadryl, all symptoms resolved.
40 2021-01-05 inability to speak Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ... Read more
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
40 2021-01-05 mouth tingling Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I ea... Read more
Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.
40 2021-01-05 mouth tingling Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,... Read more
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
40 2021-01-05 taste disorder Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times t... Read more
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
40 2021-01-05 visual impairment I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circl... Read more
I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circle. I also started to get a headache. I took 3- 200mg ibprofen. About 10 minutes later, the vision problem went away.
40 2021-01-06 mouth numbness, lip swelling Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contacta... Read more
Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration in the left arm on 31Dec2020 at 12:30 PM (at the age of 40-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, high cholesterol, and hypothyroidism. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included atorvastatin (LIPITOR), metformin, sitagliptin (JANUVIA), empagliflozin (JARDIANCE), and dulaglutide (TRULICITY). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 07:00 AM, the patient experienced swollen and numb upper lip. The events were reported as non-serious. The patient did not receive any treatment for the swollen and numb upper lip. The clinical outcome of the swollen and numb upper lip was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
40 2021-01-07 ear pain, pain in jaw, mouth numbness Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ... Read more
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
40 2021-01-07 ear pain Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom ... Read more
Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom lip droop, left ear pain. She was ordered steroids by her PCP.
40 2021-01-07 mouth tingling, swollen tongue Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and righ... Read more
Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
40 2021-01-07 mouth tingling Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue a... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue and neck swelling. Actions taken: Patient stated she had her own 50 mg of Benadryl with her and had taken it at 1305. She states she has other reactions to medications in the past and it feels the same way. Patient monitored, EMS called and care transferred. Patient was alert and oriented.
40 2021-01-07 light flashes or floaters in the eye After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Ra... Read more
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.
40 2021-01-07 swollen tongue Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re... Read more
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
40 2021-01-07 ringing in ears Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread... Read more
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
40 2021-01-07 tongue discomfort bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; ... Read more
bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
40 2021-01-08 pain in jaw 1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa... Read more
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
40 2021-01-08 mouth tingling, hearing loss, feeling of choking 11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE... Read more
11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL
40 2021-01-09 eye swelling, lip swelling I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ... Read more
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
40 2021-01-09 pain in jaw, toothache headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, ... Read more
headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, lungs CTA
40 2021-01-09 tongue itchiness Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ... Read more
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
40 2021-01-10 taste impairment This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r... Read more
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
40 2021-01-10 swollen tongue Tongue swelling, headache, tachycardia, elevated BP
40 2021-01-11 eye pain PAIN BEHIND EYES, HEAD TO EXPLODE DOWN BAck OF HEAD
40 2021-01-11 eye swelling, eye irritation Left eye feels full, swollen, chills.
40 2021-01-12 burning mouth syndrome, ear pain heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that we... Read more
heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.
40 2021-01-12 lip swelling drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vacc... Read more
drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vaccine administered increased temp and bodyaches occurred approx. 6 hours after vaccination
40 2021-01-13 taste impairment Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand... Read more
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
40 2021-01-13 mouth numbness, eye swelling, mouth swelling In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swolle... Read more
In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swollen mouth and tingling in the face. where it took a Benadryl at the time.
40 2021-01-13 mouth tingling developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved up... Read more
developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved upon arrival to ED. no further intervention. - observed for 4 hrs, d/c to home
40 2021-01-13 vision blurred Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/visio... Read more
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium
40 2021-01-14 dry mouth 1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/... Read more
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
40 2021-01-14 ear discomfort, oropharyngeal discomfort I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing... Read more
I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.
40 2021-01-14 feeling of choking Chest tightness, Difficulty in breathing, Tachycardia, Throat tingling and burning.
40 2021-01-14 sensitivity to light within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nause... Read more
within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches
40 2021-01-14 visual impairment Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro... Read more
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
40 2021-01-15 mouth numbness, taste impairment, lacrimation increased Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I ... Read more
Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb. A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist). My neck got stiff and I was really tired. The symptoms lasted about 4 hours. When I woke up this morning the left side of my face and jaw still do not feel 100%. My left eye is watery. I'm very tired.
40 2021-01-17 eye movement disorder employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled ... Read more
employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled back and she began to drool. she has a history of passing out when not feeling well or vaccine. Eval in ED, treated with benadryl IV and fluids. D/c home.
40 2021-01-18 loss of taste, swollen tongue, mouth swelling, mouth numbness, taste impairment Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue starte... Read more
Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue started to swell up, the inside of my mouth started to swell up. I lost sense of taste to even water. I was allowed to take my 50 mg of benedryl. My BP was 171/100. I was taken to the ED and that is where I received the vaccine as well.
40 2021-01-18 eye pain, eye discomfort after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 da... Read more
after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 days. Eye pain and pressure
40 2021-01-19 loss of taste, loss of smell 1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smel... Read more
1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smell and taste are almost gone. I also had this happen also 12 days after my 1st vaccine and both my COVID swabs were negative then.
40 2021-01-19 pain in jaw Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, le... Read more
Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-19 swelling of eyelid, lip swelling swelling to left armpit, left eye, left cheeck and lips.
40 2021-01-20 inability to speak Fever, chills, headache, body aches, tired and loss of voice
40 2021-01-20 eye pain, bloodshot eyes Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approxima... Read more
Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approximately 11:00 PM) experienced sharp pain behind right eye. On 1/15/21 bumps in right eyebrow and itchiness on right side of scalp. on 1/16/21 developed redness in right eye. Pain behind right eye and itchiness persisted for >5 days. Went to Urgent Care on 1/20/21 and shingles suspected. Referred to confirm diagnosis. Antiviral pills and drops prescribed, as well as steroid drops.
40 2021-01-20 mouth numbness I received the first dose in the morning and by the evening my mouth (lips, area around lips, roof o... Read more
I received the first dose in the morning and by the evening my mouth (lips, area around lips, roof of mouth, tongue) feel numb. It is a little better, however, I still have numbness around my mouth and tongue. I don?t know if I should receive the second dose.
40 2021-01-21 mouth numbness I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm... Read more
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-22 mouth tingling Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak... Read more
Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat
40 2021-01-23 eye swelling Got vaccine around 12pm on 1/23/21 Woke up on 1/24/21 around 9am with very swollen eyes
40 2021-01-24 mouth numbness, feeling of choking, mouth tingling Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst... Read more
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
40 2021-01-25 mouth tingling 1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reac... Read more
1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reaction, lip and tongue unremarkable POX 99, P 78, bp 128/66 2:05 feels "funny, " dropping papers, appears nervous 2:20 DNS reported improved tingle 2:30 Dr. evaluated cleared resident to go home before Benadryl kicks in, tired. She stated "I feel fine"
40 2021-01-25 swollen tongue On same day of vaccination of 2nd dose, patient developed tongue swelling and neck; joint aches
40 2021-01-26 ear pain Starting 6-7 hours after the vaccine I began to have the most severe ear pain that would not go away... Read more
Starting 6-7 hours after the vaccine I began to have the most severe ear pain that would not go away with Tylenol/ibuprofen. I was unable to get up/sit up on my own. My lumbar spine seized up and spasmed feeling like I had an acute injury. I had chills but no fever.
40 2021-01-26 eye pain, bloodshot eyes, sensitivity to light I developed R eye redness, pain and photophobia on 1/21 and was diagnosed with anterior uveitis. I a... Read more
I developed R eye redness, pain and photophobia on 1/21 and was diagnosed with anterior uveitis. I am being treated with prednisolone drops and a dilating eye drop. My symptoms have improved significantly with the eye drops. I do not know if this is at all related to the vaccine - I have a h/o one other episode of anterior uveitis in my L eye in 2004, felt to be HLA-B27 associated - however I figure it is worth reporting just in case.
40 2021-01-26 mouth tingling About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no ap... Read more
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.
40 2021-01-26 swollen tongue heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs cr... Read more
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
40 2021-01-27 eye movement disorder Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day,... Read more
Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.
40 2021-01-27 extreme sound sensitivity, ear pain Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while re... Read more
Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while recalling information in a conversation; Feverish feeling but no fever; Heaviness of the body like moving in honey; Achiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248, expiration date not reported) via an unspecified route of administration on the right arm on 12Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included PCOS, Raynauds, PTSD; and known allergies: Sulpha, sulfites, pseudafed, penicillin, cephalosporins, bromfed, IV contrast, pineapple. Concomitant medication in two weeks included levocetirizine dihydrochloride (XYZAL), omeprazole, escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL) and levothyroxine sodium (LEVOTHYROXIN). On 12Jan2021 08:45 PM, the patient experienced both arms hurt, fatigue, achiness, headache that moves, ear aches, noises are louder, mind goes blank while recalling information in a conversation, feverish feeling but no fever, heaviness of the body like moving in honey. Therapeutic measures were taken as a result of the events which included Ibuprofen (ADVIL) and acetaminophen (TYLENOL). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
40 2021-01-27 mouth tingling Complaint of tingling tongue that was unfounded on exam.
40 2021-01-27 sensitivity to light weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy;... Read more
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-28 bloodshot eyes Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Too... Read more
Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.
40 2021-01-28 feeling of choking Tingling sensation in throat 5 minutes after vaccine to 45 minutes after. Sensation didn't decrease.... Read more
Tingling sensation in throat 5 minutes after vaccine to 45 minutes after. Sensation didn't decrease. Went back to work at unit. Has history of anaphylaxis to certain medications and ADR to TDaP
40 2021-01-30 mouth tingling, mouth discomfort patient reported mild tingling/burning in lower lip; symptoms did not worsen during 30 minute observ... Read more
patient reported mild tingling/burning in lower lip; symptoms did not worsen during 30 minute observation period; patient denies any additional symptoms; states that she had this same symptom after her first vaccination and that it lasted for about 1 hour
40 2021-01-31 eye pain I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis ... Read more
I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis which lasted approx 1 day.
40 2021-01-31 eye swelling, swelling of eyelid, eye pain left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; ... Read more
left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; eyelid swelling; left eye swelling; left eye swelling and tenderness; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 07:30 at a single dose for COVID-19 immunization. Medical history included seizure, COVID prior to vaccination and penicillin allergy. Patient was not pregnant at the time of vaccination. Concomitant medication included levetiracetam (KEPPRA) and lacosamide (VIMPAT). No additional vaccines administered within 4 weeks before the vaccination. The patient previously took LAMICTAL and experienced allergy. The patient experienced Left auxiliary lympadenopathy and lymphadenitis, eyelid swelling, and left eye swelling and tenderness on 15Jan2021 15:00. Patient took BENADRYL as treatment for the events and was recovering. Patient had not been tested since the vaccination. Information on the lot/batch number has been requested.
40 2021-01-31 mouth numbness, mouth tingling She pretreated with Claritin and tums. About 20 minutes after the injection she began having tinglin... Read more
She pretreated with Claritin and tums. About 20 minutes after the injection she began having tingling and numbness in her mouth that persisted all day. The following day the tingling had improved but there was residual numbness. She also noted fatigue and body aches.
40 2021-01-31 pain in jaw, toothache, mouth pain Severe headache - mostly top front of head radiating to mouth (teeth/jaw).
40 2021-01-31 mouth tingling Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. ... Read more
Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.
40 2021-02-01 eye irritation I got chills; mild headache and just tired. It lasted and then I got sick on the 1st; Got tested for... Read more
I got chills; mild headache and just tired. It lasted and then I got sick on the 1st; Got tested for COVID January 3rd, 2021; On January 1 mild headache; tired and very congested but then real runny nose (went back and forth). On January 2, I got a fever - 101. Took Tylenol. On January 3, I got a fever. I was taking zinc; vitamins. My doctor prescribed medicine but I only took it twice as I didn't like how it made me feel - made it feel like I had something in back of my throat. I still have headaches - they aren't going away and neither is the tiredness. Yesterday, I woke up fine - but when I was at work started feeling very tired; and headache was so bad it felt like eyes were burning. Today I had a mild headache. I was staying at a hotel until the tests for COVID came back negative. I normally don't have headaches and fatigue.
40 2021-02-01 mouth numbness Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the f... Read more
Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
40 2021-02-01 vision blurred, mouth numbness Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed... Read more
Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed active for 24-48 hours
40 2021-02-02 eye swelling angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelli... Read more
angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelling of eyes 1 hour after injection. less than 12 hours later, full facial swelling, hands and feet. continued to worsen for the next 5 days. swelling started to slightly subside day 5. fever until day 4. vomit day 3. chills until day 4. severe headache until day 18.
40 2021-02-03 loss of smell, ringing in ears, loss of taste December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Mond... Read more
December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.
40 2021-02-03 lip swelling, swelling of eyelid Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbne... Read more
Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbness and pain on site. Numbness subsided and pain was minimal. Went to bed and work up around 6am to face, eyes, nose and lips swollen. Barely unable to open eyes. Immediately contacted employer employee health and contacted PCP. Appointment scheduled with PCP. PCP assessment completed. Recommended prednisone for swelling. Unable to take because of previous reaction. Recommended for Benadryl to be taken every 4-6 hrs and also Ibuprophen
40 2021-02-03 swollen tongue Tongue had blisters on edges and tip and swollen. Reports of it feeling scalded.
40 2021-02-04 eye pain Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under ey... Read more
Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-02-06 visual impairment 15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred o... Read more
15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred on and off for the following 24 hours. Injection site warm to touch (compared to other arm) but without redness.
40 2021-02-07 taste impairment Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose,... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat. Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm
40 2021-02-07 mouth tingling 25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swo... Read more
25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swollen but she definitely had a tingling feeling. She felt as if she had difficulty swallowing and had some hives on her back. These symptoms all resolved after 3 hours. She never had trouble breathing and was able to eat her dinner.
40 2021-02-08 ear discomfort Received second vaccine on 2/4/21 and on 2/8/21 went to urgent care for bilateral ear pressure and s... Read more
Received second vaccine on 2/4/21 and on 2/8/21 went to urgent care for bilateral ear pressure and sinus congestion that was present since 2/7/21.
40 2021-02-09 mouth tingling, thirst, dry mouth uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; t... Read more
uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
40 2021-02-09 mouth tingling Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I though... Read more
Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I thought I was imagining it and so I didn't say anything. As I was driving home, I started to feel it more and also felt it in my tongue. When I got home, the only antihistimine I had was claritin, so I took that. Then, I got nervous, felt tightness in my chest and went to the ER. They gave me benadryl and that helped. I stayed in the ER for an hour to be monitored and they said everything was fine.
40 2021-02-09 swollen tongue, dry mouth 5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heart... Read more
5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heartrate as high 120-150 I started to get really dizzy, I had shortness of breath I felt like I was getting ready to faint . I started having getting cotton mouth(Dry mouth). 8 hours post vaccine I started the heart rate went down but I started feeling like I had something in my throat . the bumps on the back on my tongue was swollen. I took Zyrtec and Pepcid Blood pressure was high Glucose was high
40 2021-02-09 swollen tongue, burning mouth syndrome administration_date=22Jan2021, dose_number=2/administration_date=30Dec2020, dose_number=1; Swollen a... Read more
administration_date=22Jan2021, dose_number=2/administration_date=30Dec2020, dose_number=1; Swollen and tenderness in tongue; Swollen and tenderness in tongue; Tender gums; soreness on right side of neck under ear; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female patient received second dose of bnt162b2 (lot number: EL3246), intramuscularly at arm left on 22Jan2021 15:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (lot number: EH9899) intramuscularly at left arm on 30Dec2020 15:00 for covid-19 immunisation. Not Pregnant at the time of vaccination. The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen and tenderness in tongue. Tender gums and soreness on right side of neck under ear, from 24Jan2021 08:00 AM. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Prednisone and Pepcid. The outcome of the events was recovering.
40 2021-02-09 visual impairment, vision blurred blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at inj... Read more
blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at injection site
40 2021-02-11 mouth numbness, tongue disorder About 5 min after receiving the injection, throat and tongue began feeling numb and tongue felt thic... Read more
About 5 min after receiving the injection, throat and tongue began feeling numb and tongue felt thick. 30 minutes after injection, sudden need for BM. Oral, liquid Benadryl taken. BP 120/96, HR 93, SpO2 96%.
40 2021-02-14 taste disorder red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w... Read more
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
40 2021-02-15 thirst Extreme thirst for 3 days; Extreme energy/hyperactivity for 2 days; Insomnia for 3 nights
40 2021-02-16 mouth tingling, lip swelling In monitoring area shortly after vaccination, patient reported to EMS observation staff she was expe... Read more
In monitoring area shortly after vaccination, patient reported to EMS observation staff she was experiencing "lip tingling." In speaking with staff during assessment, patient's symptoms progressed to c/o lower lip swelling and trouble swallowing. Redness and swelling noted around mouth and nose. IM epinephrine administered at 18:08 and 911 called for transport to hospital.
40 2021-02-17 pain in jaw, toothache 1st dose Vaccine 1/9/21; 2nd dose vaccine 2/14/21; developed hives/rash 2/15/21, resolved with Benad... Read more
1st dose Vaccine 1/9/21; 2nd dose vaccine 2/14/21; developed hives/rash 2/15/21, resolved with Benadryl; developed chest pain, SOA, HA, jaw/teeth pain , and nausea 2/17/21; seen at Clinic 2/17/21 and sent to ED same day for eval; was d/c'd home from ED 2/17/21.
40 2021-02-18 eye pain, eye swelling 24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain... Read more
24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.
40 2021-02-19 vision blurred, double vision Symptoms started with blurred vision within 30 minutes had full double vision , dysarthria and aph... Read more
Symptoms started with blurred vision within 30 minutes had full double vision , dysarthria and aphasia . Went to sleep, woke up 1 hour later bc I felt like I couldn?t breath. My arms and legs were very heavy felt close to paralyzed. I was able to move but movement was very ataxic and labored. Next morning the limb heaviness was gone, double vision was gone but had blurry vision for approx three days. Still having word finding difficulty, but mild.
40 2021-02-21 mouth numbness After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 da... Read more
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.
40 2021-02-21 mouth tingling A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti... Read more
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move.  This lasted about an hour (15 hrs post-vaccine).
40 2021-02-22 taste disorder Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat... Read more
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
40 2021-02-22 vision blurred Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memor... Read more
Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memorable symptoms began on Feb. 19th, the worst day was Feb. 20th, when I was unable to complete my usual daily activities. My symptoms have begun to improve today, Feb 23rd. On Dec. 17th, 2020 I was diagnosed with COVID19.
40 2021-02-23 ear pain Insomnia, nerve pain in ears and legs, headache, fatigue after the insomnia, chills.
40 2021-02-23 mouth numbness Tingly face, minor numbness in left arm (injection side) maybe mouth and tongue numbness too
40 2021-02-23 mouth tingling Following the injection, after approximately four hours later I began to feel some slight disorienta... Read more
Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.
40 2021-02-23 tongue itchiness, swollen tongue, lip swelling, lip itchiness Swelling and itchiness of the upper lip and tongue about 10 minutes after the vaccination.
40 2021-02-24 mouth numbness 40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat ,... Read more
40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening." Received epi from medical team but initially refused ER visit. Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing being additonal symptoms. She was agreeable to transport after the second episode.
40 2021-02-26 ear itchiness My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and e... Read more
My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and extremely itchy face even my ears. I took a antihistamine which has helped but it still itchy. It?s currently 1 pm the following day after the first dose
40 2021-02-28 eye irritation Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, ... Read more
Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.
40 2021-02-28 gaze palsy Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant;... Read more
Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant; due date June 16 2021. First pregnancy at the age of 40.
40 2021-02-28 feeling of choking, mouth numbness About an hour after vaccination, my throat was tingling and my heart rate went up. It came down afte... Read more
About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.
40 2021-02-28 taste disorder taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter); This is a sponta... Read more
taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter); This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264: expiry date: unknown) via an unspecified route of administration in the right arm, on 27Jan2021 at 14:45, at a single dose, for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Concomitant medications included metoprolol and duloxetine hydrochloride (CYMBALTA). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Place where vaccine was administered was reported as "other". On 27Jan2021, about 7 hours post injection, the patient's taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter). A full 24 hours after first injection, taste was still altered. The event was considered non-serious. The patient did not receive therapy for the event. Outcome of the event was not recovered. The patient has not been tested for COVID-19 since vaccination.
40 2021-03-02 taste impairment, mouth tingling Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of me... Read more
Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of metallic taste, tongue feeling wierd and facial itching; no SOB, no rash or redness noted; Vitals were WNL, given Benedryl 50 mg chewable and drink of water; at no time did client c/o or appear SOB, pO2 remained at 99% and vitals remained WNL; continued observation for an additional half hour and c/o subsided; client released to home.
40 2021-03-02 ear pain, eye irritation Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade feve... Read more
Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm
40 2021-03-03 mouth numbness Pt was vaccinated in facility with a 15 min observation done. Pt ambulated to car with mother at sid... Read more
Pt was vaccinated in facility with a 15 min observation done. Pt ambulated to car with mother at side. Pt and mother left site to go home when pt told mother "my lips feel numb". Mother drove pt back to facility and came in to tell us that her daughter was in the car and c/o mouth feeling numb. Myself, Site Leader and charge nurse went outside to car. Pt was sitting on passenger side of car A/Ox3. Denies feeling sob, headache and chest pain. V/s obtained with inital v/s b/p 118/84, HR 83 O2 98% on RA. Advice pt that we could call EMS for further evaluation. Pt refused. Wanted to go home and take benadryl if numbness presist. Verbalized understanding of risk and outcomes of monitoring any other adverse symptoms.
40 2021-03-03 lip itchiness Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splo... Read more
Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splotchy patches on parts of my legs, chest, feet (mostly toes), and hands (mostly fingers). Started with my cheeks within minutes of the shot, got worse over the next hour. It took about 4-5 hours to dissipate. But even the next day, I have been a little itchy.
40 2021-03-03 swollen tongue, lip swelling lip and tongue swelling, subjective throat swelling, pruritis epi 0.5 mg IM, benadryl 50 mg IV, sol... Read more
lip and tongue swelling, subjective throat swelling, pruritis epi 0.5 mg IM, benadryl 50 mg IV, solu-medrol 60 mg IV, pepcid 20 mg IV
40 2021-03-03 swollen tongue Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience t... Read more
Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing, patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.
40 2021-03-04 oropharyngeal discomfort shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP ... Read more
shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.
40 2021-03-04 vision blurred, sensitivity to light After getting the shot, I walked over to the observation area a few yards away. I sat down and my vi... Read more
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
40 2021-03-05 eye itchiness Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of ana... Read more
Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of anaphylaxis to TDap and NSAIDs. Pt stated felt similar to other reactions in past. 0917 BP 175/112 and 0927 170/105. Pt. states forgot to take BP meds. 0921 Benedryl 50 mg IM given per Dr. orders. Pt. observed for 20 min and reported all symptoms subsided. Pt. released to home driven by spouse.
40 2021-03-05 ringing in ears, eye strain 8 minutes after the administration of the vaccine (while in the observation area) I started to feel ... Read more
8 minutes after the administration of the vaccine (while in the observation area) I started to feel really off (dizzy, anxious, ringing in right ear). I ended up becoming unconscious with seizure like activity. They rushed me to the ER and kept me for 6 hours with lots of testing. XRay, blood test, CT of head, EKG, Urine test...all came back normal. Doctor said it was likely a reaction to the vaccine. I am 40 years old with no history of seizures or allergic reactions to vaccines. The week following I experienced confusion, migraines, dizziness, slow cognitive processing, eye strain, word finding difficulties, and exhaustion. I had to take a week off of work to recover. This is the second week and I am still experiencing headaches and occasional dizziness/eye strain.
40 2021-03-07 loss of smell chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous... Read more
chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
40 2021-03-07 vision blurred Dizziness, blurry vision, took oral Tylenol. BPs 98/68 (pulse 58), 97/66 (pulse 59).
40 2021-03-08 ear pain Pain in back started then spread to right side and chest in about a week, called doctor's office and... Read more
Pain in back started then spread to right side and chest in about a week, called doctor's office and they said to report as a side effect of COVID vaccine. That pain has lessened but not completely gone. Ear pain started on 3/7/21, ear pain lessened after 24 hours but not completely gone.
40 2021-03-09 mouth numbness tongue numbness, headache and shortness of breath
40 2021-03-09 bloodshot eyes this morning she noted a red blotch on her left eye sclera. her right eye is fine. she denies rubbin... Read more
this morning she noted a red blotch on her left eye sclera. her right eye is fine. she denies rubbing her eye, foreign body, or coughing or sneezing or force. instructed not likely related but asked to call back if worsening, vision loss, or blurred vision. wash hands well after touching face. call back prn.Followed up with patient today. She said that the red blotch in her eye is still there but not as red and can tell that it is going away. It doesn't bother her. She did contact her PCP and they told her that it is likely not related. She thanked me for my call. Will close case.
40 2021-03-09 sensitivity to light, tongue disorder A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt v... Read more
A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt very fatigued, had a low fever for a couple hours, sore neck and shoulder to the injection site, sore throat, headache, light sensitivity and hazy/foggy feeling. I also had a finger feel sore and inflamed for about 5 days. It has been 1 week now and I still have major fatigue, headaches, brain fog, morning sore throat and just a feeling of ?not well?. I try to workout, but after I get so fatigued I can?t perform regular daily tasks. I have been so foggy, I can?t help my kids with their school work.
40 2021-03-09 vision blurred blurred vision, diaphoresis, hypotension, placed in trendelburg position
40 2021-03-10 dry throat About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and start... Read more
About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and started getting uncomfortable. My throat then started to get dry and began breaking out with a rash on my neck and chest. This lasted about 30 minutes before the symptoms started to cease (in total 45 minutes after receiving the vaccine). Within 2 hours after receiving the vaccine, all symptoms had subsided. Treatment - at the vaccine clinic, EMTs observed me and took my vital signs. My blood pressure was slightly elevated, but did not require medical treatment. They continued to monitor me with the recommendation that I use my EPI-pen if symptoms got worse and instructed me to seek emergency medical treatment if symptoms got worse. No further treatment was sought out as symptoms all started to improve.
40 2021-03-10 mouth numbness Swelling of the right side of the pharynx and numbness of the tongue almost immediately
40 2021-03-10 mouth numbness 20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then r... Read more
20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then resolved. Myalgias, fatigue and athralgias lasted a week and improved in 1 week in severity but intermittent athrlagias continue to occur. Over 1 month post 2 nd injection developed numbness of bilateral hands and feet and numbness of the mouth had recurred and is persistent for 6 days now.
40 2021-03-12 taste impairment Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I... Read more
Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I began feeling dissociated. Almost out of body, like I was under the influence. I began to struggle to answer questions and stay awake. I willed myself to stay calm and stay awake. I was given water and observed for an hour. My face began to feel numb and the roof of my mouth itchy. The ?high? feeling was eventually replaced by the feeling of being extremely tired. After and hour I was good to drive but extremely tired when I got home. About an hour after the shot I can taste a blood or metallic taste in my mouth. I still feel ?drugged? or tried.
40 2021-03-12 vision blurred Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, ... Read more
Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, rash on face, extreme fatigue
40 2021-03-13 tongue discomfort Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like ... Read more
Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like it was on fire and so did the fingers on my right arm. Now my whole body hurts and I feel like I?m going to throw up.
40 2021-03-14 mouth tingling Tingling in mouth and tongue.
40 2021-03-16 drooling, mouth tingling Caller states that she got her Vaccine at 2pm today. Now with a tingling sensation on her lips and ... Read more
Caller states that she got her Vaccine at 2pm today. Now with a tingling sensation on her lips and an increase in salivation. Able to speak in long sentences. Instructed to increase her fluid intake, use mints to her secretions and if it worsens or she notice any lip swelling or resp distress, to report to the nearest ER. RN
40 2021-03-16 vision blurred Fever/chills, intense body aches, headache, occular blurring, muscle weakness, loss of appetite
40 2021-03-17 swollen tongue Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid... Read more
Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid vaccine with some feeling like throat and tongue were swelling but EMTs on the scene administered IV benadryl with the first dose. With doctor recommendation to receive the second dose about 20 minutes after she received the second dose she started feeling her tongue have a fuzzy swelling sensation and began coughing frequently around 11 a.m.. Patient took 50 mg of Benadryl of her own immediately before the vaccine in order to counteract the same reaction from the first one. Due to increasing symptoms she received Epinephrine 0.3 mg/0.3 ml one shot at 11:09 a.m. and a second shot at 11:17 a.m. Patient began to show signs of improvement from the Epipen but not enough with one shot so she proceeded with the second one. She was able to leave the vaccine clinic to see her general practitioner that afternoon. She expressed that she felt jittery after the shots and we determined that the Benadryl liquid she had with her and took had Phenylephrine in it as well which combined with the Epinephrine was causing the shakiness. She felt stabilized but weak. Her blood pressure was 140/100 at 11:50 a.m. and 137/88 at 11:55 a.m. Her allergist and general practitioner were contacted and notified of the incident and they instructed her further to use Benadryl tonight and to contact them tomorrow about any further concerns. She reported this evening at 5:27 p.m. that she was okay and did not have any further issues or the feelings of the allergic reaction.
40 2021-03-17 vision blurred BlurredVision, Dizziness, Myalgia, Arthralgia, Fever, Angioedema, INJECTION SITE PAIN, SWOLLEN GLA... Read more
BlurredVision, Dizziness, Myalgia, Arthralgia, Fever, Angioedema, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative: Other Relevant History:
40 2021-03-18 lip swelling, swollen tongue Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I wa... Read more
Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.
40 2021-03-18 mouth itchiness, swollen tongue I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, t... Read more
I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
40 2021-03-18 mouth tingling, feeling of choking My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic ... Read more
My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic reaction. I had taken a Claritin for allergies before I received the injection. The numbness started approximately 30 minutes after receiving the injection. It last until I took additional allergy medicine three hours after the injection.
40 2021-03-18 ringing in ears Ringing in ears. The first time it happened I woke up and thought the sound was external, and I wok... Read more
Ringing in ears. The first time it happened I woke up and thought the sound was external, and I woke up my husband who said he didn?t hear anything. I realized at that point it?s the ringing in my ears. I hear it more at night time.
40 2021-03-18 ringing in ears Severe headaches which resided after 2 days. On the third day, I began to experience ringing in my e... Read more
Severe headaches which resided after 2 days. On the third day, I began to experience ringing in my ears which has not resolved.
40 2021-03-18 ringing in ears Tinnitus
40 2021-03-19 taste impairment Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pati... Read more
Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient states that she has metallic taste in her mouth post observation of 30 minutes -- patient states she still has it upon leaving
40 2021-03-19 taste impairment Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness la... Read more
Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness lasted two days: fever muscle/joint pain still continues: insomnia
40 2021-03-19 swelling of eyelid Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet,... Read more
Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet, with mild swelling and itching to feet and lower legs. Took 2 benadryl and went to sleep. Woke up this morning with facial swelling, eyes swollen shut. Took Claritin and states improved greatly. Reports itchiness in throat but denies difficulty breathing, throat swelling, chest pain or shortness of breath. Rash on feet/legs was gone when she woke up, still has itchy sensation to body but no rash. Patient reports improving symptoms at time of evaluation in Urgent Care, but would like to report side effect/reaction.
40 2021-03-19 ringing in ears I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a car... Read more
I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a cardiologist and have subsequently developed tachycardia with changed in position/posture. I recently developed tinninutus on 3/13 that has not resided.
40 2021-03-20 loss of taste The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up ... Read more
The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up with the inability to taste. I can smell but no taste. ?Pfizer-BioNTech COVID-19 Vaccine EUA?
40 2021-03-20 ringing in ears, hearing loss This report is in relation to acute sudden onset tinnitus in left year one day following first shot ... Read more
This report is in relation to acute sudden onset tinnitus in left year one day following first shot of COVID vaccination. Received first COVID vaccine shot in my left arm. I felt a bit tired and foggy but nothing too bad or out of the ordinary. Exactly 31 hours later, I was talking with my daughter when a very loud ringing noise entered my ears. It subsided slightly but then a persistent ringing -- tinnitus -- remains in my left ear. I saw an audiologist who indicated a slight dip in hearing acuity in the left ear at a higher pitch. I am currently on prednisone (20mg 1x per day) and doxycycline but it has been 4 days with no dissipation or relief. I have not suffered from tinnitus before.
40 2021-03-21 ear discomfort, ear pain Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week... Read more
Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week. There has been no change, no easing of symptoms. It persists, disrupts my daily life, including increased anxiety and lack of sleep. In addition to the ringing, my ears feel full and hurt. I've been to 3 doctors (PCP, Allergist, ENT) since Thursday March 18, and no one has been able to help me or offer much advice. In addition to ear issues, I have loss of appetite, nausea, and diarrhea that also persist. Odd sensations in my head, like shooting pains or soreness, also occur.
40 2021-03-21 mouth tingling, mouth numbness Felt numbing/tingling on and around lips. Lasted about 30 minutes then went away
40 2021-03-21 sensitivity to light, eye pain, vision blurred About ten days after the vaccine, I got Iritis in my left eye. I noticed some blurriness and my eye ... Read more
About ten days after the vaccine, I got Iritis in my left eye. I noticed some blurriness and my eye was painful and got worse over the course of three days. I went to the eye doctor and they diagnosed Iritis in my left eye. Sensitive to light and darkness and it was very painful. I was prescribed Steroids and it took two weeks before my vision improved and the pain was lessened. It took six weeks of Steroids before the condition was resolved. No symptoms after the second dose.
40 2021-03-22 mouth numbness Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. C... Read more
Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. Currently still feel numbin face.
40 2021-03-22 pain in jaw High fever, 102.5. Headache, joint pain (specifically jaw and knees), lethargy, chills
40 2021-03-22 mouth tingling Pt presented to the medical tent with complaints of tingling in her tongue. States has long history ... Read more
Pt presented to the medical tent with complaints of tingling in her tongue. States has long history of allergies, has 2 epi pens with her and premedicated herself prior to coming to the vaccination site with 50 mg of PO benadryl at 1100. As pt was monitored she developed a rash on neck that was splotchy, flat, red. Tongue tingling stopped and moved to her fingers. BP was 152/90, other VS were WNL. Seen by MD on site. 1252 pt was feeling better, rash gone, all tingling gone. Pt left on own from vaccine site.
40 2021-03-22 ringing in ears Constant Tinnitus with spiking attacks, non-stop
40 2021-03-23 dry mouth Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area a... Read more
Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area and lymph nodes. Patient states her mouth feels dry.
40 2021-03-24 gaze palsy, vision blurred 2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It wa... Read more
2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It was like a seizure. I was unable to talk, my eyes rolled back, and my right shoulder and arm seized up. I was sputtering and unable to make it stop. Lasted for a minute or two then stopped for a minute and happened again. I felt disoriented, confused, scared. I was unable to walk straight or visually focus on anything. I contacted my primary care doctor and she recommended I be seen immediately but advised I call Providence and speak with a nurse. I did that and the nurse said to come in to the ER immediately. I did.
40 2021-03-24 mouth tingling, lip swelling 03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo... Read more
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
40 2021-03-24 swollen tongue, mouth itchiness 11:26am mild dizziness and confusion. Roof of mouth itching 11:35am moderate to severe dizziness a... Read more
11:26am mild dizziness and confusion. Roof of mouth itching 11:35am moderate to severe dizziness and confusion. Roof of mouth itching and mild tongue swelling. Saw nurse at observation site and was taken to paramedics. They took vitals and blood glucose which were normal. They gave me two shots of 25 mg of Benadryl, which helped tongue swelling but nothing helped dizziness and confusion. Agreed to go to the hospital by ambulance. By the time I was seen in the ER, symptoms resolved other than fatigue from benadryl. Discharged around 2:30pm
40 2021-03-24 tunnel vision Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self... Read more
Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit
40 2021-03-25 eye twitching Day 2 tired, Day 3 and 4 headache, Day 5 and 6 - intermittent eye twitch with ocular migraine sympto... Read more
Day 2 tired, Day 3 and 4 headache, Day 5 and 6 - intermittent eye twitch with ocular migraine symptoms in right eye.
40 2021-03-25 dry throat Dry throat, cough. BP 133/88 (pulse 61).
40 2021-03-25 swollen tongue Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine,... Read more
Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine, Benadryl and Zofram
40 2021-03-25 tongue discomfort Burning at tip of tongue without swelling and whole body feeling hot
40 2021-03-26 swelling of eyelid 4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not s... Read more
4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not sure when it began to swell. I didn't think much of it, until about 2 hours as I could feel that it was more swollen. I was with friends, they recommended benedryl. So, went and talked to a pharmacist. On the way there, back began to feel itchy (similar to when I have broken out in hives in the past when an allergic reaction starts). Pharmacist recommended 25 ml of liquid benedryl every 4-6 hours and increase to 30 ml if swelling remains. After 1-2 days, if still present to go to doctor. I already have a doc office visit early Monday morning.
40 2021-03-26 toothache After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fati... Read more
After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fatigue, intense muscle weakness & achiness, felt like weights in my veins. Sleep overnight was disrupted often. Intense strange dreams, perhaps lucid. 2nd Day- 9am: Fever & weakness subsided, muscles remained achy particularly with increased activity. Tiredness. 3pm: Fever returned. 5pm: Strong heart palpatations. Achy muscles. 8pm: Tiredness. Strange dreams, still lucid. 3rd Day- Still slight achiness. 3pm: Intense heart palpatations, pre-menstrual cramping (11 days early, my cycle is extremely regular). 5pm: Heart palpatations, muscles felt almost an electric pulsivity. 6pm: Tooth pain for about two hours. 8pm: Vaginal discharge (clear lubricant), lasted till 3am. 4am: Urine had extremely sour smell. *3rd day indicated to me that my hormones/hypothalamus may have been affected? Very strange, out-of-cycle behaviors. I have been sexually inactive for over 6 months.
40 2021-03-27 loss of taste Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you a... Read more
Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you answers- it has not been doing daily checks on me - it says I?m good when still having symptoms- there is not way to contact or correct info on that system.
40 2021-03-27 lip swelling lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lip... Read more
lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lips felt numb, swollen; Blood pressure was high; pulse was high; gasping for air; unable to straighten out my legs/couldn't lift her legs; ferritin levels were low; throat was closing up; unbalanced; couldn't stand up; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER), first dose at the age of 40-years-old via an unspecified route of administration, administered in arm left on 09Mar2021 13:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan; vitamin b complex (VITAMIN B); vitamin c [ascorbic acid]; colecalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient reported within 10 minutes lips felt numb, swollen. Numbness spread throughout face, checked in with the medic and had vitals checked. Blood pressure was high, and pulse was high. Numbness spread throughout whole face. Ambulance was called and she was transported to the hospital. Within the hour of getting the shot she became unbalanced. She was gasping for air at times and started to feel numb in both arms. Upon arrival to the emergency room her legs started to feel numb. By nightfall she was unable to straighten out my legs. She couldn't stand up or lift her legs no matter how hard she tried. She was admitted to the hospital. A brain MRI was done and came back normal. Another one may be done. Bloodwork revealed ferritin levels were low and she was getting treatment for that (ferrous sulfate). While sleeping at night she woke up a few times gasping for air feeling like her throat was closing up. Today, she was able to stand up, but unable to stand up straight. She met with physical therapy and is using a walker. The patient was hospitalized for 3 days from 09Mar2021 to 12Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: high on 09Mar2021, heart rate: high on 09Mar2021, magnetic resonance imaging brain: normal on 09Mar2021, sars-cov-2 test: unknown results on 09Mar2021, serum ferritin: ferritin levels were low on 09Mar2021. Therapeutic measures were taken as a result of the events. The patient did not recover from the events.
40 2021-03-28 bloodshot eyes, vision blurred, eye swelling starting nearly exactly 48 hours after vaccination: - fever: 99.5 - 101 (~48 hours) - chills (~48 ho... Read more
starting nearly exactly 48 hours after vaccination: - fever: 99.5 - 101 (~48 hours) - chills (~48 hours) - night sweats (~96 hours) - fatigue (~ 7 days) - muscle aches (~7 days) - headache (~7 days) - bloodshot & swollen eyes & blurred vision (started 5 days after vaccine, got Rx for bacterial eye infection 9 days after vaccine)
40 2021-03-28 ringing in ears, hearing loss, deafness On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/202... Read more
On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous
40 2021-03-29 eye swelling Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous repor... Read more
Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient she received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included variable immune deficiency, asthma, and eosinophilic esophagitis (EOE). Allergies to medications included amoxicillin, erythromycin, clindamycin, ciprofloxacin (CIPRO), sulfamethoxazole/ trimethoprim (BACTRIM), and oxycodone/ paracetamol (PERCOCET). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Feb2021 at 17:15, the patient experienced left eye swelling, severe itching all over, severe headache, and stiff neck. The patient was not treated for left eye swelling, severe itching all over, severe headache, and stiff neck. The clinical outcome of left eye swelling, severe itching all over, severe headache, and stiff neck was not recovered.
40 2021-03-29 mouth tingling, mouth numbness lip tingling and numbness
40 2021-03-29 ringing in ears I received my second dose of the Pfizer vaccine on a Tuesday evening and had no adverse symptoms tha... Read more
I received my second dose of the Pfizer vaccine on a Tuesday evening and had no adverse symptoms that night. When I woke up the next morning, I had a very, very bad headache and ringing in my ears. The headache began to subside by that night, but the tinnitus continued. By the following day (Thursday), the headache was gone but I was still tired and the tinnitus continued. By Friday, I felt basically back to normal, except for the tinnitus. It is now Tuesday, one week from the shot, and the tinnitus continues.
40 2021-03-30 taste impairment, mouth tingling, eye irritation sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; m... Read more
sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.
40 2021-03-30 ear pain Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; t... Read more
Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
40 2021-03-30 oropharyngeal discomfort Patient got her covid 19 vaccine. 5 minutes after her shot she said her throat was hot. BP was 135/9... Read more
Patient got her covid 19 vaccine. 5 minutes after her shot she said her throat was hot. BP was 135/90. Pulse 75. No signs of distress. I gave her 50mg of benadryl. Patient stayed for 30 minutes. All symptoms were resolved by when she left.
40 2021-03-30 swollen tongue, mouth itchiness Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burn... Read more
Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burning from itching so bad. Inside of mouth and throat itching. Chest felt like someone was sitting on it.
40 2021-03-30 toothache Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree feve... Read more
Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree fever; lethargy; shivers; slept for 17 hours on and off; numbness in my face and fingers; numbness in my face and fingers; zinging pain in my teeth; This is a spontaneous report from a contactable Other HCP. This 40-year-old female Other HCP (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 11Feb2021 at 03:00 pm to 11Feb2021 at 03:00 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported other. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history included Known allergies: Sulfa (unspecified dates). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9262) via an unspecified route of administration from 21Jan2021 at 3:30 pm to 21Jan2021 at 03:30 pm on left arm at single dose (dose number; 1) on left arm for covid-19 immunisation. Concomitant medications included (other medications in two weeks) Ibuprofen and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C) and birth control from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. If other vaccine in four weeks; no. On 12Feb2021 at 02:00 pm, patient experienced nerve pain in all of her skin (including hair follicles and teeth), extreme headache, 101 degree fever, lethargy, and shivers. This hit her at almost 24 hours after injection. She slept for 17 hours on and off. She awoke this morning with numbness in her face and fingers, but also zinging pain in my teeth. The reported adverse events did not result in emergency room or physician's office visit. Treatment received was reported as no for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.
40 2021-03-30 vision blurred Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the... Read more
Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area. The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.
40 2021-03-31 eye irritation burning eyes within a few minutes of vaccination, no swelling, no SOB, no tingling
40 2021-03-31 eye swelling Body aches, chills, mild swelling of eyes
40 2021-03-31 mouth tingling Dizziness, 1:30 pm, lasted 12hrs. Headache, 1:30 pm, lasted 12hrs. Tingling tongue, 1:30 pm, ongoing... Read more
Dizziness, 1:30 pm, lasted 12hrs. Headache, 1:30 pm, lasted 12hrs. Tingling tongue, 1:30 pm, ongoing. Tingling roof of mouth, 1:30 pm, ongoing. Tingling lips, 1:30 pm, ongoing.
40 2021-04-01 dry eye 15:21-REceived vaccine injection L deltoid. 15:30-Arrived in observation area, reported onset of H/A... Read more
15:21-REceived vaccine injection L deltoid. 15:30-Arrived in observation area, reported onset of H/A, LUE pain and warmness, numbness of left UE and LE and dry eyes.Dr. present. 16:09-VS: 175/69; HR 80; SpO2 98%. 16:14-Epinephrine 0.3mg L lat thigh per Dr. 16:19-VS: 184/91; HR 74; SpO2 98% 16:40-VS stable, pt W/O discomfort. Released home per Dr.
40 2021-04-01 taste impairment, mouth numbness Patient received Pfizer EW0150 by Nurse. Patient in observation area notified Nurse stated feeling o... Read more
Patient received Pfizer EW0150 by Nurse. Patient in observation area notified Nurse stated feeling of dizziness, flushness, numbness in tongue, throat itching and metallic taste. No audible wheezing, no shortness of breath, and no difficulty swallowing. (BP 153/99, HR, 77, Spo2: 98%) Patient with history of Asthma/Anaphylactic reactions. Allergies to Penicillin. Under observation, patient reports of improvement in condition, although still persistent throat itching and tongue numbness. 25mg Benadryl PO administered. HR: 83, BP:118/80, Spo2: 99%, patient further monitored and states feeling well with all symptoms completely resolve. Pt dc/ed educated on s/s to look out for. (HR 77, BP:112/70 O2:99%)
40 2021-04-01 lip swelling, mouth tingling Patient complained lips tingling & tongue was swelling. Onsite EMS was called vitals HR 82 BP 132/8... Read more
Patient complained lips tingling & tongue was swelling. Onsite EMS was called vitals HR 82 BP 132/87. 25 diphenhydramine was given She felt better and went home.
40 2021-04-01 tongue disorder, oropharyngeal discomfort She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction sta... Read more
She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction started at 1:15 and her headache was getting bad and turning into a migraine, and took her migraine medicine. She was getting a stretching and painful sensation in her skin over her head. She lost her ability to swallow, and everything around her face and neck were numb. She called the hotline and called her doctor, and was able to focus very hard and able to swallow but felt very narrow passageway. She then felt like she had a bubble in her throat, and then decided to call 9-1-1. The first responders came to her house and said that they could not see anything in her throat, they gave her Benadryl and within the hour everything seemed to dissipate and they stayed with her until she stabilized. Her BP was high and her heart rate was high as well, 98-100. Her temperature was 98.5. She felt really awful and nothing was going on with her throat or breathing after the Benadryl and felt foggy and tired and by the third day she was completely fine.
40 2021-04-02 deafness unilateral, ringing in ears 9:40am injection. 10:30am migraine started. 10:40am strong ringing in my left ear, and feel dizzy. 1... Read more
9:40am injection. 10:30am migraine started. 10:40am strong ringing in my left ear, and feel dizzy. 11am spine, back, and joints hurt. Ringing in both ears, but I have lost partial hearing in my left ear. 10:22pm, still ringing in left ear, partial hearing, small headache, deep aches.
40 2021-04-02 sensitivity to light Generally occurring and resolving within 36 hours: Generalized neuropathic pain that turned graduall... Read more
Generally occurring and resolving within 36 hours: Generalized neuropathic pain that turned gradually into generalized nociceptive pain / soreness; Pounding headache at the base of the brain; Tachycardia; Sensation of pounding heartbeats; Nausea; Sensitivity to light; Loss of appetite and thirst; Low-grade fever Still occurring at 48-53 hours: Nausea Light headache; Sensitivity to light; Some sensation of heart racing; Localized pain in different areas of the body
40 2021-04-03 mouth tingling, feeling of choking Patient reported throat/lip tingling and headache within 10 minutes of receiving vaccine. Patient wa... Read more
Patient reported throat/lip tingling and headache within 10 minutes of receiving vaccine. Patient was given benadryl and observed. Condition improved.
40 2021-04-03 taste disorder This was my second shot, I had no adverse reactions to the first. For 8 days after my second shot, I... Read more
This was my second shot, I had no adverse reactions to the first. For 8 days after my second shot, I had a continuous headache stemming from the base of my skull. I had read this as a possible side effect so I was not concerned. On the 9th day, I woke up without a headache and thought my symptoms were over. However on that day, my sense of taste started changing. I started putting a lot more salt on things. In the following 3 days, it's progressed that anything sweet has a rancid taste. Bitter and salty items taste just fine but even plain water now tastes foul and it seems to be getting worse each day. I've never experienced this before so I am assuming it's the vaccine. At a guess, this isn't a big deal. I wouldn't be concerned except it started a week after vaccination instead of immediately. I thought it best to at least document it by informing someone.
40 2021-04-03 ringing in ears Ringing in ears - still hasn't gone away 24 hours later.
40 2021-04-03 ringing in ears Constant Bilateral Tinnitus, with attacking episodes multiple times a day; This is a spontaneous rep... Read more
Constant Bilateral Tinnitus, with attacking episodes multiple times a day; This is a spontaneous report from a contactable physician (patient). A 40-year-old non-pregnant female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1283) first dose via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included iron supplement (SPATONE IRON supplement) for unspecified indication. On 14Feb2021 the patient experienced constant bilateral tinnitus, with attacking episodes multiple times a day (tinnitus) (disability). Therapeutic measures were taken as a result of constant bilateral tinnitus included prednisone taper. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not underwent diagnosed with COVID-19. After the vaccination patient did not tested for COVID-19. The outcome of the events was not recovered.
40 2021-04-04 eye swelling, eye pain, eye itchiness, bloodshot eyes 4am the day after my first shot I woke up to swollen, blood shot eyes which were irritated and itchy... Read more
4am the day after my first shot I woke up to swollen, blood shot eyes which were irritated and itchy. After an hour and a half the symptoms were not getting better so I decided to take claritin since it was similar to the allergic reaction I have to mold. An hour later my eyes were better but still sore around them. The next day they were completely better. Also, since taking the vaccine I seem to forget things easily, things that I put in the microwave are sitting there the next morning which is very unusual for me to be so forgetful so many times and even at work my focus was scattered and things that were routine were becoming challenging to remember to complete. After 2 weeks it seems to have faded, although once I became aware of what was happening I have made a conscious effort to remember things. I realize that these may seem like small events, but I feel that it is something that should be looked into as it was/is rather concerning since this was only my first shot and the second is supposed to react worse. I am still contemplating whether getting a second shot is wise for me.
40 2021-04-04 swelling around the eyes, vision blurred, ringing in ears Pt received shot at 1145. At 1220, pt reported sx fo puffy eye lids (no puffiness visible outwardly)... Read more
Pt received shot at 1145. At 1220, pt reported sx fo puffy eye lids (no puffiness visible outwardly), ears ringing, blurry vision, feeling hot, weakness in muscles. VS: BP 126/68, P85, RR18, O2 99% RA, T98.6F. Pt takes benadryl 25mg po bid. Last dose 0400 today. Pt reports multiple previous hospitalizations for congestive heart failure, tachycardia, and bradycardia. She takes ?1500 of Levothyronine? and ?Mididrine four times a day to raise my blood pressure.? She does not want more benadryl at this time. She is calm outwardly. No signs of distress noted outwardly. Diminished lung sounds in bilat lower lobes. Pt smokes cigarettes. Dr consulted. Pt advised to wait in high risk obs for another 30 min to see if symptoms resolve. After about 5 minutes, pt requested EMS. No worsening conditions noted or reported. EMS called and came to assess pt. Pt left via EMS to go to hospital at approximately 12:15pm. Pt notified to follow up with her PCP prior to second dose of vaccine.
40 2021-04-04 swollen tongue, lip swelling, mouth tingling Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling... Read more
Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling. Treated at home with 50 mg Benadryl every 6 hours, Pepcid, and Predinsonl (steroid pack).
40 2021-04-05 loss of taste Lost sense of taste, reduced sense of smell
40 2021-04-05 eye swelling About 90 minutes after the shot, my face swelled up and had hives. My left eye would not open all th... Read more
About 90 minutes after the shot, my face swelled up and had hives. My left eye would not open all the way. I had hives on my back, chest and both arms. I got the symptoms under control after 9 Benadryl pills. 2 days after the shot - my lymph nodes swelled up in my neck and on my left clavicle. I did not treat these. 3 days after the shot, out of nowhere, my left cheek swelled up and there were hives and my eye was half swollen shut. Symptoms were under control after 2 Benadryl pills. My lymph nodes remain slightly swollen, but not as severe as on Day 2.
40 2021-04-06 ear discomfort I woke up with acute vertigo on Thursday. The room was spinning. I could not function from about 8:0... Read more
I woke up with acute vertigo on Thursday. The room was spinning. I could not function from about 8:00 a.m. until about 6:00 p.m. I went to the doctor the next day, Friday, and was diagnosed with labyrinthitis due to allergies. I had no allergy symptoms. By Saturday, I was no longer dizzy but my ears felt full and continue to feel clogged 6 days after the onset of the vertigo.
40 2021-04-06 mouth swelling, mouth tingling, swollen tongue Numb, swollen and tingling tongue and mouth (lasted for about a week) Headache, severe dizziness
40 2021-04-07 lip swelling Lip swollen
40 2021-04-07 light flashes or floaters in the eye dizziness "flashes of light". Evaluated by EMS-Cleared
40 2021-04-08 lip swelling Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactio... Read more
Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.
40 2021-04-08 mouth tingling 10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest a... Read more
10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest and neck. arrived to obs, 1830 bp 140/69 hr 95 rr 18 sats 96%, feeling hot. water and apple juice given, started feeling relief and blotchy neck and chest improving. 1838 bp 112/66 hr 97 rr 18 sats 95% on ra. 1847 bp 118/67 hr 67 rr 20 sats 99% on ra, blotchty areas resolved, and facial/mouth tingling resolved as well as throat tightness. escorted to exit with no further issues. instructed on benadryl once home.
40 2021-04-08 swollen tongue Patient described a swollen tongue and senation in back of throat sensation. Onsite EMS was called v... Read more
Patient described a swollen tongue and senation in back of throat sensation. Onsite EMS was called vitals BP 128/60. Patient recovered and went home.
40 2021-04-08 swollen tongue 4/7/21 8pm-Itchy skin, rash on injection site. 4/8/21 7am-swollen throat and tongue, itchy skin.
40 2021-04-08 ringing in ears Tinnitus in both ears
40 2021-04-09 ear discomfort both ears have a red flaky rash with small white bumps. Skin in dry to the touch and very itchy. ras... Read more
both ears have a red flaky rash with small white bumps. Skin in dry to the touch and very itchy. rash has lasted 6 days at time of reporting
40 2021-04-09 eye movement disorder Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head ... Read more
Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events. Follow up attempts are possible. Further information is expected.
40 2021-04-09 eye itchiness slept over 20 hours day 4, plus 12 day 5; Joint and muscle pain; Joint and muscle pain; extreme fati... Read more
slept over 20 hours day 4, plus 12 day 5; Joint and muscle pain; Joint and muscle pain; extreme fatigue/exhausted; Congested with runny nose; Congested with runny nose; itchy eyes; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) intramuscular, administered in Arm Left on 29Jan2021 09:45 am (at the age of 40-years-old) at a single dose for covid-19 immunisation. Medical history included sinus tachycardia, panic disorder, depression, chronic fatigue syndrome, PCOS. Allergies to medications, food, or other products was Penicillin. Concomitant medication patient received within 2 weeks of vaccination included Metformin 500mg, Metoprolol 50 mg, Paroxetine 50 mg and vitamin D. The patient previously took first dose of BNT162B2 (lot number: EL0140) on 08Jan2021 on right arm at a single dose for covid-19 immunisation and 2 weeks or so after first shot, noticed severe itching on my left upper thigh with bumps and after this shot, itching has spread to face and arms. The patient experienced joint and muscle pain, extreme fatigue/exhausted on 31Jan2021, slept over 20 hours day 4, plus 12 day 5 on 01Feb2021 and congested with runny nose, itchy eyes, generally feeling ill in 2021. The event was considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Oropharyngeal: negative on 01Feb2021. The outcome of all the events was not recovered.
40 2021-04-09 vision blurred, light flashes or floaters in the eye Fatigue on-going. Retinal/occular migraine - left eye sight blurry, flashing, spinning zig zag light... Read more
Fatigue on-going. Retinal/occular migraine - left eye sight blurry, flashing, spinning zig zag lights without bad headache. Never experienced the vision issue before.
40 2021-04-10 eye discomfort Red raised areas that start at left eyebrow and go into hairline. Red raised bumps throughout scalp ... Read more
Red raised areas that start at left eyebrow and go into hairline. Red raised bumps throughout scalp on the left side. Left swollen lymph node behind ear that is continuing to swell. Pressure from lymph node swelling now felt near left eye. All bumps can be itchy at times.
40 2021-04-10 thirst, loss of taste Adverse effects were Covid-19 like symptoms that consisted of; foggy brain, extreme thirst, chills, ... Read more
Adverse effects were Covid-19 like symptoms that consisted of; foggy brain, extreme thirst, chills, shakes, cold, fever, body aches, loss of taste and extreme exhaustion.
40 2021-04-11 loss of taste Lethargy High fever Migraine Loss of taste Body aches
40 2021-04-12 dry mouth Within minutes of receiving the injection I experienced waves of dizziness to the point of almost pa... Read more
Within minutes of receiving the injection I experienced waves of dizziness to the point of almost passing out, rapid heartbeat, full body hot flashes, sweating, hand tremors,, dry mouth Observed for 30 min and released with no intervention. Waves of vertigo continued throughout the day, but are decreasing in frequency but not intensity as days go on. Within an hour of injection psoriasis on left leg flared and was raised, red and extremely itchy through Sunday, 4.11.21. Severe headache through end of day on 4.9.21. Treated allergic symptoms with 10ml Benadryl every 5 hours for 2 days, Ibuprofen PRN for pain. All symptoms subsided except for headache and dizziness/vertigo but appears to be decreasing in frequency but not intensity.
40 2021-04-12 lip swelling had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administrati... Read more
had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administration
40 2021-04-12 swollen tongue Flushed face and chest pressure at 09:34. Patient brought her own childrens oral Benadryl and took 4... Read more
Flushed face and chest pressure at 09:34. Patient brought her own childrens oral Benadryl and took 40 mL as instructed by her doctor . At )9:53, patient stated her throat was getting tight and her tongue swelling so she received a epipen.
40 2021-04-12 ringing in ears Tinnitus
40 2021-04-12 ringing in ears Tinnitus in both ears
40 2021-04-13 swollen lips Rash on entire body mainly torso. Extra sensitive gums that bled when teeth were brushed. Rash on in... Read more
Rash on entire body mainly torso. Extra sensitive gums that bled when teeth were brushed. Rash on inside of both lips and in the back of my throat. Diarrhea, body aches, vomiting, mild fever, splotchy skin,
40 2021-04-13 dry mouth Patient developed temporal headache 5 minutes post vaccination, along with slight dizziness, dry mou... Read more
Patient developed temporal headache 5 minutes post vaccination, along with slight dizziness, dry mouth, and inability to catch a deep breath. Patient laid down to rest, had vitals checked. Patient was moved to a sitting position after 10 minutes, and stated that she felt better. She was given some water and monitored for another 10 minutes. Vital signs were rechecked and she was released.
40 2021-04-13 ear swelling, ear pain Have developed large red welt at injection that has been spreading slowly and continuously over past... Read more
Have developed large red welt at injection that has been spreading slowly and continuously over past 30 hours. Started approximately size of dime, is larger than a quarter after 30 hours. Red in color, hot, swollen. Left ear is starting to get swollen and painful on inside - due to swollen lymph node under ear.
40 2021-04-13 mouth numbness Headache & Numbness in lips/nose within the 1st hour. I called to report symptoms and was advised t... Read more
Headache & Numbness in lips/nose within the 1st hour. I called to report symptoms and was advised to monitor and if gets worse to call back and go to ER. At this time I am ok and no need to go to ER as I am not having trouble breathing and no swelling.
40 2021-04-13 mouth tingling I started to feel a tingling sensation on my tongue about 2 hours after the injection. It did not ge... Read more
I started to feel a tingling sensation on my tongue about 2 hours after the injection. It did not get worse and has remained constant. I fell asleep and woke up with the sensation of my tongue tingling. It has been almost 24 hours since the injection and it still tingles.
40 2021-04-14 loss of taste Severe leg pain (inability to stand for longer than a minute). Extreme fatigue. Facial numbness. Los... Read more
Severe leg pain (inability to stand for longer than a minute). Extreme fatigue. Facial numbness. Loss of taste.
40 2021-04-14 mouth tingling I have been experiencing these symptoms for three days now. -moderate dizzy spells/vertigo -severe... Read more
I have been experiencing these symptoms for three days now. -moderate dizzy spells/vertigo -severe headache -severe fatigue -sore arm in injection site -swollen lymph nodes -tingling in tongue -achy muscles/joints
40 2021-04-14 ringing in ears, ear discomfort Less than 24hrs after first shot on 03/24/2021 right ear is muffled. Feels like it clogged. Never we... Read more
Less than 24hrs after first shot on 03/24/2021 right ear is muffled. Feels like it clogged. Never went away Less than 24hrs after second shot on 04/14/2021 right ear is still muffled and now I have a buzzing sound in my ear.
40 2021-04-14 tunnel vision Tunnel vision, near syncope, rapid heartbeat, rapid increase in blood pressure. Lasted at least 30 ... Read more
Tunnel vision, near syncope, rapid heartbeat, rapid increase in blood pressure. Lasted at least 30 minutes while I waited at the clinic. Was given one Benadryl. Symptoms cleared but was still not symptom free when I drove home.
40 2021-04-15 eye twitching My left eye started twitching within two days of getting the first dose. This persisted and accelera... Read more
My left eye started twitching within two days of getting the first dose. This persisted and accelerated after the second dose. While it has mostly subsided, the twitching does occasionally return.
40 2021-04-15 taste impairment Burning in chest and throat. And weird taste along with it. As if after getting and iodine shot for ... Read more
Burning in chest and throat. And weird taste along with it. As if after getting and iodine shot for a cat scan.. the same metallic taste.
40 2021-04-15 taste impairment Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Tod... Read more
Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Today Three weeks later I experienced same icy sensation plus numbness/weakness, decreased sensation in fingertips. 2. Still have bad Headaches still after 3 weeks 3. Extreme Fatigue still after 3 weeks 4. Last few days, three weeks after shot, I have worsening/ Increased joint pain, spiky pain in joints, chills and entire body aches like I have the flu. No fever, no runny nose, etc. Just the body aches, joint pain like people experience with the flu. 5. Decreased mental sharpest last 2 weeks since shot. 6. Light headedness, dizziness. 7. Immediately after shot I experienced metal taste in my mouth. Since the shot, I still experience occurrences of metal taste every day. 8. Today experiencing slight numbness in right foot. 9. Swelling in fingers
40 2021-04-15 eye irritation, visual impairment Site: Pain at Injection Site-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Detail... Read more
Site: Pain at Injection Site-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Pt said her arm was sore for two days and also her Left Eye Burned and felt like acid was in her eye for about 90 second time periods about 3 episodes a day for 2 days.
40 2021-04-15 eye pain Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 day... Read more
Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 days, followed by swelling and itch on entire upper arm where vaccinated. Swelling and itch lasted for 10 days.
40 2021-04-15 lip itchiness, mouth pain, mouth swelling, lip swelling I woke up with a swollen and itchy upper and lower lip. Also, the area under the tongue is swollen a... Read more
I woke up with a swollen and itchy upper and lower lip. Also, the area under the tongue is swollen and sore. I have not used a different product or eaten any different foods. I am taken Benadryl and it seems to be helping.
40 2021-04-16 eye pain Asymptomatic until bedtime, 101.9 fever for 6 hours and currently 100.3, but it's fluctuating. Sever... Read more
Asymptomatic until bedtime, 101.9 fever for 6 hours and currently 100.3, but it's fluctuating. Severe shaking chills, and throbbing bone and joint pain. My perineum also oddly feels as though I've been kicked rather hard. Sleepless night until chills subsided. Then experienced mild nausea, and pain in both palms while hand washing. No congestion, but dry inflamed sinuses and eye pain. I developed a headache this morning, but only while standing.
40 2021-04-17 eye strain Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down d... Read more
Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
40 2021-04-17 taste impairment Metallic Taste in Mouth; Sweating; Vertigo; This is a spontaneous report from a contactable consumer... Read more
Metallic Taste in Mouth; Sweating; Vertigo; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration in Arm Left on 29Mar2021 16:30 (Lot number and expiry date was not reported) as single dose for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing Allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Mar2021 16:45, the patient experienced metallic taste in mouth, sweating and vertigo. Therapeutic measures were not taken as a result of adverse event. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained
40 2021-04-17 mouth itchiness 10 MINS AFTER VACCINE, FELT ITCHY THROAT AND TOP OF MOUTH. WATER GIVEN IN OBS, IMPROVED AFTER A FEW ... Read more
10 MINS AFTER VACCINE, FELT ITCHY THROAT AND TOP OF MOUTH. WATER GIVEN IN OBS, IMPROVED AFTER A FEW MINUTES, STATES JUST FEELS LIKE MILD ALLERGY TICKLE/IRRITATION IS ALL THAT REMAINS. INSTRUCTED ON BENADRYL IF NEEDED AT HOME AND TO MONITOR AND SEEK FURTHER EVAL IF WORSENS. ESCORTED TO EXIT TO MEET SPOUSE WITHOUT ISSUES AT 1545. 1530 INITIAL BP 172/97 HR 98 RR 20 SATS 98% ON RA (REPORTS SITUATIONAL ANXIETY) 1540 BP 131/88 HR 73 RR 18 SATS 100% ON RA
40 2021-04-17 tongue discomfort, dry mouth Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels ti... Read more
Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels tingly. I feel like I drank about ten red bulls my heart feels like its racing!
40 2021-04-18 deafness - Sudden loss of hearing in left ear on April 10 (5 days after second COVID shot) upon waking up in ... Read more
- Sudden loss of hearing in left ear on April 10 (5 days after second COVID shot) upon waking up in the morning around 8:00 am. - Loss of hearing was becoming more pronounced, so I went to the doctor for an exam on 4/14. Dr. could not determine cause of hearing loss. Scheduled an audiology exam and appointment with ENT for 4/15. Doctor prescribed oral steriods to try and save hearing. While I was at the pharmacy waiting for my Rx, I suddenly developed vertigo around 5:30 pm, which resulted in being sent to the ER. I could not stand, felt faint, and was vomiting excessively. - At the ER, was given lots of anti-nausea medication. Eventually, the tests determined that there was nothing obviously wrong in my brain (aneurysm, stroke, tumor, etc.), and the medication stopped the vomiting such that I was able to be discharged around midnight.
40 2021-04-18 eye swelling, eye pain My left eye is swollen and darker in color. It?s painful to blink.
40 2021-04-18 mouth numbness Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my to... Read more
Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my toes up to my head. I then became dizzy and felt very faint. The tip of my tongue also became numb. I was too embarrassed to alert the hospital worker. The sensation lasted about a minute. However, the last 2 1/2 days I have been having a fast heart rate after doing minimal activities. I feel very winded by the slightest task. I did go to a clinic today to get my vitals checked. They were fine- but I still continue to feel like my heart rate spikes when I do something as minimal as emptying the dishwasher. It?s very scary and uncomfortable and makes me fearful of taking the second shot.
40 2021-04-18 mouth tingling Approximately 50 minutes after injection, having waited the 30 minutes for observation, while drivin... Read more
Approximately 50 minutes after injection, having waited the 30 minutes for observation, while driving home my tongue started to feel wrong and the top started to tingle. Uncertain which direction this was going to go, I drove to the ER (which was near home, close to where I was at the time). I felt light-headed for a little bit just after getting a room and talking with the insurance & copay person. The doctor noticed I was flushed/red, which extended from my face down my chest and shoulders. The reaction didn't seem to progress further than that, thankfully. I was treated with Solumedrol, Famotidine, Benadryl.
40 2021-04-19 lip swelling, mouth swelling I don?t like her lips and mouth is swollen
40 2021-04-19 bloodshot eyes, sensitivity to light I received my first dose of the Pfizer vaccine on April 7th. The same day that I received it my eyes... Read more
I received my first dose of the Pfizer vaccine on April 7th. The same day that I received it my eyes turned red, blood shot. Specifically the left eye, and I had my shot in the left arm. I thought it was odd but after a day or so it went away. On 4/17 I went to the beach, and my eyes got almost sun burnt even while wearing sun glasses with a hat, under an umbrella. I go to the beach all the time and this has never happened before. I do not know if any of this is related to the vaccine and my symptoms are not drastic enough to warrant a trip to the doctor yet, however I felt that I should report this.
40 2021-04-20 loss of taste, smell distorsion Loss of taste, hard of smelling, sore arm
40 2021-04-20 mouth swelling Oral swelling, hot flashes. Patient did not seek medical attention during event, states she self me... Read more
Oral swelling, hot flashes. Patient did not seek medical attention during event, states she self medicated with diphenhydramine within an hour of vaccination. Symptoms completely resolved by next morning. Patient endorsed symptoms during screening for second dose of vaccine 21-days later.
40 2021-04-21 inability to speak Patient received first dose of COVID vaccine today, appointment time 1430, received first dose vacci... Read more
Patient received first dose of COVID vaccine today, appointment time 1430, received first dose vaccine at 1433. After receiving vaccine, patient sat in observation area and reported her voice "going away" sharing that with other allergies her voice often softens and she has a hard time communicating. No signs of shortness of breath, respirations even and not labored, oxygen sat at 100%, pulse 102, BP 112/66. Face flushed. Administered 1ml of benadryl IM, 50 mg total. Patient still expressing difficulties verbalizing and now stating a small feeling of tightness in her throat, face continued to be flushed. Administered epi pen to left thigh. Called 911. BP 110/60, 109, 100%. Gave report to ED RN and to paramedic responding. Patient then transferred to ED with paramedic assist. At time of transfer, patient reporting improvement with ability to communicate via voice, face less flushed and improved tightness in her throat.
40 2021-04-21 dry throat, eye swelling throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling,... Read more
throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.
40 2021-04-21 mouth numbness Numbness of tongue on 4/15/21 Right facial droop on 4/16/21 Went to ER on 4/16/21
40 2021-04-21 pain in jaw Several days after 2nd dose of Pfizer I started experience increased pain in my jaw as well as my ri... Read more
Several days after 2nd dose of Pfizer I started experience increased pain in my jaw as well as my right thumb. I do have TMJ though it is controlled/mild and haven?t had issues with it in a few years. After 2nd dose experience pain and discomfort throughout the day. I have also been experiencing increased pain and discomfort in my right thumb where I believe I have some signs of arthritis since receiving the 2nd dose.
40 2021-04-21 taste disorder, ear pain -LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF REC... Read more
-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF RECEIVING VACCINE - LASTED FOR 6 DAYS -UNABLE TO MOVE LEFT ARM, RAISE IT, OR LIFT ANYTHING FOR THE PAST 18 DAYS -UNABLE TO GRASP OBJECTS WITH LEFT ARM FOR THE PAST 18 DAYS -UNABLE TO SLEEP ON LEFT SIDE - CAUSES EXTREME PAIN -TINGLING AND NERVE SHOOTING PAIN ON LEFT ARM FROM FINGERS TO NECK, FRONT AND BACK CHEST LEFT SIDE -MUSCULAR NODULE DEVELOPED ON LEFT SHOULDER UP TO MY KNECK - CAUSING SEVERE EAR PAIN -EXTREME FATIGUE - LETHARGIC FOR THE PAST 18 DAYS -SEVERE JOINT/PAINT THROUGH OUT ENTIRE BODY -LOST OF TASTE -NIGHTSWEATS FOR PAST 18 DAYS -FEVERS RANGING BETWEEN 99.0 - 103 F FOR PAST 18 DAYS -NAUSE FOR PAST 18 DAYS -LOST OF APPETITE -DIARRHEA AND LOOSE STOOLS FOR THE PAST 8 DAYS (NO BLOOD) -BRAIN FEELS FOGGY ALL THE TIME - FEELING AS IN A DAZE FOR PAST 18 DAYS -SHORTNESS OF BREATH - JUST FROM WALKING OR MOVING AROUND -SKIN IS SUPER SENSITIVE AND ITCHY -UNABLE TO DRIVE BECAUSE OF THE FATIGUE AND UNABLE TO USE LEFT ARM. -UNABLE TO WORK - RELYING ON OTHERS TO TAKE CARE OF ME.
40 2021-04-21 ringing in ears Tinnitus. I had a very mild case prior to last week due to side effects of migraine medications in ... Read more
Tinnitus. I had a very mild case prior to last week due to side effects of migraine medications in the past; unless in absolute silence, I usually forgot I had it. The volume has increased by at least 3 or 4 times; it is now shrill and ever-present.
40 2021-04-21 vision blurred Patient (DOB 6/11/1980) received dose 1 of the Pfizer COVID vaccine (lot EW0162, expiration 7/2021) ... Read more
Patient (DOB 6/11/1980) received dose 1 of the Pfizer COVID vaccine (lot EW0162, expiration 7/2021) at 1050. At 1052, patient laid down on the ground with her feet propped up on her chair in the observation area. PHN and RN approached the patient to assess. Patient reported blurry vision and feeling as though she was going to faint before she laid down. Patient reported a fear of needles and fainting with previous injections. Vital signs: O2 98%, pulse 72, blood pressure 120/90, respirations 14. Patient reported eating breakfast then going on a run before coming to the vaccine POD. Patient denied allergies, medications, or medical conditions. At 1058, patient reported symptoms were improving. Vital signs: O2 97%, pulse 70, blood pressure 120/95, respirations 14. At 1102, the patient sat up, drank some water, stated she felt wobbly and laid back down. Vital signs at 1104: O2 98%, pulse 66, blood pressure 120/90, respirations 14. Patient sat up reporting decreased dizziness. At 1114, vital signs: respirations 16, O2 99%, pulse 72, blood pressure 120/98. At 1116, patient stood up momentarily while monitored closely by PHN and RN, then laid down again reporting feeling dizzy. Vital signs at 1118, O2 96%, pulse 69, respirations 16, blood pressure 120/90. Patient sat up, then laid down again reporting dizziness. PHN asked patient to contact a family member to drive her home. Patient reported she wanted to leave and wait for her husband in her car instead of the vaccination room. PHN encouraged patient to wait in the observation room so medical staff could monitor until symptoms resolved or called 911 per emergency protocol. At 1130 patient sat up. At 1138, patient stood up, denied dizziness. RN walked patient out to the parking lot. Patient left at 1140, walking with steady gait.
40 2021-04-22 loss of taste, loss of smell Received 2nd COVID vaccine on 1/9/2021. On 4/11/2021 developed headache, loss of taste/smell, and n... Read more
Received 2nd COVID vaccine on 1/9/2021. On 4/11/2021 developed headache, loss of taste/smell, and nasal congestion. Tested positive for COVID.
40 2021-04-22 lip swelling The day of and day after my arm was sore at the injection site and hard to lift. I also had a heada... Read more
The day of and day after my arm was sore at the injection site and hard to lift. I also had a headache. Both went away after 2 days. However, 9, days later I noticed red spots on my thighs that were itchy. As the day progressed they got worse and bigger and itchy. They were red raised lesions. I woke up in pain and noticed the spots all over my thighs; buttox and my lower lip became very swollen. I went to the hospital they said it was an allergic reaction to something. I had not done anything out of the ordinary in the last couple weeks other than the 2nd dose of the vaccine and a spray tan. They gave me Benadryl and steroids
40 2021-04-22 eye discomfort Upper respiratory congestion, mild nonproductive cough. Dizziness. Headache. Eye pressure. Diffus... Read more
Upper respiratory congestion, mild nonproductive cough. Dizziness. Headache. Eye pressure. Diffuse body aches: "Heaviness" in legs; not weakness. Mild nausea associated with coughing, however no emesis. Denies chest pain/abdominal pain. albuterol 90 mcg/actuation inhaler 6 puff 6 puff, Inhalation, Once, Fri 2/5/21 at 1610, For 1 dose guaiFENesin ER 12 hr tablet 600 mg azithromycin tablet 500 mg D/c with new Rx for: Azithromycin 250mg: 2tabs PO on day 1, then 1tab on days 2-5 Mucinex 600mg 12 HR tablet: 1 tablet PO BID x7 days Encounter Diagnoses 1. Suspected COVID-19 virus infection 2. Upper respiratory tract infection, unspecified type
40 2021-04-23 eye swelling, vision blurred, light flashes or floaters in the eye, visual impairment Symptoms started approximately 23 hours after my first Pfizer dose. I had a visual disturbance that... Read more
Symptoms started approximately 23 hours after my first Pfizer dose. I had a visual disturbance that lasted ten minutes. First my vision went blurry at the edges, then I saw flashes of light and eventually I saw a zigzag pattern across my vision. Since this happened the left side of my face primarily above and below my eye has been tingly and numb feeling, as well as slightly swollen. I have also had vertigo for 11 days now that is getting worse instead of better.
40 2021-04-23 lip swelling swelling of lip; This is a spontaneous report from a contactable physician (patient). A 40-years-old... Read more
swelling of lip; This is a spontaneous report from a contactable physician (patient). A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 26Jan2021 10:00 (Batch: EJ1685; Lot Number: EL3248; expiry: not reported) as single dose for covid-19 immunisation at hospital (at the age of 40 years). Medical history was none. The patient concomitant medications were not reported. No predisposing factor and no culture performed and no antipyretic use (around the date of Vaccination). On 26Jan2021 10:00, the patient experienced swelling of lip occurred after second dose. The patient also stated that the no action was taken for adverse event (no therapeutic measures were done) and reaction recurred on re-administration of product. The outcome of event was unknown. Pfizer product had a causal effect to the adverse event (Causal Relationship): Yes
40 2021-04-23 swollen tongue Pt endorsed a swollen tongue several minutes after receiving the vaccine. Pt was given Benadryl IM a... Read more
Pt endorsed a swollen tongue several minutes after receiving the vaccine. Pt was given Benadryl IM and released.
40 2021-04-23 ringing in ears Vertigo, presyncope, migraine, menstruation, back ache, nausea, tingling In the fingers, tinnitus
40 2021-04-23 vision blurred blurred vision in both eyes which lasted for 30 minutes. at 30 minutes the vision was back to 90% an... Read more
blurred vision in both eyes which lasted for 30 minutes. at 30 minutes the vision was back to 90% and returned to 100% soon after.
40 2021-04-24 taste impairment Within 15 minutes after receiving the first vaccine shot I was I was lightheaded and had a metallic ... Read more
Within 15 minutes after receiving the first vaccine shot I was I was lightheaded and had a metallic taste in my mouth. The metallic taste went away but I felt light headed until I fell asleep. At 2:00am woke up with severe muscle aches all over my body. The next morning I woke up sweating, muscle aches, lightheaded, fatigue, and nauseated. I also had a headache but it was a different type of headache than I?ve ever had before, it felt like my eyes were going to pop so I decided to check my heart rate and blood pressure and both were high. My blood pressure was 132/89, it is typically low (around 104/55). My heart rate was 109 and it?s typically in the 60?s or 70?s. I stayed with these symptoms until 04/17/2021. On 04/18/2021 I woke up for the first time since receiving the Covid-19 vaccine not sweating, hurting, and with a normal heart rate and blood pressure. As of today 04/25/2021 I am still dealing with fatigue.
40 2021-04-24 ear pain From 10pm on Monday 5 April until the morning of Wednesday 7 April (approximately 33 hours) I had a ... Read more
From 10pm on Monday 5 April until the morning of Wednesday 7 April (approximately 33 hours) I had a severe reaction to the second dose of the vaccine. The night of 5 April I had extreme chills, uncontrollable teeth chattering, and freezing sweats. I had sharp shooting pains in my feet, legs, hands, and arms that lasted 24 hours. I also had sharp shooting pains in the back of my head and then it began in my ears. When moving my head for the next full day I experienced extremely sharp pain in one or the other ear. Sometimes the pain returned in my arms. I had tightness in my chest, shallow breathing, and extreme fatigue but also could not sleep due to the pains and the sharp ear pains when turning my head. I had a fever from 100-101 degrees from the first night and still had 101 at 10pm on 6 April (24 hours later). That night I took a Motrin due to the sharp ear pains. (The first night I had only taken Tylenol.) Throughout the second night, I woke up many times drenched in sweat and upon waking up on the following morning, my fever had broken. Throughout day 3 (Wednesday 6 April), I still had tightness in my chest, shallow breathing, and periodic sharp ear pain when moving my head but my fatigue, chills, and fever had subsided.
40 2021-04-24 swollen tongue, lip swelling anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed ... Read more
anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.
40 2021-04-25 loss of taste, loss of smell Loss of smell and loss of taste greatly diminished.
40 2021-04-26 loss of taste Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm st... Read more
Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back. Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
40 2021-04-26 mouth numbness Numbness in face, tongue and arm
40 2021-04-26 swollen tongue weird feeling, itchy all over mostly arms. increased phelgm with throat / tongue/ swelling; anxiou... Read more
weird feeling, itchy all over mostly arms. increased phelgm with throat / tongue/ swelling; anxious.
40 2021-04-26 ringing in ears Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm. Woke up around... Read more
Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm. Woke up around 2:15 am to use the restroom, and got extremely dizzy... started to feel weird, and felt like there was a rush all over. My head started to feel like it was closing in and there was a static, crackling, speaker-like sound along with tinnitus in my ears making it feel like I was in a tunnel. I sat on the floor and waited several minutes until the feeling passed and was able to get back into bed. I waited several more minutes until I felt "normal" again. Was able to get back to sleep, and feel better this morning, with no dizziness, but will continue to monitor any additional symptoms closely.
40 2021-04-26 ringing in ears Numbness on both sides of my face, fluttering feeling in brain and tinnitus in both ears
40 2021-04-26 vision blurred Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred v... Read more
Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No treatment received for the events. The outcome of the events was not recovered. Information about lot/batch number has been requested.
40 2021-04-26 visual impairment, vision blurred Wed, April 14: headache, light headed, feeling of going to pass out, blurred vision, very tired, we... Read more
Wed, April 14: headache, light headed, feeling of going to pass out, blurred vision, very tired, weak, diarrhea. Thur April 15 ? very light headed, feeling of going to pass out, numb pinky, very weak, very shaky, very tired. Went to ER after almost passing out they gave me fluids, did a chest xray and ekg, covid test, pregnancy test. They sent me home saying I was dehydrated. ? slept for 4 hours after ER, felt tired, hard to focus, diarrhea then that night slept all night. Fri April 16 ? a bit better in morning but vision still not right, at dinner table felt drunk (did not have any alcohol), very tired, face felt flushed (no fever), hard to focus, headache came on before bed (took 2 Aleve) Sat April 17 ? tired, went to doctor for additional blood work, slept after appointment, face flush (no fever), vision still not right. Doctor said this is likely vaccine related. Sun April 18 ? felt same as Saturday Mon April 19 ? very tired, vision still not right, hard to focus at work, want to sleep, face felt hot and tingly (no fever) Tue April 20 ? allergy type symptoms in morning. Sneezing, runny nose, slight headache. These symptoms went away. From April 21-28 - other symptoms mostly going away except vision issues. April 28th most symptoms went away but vision is still blurry, see floaters, feels like I have Vaseline over my eyes. Going to see an eye doctor ASAP.
40 2021-04-28 ear discomfort, ringing in ears, ear pain Exhaustion and nausea for 2 days. The same time jaw tightness ear pain, ringing and fullness started... Read more
Exhaustion and nausea for 2 days. The same time jaw tightness ear pain, ringing and fullness started. These other symptoms are still present after almost 3 weeks.
40 2021-04-28 ear swelling Ear and face swelling. Headache nausea body aches chills. I tool benadryl and ibprophin
40 2021-04-28 mouth numbness 15 minutes after receiving the vaccine, she experienced numbness in her lips (felt 'swollen'). She s... Read more
15 minutes after receiving the vaccine, she experienced numbness in her lips (felt 'swollen'). She sat 15 minutes and felt it spread. She talked to the medic, it was still present 30 minutes later. She was noted to have high blood pressure (maybe systolic BP 160-180 mm Hg with elevated HR, does not recall specifics). She was sent to the ED. The numbness over that period spread to the arm and down both legs. She had loss of dexterity in hands (could not peal the aluminum top off an orange juice cup). Mild proximal arm weakness. She was not able to walk. She was numb all over but the right was more affected. She was seen in ED that day 09MAR and later admitted. Later that night had some throat closing/gasping for air sensation. She was monitored clinically, worked with physical and occupational therapy. We chose not to perform a diagnostic LP and just monitored clinically. Work-up detailed below. Discharged hospital on 12MAR. She gradually recovered over several weeks. She was even able to get second dose in series on 3/30/2021 (Pfizer-BioNTech Covid-19 vaccine, lot #: ER 8133, exp 7/2021). She was almost 100% about 3 weeks later. She had a similar return of the numbness and it was in her throat as well, but was immediately controlled by taking diphenhydramine OTC. She was 100% back to normal at our follow-up on 4/27/2021.
40 2021-04-28 taste disorder, eye discomfort 1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered tas... Read more
1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough. Reports 3 days of upper respiratory congestion, mild nonproductive cough. Diffuse body aches. Mild nausea associated with coughing, however no emesis. Denies chest pain/abdominal pain. ROS positive for: fatigue, congestion, cough, myalgias.
40 2021-04-28 ringing in ears Tinnitus in left ear
40 2021-04-29 ringing in ears The evening of the vaccine I started getting sore ovaries, which continued for about 3 days, waking ... Read more
The evening of the vaccine I started getting sore ovaries, which continued for about 3 days, waking me up that first night with the pain. It felt like they were hot and aching, like they were working very hard, something I haven't experienced before. This was 5 days after my last period finished. I had spotting the next day, which I never have, and then my breasts became very sore, lumpy and tender for the next week or more - very concerning as I have had a fibroadenoma before. Symptoms were similar to being pregnant, but I have just started my next period, and did a pregnancy test which came back negative. I have also had ongoing light tinnitus, which started a few days after the vaccine. Again, I haven't had this before, and it has been almost 3 weeks now and it is still at the same intensity. I am very worried about getting the second vaccine next week.
40 2021-05-02 loss of taste, loss of smell Headaches and New loss of taste or smell
40 2021-05-02 ringing in ears, vision blurred Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in bo... Read more
Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in both legs and ringing in both ears. Tinnitus. And I've did not have this before my vaccination.
40 2021-05-05 tongue itchiness, lip swelling, swollen tongue, mouth tingling Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy... Read more
Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy throat; and fast heart beat. Symptoms began approximately 15 minutes after I received the vaccine. I was 4.5 months pregnant at the time, due date September 5, 2021.
40 2021-05-09 loss of smell Fatigue, body aches, swelling injection site, chills, cough, runny nose, loss of smell,headache
40 2021-05-09 ringing in ears light-headed (3+ hours); tightening in neck and throat, and ringing in ears (30 mins)
40 2021-05-09 vision blurred Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shiveri... Read more
Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shivering, freezing hold or suffocating hot, eyeballs keep loosing focus, feeling like I'm having a anxiety or panic attack, short of breath. First day I felt fine, next day I woke up feeling like I was hit by a car and second day after I'm feeling all the symptoms listed above on a scale of 1-10 I'm at a 10 for discomfort
40 2021-05-13 ringing in ears Ringing in left side ear
40 2021-05-14 eye itchiness then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the wo... Read more
then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the worst was behind my eyes deep in sockets; Sharp pain both arms 1 min.; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Apr2021 at 11:15 (at the age of 40-years-old) as 1st dose, single for COVID-19 immunisation. Medical history was reported as yes but not specified. The patient's concomitant medications were not reported. On 30Apr2021 at 11:15, the patient experienced sharp pain both arms for 1 minute then itch was mild for 1 hour. Started itching all over the worst was behind her eyes deep in sockets that lasted 2 days, had to take diphenhydramine (BENADRYL). Left arm was swollen that night and lasted 2 days. On day 3, she was still itching but not as bad. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
40 2021-05-21 ear discomfort broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear ... Read more
broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear pressure; Sinus and ear pressure; Generalized aching; break out in canker sores all over my mouth; sore muscles all over; joint pain; mild itching to upper torso, breasts and under arms; low grade fever; chills; face became pink and warm; felt burning sensation throughout my body; This is a spontaneous report from a contactable nurse (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid left on 03Feb2021 12:00 (Batch/Lot number was not reported) as 1st dose, single at age of 40-years-old for covid-19 immunization. Medical history included Asthma, 3 herniated discs in neck, hx of pneumonia, hypertension (HTN). Known allergies included: Ceclor, PCN, Doxycycline, Bactrim DS, Codiene, berries and anaphylaxis to Latex. Concomitant medications the patient received within 2 weeks of vaccination included: lisinopril; hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 03Feb2021 14:00 PM, within first 24 hours the patient experienced mild itching to upper torso, breasts and under arms, also had low grade fever and chills in this time. Within first 24 hours, face became pink and warm, and felt burning sensation throughout her body. At this point the patient took Pepcid and Benedryl and it seemed to control symptoms. On 09Feb2021, the patient begun to break out in canker sores all over her mouth, total of 5 (the patient did not have a canker sore since high school), began to develop sore muscles all over and joint pain that progressed to severe by 12Feb2021. Worse in mornings. Got a flu and covid test (Nasal Swab). They were negative. 17Feb-20Feb2021 severe fatigue and cont. Joint pain. Slept 17 hours q day. Sinus and ear pressure. Generalized aching. The patient did not get 2nd vaccine. 01Mar2021 broke out in canker sores all over mouth again. Took 4 days to resolve. The patient was still having significant joint pain throughout her body, worse in mornings. The patient never had this before vaccine. Events resulted in disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event canker sores was recovered, of other events was not recovered. Follow up needed, further information has been requested.; Sender's Comments: "Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded" The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-05-24 mouth numbness About 20 minute after vaccine was administered I felt a subtle numbness feeling to the right of my m... Read more
About 20 minute after vaccine was administered I felt a subtle numbness feeling to the right of my mouth. Then it was felt on most of my right cheek. It lasted the whole day and the next morning it was mostly gone. Since then my right eyelid and under eye have been a little red which isn't normal for me. Some tingling in right leg felt as well. Mainly concerned about the face sensation and not sure if I should proceed with second shot.
40 2021-05-25 dry mouth, tongue disorder, swollen tongue My tongue became swollen and my mouth became dry. I began chewing on the inside of my cheeks and my ... Read more
My tongue became swollen and my mouth became dry. I began chewing on the inside of my cheeks and my teeth left groves on the perimeter of my tongue. The swelling lasted around 2 months and I am still experiencing extremely dry mouth and issues swallowing, especially at night. Initially my Dr prescribed an oral rinse for non-typical thrush, but it didn't really help. I saw an ETN who told me to take a multi vitamin. Both Dr's ran blood work.
40 2021-05-25 ear discomfort, ringing in ears, deafness unilateral Slight tinnitus that comes and goes in both ears. More concerning is intermittent hearing loss in r... Read more
Slight tinnitus that comes and goes in both ears. More concerning is intermittent hearing loss in right ear. Feels like hearing volume turns up and down, as though there is a blockage. There is also pressure that won?t go away (pop). I have not sought treatment and am waiting to see if issue resolves on its own. I don?t want to take steroids.
40 2021-05-25 lip swelling left side of lower lip swelled up.; This is a spontaneous report from a contactable consumer, the pa... Read more
left side of lower lip swelled up.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 23Feb2021 at 09:30 and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient's left side of lower lip swelled up, about 18 hours after the second dose. The patient had no trouble in breathing. The patient did not receive any treatment for the event. The clinical outcome of the event left side of lower lip swelled up was recovered on an unspecified date. Information about lot/batch number cannot be obtained. No further information is expected.
40 2021-05-25 pain in jaw Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal... Read more
Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal tremor of the brain; dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 40-years-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: Er8730 and Expiration date was not reported), via an unspecified route of administration, in right arm (age at vaccination 40-year-old) as 2nd dose, single for covid-19 immunisation and patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: En6208 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Mar2021 09:45 AM for covid-19 immunisation. Medical history included hypervitaminosis, migraines, and prior to vaccination, patient was diagnosed with COVID-19. The patient was allergic to Levaquin. Concomitant medications that patient received within 2 weeks of vaccination included ferrous citrate (IRON [FERROUS CITRATE]). Facility where the most recent COVID-19 vaccine was administered in hospital. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient became now not diagnosed with COVID-19. Patient underwent laboratory test which includes nasal Swab Pcr, covid test on 11May2021 and the result was pending. On 09Apr2021 10:00 the patient experienced left arm numbness 5 minutes after injection, hand tingling, left jaw pain. Left side of face and scalp began to burn one day after injection. Internal tremor of the brain and dizziness. Treatment was received for all event as medical supervision from hospital staff. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
40 2021-05-25 ringing in ears TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache W... Read more
TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache Weird twinges all over body randomly
40 2021-05-26 mouth tingling Patient stated prior to vaccine that she had itching and throat tightness after her first Pfizer vac... Read more
Patient stated prior to vaccine that she had itching and throat tightness after her first Pfizer vaccine from Pharmacy. It was resolved by PO Benadryl. Patient took 25 mg Benadryl PO prior to receiving 2nd Pfizer vaccine. After vaccine, patient reported throat tightness, mouth tingling, and shortness of breath. Epipen 0.3mg SubQ was administered. Patient taken to ER. Given methylprednisolone 125mg x 1 before discharge from ED with prednisone prescription.
40 2021-05-26 ringing in ears, deafness I became very light headed and passed completely out. I do not remember anything leading up to this ... Read more
I became very light headed and passed completely out. I do not remember anything leading up to this or while it was happening. When I came too, I couldn't hear, had ringing in my ears, couldn't walk on my own, and my husband said I was very cold. Two days later and i still have dizzy spells and extreme fatigue.
40 2021-05-27 eye pain Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the tou... Read more
Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the touch (no fever); eye pain; exhaustion; vertigo; mild nausea; Left temple throbbing and pulsating/headache; Heart pounding; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:30 (Batch/Lot Number: ER8736), age at vaccination of 40-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine headache everyday, neck pain, dizziness, head and neck hot to the touch (no fever), eye pain, exhaustion, some vertigo and mild nausea, left temple throbbing and pulsating, heart pounding an fluttering occasionally, all on 30Apr2021 at 1730. No treatments were give for the events. Facility where the most recent COVID-19 vaccine was administered: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 10May2021. The patient had not recovered from the events. Information on the lot/batch number has been requested.
40 2021-05-28 taste impairment Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp p... Read more
Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp pain in left upper chest; Chills/hot spells; This is a spontaneous report received from a non-contactable Other-HCP. A 40-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN9581 and Expiration date not reported) via an unspecified route of administration, in Arm right, on 13Feb2021 at 02:30 PM (at the age of 40 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history included Known allergies was reported as pseudoephedrine, Cephalexin, eggs, melon and concomitant medications included Multivitamin, St Johns Wort (medications in two weeks). Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246 and Expiration date not reported) via an unspecified route of administration, in Right arm, on 23Jan2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. The patient didn't receive any other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination. On 13Feb2021, at 02:45 PM, the patient had experienced Metallic taste in mouth and feeling hot initially, Chills/hot spells, nausea, vomiting, body aches, hip and back pain, sharp pain in left upper chest. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which includes Rapid Antigen Nasal Swab test post vaccination on 15Feb2021 with the result of negative, on 17Feb2021 with the result of negative, on 19Feb2021 with the result of negative, on 22Feb2021 with the result of negative, PCR Nasal Swab test on 24Feb2021 with the result of pending. There was no treatment received for AE. Outcome of the events was reported as Recovered with lasting effects. No follow up attempts are possible. No further information is expected.
40 2021-05-28 mouth tingling Onset of severe nausea followed by difficulty breathing, uncontrollable incessant dry heaving and co... Read more
Onset of severe nausea followed by difficulty breathing, uncontrollable incessant dry heaving and coughing, spasms, full body shaking, full body tremors, inability to speak, seizure like reaction, dizziness, tingling in tongue,
40 2021-05-28 toothache Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, jo... Read more
Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.
40 2021-05-31 loss of smell I sat down after vaccination and I felt sore right away up arm and up shoulder, went home, as drivin... Read more
I sat down after vaccination and I felt sore right away up arm and up shoulder, went home, as driving, migraine began, vomiting, couldn't smell. Had to go to Dr and get shot for headache and nausea, vomited for 2 days, loss of appetite, bad body aches. After that I was able to eat and drink bland and it subsided.
40 2021-05-31 ringing in ears, ear discomfort, deafness April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear A... Read more
April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear April 23 - mild ringing in both ears and thumping, pressure in head May 4th - very noticeable ticking in right ear May 9th - felt sick, off, hard to take a deep breath, pounding head, fullness in ears, ringing, emotional May 11th - ENT visit. Ears clear, hearing fine May 18th - May 23- off and on headaches, difficulty breathing May 24th - Headache that didn?t go away with medicine. Fullness in ear. Nausea May 25th - Sleepless night, stiff neck, very full head. Medicine providing no relief(Excedrin, Sudafed, Flexeril) can feel fast heartbeat, ringing, and pulsation in ears, stiff jaw May 26-28 - light head congestion May 29- headache returns May 30- head congested even after Sudafed. Ears feel ?wet? hard to take a deep breath, lots of yawning. Flushed face and blotchiness on neck. May 31 - Difficulty breathing, ringing in both ears
40 2021-06-01 lip swelling Rash over entire body -3weeks and counting, swelling of lips in the morning 2 days, swelling of left... Read more
Rash over entire body -3weeks and counting, swelling of lips in the morning 2 days, swelling of left ankle every night -3 weeks and counting
40 2021-06-01 mouth tingling Patient started with tongue tingling, felt her jaw getting tight and redness to her chest. Patient g... Read more
Patient started with tongue tingling, felt her jaw getting tight and redness to her chest. Patient given Benadryl in COVID pod as well as an Epi Pen. Patient transported to ED and given IV solumedrol and Pepcid. Racemic epi and neb given as well. patient symptoms have since improved.
40 2021-06-01 vision blurred blurred vision/After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 da... Read more
blurred vision/After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 days later; huge lump under where she received the vaccine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 1ST DOSE, single on 23Apr2021 (Batch/Lot Number: EW0170) and 2ND DOSE, single on 14May2021 (Batch/Lot number was not reported), both via unspecified route at 9:50 am, arm left for covid-19 immunisation. Medical history included does wear glasses and mild psoriasis (just uses something topical if she has a flare up) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient historical vaccine includes: flu vaccine from unspecified date for immunization. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient is calling about the Covid 19 vaccine. After she received her first Covid 19 vaccine on 23Apr2021, she had blurred vision starting on Sunday, 25Apr2021. She called the pharmacy and was told that blurred vision was a rare side effect and her vision should clear. She received the second Covid 19 vaccine on Friday, 14May2021 and she experienced the blurred vision again except this time she can't see anything unless it's about 2 inches from her eyes. She doesn't have a job she has to go to but she is a stay at home mom and she home schools her children. She can't even see the text in books. She can't drive, not even to the grocery store. She is asking how long is this going to last. Her arm has a huge lump under where she received the vaccine. The lump is still there from the first vaccine and she has another lump from the second vaccine. Her left arm now has 2 lumps. She thought that might be an allergic reaction but the same lady gave her both injections and stabbed her pretty hard when she gave the Covid 19 vaccine. The pharmacist did tell her she can get blurred vision with any vaccine but she always gets her flu vaccine and she's never had blurred vision before. She received her second Covid 19 vaccine on Friday, 14May2021 in the left arm. She can't find the vaccine record card, she had two vaccine records card because she forgot to bring the first vaccine record card to her second appointment. The NDC for the second vaccine is on her receipt. NDC 59267-1000-01, Lot/Expiry not known for second dose. First Covid 19 vaccine information is in the suspect product field. She received her first Covid 19 vaccine on Friday, 23Apr2021 and she had blurred vision on Sunday, 25Apr2021. She thought at first it was pink eye or conjunctivitis because her vision was blurry and she thought, what did her children bring home to her. Her eyes weren't pink though. She called the pharmacist and he told her it was a side effect. Her vision did get better about a week before the second Covid 19 vaccine but it wasn't completely back to normal. She received the second Covid 19 vaccine on 14May2021 and she experienced more blurred vision on Sunday, 16May2021 but it's much worse and it's not gotten better. She's trying to read from her coffee machine and she can't even see what it says. This can't be normal. Does she need to see an optometrist? She reports she could still drive after her first Covid 19 vaccine because the blurry vision wasn't that bad but this time it's scaring her a little bit. She reports she does wear glasses but only for night time. Her pupils don't dilate well so she tries not to drive at night.The reporter added that around 48 hours after my first dose I began having blurred vision, it got slightly better before my 2nd dose, however, it did not get completely better. After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 days later. The outcome of the event was recovering for blurred vision and not recovered for the other event. The patient was did not required emergency room and physician office visit. Follow up attempts are needed. Further information has been requested.
40 2021-06-01 visual impairment, eye pain I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had... Read more
I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had what looked like blinds (white/black) lines in my vision, then half moon shape in my vision in my right eye for days. Dizziness (I felt like I was on a boat dock), confusion, tiredness and pain the back of the eye for two weeks, numbness of the eyes. I went to the Opthalmologist who stated that I was having an ocular migraine. My Neurologist also said I was having an Ocular Migraine, but I?m stuck in the Postdrome Stage. Gave me Topiramate daily and told me stay away from screens and reading (that means no working and no TV). With the meds, I?m 70% back to my old self, I can drive again, run errands, do yard work, but I can?t work. We increased the dose, still can?t use screens and side effects pushed us to find another drug. Started new drug Amitriptyline on May 30, and symptoms are not disappearing. I have had symptoms (mostly eye numbness, vision issues, dizziness) continuously all day, everyday for 3 39 days and counting
40 2021-06-02 ear pain affected her immunity; Hashimoto thyroiditis; test showed higher level of TSH; feeling pain on left ... Read more
affected her immunity; Hashimoto thyroiditis; test showed higher level of TSH; feeling pain on left side a lymphatic thyroid pain and ear pain.; feeling pain on left side a lymphatic thyroid pain and ear pain.; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL8982, expiration date unknown) via an unspecified route of administration at arm right on 04Feb2021 at 10:00 AM at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included in vitro fertilization (IVF). Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL0142, expiration date unknown) via unspecified route of administration at right arm on 13Jan2021 at 10:00 AM at age of 40-year-old for COVID-19 immunization. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included desogestrel, ethinylestradiol (ENSKYCE) within 2 weeks of vaccination. Patient reported that she never had thyroiditis in her life before. On 20Feb2021 at 06:00 AM (about two weeks after 2nd dose), patient started feeling pain on left side a lymphatic thyroid pain and ear pain. Doctor prescribed antibiotics. She was in the middle of IVF process and had all record no thyroid issues before this date. Blood test on 29Apr2021 showed higher level of TSH, on 08May2021 showed higher level and on 14May2021 showed that level become 6.05. Patient made appointment with endocrinologist. And today on 19May2021, she was diagnosed with acute Hashimoto thyroiditis. She had all her thyroid records never had any issues. Patient stated that she was not too sure if this was caused by vaccine but certainly affected her immunity. Patient was prescribed levothyroxine to start from tomorrow (20May2021). Her IVF was cancelled till her TSH level get fixed. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received Ultrasound of thyroid, antibiotics, levothyroxine as treatment for the events. Outcome of event "affected her immunity" was unknown, of the other events was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Patient had COVID test post vaccination included nasal swab on 30Mar2021 which was negative. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on autoimmune etiology of reported autoimmune thyroiditis and event occurrence post two doses of vaccination and elevated TSH levels, the causal role of BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
40 2021-06-02 ringing in ears About 12 days after my vaccination, I began to experience ringing in my ears and lightheadedness. On... Read more
About 12 days after my vaccination, I began to experience ringing in my ears and lightheadedness. On May 9, it began, and it was very loud (more so on my right ear). Then it subsided and became more high pitched but less loud and noticeable, but more noticeable in my left ear. It continued for me as a new background noise for weeks. After some time, I went to an ENT, they did a hearing test, which came back normal. The ringing continued. I saw my primary doctor. He suggested it might be seasonal allergies, despite this never happening to me before during allergy season. He prescribed an OTC nasal spray. The ringing continued and finally subsided during the 1st week of June. Every now and then my ear will feel full and ringing will return, but it?s sporadic now (really only happened twice from 5/30 - 6/3 and not constant anymore. Sometimes noticeable at night now.
40 2021-06-03 mouth numbness, oropharyngeal discomfort doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little ... Read more
doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little numb; hard to swallow; Throat was closing up; mouth feeling numb; couldn't really speak; Coughing; super shaky; feet was also feeling numb; face looked swollen; Chest tightness; chest pain; abnormal EKG; Her throat was a little sore; tired; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left Arm on 17May2021 12:30 (Batch/Lot Number: EW0167) as single dose (at the age of 40-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number EW0158) on 15Apr2021 at 12: 50PM (at the age of 40-year-old) in the left arm for covid-19 immunisation and on 15Apr2021 her arm was numb on the side where she received the injection for more than 24 hours, it went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days, but the patient was unsure if that is an adverse reaction. The patient experienced tongue was a little numb on 17May2021 with outcome of recovering , hard to swallow on 17May2021 with outcome of recovering , mouth feeling numb on 17May2021 with outcome of recovering , throat was closing up on 17May2021 with outcome of recovering , couldn't really speak on 17May2021 with outcome of recovering, coughing on 17May2021 with outcome of recovering, super shaky on 17May2021 with outcome of recovering, feet was also feeling numb on 17May2021 with outcome of recovering, face looked swollen on 17May2021 with outcome of recovering, chest tightness on 17May2021 with outcome of unknown, chest pain on 17May2021 with outcome of unknown, abnormal EKG on 17May2021 with outcome of unknown, her throat was a little sore on 17May2021 with outcome of unknown, tired on 17May2021 with outcome of unknown, doesn't have much of appetite on 20May2021 with outcome of unknown. Details as described as follows: Reports she went to sit in the waiting area, after 5 minutes she noticed her tongue was a little numb. She took her card out of her purse, and noticed it was a little hard to swallow, this was within about 8 to 10 minutes. She sat for another 5 minutes and then decided to ask about her tongue feeling numb and was taken to the nurses station. She told them about her tongue, and as she was talking her mouth was feeling more numb and it was getting harder to swallow. As the nurse was talking to her it was like she couldn't really speak. The nurse said this is way past Benadryl and called to another nurse for an Epipen. Caller states she started to cough as her throat felt like it was closing up. They jabbed her with the Epipen within 15 minutes of receiving the vaccine. She got some relief for a couple of minutes and then her body went back into the allergic response. They put her on the oxygen finger machine and then her throat started to close again. They gave another Epipen and then the ambulance arrived. She is unsure how long after she got the second Epipen that the ambulance arrived but it was no more than 5 minutes. They told her they had to call 911 right after giving the first Epipen. When the ambulance team came, she felt like she had novocaine in her mouth, her mouth was super numb and she was super shaky. They said the shaking was normal from an Epipen. Adds her feet were also feeling numb. She didn't know before that the shaking was from the Epipen. She was able to walk to the ambulance and her husband came and the med team was asking him if her face looked swollen and he said her face looked swollen. States her mouth felt like it was moving funny and she was exaggerating her speech trying to make her mouth move right. Adds she was still unaware that this could be an allergic reaction and was just trying to remain calm. At the site, she noticed her vitals on the machine and she saw 148/70 on the blood pressure. Adds it was about the same in the ambulance, it was 148/64. She was not able to collect any information about the Epipen other than they were yellow with a blue cap and they held it in her leg for three seconds. No lot or expiration date known for the Epipens. In the ambulance she was treated with Intravenous (IV) steroids and dose of Benadryl 50mg. As she was being transported to the hospital, she started to have chest pain. They did an EKG in the ambulance with no remarkable findings. Adds she has a follow up with her Primary Care Provider (PCP) today. When she arrived at the Emergency Room (ER) they monitored her for a couple of hours. She had another EKG at the ER and was told that it was normal so they released her. She has no product information for the steroids or the Benadryl that she received. No lot or expiration date known. When she got home everything was calming down. Her throat was a little sore and she was tired. The next morning her chest was still tight. She called the doctor who told her to just relax and come back to the ER if she has palpitations or difficulty breathing. Mentions she got the results of the EKG in ER now, and it said it was abnormal as compared to a previous EKG she had, and something about the T axis. Adds now she doesn't have much of appetite and her tongue still feels a little off. Caller interrupts the call to say her doctor just called and she needs to go. Unable to complete the report at this time. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.
40 2021-06-03 mouth tingling Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and ... Read more
Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and toes returned with increasing sensation on May 21, 2021. On friday May 28, 2021 lips are now tingling and more feeling of full body tingling and weakness followed by close to fainting spells. Sunday night worst headache of life, followed by chills, almost fainted, went to ER and all tests normal. Neuropathy has not left. Sent home with no answers. Wednesday June 2, 2021 tingling of hands, feet and lips more extreme followed by moments of shortness of breath and fainting. Went back to ER all vitals normal. Two days later I have missed two days of work because my body is so weak and the nreopathy remains. Please help. I cannot continue to live with these symptoms. I had zero health issues leading up to this and all of the dr's are stumped.
40 2021-06-03 swelling of eyelid Angioedema ? large hives, swelling of face and eyes, itching and fatigue
40 2021-06-03 ringing in ears Slightly lightheaded; Slight ringing in my ears; Resting heart rate began to increase; Facial/neck f... Read more
Slightly lightheaded; Slight ringing in my ears; Resting heart rate began to increase; Facial/neck flushing; Became hot; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200), via an unspecified route of administration on the left arm on 17Mar2021 at 14:15 (at the age of 40-year-old) for COVID-19 immunisation. Concomitant medications (within 2 weeks of vaccination) included vitamin E, hydrolyzed collagen, vitamin C, biotin. She has no known allergies to any medications, food, or other products. She did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, she had not tested positive for COVID-19. On 17Mar2021 (within 2-3 minutes after the vaccination), she became slightly lightheaded with a slight ringing in her ears; Her resting heart rate began to increase from 70 beats per minute up to 131 beats per minute with facial/neck flushing and she also became hot. The symptoms resolved within the next 2-3 minutes. It was also confirmed that she was 5 hours out from receiving the vaccine without further issue. No therapeutic measures were taken to treat these events. The clinical outcome for the events became hot, facial/neck flushing, resting heart rate began to increase, slightly lightheaded, slight ringing in her ears was recovered on the same day (17Mar2021). No follow-up attempts are needed. No further information is expected.
40 2021-06-04 taste impairment Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around... Read more
Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye; Fatigue; ended up sleeping nearly 12 hours; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 40-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0186), via an unspecified route of administration in Arm Left on 28May2021 15:00 (age at vaccination 40years old, No pregnancy at time of Vaccination) as single dose for covid-19 immunization. Medical history included lactose intolerance from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. Concomitant medication(s) included Vitamin C, Vitamin D, Calcium Citrate, Iron taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination the patient was not diagnosed with covid-19. The patient received other medications in two weeks. On 28May2021 21:00 the patient experienced mild metal taste in mouth approx. 1 minute after shot was administered; dissipated a few minutes afterward. Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; no swelling. Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye. Fatigue; ended up sleeping nearly 12 hours. After 42 hours, migraine has gone away; remaining symptom is soreness - now reduced to half the area and still concentrated around site injection area. Patient was not received treatment for the events. Since the vaccination, the patient has not been tested for covid-19. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
40 2021-06-06 lacrimation increased I had an allergic response that included itchiness, watery eyes, congestion... then settled into bro... Read more
I had an allergic response that included itchiness, watery eyes, congestion... then settled into bronchitis. I still have the bronchitis.
40 2021-06-07 oral mucosal blistering, mouth pain 3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the i... Read more
3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the inside of my mouth was in a lot of pain. A fever blister formed on my lower lip (left) and the inside of my mouth felt raw. It has been going on 2 days now- it?s hard to eat and hurts to talk. My gums are sore and I can feel raw spots on the roof of my mouth-like blisters.
40 2021-06-07 feeling of choking, mouth tingling Patient complained of tingling of the mouth and throat "like when I have peanut allergy". Patient re... Read more
Patient complained of tingling of the mouth and throat "like when I have peanut allergy". Patient reported that she took a Zyrtec and denied difficulty swallowing or breathing. Vital signs stable. Complained of nausea and that her chest felt heavy. EMS called and was taken to the hospital.
40 2021-06-07 swelling of eyelid Facial hives Eye lid swelling Symptoms began at 630pm 2 25 mg tablets (50mg total) taken orally at 7... Read more
Facial hives Eye lid swelling Symptoms began at 630pm 2 25 mg tablets (50mg total) taken orally at 7pm Symptoms resolved within 4 hours
40 2021-06-07 vision blurred speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; h... Read more
speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; headache; fatigue; itching skin; loss the ability to focus eyesight on phone, computer screen or books.; This is a spontaneous report from a Non-Contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3302), via unspecified route of administration in the Left arm, on 25May2021 at 10:30 AM, as a single for COVID-19 immunisation. Medical history included Hypothyroid. Concomitant medications included armour, liothyronine and spironolactone. The patient had no known allergies. On 25May2021 at 02:30 AM, the patient experienced Blurry eyesight, fever, clammy skin, headache, fatigue, itching skin, speech difficulties (could not think of words, slurred words), loss the ability to focus eyesight on phone, computer screen or books. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was recovered with lasting effects. No follow-up attempts are possible. No further information is expected.
40 2021-06-08 ear discomfort The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night i... Read more
The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night it progressed into a fever of 104, severe body aches in almost all my joints, headaches, bradycardia and body chills. The fever was minimal reduced by switching Tylenol and Ibuprofen every few hours to about 102. Fever, chill and body aches started to subside in about 24 hours. Today I have sore throat, pressure/fluids in ears, slight chest pains and bradycardia, light headache and swollen lymph nodes in throat , inject site is still sore but most bothering is dizziness that is setting in.
40 2021-06-08 oral mucosal blistering AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY ... Read more
AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY PAINFUL. SAW MY PA ON 03/25/21. VALTREX PRESCRIBED. BLISTERS WERE MUCH BETTER WITHIN 48HOURS. 03/27/21 UNEXPECTEDLY HAD MY PERIOD. I HAD JUST FINISHED UP MY PERIOD WHEN I HAD THE VACCINE ON 03/18/21. THIS PERIOD WAS UNLIKE ANY OTHER. THE BLEEDING WAS INCREDIBLY HEAVY, FULL OF CLOTS AND LASTED 9 DAYS. MY USUAL CYCLE IS 5. AFTER SECOND DOSE: ANOTHER UNEXPECTED PERIOD. THIS TIME NOT AS HEAVY, NOT AS MANY CLOTS AND DID NOT LAST AS LONG. SORE UNDERNEATH ARM AND LYMPH NODE UNDER ARM SWELLED.
40 2021-06-09 lip swelling, lip itchiness Lips swelling, itchiness, dryness, peeling and redness 2 weeks after vaccine, went to the doctor and... Read more
Lips swelling, itchiness, dryness, peeling and redness 2 weeks after vaccine, went to the doctor and was told to take a histamine for a few days and if it doesn?t improve to take a steroid.
40 2021-06-09 sensitivity to light Fever over 103°, chills, severe headache with light sensitivity, rash halfway down my arm on the ar... Read more
Fever over 103°, chills, severe headache with light sensitivity, rash halfway down my arm on the arm where injection was given
41 2021-01-01 mouth tingling, mouth numbness perioral tingling, numbness
41 2021-01-03 swelling of eyelid, lip swelling 12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early mo... Read more
12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.
41 2021-01-03 taste disorder, taste impairment Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint ... Read more
Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.
41 2021-01-04 loss of taste, loss of smell I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on t... Read more
I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.
41 2021-01-04 lip swelling, lip blister Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ... Read more
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
41 2021-01-04 mouth tingling At around 0910, employee reported tingling on tongue and roof of mouth while in the monitoring area ... Read more
At around 0910, employee reported tingling on tongue and roof of mouth while in the monitoring area post vaccination. RN obtained V/S: 122/76; pulse 78; resp 18; pupils equal and reactive; skin pink. Employee was alert and oriented. She reported slight reaction about 30min. post vaccination. Dr. was notified and assess the employee. Dr. ordered Benadryl 25mg PO at 1001. This was administered by RN. Employee was monitored for another 20 minutes and then was aloud to leave. Employee was feeling better before leaving. She was instructed to seek medical attention if symptoms returned or new symptoms occured. She verbalized understanding.
41 2021-01-04 sensitivity to light Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Na... Read more
Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
41 2021-01-05 taste impairment got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a conta... Read more
got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140/ELO140), via an unspecified route of administration, at the left arm on 30Dec2020 06:30 at a single dose for COVID-19 immunization at a hospital. Medical history included seasonal allergies and doesn't take medications. On the same day of 30Dec2020, about an hour after vaccination, patient got a very metallic taste in mouth, which lasted for about 12-18 hours and did sleep a lot, which she expected, but woke up about 11 at night and still had it and it was gone. Patient knew she slept longer than she normally does, went to bed at 1PM and slept until 11PM, which is not usually normal. Was up for about an hour or two and then went back to bed until 8AM of 31Dec2020. Patient was concern was if it was some type of reaction that it would mean she was going to have a stronger reaction to the second one and stated it was irritating but not a huge deal. Patient also felt tired and expected it as she worked five 12-hour shifts in a row. Patient was not sure if the metallic taste was connected to the COVID-19 vaccine. No prior vaccinations within 4 weeks. Outcome of the events was unknown.
41 2021-01-05 mouth tingling, lip itchiness Broke out in red rash on neck, chest and arms. Lips itchy and tinging.
41 2021-01-05 swollen tongue TOUNGE SWELLING , FELT HOT 5 MIN AFTER POST INJUCTION. EPINEPHRINE GIVEN. ED VISIT
41 2021-01-06 taste impairment Metallic taste in mouth
41 2021-01-06 ear discomfort Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine unt... Read more
Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.
41 2021-01-06 pain in jaw, ear pain I Initially just had a sore left arm which felt better the next day. I woke up the morning after t... Read more
I Initially just had a sore left arm which felt better the next day. I woke up the morning after the Vaccine (1/6/21) and experienced right jaw pain which extend it to my ear which was worse during chewing and talking. Today on January 7 it is still present however seems milder
41 2021-01-06 mouth tingling PARATHESIA OF LOWER LIP
41 2021-01-06 swollen tongue Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination.... Read more
Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.
41 2021-01-07 oropharyngeal discomfort Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something... Read more
Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.
41 2021-01-07 swollen tongue Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported ... Read more
Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported feeling like tongue was swelling. Patient was given 50 mg PO Benadryl. No improvement patient was escorted to ED by RN for evaluation
41 2021-01-07 ringing in ears Achy body, headache, ear ringing, chills and a temperature.
41 2021-01-08 mouth discomfort, tongue discomfort Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and pro... Read more
Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and progresses to full mouth Fatigue, headache, body aches
41 2021-01-08 mouth tingling, taste impairment, mouth numbness, lip swelling 1st event: Metallic taste in mouth; then felt like I had a 'fat lip' on left lower lip; and left hal... Read more
1st event: Metallic taste in mouth; then felt like I had a 'fat lip' on left lower lip; and left half of tongue- tip only- went numb Injected with 50mg of Benadryl in my left upper thigh 2nd event: 4.5 to 5 hours later- Metallic taste returned {Liken to cold house key metallic taste} in center of tongue- width of 1-2 mm, taste lasted 30-45 seconds. Left side of lips went numb (upper and lower) with lower again feeling swollen. Left upper part of tongue again went numb. Took 25 mg tablet of Benadryl. Odd feeling in tongue lasted for a few days after vaccine.
41 2021-01-08 mouth tingling Angioedema Tongue Tingling Narrative: Tingling decreased after 20 mins.
41 2021-01-08 drooling, taste impairment employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of h... Read more
employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.
41 2021-01-08 swollen tongue Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vacci... Read more
Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine. Visited immediate care; received IV of Benadryl, Pepcid & Steroid.
41 2021-01-09 mouth swelling About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 m... Read more
About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 min and they did blood pressure and oxygen check. about 10 min in, I felt a little funny in my mouth, like a little bit of swelling, but never to the point of issue with breathing or swallowing. Numbness seemed to have subsided by the 60 minute time and I went home. No other symptoms.
41 2021-01-10 mouth swelling, mouth discomfort cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and ... Read more
cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
41 2021-01-10 swollen tongue, lip itchiness Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and chee... Read more
Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and cheeks and stiffness to jaw. Notified vaccine team. Received Benadryl IM with return to baseline and transported to the ER for monitoring. Received 4 days of Prednisone and Pepcid PO.
41 2021-01-11 loss of taste, loss of smell 41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes a... Read more
41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell. Patient's initial symptoms started on 1/8/2021 with some rhinorrhea. The following day on 1/9/2021 she went to the gym feeling fine. That evening she felt fatigued and attributed to her workout earlier in the day. The next day she developed a severe headache with fever, sweats, chills and body aches. Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms. Patient presented to the office today on 1/12/2021 for testing and was Covid positive. Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell. At that time the duration of her symptoms was 3 days. She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness. She had the second Pfizer Covid vaccine on 1/8/2021. Patient works in administration of a medical facility. She has minimal contact with clinical staff and patients. No one in her office has had Covid symptoms or infection. Patient's other contacts are at home and the gym. She does attend a gym class with 10 other participants. She does not know whether anyone in the gym class has had symptoms.
41 2021-01-11 dry throat Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Be... Read more
Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Benadryl 25 mg po given at 8:40 and manager called to take her from work due to Benadryl
41 2021-01-11 toothache, ear pain I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which ... Read more
I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
41 2021-01-11 vision blurred, visual impairment, sensitivity to light Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and dif... Read more
Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and difficulty focusing eyes (symptoms of ocular migraine). Severe symptoms lasted 5 hours, mild symptoms lasted through the evening and next day (today I still have a mild headache and nausea). I have previously had 1 migraine (~5 yrs prior) in the setting of repeated fume exposure during a renovation at my workplace, no other history of migraine.
41 2021-01-11 vision blurred Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue... Read more
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
41 2021-01-12 dry mouth, dry eye Excruciating headache, dry mouth and eyes, Nausea and vomiting
41 2021-01-12 eye itchiness, eye pain positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have he... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain
41 2021-01-12 eye itchiness 24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the ... Read more
24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
41 2021-01-12 feeling of choking, mouth numbness POST VAC. SHOT C/O OF THROAT TINGLING, TONGUE FEELING HEAVY AND NUMB. EMS PRESENT. 1427: VS: BP:... Read more
POST VAC. SHOT C/O OF THROAT TINGLING, TONGUE FEELING HEAVY AND NUMB. EMS PRESENT. 1427: VS: BP: 143/91, O2 SAT R.A.: 98%; P: 78. 1435: VS: 144/88; 02 SAT R.A.: 98%; P: 78; 1440: LEFT SITE, NO OTHER COMPLAINTS.
41 2021-01-12 tunnel vision Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progre... Read more
Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok.
41 2021-01-13 loss of taste Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours a... Read more
Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.
41 2021-01-13 eye pain Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigu... Read more
Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.
41 2021-01-13 lip swelling swollen lip
41 2021-01-13 mouth tingling, mouth numbness Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/l... Read more
Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/lower arm for 5 days.
41 2021-01-13 mouth tingling Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no... Read more
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
41 2021-01-13 mouth tingling Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL324... Read more
Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.
41 2021-01-13 taste disorder, mouth tingling Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips... Read more
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
41 2021-01-13 ringing in ears 1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm... Read more
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
41 2021-01-13 ringing in ears I was approached by a person in the center at approx 1000 stating she had an employee that received... Read more
I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
41 2021-01-14 dry mouth Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at i... Read more
Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at injection site; Soreness at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 31Dec2020 12:45 at left arm, at single dose for covid-19 immunization. Medical history known allergies: penicillin, chocolate from an unknown date. Concomitant medication included acetylsalicylic acid (ASPIRIN) and Birth control pills. The patient previously took erythromycin and known allergies: Erythromycin. The patient was not pregnant at the time of vaccination. The patient experienced fatigue, dry mouth, low grade fever, chills, headache, itchy rash at injection site, soreness at injection site on 31Dec2020 15:00. No treatment was received for all events. The outcome of the events was recovered on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. No follow up attempts are possible. No further information is expected.
41 2021-01-14 mouth numbness Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I ... Read more
Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.
41 2021-01-14 lip swelling, mouth swelling, mouth itchiness, lip itchiness, tongue itchiness About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongu... Read more
About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.
41 2021-01-14 feeling of choking, mouth tingling Slight tingling sensation on tongue and part of throat Heart rate increased with anxiety
41 2021-01-14 sensitivity to light Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, join... Read more
Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.
41 2021-01-14 toothache, pain in jaw Tooth pain across the entire lower jaw that lasted for about 18 hours. Treated with ibuprofen.
41 2021-01-14 toothache, pain in jaw Toothache across the entire lower jaw, which lasted for about 12 hours. Treated with ibuprofen.
41 2021-01-15 dry mouth Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFi... Read more
Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFib" and heart rate was 145-155. Blood pressure became elevated much higher than baseline (Normal is 90/60). Paramedics came to evaluate and performed numerous 12-lead EKG's and noted multiple Premature Ventricular Contractions and transported me to the hospital where I was observed and consulted on from ED Physician. Later was evaluated by electrophysiology cardiologist with echocardiogram and EKG. Multiple physicians have advised not to get second vaccine.
41 2021-01-15 tongue itchiness I started itching while being monitored post vaccine administration within the 5 minutes of the vacc... Read more
I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.
41 2021-01-16 oropharyngeal discomfort, pain in jaw Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n... Read more
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
41 2021-01-17 loss of smell Sore arm, body aches, headache, cough, loss of smell
41 2021-01-17 inability to speak Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t... Read more
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-01-17 dry mouth headache, dry mouth, and arm pain
41 2021-01-17 eye pain, vision blurred, swollen tongue, mouth pain, ear pain Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a ... Read more
Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day
41 2021-01-17 oropharyngeal discomfort, ear itchiness 5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm p... Read more
5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm pain/ache- lasted less than 5 minutes. 30 minutes after vaccine rash, itching- lasted 2 days. 1 hour after vaccine- severe headache lasted 4 days. 4 hours after vaccine- ears/throat itching. Took Benadryl 50mg, Tylenol 1000mg, Albuterol Inhaler 2 puffs, and Famotidine 20 mg 4 hrs after vaccine.
41 2021-01-17 pain in jaw Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain... Read more
Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)
41 2021-01-17 vision blurred tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa... Read more
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
41 2021-01-18 eye itchiness, lip swelling, swelling around the eyes Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scrat... Read more
Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scratchy thoat. Mildly scratchy eyes. Was better by morning and gone by the next evening. Did not take Benadryl.
41 2021-01-18 eye swelling, eye itchiness 22 hours after the second dose started to have an allergic reaction, hives all over back and chest a... Read more
22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.
41 2021-01-18 eye swelling 5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/... Read more
5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/o & talking w/friend. Over the course of 30 min cheeks feeling improved but felt that cheeks remained a bit numb. L eye puffiness gone. Left amb after 45 min HR 96, BP 112/70, pulse ox 99%.
41 2021-01-18 lip swelling, mouth numbness, taste impairment tip of tongue numb; Metallic taste; lower left lip felt swollen; This is a spontaneous report from a... Read more
tip of tongue numb; Metallic taste; lower left lip felt swollen; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 and expiration date not provided), via an unspecified route of administration (Right arm) first dose on 02Jan2021 10:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Jan2021, the patient experienced metallic taste, lower left lip felt swollen, and tip of tongue numb. The patient was treated with Injection 50 mg Benadryl L thigh. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not tested for COVID-19.
41 2021-01-18 swollen tongue, swelling of eyelid Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Develop... Read more
Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Developed swelling on inner canthus L eye. Saw Dr. 1/14/21 and famotidine was ordered. This reduced hives. In 1/16/21 developed swelling of R inner canthus. Took Benadryl and famotidine hs on 1/17/21. Took famotidine 1/18/21 before work, but developed hives under arms and tongue began to swell that evening. Took another dose of famotidine. Tongue improved within 40 minutes but L side of face began to swell. Took Benadryl 50mg. Facial swelling improved but did not go away. Called Dr. this am and was ordered a Medrol dose pack. If this is not effective then she will be referred to Dr., allergist.
41 2021-01-18 vision blurred Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, f... Read more
Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed
41 2021-01-19 drooping eyelid My right eyelid drops for a second or two and then normalizes. This happens multiple times a day.
41 2021-01-20 eye swelling, eye pain, swelling around the eyes, eye twitching, eye irritation, mouth tingling tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is ... Read more
tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.
41 2021-01-20 oropharyngeal discomfort Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symp... Read more
Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symptoms resolve within a half hour and patient was released to return to work
41 2021-01-21 ear discomfort Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-e... Read more
Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-epi 3mg via epi pen. Outcome- called 911 and medics took over
41 2021-01-21 eye pain I had eye pain and drainage, body aches, abdominal pain, headache and joint pain.
41 2021-01-21 mouth tingling Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patie... Read more
Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patient had her own personal Benadryl on hand and administer 50 mg orally to self. Pt was watched for 20 minutes by EMT following administration- she reported her throat continued to feel scratchy. Patient was driven and advised to go to emergency room. hospital was contacted per EMT and informed that patient was in route to hospital following a reaction to COVID-19 vaccine.
41 2021-01-21 mouth tingling Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav... Read more
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
41 2021-01-21 vision blurred, eye discomfort Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injectio... Read more
Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injection. During waiting period experienced "vision blurring" and "pressure behind eye". Spoke with Dr, monitoring vaccine site. Advised to wait 15 more minutes before leaving. Left vaccination site and started driving home. (Around 1:40pm) Within a few minutes had "extremely sore neck, couldn't turn neck left or right without discomfort" , and felt "thickening of neck." Pain spread from neck to shoulders and mid back. Called Dr, advised to go to return if close or go to nearest ER. Was already miles away from original site so patient went to ER. Received Benadryl. Felt like "giant muscle spasm that wouldn't stop."
41 2021-01-22 mouth numbness Numbness right side of throat, right side of tongue, right side of face and right side of neck. Sym... Read more
Numbness right side of throat, right side of tongue, right side of face and right side of neck. Symptoms still present at the time of release
41 2021-01-22 mouth discomfort Chest pain, lethargy, burning airway
41 2021-01-23 mouth numbness Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbe... Read more
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
41 2021-01-23 taste disorder, mouth numbness Reports tongue numbness and strange taste at 4:10PM 415pm Benadryl 25mg and water 422 pm patient rep... Read more
Reports tongue numbness and strange taste at 4:10PM 415pm Benadryl 25mg and water 422 pm patient reports has no numbness and can't describe the taste but feels good and was able to go home instructions of any more or worsen symptoms to go ER
41 2021-01-24 lip itchiness Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given ... Read more
Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given Benadryl 50mg Im to L Deltoid. She said within 5 minutes she was feeling better already. She called a friend that is a nurse practicioner to come and pick her up. no other problems noted
41 2021-01-24 swollen tongue, mouth tingling At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki... Read more
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
41 2021-01-24 swollen tongue This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immun... Read more
This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.
41 2021-01-25 ear pain Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tma... Read more
Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tmax 100.4. Also states she had visual hallucinations, "wild" dreams, and seemed "incoherent" when talking with her husband. All symptoms have resolved but still has swollen lymph nodes in neck that wax and wane. Also c/o right side ear pain and right side sore throat x 2 days. Right side ear pain started on 1/24/21, 5 days after vaccine.
41 2021-01-25 mouth tingling, swollen tongue heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the to... Read more
heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-01-25 swollen tongue Hives, itching, tongue swelling
41 2021-01-25 visual impairment Itchy throat, sudden warmth, see spots, chest tightness.
41 2021-01-26 deafness, visual impairment, blindness seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss o... Read more
seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
41 2021-01-26 eye bleeding Woke up on broken blood vessel in left eye: sub conjunctival hematoma
41 2021-01-26 eye irritation weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding... Read more
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
41 2021-01-26 mouth numbness severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left... Read more
severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested.
41 2021-01-26 mouth tingling, swollen tongue Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial a... Read more
Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial and tongue swelling. Followed by 1 week of swollen glands and tender jaw.
41 2021-01-27 ear pain I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed he... Read more
I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed headaches and increasing ear/TMJ pain up until today (1/28). The TMJ and ear pain is less today, but it's still difficult to open my mouth. I have tried Tylenol and Ibuprofen to alleviate the discomfort, but the OTC meds to not help.
41 2021-01-27 mouth numbness, mouth tingling 15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips... Read more
15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips - "very subtle". Lasted one hour then subsided. No return to numbness or tingling as of 1/28/21.
41 2021-01-27 oropharyngeal discomfort Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 mi... Read more
Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 minutes patients symptoms resolved and patient felt back to normal, leaving the clinic without further issues
41 2021-01-27 pain in jaw Headache, Jaw pain/stiffness.
41 2021-01-27 pain in jaw Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a... Read more
Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the right arm on 09Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included thyroid cancer. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath with activity, night sweats, and right jaw pain on 11Jan2021. Right jaw pain resulted in physician office visit. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.
41 2021-01-27 mouth tingling 40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s.... Read more
40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.
41 2021-01-27 swollen tongue PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 1... Read more
PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 10ML. PATIENT SENT TO ED.
41 2021-01-28 taste impairment weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; T... Read more
weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering. Information on the lot/batch number has been requested.
41 2021-01-28 ear pain, ear discomfort It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches a... Read more
It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.
41 2021-01-28 eye itchiness "Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove h... Read more
"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.
41 2021-01-29 mouth numbness Numbness of lips on 1/28/2021 and then developed numbness of tongue and eye would not close. Saw ph... Read more
Numbness of lips on 1/28/2021 and then developed numbness of tongue and eye would not close. Saw physician who treated her with steroids, anti-virals and OTC eye drops for lubrication of eye.
41 2021-01-30 mouth discomfort, mouth swelling At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute ma... Read more
At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute mark: Still coughing Swollen mouth Lips burning and itchy - took Flovent inhaler and drank water About 45 minutes Same and worse , nurse gave me 25 mg of Benadryl After about 20 minutes coughing reduces, Swelling reduces but still itchy in moisture Still swollen at about 30 minutes of the Benadryl and the nurse gave me another dose of Benadryl. Symptoms started to get somewhat better I was very tired from the Benadryl Next day my mouth was still swollen Next day chest was very very tight and took inhaler constantly Third day after vaccine had an asthma attack, hadn?t had an asthma attack since I was in middle school. Dr prescribed prednisone and to take Zyrtec along with my inhaler I cannot return to exercise until 10 days after the start of prednisone
41 2021-01-30 swelling of eyelid Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the n... Read more
Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the night. Hives covered 95% of body, including eyes which began to swell shut. Took 50mg Benadryl with little relief. Went to Urgent Care and was given: 01/31/2021 0836 famotidine (PEPCID) injection 40 mg 40 mg Intravenous 01/31/2021 0836 diphenhydrAMINE (BENADRYL) injection 25 mg 25 mg Intravenous 01/31/2021 0836 methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg 125 mg Intravenous 01/31/2021 0840 EPINEPHrine (EPIPEN) injection 0.3 mg 0.3 mg Intramuscular Raised lesions started to flatten 1.5 hours after medications were administered Dx to home with prescription for Epi Pen, prednisone PO 60mg 1dose/day and instructed to continue taking 50 mg Benadryl q4-6 hours and Pepcid OTC 1 dose per day. Instructed to follow up with PCP in 1 week.
41 2021-01-31 vision blurred, sensitivity to light 12/18/20: I recieved first dose Covid vaccine, 12/20/20: developed blurry vision, diminished color,... Read more
12/18/20: I recieved first dose Covid vaccine, 12/20/20: developed blurry vision, diminished color, altered depth perception, light sensitivity in right eye, 12/21/20: exam by opthalmologist (Dr), 12/23/20: MRI with and without contrast: showed active inflammation on right optic nerve, optic neuritis - referred to neuro opthalmologist, 12/29/20: examined by Dr. (neuro-opthalmologist), confirmed optic neuritis and referred to Dr. (neurologist) for further eval of possible MS, 01/18/21: virtual meeting with Dr., labs ordered. 02/01/21: no treatment to date and I am still experiencing all original symptoms, though have slightly improved since initial onset. Planned follow up with Dr. (neurologist) this week and follow up with Dr. (neuro-ophthalmologist) next week
41 2021-02-01 mouth numbness Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, pani... Read more
Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.
41 2021-02-01 swollen tongue Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose recei... Read more
Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose received on 1/12/2021 without any problems or reaction. Patient reported history of anaphylaxis to shellfish so she was asked to wait 30 minutes post vaccination for observation. Around 15-20 minutes after receiving vaccination, it was noted patient was rubbing her throat. RN at vaccine clinic asked patient if she was ok and she reported she was fine, she thinks it is in her head. RN noted she continued to rub her throat and asked her to describe what it felt like. Patient felt sensation of tickle in her throat and asked for water. Patient also noticed began to itch all over. Patient provided water and 25 mg PO Benadryl. Patient noted it felt like her throat was starting to close and her tongue felt it might be swelling. Epinephrine 0.3 mg IM was administered at 12:07 and patient arrived in ER at 12:08. Patient received another dose of IV benadryl and famotidine and kept for observation. She was discharged home after a couple of hours.
41 2021-02-01 swollen tongue 4 minutes- severe dizziness 6 minutes throat and tongue swelling 8 minutes - asthma attack
41 2021-02-03 extreme sound sensitivity, sensitivity to light Both times I received the vaccine on the third day I my migraine was triggered and I experienced se... Read more
Both times I received the vaccine on the third day I my migraine was triggered and I experienced severe migraines, nausea and vomiting with extreme pain and sensitivity to light and sound. I also experienced severe body pain after both shots. I did not see my physician who I listed but she has notes about my history or migraines. It was suggested on the CDC tracking app to report here too since my reactions were severe.
41 2021-02-03 mouth numbness Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating his... Read more
Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating history of anaphylaxis to iodine. 30 minutes after vaccination, client reported she had numbness of her tongue (anterior 1/3), some numbness of her lower cheeks/jaw. No difficulty breathing. BP120/85; HR 80. After a few minutes was reassessed and vitals were unchanged. Client felt anxious. No rashes, no breathing issues but continued anxiety and symptoms of numbness continued. 911 called. EMS assessed and vitals unchanged. Numbness lessened to just tip of tongue. Normal speech. EMS did not transport and father arrived to pick her up at 12:15 pm.
41 2021-02-03 oropharyngeal discomfort, inability to speak My throat feels like its closing up, it doesn't feel very sore but my voice is very hoarse.
41 2021-02-04 lip swelling Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills;... Read more
Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered. Information on the lot/batch number has been requested.
41 2021-02-05 feeling of choking, mouth tingling Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachyca... Read more
Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not. However, PCP felt pt should go ahead and take the second dose. Pt's baseline HR is around 66. HR taken - 73. Patient said it felt like pins on her tongue. Drank one bottle of water, denied SOB or throat issues. HR monitored for another 30 minutes and returned to baseline. Patient had another bottle of water and tinglyness dissipated. Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.
41 2021-02-06 ear pain Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morn... Read more
Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morning. 2nd dose, felt foggy, L arm pain & bad headache hours after. Fatigue the same night, had chills, couldn?t sleep and woke up with a temp of 100.3, sinus & ear pressure/pain, congestion & then a runny nose, headache, L arm & neck pain, felt like I was swallowing rocks, sore throat, diarrhea
41 2021-02-08 ear discomfort, ringing in ears Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. ... Read more
Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. By Thursday/Friday I noticed that it seemed as though the glands in my neck were swollen (slightly affecting my salivary glands especially on left side). My left armpit is very swollen and remains swollen to today. By Friday and into Saturday and currently I developed tinnitus in both ears. My ears feel stuffy, like I went up in an airplane and they need to pop. The tinnitus is really loud, especially at night and has triggered my anxiety. I?m so upset and scared I?ll have tinnitus for life now. I?m an avid bird watcher and I?ve also prided myself on excellent hearing, so I?m taking this hard. Very, VERY, scared.
41 2021-02-08 mouth tingling Patient felt itchy throat and felt like her tongue was tingling about 12 minutes after vaccine admin... Read more
Patient felt itchy throat and felt like her tongue was tingling about 12 minutes after vaccine administration. Was evaluated in clinic and found to be AAOx3, NAD, nontoxic, no swelling of lips or tongue, lungs CTA with good air entry, regular rate and rhythm, given x1 dose of diphenhydramine and transported to the Emergency Center where she was evaluated again. Found to be in similar condition as above so given an additional 75 mg total of diphenhydramine. Sent home after short observation period.
41 2021-02-08 mouth tingling I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness a... Read more
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
41 2021-02-09 ear pain Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This ... Read more
Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 22Jan2021,16:30 at SINGLE DOSE (first dose, left arm) for COVID-19 immunization. Medical history included allergies: Latex from an unspecified date. Patient did not have COVID-19 prior vaccination. Patient is not pregnant. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced head and nasal congestion, ear ache, body aches, fatigue and, sore arm all on 23Jan2021 01:00. No treatment was given. Patient was not tested for COVID-19 post vaccination. Outcome of the events was recovering.
41 2021-02-09 ear pain States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 162... Read more
States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 1625 BP 104/? O2 sat unable to obtain due to cold periphery 1630 BP 118/? O2 sat 97% cold periphery 1640 BP 137/86 HR 76 O2 sat 98% RR 16 lungs clear 1645 BP 127/75 HR 70 O2 sat 100% RR 16 1650 BP 130/79 HR 70 O2 sat 100% RR 18 lungs clear After 40 minutes stated felt better provided snack bar, apple and water was able to leave area at a baseline level.
41 2021-02-09 eye itchiness Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen... Read more
Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-02-09 mouth numbness, loss of taste, mouth tingling This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284) on 1/7/2021. She reports be... Read more
This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284) on 1/7/2021. She reports being in good health, had no illness exposures (does work in hospital with children), and had no recent travel. She reports following her Covid vaccination, she had a sore arm at vaccine site for 4-5 days with no other issues. On 1/31 (day24) while putting on lipstick to take a selfie to send to her friend she noticed the right side of her lower face (lip area) felt "weird"- tingled and the corner of her mouth would not smile symmetrically with left. Her friend commented something was off with this picture. The next day this droop worsened with loss of facial lines/wrinkles on right (nasolabial fold), had tingling/numbness to lips and corner of mouth and inability to smile on right. This prompted her husband to bring her to the ER on 2/1/2021. She denied any fever, headache, weakness to arms/legs, no SOB/CP, dysphagia or speech issues or trauma. ER providers exam noted normal CN evaluation but documented mild right sided decrease in nasolabial fold vs left and loss of taste to anterior right tongue. She had no involvement of eye or forehead. She was diagnosed with early Bell's Palsy and treated with oral steroids and anti-virals. AS of 2/10/2021 with use of medications, she advised her facial weakness/droop had resolved but still has tingling. Her smile is symmetrical at this time. No c/o on loss of taste. Has diagnosis of Bell's Palsy. IHD case 9967.
41 2021-02-09 toothache At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front ... Read more
At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front 4 teeth were in so much pain I cried. I took 100mg of Tylenol and the pain lessened in about 2 hours. At approximately 10am on 2/5/21, I became clammy with shivers yet I was feeling over heated. My temperature was 99.3 degrees. I did not take any medicine but instead took a nap. When I woke up, my temperature felt normal. I did feel dizzy until around 4:3pm that same day. I still get headaches in the front of my forehead since 2/5/21.
41 2021-02-10 ear itchiness, mouth itchiness Itchy mouth, swollen face, itchy scalp, itchy ears
41 2021-02-10 ringing in ears I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have... Read more
I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have difficulty concentrating and sleeping. I happened to tell someone else about this and she reported that her Tinnitus was significantly worse following dose #2 of Pfizer vaccine.
41 2021-02-11 eye irritation, eye itchiness Hard to breath right chest but took inhaler and was better. Hives took 50 mg of Benadryl at sight th... Read more
Hard to breath right chest but took inhaler and was better. Hives took 50 mg of Benadryl at sight then after one hour went to primary Dr to get checked out. Was told to take 25-50 mg of Benadryl every two hours and Pepcid 20 mg one tablet 2 time daily, itchy burning eyes use eye drops, come and go since 01/29/2021. I get really tired and upset stomach also 2/09/2021
41 2021-02-11 mouth pain, toothache, pain in jaw About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet. Within abo... Read more
About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet. Within about an hour of one tooth hurting, all of my upper molars and jaw hurt and had a nerve sensation. It was like the roots of all the molars were irritated. The nerve sensation also felt like it was in the upper jaw/face area. My entire pallet became irritated. This lasted for about two hours and then went away completely.
41 2021-02-12 mouth numbness Information reported by individual involved as follows. AFTER 2ND VACCINE OF PFIZER I HAD SEVERE MU... Read more
Information reported by individual involved as follows. AFTER 2ND VACCINE OF PFIZER I HAD SEVERE MUSCLE ACHES AND FEVER ABOUT 12 HOURS POST VACCINE WHICH IS EXPECTED DIAGNOSED MILD CASE OF BELLS PALSY. LEFT SIDED FACIAL NUMBNESS TO CHEEK, TONGUE, MOUTH GUMS, INCREASED SNORING, THESE SYMPTOMS WERE NOTED SHORTLY AFTER VACCINE #2. I DID NOT PUT IT TOGETHER AT THE TIME THAT I WAS HAVING REACTION TO THE VACCINE ONLY AFTER DOING SOME RESEARCH ON WHAT COULD BE LEADING TO LEFT SIDED TONGUE NUMBNESS DID I REALIZE I COULD BE HAVING BELLS PALSY A REACTION TO THE VACCINE. WENT TO EMPLOYEE HEALTH ON 2/1/21 AND THEY NOTED POSTIVE MILD CASE OF BELLS PALSY. AFFECTED IS LEFT SIDE OF FACE, GUMS CHEEK TONGUE AND SLIGHT DROOP
41 2021-02-12 mouth tingling 7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that m... Read more
7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that my Heart rate went from 88 to 141 in the past 5 minutes while sitting. I then felt flushing throughout my body. I had the sensation of tingling on my face and lips and told the present employees that I felt weird. They retrieved the doc, who then took my pulse ox - registered at 96/97. Then they took my blood pressure and it was 180/100 (I typically have low blood pressure 98/60). I started to feel disequalibrium and nauseous and the doc to be back to a room. She administered a dose of IM EPI and IM benedryl and called EMS. My symptoms persisted and the doc told the EMS workers I had urticaria on my face during her case presentation. I was transported to the ED, where I was monitored. My symtoms had reduced following epi and benedryl but returned when I was in the ED. The doctor administered pepcid and solu-medrol and zofran. They also conducted and EKG- reportedly normal. These medications helped control my symptoms and my BP had returned to normal (120/70) following meds. discharged on a tapering dose of steriod and zofran prn.
41 2021-02-15 mouth numbness Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine ... Read more
Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine were reported or noted. Per patient, after she left our office, at 12:20 pm, she experienced "chest tightness, racing heart rate, could not feel her tongue and throat was tight." She went home, took Benadryl (25 mg) and she was "ok" after that - symptoms subsided. She followed up with her primary care provider, who advised her not to receive the second vaccination due to this adverse reaction. Patient informed our office, of her adverse reaction on 2/15/21 - we are reporting today because she was able to provide more information regarding the event.
41 2021-02-17 dry throat 41 y old female received first dose of her COVID vaccination, she started feeling dizziness and mild... Read more
41 y old female received first dose of her COVID vaccination, she started feeling dizziness and mild sensation of dry / inflamed throat. she denied any sob, wheezing, chest pain, rash, or any other sx. denies pervious allergies. PE: lungs ; CTA bil , heart; RRR. neuro: alert and oriented. responding. 08;15: BP: 146/88, HR: 72 O2:100% 08:38: BP: 152/86 HR: 67 Sats: 100% - pt was feeling much better and denied any sx Pt was monitored for 30 mins and reported resolution of sx before she left the clinic. she was able to drink apple juice without any issues.
41 2021-02-19 ear discomfort Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night c... Read more
Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night chest was flushed. Flushing lasted about 2 hours Dose 2: Due to flushing with last infusion, nurse told me to wait there 30 minutes after infusion. About five minutes after starting getting a headache and left ear was stopped up. Was told to take Benedryl if rash(flushing) came back with this infusion and to report symptoms to CDC. Headache and nausea felt till next day. Felt sick and headache riding in car. At 0130 am on 2/18/21 was awoken by pain under right arm. Very mild swelling noted but very sore to put arm down and tender to touch. Underarm still sore as of today Feb 20, 2021. Second day joint pain in shoulders, elbows, fingers, and knees. Joint pain improved but still there as of Feb 20, 2021. Ibuprofen and Tylenol did not help headache or joint pain. Third day headache off and on with nausea once, right hip pain. Feb 20, 2021 Fourth day underarm and joint pain improving , nasal and ear congestion
41 2021-02-20 tongue disorder, lip swelling, taste disorder got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being t... Read more
got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being taken away and the taste (just like after getting an IV cleaned with saline). Nurses told me to sit up front to be observed and waited 30 minutes. After the 30 minutes, I began getting very warm (went outside to get fresh air); went to vehicle, took mask off face, was still feeling very hot, Face was bright red, lips were very red (looked like I had on makeup and I didn't have any on). Took 4 children's Benadryl (dissolvable). Went back to work. redness started to go away. Throughout the morning, I continued having the feeling of breath being taken away and the taste. It wasn't as bad, so I didn't worry. My lips were not too swollen, face was still swollen. I have had MANY reactions to food allergies and didn't wanna "cause" a scene. By 1:30, I was in a meeting trying to talk and my tongue started to feel thick and it was harder to talk. I took 2 adult Benadryl's and tried to work some more to keep my mind off of the reaction. I ended up being very tired and laid down. I slept till about 5pm and seemed okay after. Nothing else was done. My muscle was sore, no other symptoms.
41 2021-02-21 lip itchiness, swollen tongue itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongu... Read more
itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat
41 2021-02-21 lip swelling During the 15 minute observation period, pt reported upper lip swelling and hives on face.
41 2021-02-21 mouth tingling Flushing, tachycardia, lip tingling
41 2021-02-22 mouth tingling, swelling around the eyes, eye itchiness, swollen lips Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The followi... Read more
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
41 2021-02-24 mouth discomfort About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burn... Read more
About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burning waves down both sides of my spine (just to the left and right) starting in my neck and settling in my groin. It felt like intense burning and buzzing waves going down from my neck. The paramedics came, said there were no signs of anaphylaxis, and took me to ER. They gave me benedryl and pepcid in an IV, I felt drowsy. The waves eventually subsided and were gone around the time of the benedryl (not sure if before or after).
41 2021-02-25 ringing in ears Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance.... Read more
Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
41 2021-02-25 tongue disorder Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received... Read more
Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received 50 ml injection at that time. All symptoms resolved within 5 hours.
41 2021-02-26 thirst Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The nig... Read more
Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The night of 2/25 (almost 6 days later) experienced flu like symptoms - chills, shaking due to cold, fever, thirst, joint and body aches, light headedness, fatigue. Morning of 2/26 chills and fever had subsided, had 8/10 severity headache that gradually decreased throughout the day. Body aches gradually subsided throughout the day and all symptoms were resolved by 6pm on 2/26. I had very similar symptoms after my first dose as well - initial injection 1/29 at 12:30pm, flu like symptoms began early morning of 2/1 that lasted about 15 hours.
41 2021-02-27 mouth numbness Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms s... Read more
Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms subsided after 60 minutes. I also experienced dizziness and weakness right after taking the vaccine, which lasted for 24 hours. Other symptoms include tiredness, headache, muscle pain, chills, low-grade fever, and nausea, which have lasted for 24 hours and continue now.
41 2021-02-28 double vision, visual impairment MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in ... Read more
MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in the pons at origin of cranial nerve 6; single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6; Development of double vision/double vision with right gaze and head turning; mild chills; headache; significant diarrhea; vision noted to be off; This is a spontaneous report from a contactable other health care professional, the patient. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 14Jan2021 at 01:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included spontaneous coronary artery dissection with stenting (reported as "five years ago") and complex migraines from an unspecified date. The patient is allergic to Tramadol, Codeine and Novocaine. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899) on 23Dec2020 at 01:15 AM as a single dose in the left arm for COVID-19 immunization.The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN).The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported the development of double vision on 25Jan2021 at 06:00. She was hospitalized and remained hospitalized for three days. She reports having had an MRI (date not specified) which showed an inflammatory lesion of the Pons. She further described the events as follows: Initially mild chills and headache "the day after" developing into significant diarrhea for four days and on and off diarrhea for several weeks. One week after vaccine vision noted to be off but no official work up developing into double vision with right gaze and head turning three weeks after vaccine. She also stated that there was a single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6. Treatment received included Solumedrol and Pepcid infusion. Lab data included an MRI on an unspecified date which showed inflammatory lesion of the Pons and COVD-19 testing as follows: SARS-CoV-2 Nasal Swab PCR test on 20Jan2021 and on 11Feb2021 both of which were negative. The clinical outcomes of brain inflammation, double vision, chills, headache, diarrhea, vision decreased and cranial nerve disorder were reported as recovering. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-02-28 thirst Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday mor... Read more
Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday morning was restless sleep and headache with severe joint pain and thirst. All Saturday same. Skin hurt to touch and knees and finger knuckles hurt to touch. Vomiting. Throbbing injection arm pain and the urge to constantly stretch all limbs. Sunday all subsided except the throbbing arm pain. Sunday evening at 8 pm throbbing arm worse and headache. Monday 3am restless sleep and miserable comfortableness. Throbbing arm and restless painful shockwaves through entire body. Skin severely hurt to touch. Went to the ER. Treated with Atavan and prescription Motrin.
41 2021-02-28 ringing in ears ringing/buzzing in ear, pain/heaviness, headache
41 2021-03-01 eye swelling pt stated that soon after she received the covid vax she felt like the back of her neck was on fire.... Read more
pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.
41 2021-03-01 oropharyngeal discomfort, mouth tingling Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
41 2021-03-01 pain in jaw Sore arm Jaw pain Skin sensitive on face Headache
41 2021-03-02 loss of taste, mouth numbness Patient received her second covid 19 vaccine on the 18th of February - about four hours after she de... Read more
Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room
41 2021-03-02 eye itchiness, taste impairment face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really... Read more
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
41 2021-03-02 mouth numbness, drooping eyelid On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakn... Read more
On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakness began spreading to my right cheek and right side of lips. By 3/2/21 the numbness weakness covered the entire right side of my face and caused mouth and eye droop. Went to the ER and was diagnosed with Bell?s Palsy.
41 2021-03-02 lip swelling My lips got swollen after 24 hour of vaccine, took Benadryl but lips are still swollen after takin i... Read more
My lips got swollen after 24 hour of vaccine, took Benadryl but lips are still swollen after takin it.
41 2021-03-02 swollen tongue Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. o... Read more
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.
41 2021-03-02 tongue disorder Reports symptoms began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her ... Read more
Reports symptoms began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her tongue and roof of mouth, taste was off. on 3/3/21 midnight was awakened from sleep from pain in all of her joints, back and neck. Experienced dizziness and fatique in the morning.
41 2021-03-03 mouth numbness, mouth tingling With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in m... Read more
With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in my legs and tingling on my tongue. Took Benadryl - tongue tingling went away and the legs tingling and numbness was the same and started getting worse - they monitored my vitals and everything looked good and numbness remained. I had a driver and they allowed me to leave due to the Benadryl _ just took that one dose of Benadryl (didn't take anymore after that) and then the numbness in my legs remained for about two and a half weeks. I used a cane for two days. I had a fever and chills that first night, body aches and injection site pain and severe fatigue and those symptoms lasted one day except fatigue was for three days. The day after the shot was the worse of the symptoms. They followed up with me that evening and they followed up with me at work. I had the next dose - February 4, 2021 and experienced everything except the numbness in the tongue. Informal doctor visit because I work there.
41 2021-03-03 lip swelling Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccinat... Read more
Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.
41 2021-03-03 mouth tingling, taste impairment After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in... Read more
After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in her arms and lips. She struggled to get up. Her breathing seemed fine but neck was red. She laid on floor with legs elevated until her dizziness subsided. She originally said she felt better but then dizziness returned. Called 911 and had Epi-pen ready. She was breathing fine when paramedics arrived. Her husband later called at 7:45pm and reported she was feeling fine. He said the emergency room gave her a steroid, anti-histamine, and pepcid. She is not going to receive the second covid shot. Her husband later stated she got a full body rash when she had covid. I also advised them to register on the v-safe site.
41 2021-03-04 ear discomfort Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes th... Read more
Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.
41 2021-03-04 mouth tingling, taste impairment Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21.... Read more
Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21. She reports she took a nap yesterday after getting home and felt better afterwards. Today she feels well. Denies any other questions or concerns. She is appreciative of the phone call. Progress Notes at 2/28/2021 7:34 AM Expand AllCollapse All VACCINE CLINIC 2/24/2021 Subjective Patient is a 41 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. She does mention having a history of anxiety and did take her duloxetine and Wellbutrin today. Denies use of her Ativan recently. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness and headaches Patient denies chills, facial swelling, chest tightness, shortness of breath and wheezing +nausea and metallic taste in mouth: Previous Reactions: Denies Objective Vitals Vitals: 02/24/21 1427 02/24/21 1434 BP: 126/70 112/68 Pulse: 81 80 SpO2: 99% 96% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol and water Follow up response to treatment: good. She noted some lightheadedness prior to discharge but other symptoms were improved. I walked patient around the bay area and she was feeling okay. Her vitals were stable. Pt was escorted out of the facility. Patient discharge: Stable to go home and follow up with PCP. Electronically Signed 2/24/2021 2:43 PM
41 2021-03-06 taste impairment, mouth tingling Metallic taste in the mouth, tingling of the mouth, nausea. Refused evaluation from EMS, cleared by... Read more
Metallic taste in the mouth, tingling of the mouth, nausea. Refused evaluation from EMS, cleared by medic on site.
41 2021-03-07 hearing loss 1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body ache... Read more
1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body aches, low grade fever, woke up early morning (6 or 7am) with nausea, weakness- husband had to help me to bed, headach by 4pm fever was getting higher, body aches and chills worsen. Called Telehealth for support and was advised to go to ER At ER arrived with high fever, full rigor, bones felt like they were breaking one by one so bad body aches, chills 1/12/21: First day of cognitive issues - sever fatigue, could not comprehend anything, could not work or do school 1/17/21: Realized the cognitive issues were bad and needed to see DR, dizziness, audio distorted, couldn't follow directions 1/18/21: First Dr apt at medical center Currently still in Dr's care 2/23/21: First Nuro apt with specialist
41 2021-03-07 lip swelling, eye swelling o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief... Read more
o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction. Pt fell asleep on the couch approx 2200. She awoke 2 hours later with itching of her hands. Over the next hour she developed a full body rash, itching, and swelling of face. No wheezing, no difficulty swallowing. Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs. No h/o allergic reactions, no h/o asthma. Emergency Department Course and Clinical Decision Making: Patient presents with urticaria and swelling to her face eyes and lips. Shortly upon being roomed she started to feel very nauseated and started vomiting. No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis. Patient was immediately given epinephrine intramuscularly, 0.3 mg. An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran. Patient's urticaria and swelling started to nearly immediately improved after the epinephrine. She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan. 0500 Pt has been resting. Urticaria resolved, swelling to face resolved. Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations. Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.
41 2021-03-07 swollen tongue At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noti... Read more
At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noticing nausea, headache and a neck ache. Within 5 minutes of these symptoms, my tongue felt swollen and my speech was slowed and slurred. Within ten minutes of these symptoms occurring, my nausea went away as well as my swollen tongue and speech problems. The neck ache and headache progressed into a migraine. I took Tylenol and went to sleep. I woke four hours later with abdominal pain, nausea, head ache and neck ache as well as pain at the injection site. Again I took Tylenol. I experienced fatigue, migraine, neck and back ache, night sweats and axillary adenopathy over the next 5 days. Today is day 6 and I haven't gone a day without neck pain and headache yet. It usually occurs in the afternoon. I continue to take Tylenol and it feels better.
41 2021-03-08 eye irritation, oropharyngeal discomfort Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes,... Read more
Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes, face, abdomen Nauseous Pressure in head/face/ears Throat discomfort Headache Overall sick feeling Over the next couple days, my lips have broken out. I have some small mouth/tongue sores. Feeling of a cold coming on. Sinus pressure. Throat discomfort, congestion. Sneezing. Eyes burning. Face burning. Itchy patches on scalp. Face breaking out.
41 2021-03-09 swelling of eyelid I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw th... Read more
I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.
41 2021-03-09 vision blurred, taste disorder, lacrimation increased, ringing in ears Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s... Read more
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
41 2021-03-10 mouth numbness She received the vaccine at 0930 and had itching her lips became numb shortly after starting around ... Read more
She received the vaccine at 0930 and had itching her lips became numb shortly after starting around 1200. She developed hives around her entire body on her left jaw, face, arms, and rack. Rash resolved within 24 hours with a lot of Benadryl.
41 2021-03-10 mouth tingling lips and tongue tingling, lump in throat. Evaluated by EMS-Cleared
41 2021-03-10 swollen tongue, oropharyngeal discomfort ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR T... Read more
ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR TO COMMING FOR SECOND VACCINATION AT 1125 12:57 PT STATES S/S OF ANAPHYLACTIC REACTION, SCRATCHY THROAT, TONGUE SWELLING, HIVES, ITCHING VS TAKEN: HR 120,RR 20,BP 150/78, SPO2 100% RA 1258: EPI PEN GIVEN X 1 IM TO LEFT VASTUS LATERALIS, PT TOLERATED WELL. 1259: SQUAD AND ER NOTIFIED FOR NEED OF TRANSPORT TO CPH. 1301:DEXAMETHASONE10 MG IM IN RT LETOID GIVEN X 1, PT TOLERATED WELL. 1305: 20 GUAGE SL PLACED TO RT WRIST. PT TOLERATED WELL. 1315: REPEAT VS TAKEN AND STABLE HR 95, RR 20, BP 140/74, SPO2 100% RA. 1315 RESCUE ARRIVED AND TRANSFERED TO CPH
41 2021-03-11 lip itchiness Anaphylaxis, swollen throat, itchy lips, hives.
41 2021-03-12 mouth tingling FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HA... Read more
FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HANDS AND LIPS WITH LIKE PADDING AND TINGLING. PAIN IN THE INJECTION SITE.
41 2021-03-13 lip swelling The day after the vaccine, my top lip started to swell, burn a little and slightly red. I have had J... Read more
The day after the vaccine, my top lip started to swell, burn a little and slightly red. I have had Juvederm lip injections for almost 2 years but had recently gotten a touch up on only my top lip last November of 2020. Bottom lip is fine. Consulted with my doctor. Took Benadryl and was prescribed Claritin and steroids.
41 2021-03-14 ear discomfort 1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, ... Read more
1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, PRESSURE IN RT. EAR AND HEADACHE: 1145. 1150 LOWERED TO THE GROUND, STATING SHE COULD NOT BREATHE. EMS CALLED. EPI VIA IM (PEN) ATTEMPTED X3, 3RD DOSE SUCCESSFUL. EMS ARRIVED SHORTLY AFTERWARDS.
41 2021-03-14 swollen tongue Sensation of tongue swelling during observation-about 15 minutes after vaccine, Medical Emergency te... Read more
Sensation of tongue swelling during observation-about 15 minutes after vaccine, Medical Emergency team called and arrived less than 10 minutes after call, they assessed and brought pt to ED. Pt's vitals were recorded & stable and information sheet given to ED team. Copy scanned into pt's chart.
41 2021-03-14 visual impairment A day after the second dose, vision in my right eye was impacted. It progressively got worse. I saw ... Read more
A day after the second dose, vision in my right eye was impacted. It progressively got worse. I saw an eye doctor for an emergency visit on Saturday, 3/13. He did a full exam with dilation, and suspects it is an optic neuritis. Today, I had a visual field test, but I am unaware of the results yet. There has been no improvement in my vision since Saturday when I saw the doctor.
41 2021-03-15 swelling of eyelid very swollen eye lids for around 24-48 hours
41 2021-03-15 vision blurred Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn... Read more
Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn't breathe at 9:55am. She showed no signs of any breathing difficulty. Patient reported a past history of anaphylaxis to bee stings. At 9:57am 50mg of Benadryl was given. 9:58 am she reported she was sweaty, had blurred vision, and was hot. At 10:05, patient said she started to feel better. We asked that she wait the full 30 minutes. By 10:20am, she was feeling fine and the symptoms had resolved.
41 2021-03-18 loss of taste, loss of smell Loss of smell and taste, body achy, nausea,
41 2021-03-18 mouth discomfort, tongue discomfort I had dizziness and a headache that jumped around my head within 20 minutes of the shot. About two h... Read more
I had dizziness and a headache that jumped around my head within 20 minutes of the shot. About two hours in it felt like my tongue was increasingly getting heavier and heavier for around a 10 minutes timeframe. It then stopped but for two days it felt like I had burnt my tastebuds. Starting two days ago I have developed a red rash on my arms that burns at times and seems to come and go.
41 2021-03-19 dry mouth, thirst Dry mouth and thirst
41 2021-03-19 oropharyngeal discomfort 10:54 Throat thick, report feeling "funny"/ strange. BP 110/60 10:57 EPI administered, BP 110/80 Th... Read more
10:54 Throat thick, report feeling "funny"/ strange. BP 110/60 10:57 EPI administered, BP 110/80 Throat feels better. Shaky. 11:02 Transported
41 2021-03-19 tongue itchiness, mouth itchiness 25 minutes after vaccine shot: throat started to get itchy 30 minutes after vaccine shot: roof of mo... Read more
25 minutes after vaccine shot: throat started to get itchy 30 minutes after vaccine shot: roof of mouth and tongue started to get itchy - went to see nurse : took 50mg Benadryl 40 minutes after vaccine shot: difficulty swallowing: need to clear throat 50 minutes after vaccine shot: nurse suggested taking my EpiPen but I was still able to breathe (all other symptoms were still very present Approximately 25-30 minutes after taking Benadryl symptoms began to subside. No EpiPen was administered. Approximately 95 minutes after vaccine shot: symptoms were reduced enough to go home.
41 2021-03-20 bloodshot eyes Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face... Read more
Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
41 2021-03-21 eye irritation, eye pain Red eyes, painful and burning . Went to the ER and then was sent to ophthalmology and was diagnosed ... Read more
Red eyes, painful and burning . Went to the ER and then was sent to ophthalmology and was diagnosed with keratoconjunctivitis. The doctor said she has seen this in patients that receive the Covid shot.
41 2021-03-21 eye swelling Swollen eyes burning skin jittery feeling
41 2021-03-21 ringing in ears Tinnitus in left ear started less than 2 hours after vaccine and hasn?t let up since
41 2021-03-22 ear discomfort, oropharyngeal discomfort, oral mucosal blistering, burning mouth syndrome I took a bite of an apple around 2 pm the day of the injection and the roof of my mouth immediately ... Read more
I took a bite of an apple around 2 pm the day of the injection and the roof of my mouth immediately blistered up. The glands at the back of my tongue were inflamed, my epiglottis hurt and my esophagus hurt the whole way down to my stomach in my chest. My inner ears felt pressure and throbbed. By that night my whole tongue hurt and I couldn't touch anything to it. This reaction stayed like this for 2 days and each time I tried to eat anything -even soft foods like yogurt- the roof of my mouth blistered up. My esophagus and epiglottis felt damaged. I ended up not eating much for a couple of days due to the pain and reactions.
41 2021-03-22 ear discomfort, tunnel vision About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt ... Read more
About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription
41 2021-03-22 mouth numbness lip numbess and throat tightness
41 2021-03-22 mouth tingling, taste impairment Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into nec... Read more
Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.
41 2021-03-22 mouth tingling Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; ... Read more
Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; worse around lymph nodes (axillary, neck, and inguinal). No rash, fever, shortness of breath, swelling of tongue/throat/lips, eye redness, palpitations, fever. Erythematous skin.
41 2021-03-23 mouth tingling, mouth numbness, lip swelling Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minut... Read more
Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.
41 2021-03-23 ringing in ears, vision blurred 3-23-21 4:16PM PT STATES 'EYES FEEL WEIRD, HARD TO REFOCUS QUICKLY AND EARS RINGING'. PT PLACED IN C... Read more
3-23-21 4:16PM PT STATES 'EYES FEEL WEIRD, HARD TO REFOCUS QUICKLY AND EARS RINGING'. PT PLACED IN CHAIR. A/O, PINK, W/D, RESP REG WITH EASE. PERLA. NO NEURO DEFICIT. GOOD MOTOR/SENSORY NOTED. COMFORT GIVEN. 4:17PM STATES SHE 'FEELS BETTER NOW'. 4:25PM AMBULATORY TO EXIT - GAIT BRISK AND STEADY. NO DISTRESS NOTED. 3-24-21 9:45AM PT STATES SHE 'FEELS MUCH BETTER'.
41 2021-03-23 ringing in ears Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2,... Read more
Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2, highest 99.6. Also experiencing chills, lymphnode on left side of neck, little to no appetite, diarrhea, full body aches, dizziness, ringing in ears, knee pain, headache, nausea, sweating, tiredness. I have not been to work this week.
41 2021-03-24 ear swelling 5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back... Read more
5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back and upper chest. Also one small patch on lower arm. Ears became swollen. Swelling of lymph node in neck on left side (same side as the shot). Took Benadryl for 4 days but rash and swelling remained unchanged. Went to doctor on 4th day after the rash started (9 days after the shot) and she prescribed Hydroxyzine for rash. Follow-up visit scheduled for 3/31/2021.
41 2021-03-24 lacrimation increased, ringing in ears, visual impairment, vision blurred Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder an... Read more
Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-03-24 lip itchiness RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "... Read more
RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "fait" in post-vaccine waiting room. At 2:05 with pt. experienced difficulty breathing. RN gave epinephrine 0.5ml pt. on R deltoid. Then, 911 was called. Pt. was examined by paramedics refusing to go to ER. RNs encouraged pt. to see PCP. Pt.'s husband was called by pt. for ride home.
41 2021-03-24 feeling of choking Tingling in throat and a little dizzy feeling-VSS-All resolved.
41 2021-03-24 ringing in ears, double vision, vision blurred Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperatu... Read more
Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-03-25 dry mouth At approx. 1050 pt reported dry mouth, nausea, and feeling need to puke. Pt given emesis bag. Pt dry... Read more
At approx. 1050 pt reported dry mouth, nausea, and feeling need to puke. Pt given emesis bag. Pt dry heaved and reported not eating breakfast. Pt given water and stated she felt better after drinking water. Pt reported no hx of reaction to prior vaccinations. Pt denied throat irritation, itchiness, and rashes. Vital signs assessed at approx. 1056. BP 110/70 mmHg, PR 75 bpm, spO2 99% RA. Pt advised to wait 30 minutes for further observation. Vitals reassessed at approx. 1115. BP 120/80 mmHg, PR 75 bpm, spO2 99% RA. Pt reported no throat irritation and stated she felt fine. Pt advised to sign up on CDC V-safe. Pt left facility with steady gait and unlabored breathing at approx. 1120.
41 2021-03-25 hearing loss, ear discomfort Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so s... Read more
Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so swollen it caused pressure on my ear and pain in outer ear. My NP could not confirm it was from the vaccine. They put me on an antibiotic and steroids and no relief .. then ear drops... I still cannot hear out of my ear completely and the Lymph nodes in neck, collar bone and armpits are still there and it's been 16 days since I had the shot.... I am refusing the second injection because of this. Nothing on right side of body only on left which is the injection side.
41 2021-03-25 oropharyngeal discomfort, mouth numbness, mouth tingling, feeling of choking Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" star... Read more
Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over. My breathing became labored and difficult, my lips were numb. I was immediately administered an EPI pen, and was transported by ambulance to the ER . I was also treated with albuterol, solumedrol, and benedryl. I remained in the ER for the entire day, and was discharged in the evening. I was prescribed Claritin, and prednisone, and given an epi pen. I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingling in my throat/face. The Claritin was continued, and the prednisone was extended. I followed up with another doctor on Wednesday as symptoms were not resolved. Claritin has been increased and am trying to phase out the prednisone. I continue to suffer from tingling in my lips, and chest pressure. Doctors have no idea how long symptoms would last.
41 2021-03-25 mouth tingling 3/26/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screenin... Read more
3/26/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness.. and tingling of the tongue Assessment : Time of assessment 1810. Alert and oriented.and anxious, no visual swelling, rash, or redness. Actions taken: Water offered and accepted, VS taken at 1810- BP- 160/94, P- 86, O2- 100%, recheck @ 1824 - BP- 149/101 Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. she was advise to follow up with PCP regarding BP. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/26/2021 5:52 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
41 2021-03-25 vision blurred Warm and tingly all over and blurry vision
41 2021-03-26 dry mouth, mouth tingling Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Pa... Read more
Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Patient a 41 y/o female with a history of HTN and anxiety presents to the Emergency Department with facial swelling in her left cheek that began today after she received her first dose of the Pfizer COVID-19 vaccine. She had a panic attack prior to getting vaccinated today. She was also feeling anxious while receiving the vaccine and states that she experienced a tingly sensation on the inside of her cheek as well as having a dry mouth. The patient denies trouble swallowing and eating, sinus pressure, shortness of breath, rashes, and dental issues. She notes that she has gone to the bathroom more frequently today but is not experiencing any diarrhea. Additionally, she has taken hydroxyzine for her symptoms. She is allergic to penicillin.. The onset was abrupt. The course/duration of symptoms is constant. Location: Left cheek. The character of symptoms is swelling. The degree at present is minimal. The exacerbating factor is none. The relieving factor is none. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including hydroxizine. Associated symptoms: Dry mouth and tingly sensation on the inside of cheek. Associated injury none. She states she had a panic attack upon sitting down in the chair to receive her COVID shot in her left arm. She had to take her anxiety medication there and then later in the day. She states she felt as if the inside of her cheek was swollen and scratchy this made her very anxious and decided to come in to get checked out. She denies any hives any abdominal pain nausea vomiting shortness of breath chest pain or redness at the injection site. She feels mildly improved from an anxiety standpoint now compared to the onset but still mildly anxious. She has a very normal physical exam no neck tongue or lip swelling there is no redness at the injection site she has no hives abdomen is soft and tender or buccal mucosa is unremarkable ultimately patient reassured discussed it is important she get her 2nd COVID shot. She understands return precautions for signs of allergic reaction. She received no medications.
41 2021-03-26 ear pain Right lymph node in neck swelling/pain. Right ear pain
41 2021-03-26 lip swelling Lip swelling, throat pain, itching
41 2021-03-28 sensitivity to light Woke up the next morning with uncontrollable nausea and vomiting. This lasted for 24 straight until ... Read more
Woke up the next morning with uncontrollable nausea and vomiting. This lasted for 24 straight until I went to the hospital and received an intermuscular shot and a prescription for nausea medication. Also had sensitivity to light.
41 2021-03-28 swollen tongue Saturday morning- hives on body - got benadryl and 40 mg prednisone Saturday 10 am tongue swelling ... Read more
Saturday morning- hives on body - got benadryl and 40 mg prednisone Saturday 10 am tongue swelling and hives on tongue - epi pen Sunday morning - more hives- benadryl and extra strength pepsid Hives all over body still (Monday, March 29)
41 2021-03-28 vision blurred Presented self with "H/A". no blurred vision or difficulty breathing. Stated she had just a "lil b... Read more
Presented self with "H/A". no blurred vision or difficulty breathing. Stated she had just a "lil blurred vision". Also stated had not eaten since breakfast. Came directly to get vaccine after work. Husband driving car, advised if HA worsens, pull over and dial 911. Stated feel better. she thinks it was just nervousness. Allowed to leave observation area.
41 2021-03-29 double vision, visual impairment Driving home from the vaccine I had double vision and a feeling like I was going up and down in an e... Read more
Driving home from the vaccine I had double vision and a feeling like I was going up and down in an elevator. The next day I had the sore arm, aches and headache as expected. Sunday, started with carpal tunnel pain that extended from my left shoulder through my fingers as well as some vision issues where my eyes sort of had double vision again but I couldn?t blink it away for a minute. Monday morning I felt my right eye suddenly change vision where the one eye suddenly saw at a 45 degree angle. My husband said my eye looked ok but I could clearly see 2 of him and couldn?t blink it away for a solid minute or so. Today my eyes are blurry and I?m dizzy. I reported this to my doctor yesterday to see if what was happening was vaccine related and she asked me to report it here.
41 2021-03-29 eye swelling, lip swelling Swelling of lips, outer eye, took 25 mg Benadryl. BPs 140/90 (pulse 64); 122/70 (pulse 65).
41 2021-03-29 mouth tingling, taste impairment nausea, metallic taste, tingling tongue, dizzy. Evaluated by EMS-Cleared
41 2021-03-29 feeling of choking 41 yr/o female covid vaccinee this AM First dose of pfizer Medication and food allergy, but no vacc... Read more
41 yr/o female covid vaccinee this AM First dose of pfizer Medication and food allergy, but no vaccinee Throat tight, hot, scratchy Tingling sensation No swelling sensation No rash, itching No dyspnea, wheezing Got benadryl 50mg IM Mild improvement
41 2021-03-29 feeling of choking EXPERIENCED WARM TINGLY FEELING IN THROAT
41 2021-03-29 ringing in ears Severe grogginess and ear congestion with tinnitus
41 2021-03-30 lip swelling, mouth numbness The following evening - right at 24 hours after receiving the vaccine, left part of upper lip was nu... Read more
The following evening - right at 24 hours after receiving the vaccine, left part of upper lip was numb and swollen. No other unusual events. Patient had been achy from the vaccine earlier in the day, but by that time was feeling ok. Numbness lasted about an hour, swelling lasted about 12 hours. Patient did not feel ill or itchy or anything that would constitute an emergency. Patient does have photo documentation of the swelling.
41 2021-03-30 ringing in ears Warm sensation throughout body within minutes of injection. Approximately 20 minutes after shot noti... Read more
Warm sensation throughout body within minutes of injection. Approximately 20 minutes after shot noticed a feeling of nasal congestion/sinus blockage. Approximately two and a half hours after shot low grade fever and mild headache. Approximately 3 1/2 hours after shot a short bout of ringing in left ear that lasted approximately 15 minutes. Approximately 67 hours after shot bouts of mild vertigo. Approximately 74 hours after shot bout of severe vertigo lasting approximately 3 hours and subsided to mild vertigo until the following evening. 3/31 sinuses finally cleared.
41 2021-03-31 taste impairment While walking to the observation area after I got the vaccine, I became lightheaded and short of bre... Read more
While walking to the observation area after I got the vaccine, I became lightheaded and short of breath. I needed assistance to a chair. Things began to spin, voices sounded far away, I felt like it was hard to breathe and my throat began to close up. I felt really hot - my clothes were soaked with sweat and my husband (and the paramedics) said I was bright red. I genuinely believed I would pass out. When I sat for a minute with my head back I felt more stable. Then I felt like I had pins and needles all over my body, worst in my feet. The symptoms felt like they came in waves - once I sat down I felt less dizzy, but still struggled with my breathing. When one thing got better, another would intensify. After a couple of minutes my breathing felt much better and I got a metal taste in my mouth and my feet really hurt with pins/needles. The whole thing lasted about 8 minutes, when although I felt tired and my clothes were wet, my body felt safe and almost back to normal. I was surrounded by nurses and paramedics who monitored my vital signs and had medicine nearby, but never administered anything. My body recovered on its own and after 15 minutes I felt great and I gathered my things and drove home. The EMT who said goodbye encouraged me to call my doctor if I felt I was getting worse.
41 2021-03-31 swollen tongue, bloodshot eyes, lip swelling, eye itchiness Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens... Read more
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
41 2021-04-01 oropharyngeal discomfort Pfizer-BioNTech COVID-19 Vaccine EUA 41-year-old female with history of anaphylaxis to fish and cas... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 41-year-old female with history of anaphylaxis to fish and cashews, asthma, aortic stenosis, eosinophilic esophagitis, and chronic idiopathic urticaria presenting to emergency department for chest tightness, dyspnea, nausea, vomiting, and throat discomfort following 1st dose COVID-19 vaccination (Pfizer). Vital signs remained normal and stable during this ED visit. On presentation, patient was in moderate distress. Physical exam was notable for retching and tachypnea upon arrival. Patient's presentation consistent with anaphylaxis likely due to COVID-19 immunization (Pfizer). Epinephrine, famotidine, benadryl, solumedrol, zofran, and fluids administered with complete resolution of symptoms. Patient observed for 4 hours without worsening of symptoms. Patient discharged home.
41 2021-04-01 swollen tongue, eye swelling 22 mins post vaccination at 10:50, pt c/o swelling on eyes, face and tongue. On site MD and ALS ambu... Read more
22 mins post vaccination at 10:50, pt c/o swelling on eyes, face and tongue. On site MD and ALS ambulance reported and assisted patient, BP 124/86, pulse 99, BS 108 and EKG normal; no meds given, transported to the nearest hospital by ambulance due to continued altered mental status possible stroke.
41 2021-04-01 ringing in ears, vision blurred Body aches and ringing in my ears started about 5 hours after the shot. I went to bed at 10pm thinki... Read more
Body aches and ringing in my ears started about 5 hours after the shot. I went to bed at 10pm thinking I was feeling ?fine?. I woke up at 1am, covered in sweat, nauseous and the room was spinning. I stood up because I thought I was going to throw up and lost consciousness. After a few minutes my husband called 911 because I was non responsive and vomiting. I gained consciousness as the paramedics were arriving, but had slurred speech and couldn?t see clearly. As they took me to the hospital I was awake and speaking but extremely weak. They did an ecg. At the hospital they did a blood test and ecg. They gave me an IV of fluids which helped. They had a hard time getting my blood pressure for the first few minutes, trying multiple cuffs. Ultimately, they said the echo looked ok, so they discharged me since I was no longer having an emergency episode and advised that I follow up with my primary and cardiologist
41 2021-04-02 mouth tingling, lip swelling, mouth numbness angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/ti... Read more
angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-04-02 swollen tongue, tongue itchiness patient reports throat and tongue itching and tongue swelling and scratchiness of her voice, admitte... Read more
patient reports throat and tongue itching and tongue swelling and scratchiness of her voice, admitted to EC and given Benadryl, Solumedrol, morphine, and discharged home on same day.
41 2021-04-04 sensitivity to light Malaise, Headade like migrane, lgiht sensitivity, nausea, vomiting (3 times), shortness of breath
41 2021-04-05 eye swelling, eye itchiness 3-4 days after the first vaccine I had itchy neck and slight redness. Also, under the eyes I had sma... Read more
3-4 days after the first vaccine I had itchy neck and slight redness. Also, under the eyes I had small red patches that were mildly itchy. It went away after about a week. 4 days after the 2nd vaccine, in those same spots I experienced swelling, redness, itch. 6 days after the 2nd vaccine shot, my primary physician prescribed 3 doses of prednisone and Benadryl to alleviate the itch. Swelling and redness subsided but very mild itch was till there. On 04.05.21 (18 days after the 2nd shot) my face and neck swell up and are red and itchy. I also feel itchy ob my legs and beck. Benadryl did not help.
41 2021-04-05 mouth tingling, lip swelling, swollen tongue I waited the 30 min for high risk and about 5 min after I left my face started burning like I had a ... Read more
I waited the 30 min for high risk and about 5 min after I left my face started burning like I had a bad sunburn, started tingling and felt numb. Took Benadryl before bed. Woke up face slightly swollen and a little tingly. By 8am my tongue started tingling. Took 2 Benadryl and scheduled an apt with my PCP. Apt at 1:30 with PCP. Redness across chest & on & off tingling in face, lips & tongue. Slight swelling noticed by the doctor steroid shot & told to continue Benadryl & add pepcid. Still slight face, lips & tounge tingling & swelling.
41 2021-04-05 ringing in ears, visual impairment Pt felt dizzy, sweating, ears were ringing, spots before her eyes. Gave pt water, had her elevate he... Read more
Pt felt dizzy, sweating, ears were ringing, spots before her eyes. Gave pt water, had her elevate her legs and recline, started to feel better after about 5 minutes.
41 2021-04-05 vision blurred during injection she had pain in left side of neck. about 1 hours after, she developed blurry vision... Read more
during injection she had pain in left side of neck. about 1 hours after, she developed blurry vision in left eye and numbness to left jaw and cheek area. took 50mg benadryl and used ice pack. in the morning she noticed swollen left side of face and continued numbness, tingling, which includes some near her eye. some flushed skin to area. Denies facial paralysis or weakness. Her eye no longer has blurry vision.
41 2021-04-06 swollen lips I started developing a psoriasis-like rash below my lip and spreading down to my chin. I first saw b... Read more
I started developing a psoriasis-like rash below my lip and spreading down to my chin. I first saw bumps 2 days after my vaccine on April 1. Thinking it was acne, I began treating it with salicylic acid. That did not help and the rash continue to grow and develop bumps like whiteheads. The spreading and discomfort of the rash prompted me to visit my local urgent care. The doctor was unable to say exactly what caused the rash. Then, I began reading about possible vaccine side effects and I saw a picture of a rash that looks just like the rash below my lip. In this article - the bottom picture looks like the rash I have.
41 2021-04-06 pain in jaw - w/in 15 min nausea and slight vertigo. Soreness in left arm. - w/in 45 min nausea & vertigo wen... Read more
- w/in 15 min nausea and slight vertigo. Soreness in left arm. - w/in 45 min nausea & vertigo went away, soreness travelled into left side of neck/head & jar. Sinus pressure and then difficulty swallowing. - w/1n 60 min itching (no hives) and periodic difficulty swallowing - w/in120 min all symptoms dissipated except for slight soreness in left arm.
41 2021-04-07 mouth swelling, swollen tongue Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild
41 2021-04-07 ringing in ears, ear discomfort As I was walking out of the vaccine sight on 3/10 after receiving my second COVID vaccine, after my ... Read more
As I was walking out of the vaccine sight on 3/10 after receiving my second COVID vaccine, after my required 15 min wait, I noticed my ears starting to get clogged (similar to being in an an airplane ascending) and they started ringing. I didn't think much of it right at the moment because it was warm and windy thought it might be the storm and pressure change (I've never had an issue with storms/pressure in the past though). The clogged feeling lasted approximately 45-60 minutes and then just stopped. The ringing has been pretty consistent since. It is a lot less noticeable in the day but at night when it's really quiet it's much more noticeable and loud.
41 2021-04-08 lip swelling Hives worsening over 2 week period causing lip and face swelling. Also had body ache, fever, and hea... Read more
Hives worsening over 2 week period causing lip and face swelling. Also had body ache, fever, and headache for 2 days. Prendison prescribed with Benadryl, follow up appointment in 2 days. If symptoms worsen or trouble breathing or swallowing go to emergency room.
41 2021-04-08 ringing in ears Got Pfizer-BioNTech COVID-19 Vaccine EUA about 5:55 pm on Thursday April 8th. Started to feel sorne... Read more
Got Pfizer-BioNTech COVID-19 Vaccine EUA about 5:55 pm on Thursday April 8th. Started to feel sorness after 10 minutes at the shot site. 3 hours after got like a whoosh sounds in ears. Sore left arm. Went to bed. Woke up with a headache and feeling drowsy. took acetaminophen at 9am. Headache is gone. Still drowsy. It is 2:15 pm on Friday april 9th. And whoosh sounds in ears came back like 30 minutes ago.
41 2021-04-08 visual impairment Pfizer-BioNTech COVID-19 Vaccine EUA first dose administered approximately 2:52pm. Reaction started ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA first dose administered approximately 2:52pm. Reaction started approximately 2:57pm after seated in observation area; sense of feeling "not right" then heart started racing, chest felt tight, vision got strange and I couldn't really move. Once this episode passed I got up and told a volunteer I thought I was having a reaction. Moved to secondary observation area, hooked up to machine that tracked heart rate and blood pressure. Next episode occurred at approximately 3:10pm; heart rate shot up to 160 (unsure of BP), same feelings of immobility accompanied with urge to pee/poop. These episodes continued for 4-5 rounds until approximately 4pm and lasted multiple minutes each time.
41 2021-04-09 mouth tingling Patient came to Vaccine POD to receive first dose of Pfizer vaccine (LOT #ER8731, Expires 07/2021) o... Read more
Patient came to Vaccine POD to receive first dose of Pfizer vaccine (LOT #ER8731, Expires 07/2021) on 4/10/2021. Patient has a medical history of hypertension and has allergies to ibuprofen and penicillin. Patient received approval from her doctor and specialists to receive Pfizer vaccine. The patient gave verbal consent to receive the Pfizer vaccine and was vaccinated at 1459 by RN. The patient was given an observation time of 30 minutes with RN, who was performing the EMT observer role on site. At 1530, the patient reported experiencing "tingling" in her lips and tongue. Lead RN was called to assist with the patient. The patient presented with redness localized on face. The patient was assisted to anti-gravity chair at 1531. At 1532, the patient's vitals were taken by RN: BP 160/90, HR 83 BPM, RR 21/min. RN administered 50mg/1mL Benadryl IM in the patient's right arm at 1537. The patient denied difficulty breathing. The patient's vitals were reassessed every 5 minutes for 30 minutes. The patient remained A&Ox4 throughout 30 minute observation period. The patient's vitals at 1538 were: BP 200/118, HR 88 BPM, RR 22/min. The patient states she forgot to take her blood pressure medication in the morning. She states her baseline blood pressure is around 160 systolic. At 1543, the patient's vitals were: BP 160/102, HR 90 BPM, RR 22/min. Visibly, the patient was less flushed. Patient was able to look at herself through her cell phone camera and pallor returned to normal limits, per patient. At 1548, the patient's vitals were: BP 155/108, HR 83 BPM, RR 20/min. At 1553, the patient's vitals were: BP 160/102, HR 79 BPM, RR 18/min. The patient states the tingling in her lips and tongue has resolved. The patient sat up with her feet dangling below her, her vitals were as follows: BP 167/110, HR 79 BPM, RR 17/min. The patient reported "feeling better" and requested to drive herself home. RN provided patient with education about side effects of Benadryl, including fatigue. Patient states she is unable to find a ride and must drive herself home. Patient states she is "feeling fine" and lives "3 minutes away". The patient was given education related to when to seek medical care, including shortness of breath, chest tightness, and sensation of throat tightness. The patient demonstrates understanding of teaching and states she will call her doctor if her symptoms worsen. The patient's gait was steady and patient denied any dizziness or lightheadedness. At 1601, the patient requested to drive herself home. She was escorted to her car by RN. Upon departure, patient was ambulatory, A&Ox4, with no reports of trouble breathing, dizziness, or lightheadedness. Patient drove herself home AMA at 1604.
41 2021-04-09 ringing in ears Approx. 36 hours after the first shot, I noticed an intense ringing in my ears that has not gone awa... Read more
Approx. 36 hours after the first shot, I noticed an intense ringing in my ears that has not gone away. For the first 48 hours I also experienced dizziness, confusion, mood swings, and soreness in my arm. I still have occasional dizziness and mild vertigo.
41 2021-04-10 mouth pain, burning mouth syndrome Pins and needles in mouth and tongue 1 day following vaccine. Continued worsening until going to ER ... Read more
Pins and needles in mouth and tongue 1 day following vaccine. Continued worsening until going to ER April 10th, pins and needles and burning all over body for a full day period. Continuing to get worse. Have been referred to rheumatologist and neurologist, but no one knows what is going on or how to treat. Only tell me ?I am not the only one?. Feels like arthritis in hands. Pain mostly in mouth, tongue, spine, feet, legs.
41 2021-04-10 ringing in ears, ear discomfort, deafness Tinnitus, loss of hearing, pressure in ears.
41 2021-04-11 ear discomfort I got a little light headed a little while after the shot, but when I woke up the next morning, I wa... Read more
I got a little light headed a little while after the shot, but when I woke up the next morning, I was very dizzy and lightheaded with a lot of pressure in the ears. I had no other side effects -- no fever, no nausea, even the arm was barely sore. I am still experiencing all of the same symptoms and at times they can be quite severe. We are thinking that the vaccine caused my vestibular system to flare up and so far it is not turning around.
41 2021-04-11 mouth numbness She states that 1 minutes after receiving the COVID vaccine in her right shoulder, she noticed incre... Read more
She states that 1 minutes after receiving the COVID vaccine in her right shoulder, she noticed increased pain, swelling, itching, redness at the site of the injection. She also noticed that her right shoulder became numb and tingly which spread into her upper neck, distal right arm and right lower extremity. She also endorses numbness of the right side of her face and mouth. She denies any muscle fatigue or weakness. She states that after receiving the vaccine she became dizzy and lightheaded upon standing but denies any loss of consciousness.
41 2021-04-11 oropharyngeal discomfort, mouth tingling, dry mouth Following symptoms were experienced about 7 minutes aster receiving the vaccine: Feeling of warmth i... Read more
Following symptoms were experienced about 7 minutes aster receiving the vaccine: Feeling of warmth in abdomen followed by increased heart rate and palpitations. HR 148/min (normal resting heart rate 50-60/min). Blood measure 150/100 (baseline around 115/80). Also feeling of dry mouth. Observation prolonged - BP dropped to 130/90 after about 30 minutes, HR dropped to 80. Episdoes of increased HR kept re-occurring for about 2 hours after the shot. No respitatory distress or cutaneous symptoms. After about 90 minutes after the vaccine, feeling tingling in lips and scratchy throat. Administered Benadryl 25mg per mouth, lip tingling and scratchy throat resolved within 30 minutes thereafter. All of the above symptoms resolved about 4 hours after the vaccine, HR at 60. Following symptoms developed within 12 hours of the vaccine: Chills, fever (100F), myalgia, artralgia, fatigue, nausea. Treated with ibuprofen and acetaminophen, resolved about 48 hours after the vaccine. Note: No known history of Covid.
41 2021-04-11 pain in jaw, mouth numbness 1. Right side of jaw immediately got very tight and stiff and painful, still has not gone away 5 day... Read more
1. Right side of jaw immediately got very tight and stiff and painful, still has not gone away 5 days later 2. Tip of tongue slowly became weird/numb feeling, has not subsided 5 days later
41 2021-04-11 mouth tingling I began feeling extreme pain, nausea, fatigue and headache within a few hours of the shot. The join... Read more
I began feeling extreme pain, nausea, fatigue and headache within a few hours of the shot. The joint pain and fatigue increased and has persisted as of Monday (day 5 following first dose) becoming extreme at times. I have severe headache on and off. I threw up 2x a day from Thursday-Sunday. My lips began tingling on and off on Wednesday evening April 7 and that has continued ever since. I have also had tingling in my extremities especially my legs and feet, but also my left hand. Fatigue has not improved and as of today, I began to get worse (onset of chills and fever as of 4/12).
41 2021-04-11 vision blurred Reports to virtual urgent care one day after 1st pfizer covid vaccine with pain in left neck , blurr... Read more
Reports to virtual urgent care one day after 1st pfizer covid vaccine with pain in left neck , blurry vision, left facial numbness immediately after. The next day face is still numb/tingling/red. No other symptoms. Advised to follow up with PCP or go to ED if symptoms worsen.
41 2021-04-12 ear discomfort Sore arm near injection site, Achy joints, chills, head feeling hot, intense headache for 5 hours, b... Read more
Sore arm near injection site, Achy joints, chills, head feeling hot, intense headache for 5 hours, blocked right ear
41 2021-04-12 mouth tingling Client received first dose of COVID vaccine @ 11:55am, began feeling dizzy @ 12:00pm. Vital signs s... Read more
Client received first dose of COVID vaccine @ 11:55am, began feeling dizzy @ 12:00pm. Vital signs stable, placed in a zero gravity chair. At 12:04 pm, client complained of tingling in lips, no shortness of breath. Dizziness and tingling lips resolved @ 12:30pm, instructed to follow up with primary care MD. Client walked out of observation area with significant other.
41 2021-04-12 smell distorsion Phantom smell of cigarette smoke, started 2 days after my shot off and on. It keeps increasing in f... Read more
Phantom smell of cigarette smoke, started 2 days after my shot off and on. It keeps increasing in frequency and duration. I?ve had symptoms for 10 days now.
41 2021-04-13 taste impairment For 6 days after the shot I experienced a metal taste in my mouth and tenderness in left tonsil with... Read more
For 6 days after the shot I experienced a metal taste in my mouth and tenderness in left tonsil with a sore throat.
41 2021-04-13 mouth numbness, mouth tingling *Lips tingled then went completely numb - started 30 minutes post shot and lasted for about 2 hours ... Read more
*Lips tingled then went completely numb - started 30 minutes post shot and lasted for about 2 hours *Burning flush feeling - like "niacin flush" - felt over face, neck and upper body starting about 45 minutes post shot and lasting for about an hour *Severe headache / migraine - started slowly about an hour after shot and built up to migraine at 2 hours post shot. Lasted for almost 2 days and then went away to dull headache on 2nd morning after shot. Took Tylenol starting 8 hours post shot and repeated every 6 to 8 hours. *Brain fog / inability to concentrate - started 3 to 4 hours after shot most severe 6 to 10 hours post shot. Slowly came back with 2nd night of sleep. *Dizziness - started 40 minutes post shot while driving home. Most severe about 2 hours post shot then lessening. Lasted a day and a half and then just went away. *Severe Arm pain - pain in injection site arm for so severe that I couldn't move the arm above chest level or touch it against anything for a day and a half. Woke up on 2nd morning after shot and pain is completely gone.
41 2021-04-13 taste disorder Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waitin... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waiting period until 5 or 6 hours later, there was a weird taste in my mouth and a tightness in the back of my throat, as though the glands were swollen and constricted my throat making it uncomfortable to swallow. There was no pain. Between a rating of 1 to 10, the discomfort level was about 5. I also felt weakness in my whole body and walking felt strange and lasted for the entire day. The injection site has mild soreness even 24 hours later.
41 2021-04-13 vision blurred blurred vision (mild?)
41 2021-04-13 visual impairment Two weeks after getting the second dose of the vaccine, I had two episodes of vertigo. I have no hi... Read more
Two weeks after getting the second dose of the vaccine, I had two episodes of vertigo. I have no history of vertigo. I also developed bouncy vision where it looks like things are bouncing up and down or moving side to side when I walk or turn my head. It has not resolved. I am scheduled with a neurologist on 5/4/21 to determine if I have any vestibular damage. It is possible this is permanent and at this current time it is very disabling. I am not sure if this is related to the vaccine but I thought it best to report it in case other reports of this come up.
41 2021-04-14 loss of smell, taste impairment, loss of taste Loss of taste Metallic taste The morning after I received the first dose, I woke up with a strong me... Read more
Loss of taste Metallic taste The morning after I received the first dose, I woke up with a strong metallic taste in my mouth. It lasted for a couple of hours. Then it became a total loss of taste (unable to taste any food) that lasted about 8 hours. I also experienced a partial and minor loss of smell, which also resolved in about 8 hours.
41 2021-04-14 eye itchiness, swelling around the eyes Itchy eyes; Swelling around eyes; Face tingling AFTER SECOND DOSE ONLY
41 2021-04-14 hearing loss Within 2 hours after vaccination, developed pain behind her right ear. Felt as if there was fluid a... Read more
Within 2 hours after vaccination, developed pain behind her right ear. Felt as if there was fluid and affected her hearing. She took Tylenol at that time. Around 2 a.m. the following morning (4/15), she rolled over in bed and felt a sharp pain on the left side of her neck. She got up and looked in the mirror and saw that the area was swollen and continued to get larger as the morning went on. She didn't take any medication this a.m. Took her child to school and then came for evaluation.
41 2021-04-14 mouth numbness Dizziness, numbness in face, tongue, and throat feeling tight. 4:00 PM Vital Signs: BP 116/78 HR 4... Read more
Dizziness, numbness in face, tongue, and throat feeling tight. 4:00 PM Vital Signs: BP 116/78 HR 40 O2Sat 97% Skin Signs: Diaphoretic, Other - Cool fingers Circulation: Cap Refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Approx 10 min after vaccine, tongue and lips began to feel slightly numb. Briefly a little dizzy, but that soon passed. Taken to triage at 4:05 PM when numbness increased. 4:15 PM Vital Signs: BP 124/76 HR 66 O2Sat 98% Skin Signs: Cool and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally 4:30 PM Vital Signs: HR 69 O2Sat 96% Skin Signs: Cool and dry 4:40 PM Vital Signs: BP 130/78 HR 67 O2Sat 99% Notes: Decision made to call husband to transport to hospital. Face and tongue feeling worse. 5:00 PM Vital Signs: BP 132/80 HR 62 O2Sat 99% Sent to ER with husband 5:10 PM 04/14/2021: 11:45 AM: Follow up phone call to patient. Doing very well today. Stated she was observed in ER for 1 hour last night. Symptoms gradually subsided over 4 hours. No treatment needed.
41 2021-04-14 oropharyngeal discomfort Chil, running nose, sneezing, and scratching throat.
41 2021-04-14 light flashes or floaters in the eye, eye floaters, visual impairment, ringing in ears VERTIGO, VISUAL HALLUCINATIONS, RACING THOUGHTS, INSOMNIA, VISUAL DISTURBANCES (FLASHING LIGHTS, BLA... Read more
VERTIGO, VISUAL HALLUCINATIONS, RACING THOUGHTS, INSOMNIA, VISUAL DISTURBANCES (FLASHING LIGHTS, BLACK FLOATERS), SHORT TERM MEMORY LOSS, RINGING IN EARS, LONG LASTING BRAIN FOG NO EFFECTIVE TREATMENT AVAILABLE BRAIN FOG STILL CONTINUING- 4 WEEKS AFTER VACCINE FIRST ADMINISTERED
41 2021-04-14 swollen tongue 10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 ... Read more
10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 mins after adminstration tongue, face and throat swelled up. Hand of injection arm went purple, cold and numb. Toes went purple and cold. Had to get taken in ambulance to er hospital due to blood pressure and lack of oxygen. When arrived at hospital broken out in hive,blood pressure went up to 175/104 and severe pain in kidneys, stomach, lower abdominal, legs, arms. Day 2 high blood pressure, fever, hives, stomach, kidney and lower abdominal pain. Painful to urinate and poop.
41 2021-04-15 ear discomfort, smell distorsion, ringing in ears, sensitivity to light Around 8:00pm I started experience ear fullness and tinnitus (pulsing with my heart beat) in my righ... Read more
Around 8:00pm I started experience ear fullness and tinnitus (pulsing with my heart beat) in my right ear along with a mild headache on that side. At 11:00pm I woke up with one of the worst migraines of my life and I was shaking uncontrollably. Only a mild temperature of 99.2. I took two Extra strength Tylenol and 30 minutes later the shaking subsided by the temperature did not. The headache persisted until 11:00am on Friday. Migraine symptoms included aching and shooting pains on the right side of my head near my temple, neck pain, light and smell sensitivity. I also smelled things that were not there--like the smell of burnt toast and garlic. I regularly get migraines and have seen a neurologist for these, but do not take prescription medication. I had tinnitus in the same ear about 12 years ago, but have not experienced symptoms since.
41 2021-04-15 eye swelling, swelling of eyelid, mouth discomfort, lip swelling, lip itchiness Developed arm soreness, headache, and right eye swelling with eczema a few hours after 2nd dose. Had... Read more
Developed arm soreness, headache, and right eye swelling with eczema a few hours after 2nd dose. Had whole body aches and chills throughout the night. Woke up with swollen, red, itchy face. Had fatigue and dizziness throughout next day. Side effect subsided within 24 hours. 6 days post 2nd shot, developed face swelling, redness and itch. Woke up the morning of 7 days post 2nd shot with extremely swollen eyes, cheeks and lips that were red and burned. Went to ER and received 3 IV drugs, including Benadryl, took 3d of oral prednisone and also a topical steroid prescribed by dermatologist. Swelling and redness subsided within 48hrs but flared again 14d post 2nd shot. This flare was mild compared to d7, is limited to mild swelling of lips, redness and itch of lips and eyelids and is being treated with topical steroids.
41 2021-04-15 visual impairment he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp... Read more
he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5. The shivering quickly changed to more of a convulsing and temp got up to 104.7F. When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding. But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21. I could not brush my hair because my scalp was too tender. I couldn't let anything touch me and put pressure against any part of my body. Then at 3:30 that afternoon, I went to bathroom and had a bowel movement. It was so excruciating that I truly though my colon might have come partially out. I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying. When I was finally able to go back to the bathroom to flush, I was expecting a large BM. It was not. It was about 2" x 1" and soft. There was no blood. It just felt like it tore me up. ****Then at 7:30 PM on 3-5-21 was when things got very serious. I was sitting down watching TV after a light meal. Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades. Within 5 minutes, it was at its worst....I was have rated it 11/10 pain. The pain was just very deep, behind the spine, about palm sized radius and unrelenting. My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today." So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine. An hour later, these meds hadn't touched it. I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB). Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain). I called another provider who was on call and told her. She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER. I was asleep in an hour. I took it easy the next two days but started feeling back to normal during the days. I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out. That following Tuesday, the deep upper back pain returned.
41 2021-04-16 dry eye Soreness in arm, back pain and fever of 100.4 as of 5:25 pm in 4-17/21. Extreme fatigue, body aches ... Read more
Soreness in arm, back pain and fever of 100.4 as of 5:25 pm in 4-17/21. Extreme fatigue, body aches and my eyes are feeling dry as well.
41 2021-04-16 visual impairment Migraines resistant to OTC NSAIDs. I woke up with the migraine on 23 March. Pain phases lasted multi... Read more
Migraines resistant to OTC NSAIDs. I woke up with the migraine on 23 March. Pain phases lasted multiple days, with multiple nausea, visual disturbance, aphasia, and facial neuropathy phases. These have been common for me in the past, but have only rarely occurred the last few years. Migraines would fade after 3-4 days, then come back 1-2 days later for the 3 weeks following the injection.
41 2021-04-17 swollen lips Rash developed on Monday after Friday shot. Bad reaction on the top of my right hand, as well as a s... Read more
Rash developed on Monday after Friday shot. Bad reaction on the top of my right hand, as well as a sight rash on my left wrist, top of left hand, bottom lip. By Tuesday right hand was blistered and extremely painful, with blisters. By this morning, skin was peeling and revealing very pink new skin. Painful burning sensation throughout.
41 2021-04-17 feeling of choking, mouth tingling, mouth numbness Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tin... Read more
Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; She felt panicky, because it felt like her throat was "closing"; very odd, uncomfortable feeling; This is a spontaneous report from a non-contactable consumer reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 in left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced mouth & throat felt numb & tingly. She felt panicky, because it felt like her throat was "closing". It was a very odd, uncomfortable feeling that lasted roughly 1.5-2 hours. It scared her. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered on unspecified date. No follow-up attempts are needed. No further information is expected.
41 2021-04-17 ringing in ears 4/18/21: Awakened with a loud, sharp ringing in my right ear. The ringing is consistent and botherso... Read more
4/18/21: Awakened with a loud, sharp ringing in my right ear. The ringing is consistent and bothersome and causes a feeling of being "off". 4/17/21: Nausea, headache, and mild fever
41 2021-04-17 toothache face hurts; Tooth hurts; This is a spontaneous report from a contactable consumer (patient). A 41-... Read more
face hurts; Tooth hurts; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) at SINGLE DOSE in Left shoulder for covid-19 immunisation. The patient medical history was not reported. No Prior Vaccinations (within 4 weeks). The patient's concomitant medications were not reported. The only medication she takes is cholesterol pills. She received her first dose of the Pfizer Covid 19 Vaccine this morning and ever since she came home, her tooth hurts and her face hurts on 1Apr2021. She would like to know if teeth and face hurting are side effects from the vaccine. She reported her teeth at the top are hurting, teeth on the bottom are okay. Said its the both sides of mouth on the top that are hurting. The patient reported this is happening off and on. The outcome of Tooth hurts was unknown, of face hurts was recovering. No follow-up attempts possible. No further information expected.
41 2021-04-18 dry throat Pt c/o tickle in throat which began a few minutes after vaccine administration. Tickle/ dry sensatio... Read more
Pt c/o tickle in throat which began a few minutes after vaccine administration. Tickle/ dry sensation in throat alleviated with water. Throat itchiness better, discharged home. ED precautions given.
41 2021-04-18 ear discomfort, ringing in ears, deafness A day after receiving my first vaccine, the onset of ringing in my ears began and my ear felt full a... Read more
A day after receiving my first vaccine, the onset of ringing in my ears began and my ear felt full and I had dizziness. I went to my primary Doctor and she ruled out ear infection and referred me to an ENT doctor and an audiologist. They gave me an audiogram and then the ENT doctor could not give a definite diagnosis except that I now have hearing loss in both my ears and tinnitus could be a chronic issue. I continue to suffer hearing loss and tinnitus in my ears since I received my vaccine and it continues to this day.
41 2021-04-18 mouth numbness, mouth tingling, feeling of choking Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness a... Read more
Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness and mild facial swelling of the right cheek. Pt. stated feeling "a sense of doom." She felt warm to the touch. Denied chest pain or dyspnea. 911 called at 1213. FD station is steps away from our site, so we rang their doorbell and they responded and were on site at 1216 with their 3 BLS supporting the 3 RN's on site mananging the event. Vitals #1: @1214 BP 180/100, P 100, RR 24, O2sat 98%. Vitals #2: @1219 BP 180/120, P 85, RR 22, O2sat 98%. ambulance arrived at 1220. Pt. remains with same and not worsening symptoms. Vitals #3: @1225 BP 150/120, P 98, RR 22, temp 100.1F. Pt. left in ambulance at 1230.
41 2021-04-18 mouth numbness Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms aro... Read more
Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms around right eye; Weakness in arms and legs; Feels tugging in the back of her head and symptoms around right eye; Neuropathic Symptoms on Right Side of Face; Numbness on Right Side of Mouth; she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her Bell's Palsy, and the corner of mouth started to have numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 41-year-old) as single dose for covid-19 immunization. Medical history included facial paralysis from 1998 to an unknown date, Bells palsy at age 18 , ongoing temporomandibular joint syndrome , asthma exercise, depression, pain, hypoaesthesia, Numbness in face in the past (June 2020 tele-visit with neurologist), fatigue, headache, anxiety. Concomitant medications included gabapentin (GABAPENTIN) taken for neurological symptom, hydroxyzine (HYDROXYZINE) taken for anxiety. The patient experienced she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her bell's palsy, and the corner of mouth started to have numbness on 01Mar2021 with, neuropathic symptoms on right side of face on 01Apr2021 with, numbness on right side of mouth on 01Apr2021, weakness of right eye numbness in right eye, feels tugging in the back of her head and symptoms around right eye, weakness in arms and legs, feels tugging in the back of her head and symptoms around right eye. Caller states basically she had Bell's Palsy years ago and was left with cranial nerve damage. She stated she noticed after the first Pfizer vaccine, that in that area of the face that she had Bell's Palsy, she started having neuropathic symptoms. and stated that it started thursday. States it has been there for a couple of days and she still has a little bit of neuropathic symptoms but not as great as when the onset began. The outcome of the events was recovering. Information about batch/lot number has been requested.
41 2021-04-18 mouth tingling Pfizer-BioNTech COVID-19 Vaccine EUA: patient experienced worsening left-sided facial droop, dizzine... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient experienced worsening left-sided facial droop, dizziness, tongue heaviness, and weakness within minutes after reciving vaccine. Vital signs within normal ranges except for blood pressure 141/06. Patient observed and monitored, diagnosed by neurology with myasthenia flare, and discharged to home ambulating independently and stable.
41 2021-04-18 ringing in ears I felt fine until I got up in the middle of the night to use the restroom. It was when I tried to ge... Read more
I felt fine until I got up in the middle of the night to use the restroom. It was when I tried to get up from the toilet that I lost consciousness and fell forward. My husband discovered me laying there some time later. Before passing out I felt hot, and my ears were ringing.
41 2021-04-18 tongue discomfort 1400 - Patient complaint of "feeling funny" and "my tongue feels weird." Patient taken to treatment... Read more
1400 - Patient complaint of "feeling funny" and "my tongue feels weird." Patient taken to treatment area to be assessed. She then stated that it "was hard to swallow." BP = 158/94, HR = 109, O2 Sat = 99% 1402 - Nurse assessed patient and implemented COVID vaccine reaction order set - patient given Benadryl 50mg PO. 1409 - Patient given Pepcid 20mg PO and monitored for 30 minutes after medication given. BP = 146/97, HR = 92, O2 Sat = 100% 1435 - Patient stated she feels fine and would like to leave. Recommended she follow-up with PCP to see if they recommend for her to receive 2nd dose when scheduled, and to inform staff if getting 2nd dose of previous reaction. BP = 152/93, HR = 95, O2 Sat = 100%
41 2021-04-19 dry throat Patient complained of itchy and dry throat. Denies swelling, difficulty breathing, and itching. The ... Read more
Patient complained of itchy and dry throat. Denies swelling, difficulty breathing, and itching. The doctor on site evaluated her. Vital signs stable. Felt better after drinking water. No problem swallowing. Symptoms resolved completely and she was discharged from the vaccine clinic.
41 2021-04-19 dry throat Patient had itchy, dry throat. BP 143/98 -- > 144/98 -- > 118/78 (11:09AM), HR 86 -- > 77 -- > 63, R... Read more
Patient had itchy, dry throat. BP 143/98 -- > 144/98 -- > 118/78 (11:09AM), HR 86 -- > 77 -- > 63, RR 16, O2 100% -- > 99%, Temp 99F -- > 98.8F. Given Benadryl 50 mg IM at 10:50AM. Patient stable and released from vaccination site at 11:21AM.
41 2021-04-19 ear discomfort, ringing in ears Major symptoms are plugged/whooshing/ringing/popping ears. Pressure in my head. Dizziness, especial... Read more
Major symptoms are plugged/whooshing/ringing/popping ears. Pressure in my head. Dizziness, especially when I look up after looking down at my phone. My hands and feet get so cold they hurt. I can put my frozen feet by my space heater and they don?t warm up, they just hurt more. Inability to concentrate and foggy brain. During meetings I find myself starting sentences but I can?t finish them, it?s like I stop and wait for my friends/family/coworkers to finish my thoughts. Other symptoms that don?t bother me as much. Constant sinus drainage and occasional sneezing. Dehydration. Insomnia and vivid dreams.
41 2021-04-19 ringing in ears Persistent tinnitus
41 2021-04-20 eye bleeding, bloodshot eyes, eye swelling blood vessels in her left eye popped and eye looks bloody; Caller adds that it is gross; Caller adds... Read more
blood vessels in her left eye popped and eye looks bloody; Caller adds that it is gross; Caller adds that it looks like it is getting red, more red, it does not look like it is spreading but it is getting darker; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 05Apr2021 10:15 (Lot Number: ER8732) at age of 41 years old as single dose for covid-19 immunisation, alpha-1 antitrypsin deficiency, liver disorder, lung disorder. Medical history included ongoing alpha-1 antitrypsin deficiency, ongoing factor v leiden carrier, ongoing bipolar disorder, diabetes mellitus (she did not know if it meant anything but it turned out they were both very very diabetic. She adds this scares her, she does not want a needle), iron deficiency, vitamin d deficiency, lung disorder, emphysema, chronic obstructive pulmonary disease, hypertension, insomnia, depression, dumping syndrome and acid reflux. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no vaccines administered on same date with the Pfizer vaccine considered as suspect. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was none. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for alpha-1 antitrypsin deficiency, emphysema, chronic obstructive pulmonary disease from an unspecified start date and ongoing; colestipol taken for dumping syndrome from an unspecified start date and ongoing; dexlansoprazole (DEXILANT) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; iron taken for iron deficiency; lamotrigine (LAMICTAL) taken for bipolar disorder from an unspecified start date and ongoing; levomefolic acid (L-METHYLFOLATE) taken for depression from an unspecified start date and ongoing; lisinopril taken for hypertension; amlodipine besilate (NORVASC) taken for hypertension from an unspecified start date and ongoing; alpha-1-antitrypsin (PROLASTIN-C) taken for alpha-1 antitrypsin deficiency from an unspecified start date and ongoing (did not have dosage, she got an infusion into a port once a week. She got five bottles. She was on this for alpha-1, maybe 10 years); tiotropium bromide (SPIRIVA) taken for lung disorder, alpha-1 antitrypsin deficiency, chronic obstructive pulmonary disease, emphysema from an unspecified start date and ongoing (Caller thinks it is a standard, it is once a day. She has been on for 10 years. It does not say anything else, it just says Spiriva handihaler); temazepam taken for insomnia; vilazodone hydrochloride (VIIBRYD) taken for bipolar disorder; colecalciferol (VITAMIN D3) taken for vitamin d deficiency; olanzapine (ZYPREXA) taken for bipolar disorder from an unspecified start date and ongoing; multivitamin (Dosage text: Caller takes one a day, it does not really have a dose, she does not see a dose thing on it. has been taking for about 20 years, Caller states she eats like crap). The patient got her first shot yesterday (05Apr2021), and then woke up with the blood vessels in her left eye were popped, and her whole eye looked bloody. She added this was kind of tripping. She wanted to know if this had anything to do with the shot (Pfizer Covid19 vaccine) or anything else. It was gross, and she did not like looking at it. It looked like there was blood around her eye, and it started when she woke up this morning it was like that. It looked like it was getting red, more red, it did not look like it was spreading but it was getting darker. She clarified and stated that it was a lot of pets. She did start an allergy drop a week and a half ago, Pataday (lot number 102C5, expiration date Dec20211, over the counter) eye drop; it was a 0.2 % antihistamine. Treatment reported as: just the Pataday eye drops, which were for allergies. She did not know what was up with the pollen this year but it was trying to kill her. She started these a week and a half ago. The events did not require a visit to Physician office or Emergency Room. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.
41 2021-04-20 mouth itchiness, oropharyngeal discomfort My mouth and tongue became itchy about two minutes after the injection. My throat felt strange. My... Read more
My mouth and tongue became itchy about two minutes after the injection. My throat felt strange. My arms were itchy as well. The pharmacist gave me two children's chewable Benadryl. My symptoms remained, so the pharmacist injected me with an EpiPen and called an ambulance. I was taken to the ER at the hospital. By 5:00 pm, the ER staff gave me IV fluids, Benadryl, and steroids. I was experiencing nausea, and so Pepcid was also given via IV. I also had a rash on my arms and legs.
41 2021-04-20 mouth itchiness PT COMPLAINED OF ITCHING IN MOUTH AND THROAT . WE GAVE HER Benadryl with no relief than administered... Read more
PT COMPLAINED OF ITCHING IN MOUTH AND THROAT . WE GAVE HER Benadryl with no relief than administered an epi pen. we called 911 and pt went to the ER
41 2021-04-20 oropharyngeal discomfort Pt. had rash on left side of neck to mid-clavicular line and slight ticking in her throat. Pt. deni... Read more
Pt. had rash on left side of neck to mid-clavicular line and slight ticking in her throat. Pt. denies difficulty swallowing. SOB, other complaints. Pt. was give 50 mg PO diphenhydramine w/ relief from S/S
41 2021-04-20 ringing in ears Tinnitus. I historically have had minor tinnitus, that happens infrequently and sporadically. I had... Read more
Tinnitus. I historically have had minor tinnitus, that happens infrequently and sporadically. I had my first vaccination on Sunday and I really noticed this began yesterday on Tuesday, it has worsened and is more frequent than usual. I decided to Google this symptom in regards to the covid vaccine and found this to be an adverse effect I should maybe report. I'm able to work and live normally, it's not that much of a bother at this time. I have not notified my pcp of this, and don't feel I need to be seen by them.
41 2021-04-21 loss of taste Tested positive for COVID on 4/21.....well after the full vaccination series was completed on 1/7/21... Read more
Tested positive for COVID on 4/21.....well after the full vaccination series was completed on 1/7/21. Mild symptoms including loss of taste and small dry cough
41 2021-04-21 taste impairment I noticed a metallic taste in my mouth around April 12 and I still have it. It seems to have improve... Read more
I noticed a metallic taste in my mouth around April 12 and I still have it. It seems to have improved but I?m nervous now that it has lasted so long and I?m due for my second vaccine on April 27.
41 2021-04-21 mouth tingling 20 minutes after my second shot, I developed wheezing at the base of my throat. It did not escalate ... Read more
20 minutes after my second shot, I developed wheezing at the base of my throat. It did not escalate to full anaphylaxis but remained a steady wheezing feeling for a number of hours after. It dissipated be evening but returned 4 days later along with tingling in my lips that comes and goes. It continues on and off 2 weeks post vaccine. I do not have any other illnesses or reasons to think this other than a side effect from the vaccine. I do not have a history of asthma either.
41 2021-04-21 ringing in ears Day of vaccine, approximately 2 hours later, the left-side of my face went numb for approximately 8 ... Read more
Day of vaccine, approximately 2 hours later, the left-side of my face went numb for approximately 8 hours. 6 days later, I experienced chills followed by hot flashes, nausea, dizziness, weakness (needed support to walk), headache and ringing in my ears. The chills, nausea, weakness, etc. came in waves for the next 6 days. The tinnitus and dizziness has stayed.
41 2021-04-21 ringing in ears Severe tinnitus. Both ears have been ringing loudly, constantly for weeks following the vaccine. It ... Read more
Severe tinnitus. Both ears have been ringing loudly, constantly for weeks following the vaccine. It has now been at least 2 weeks. Primary physician has referred me to ENT.
41 2021-04-21 vision blurred 41 y/o F w/ PMHx panic d/o presenting with difficulty talking, reporting ?feeling a lump in my throa... Read more
41 y/o F w/ PMHx panic d/o presenting with difficulty talking, reporting ?feeling a lump in my throat,? chest tightness/shortness of breath, hazy vision, and tingling in bilateral arms/hands 10 minutes after her first dose of Pfizer (given at 12:03 PM - symptom onset at 12:13 PM). Reports symptoms started suddenly with chest tightness and hazy vision which then resolved after approximately one minute. Reports symptoms then localized to her throat and she felt like she had to gag. After 2-3 minutes of having difficulty talking, she reports she feels like she can fully talk again. Reports her throat swelling sensation has resolved and only residual symptoms are a ?caffeine rush feeling? and tingling in her hands. She did not have water or breakfast today and endorsed feeling nervous prior to her vaccine today. Only medical hx includes panic d/o (occasional - last panic attack 1.5 yrs ago). Not on daily or prn medications and never has been; no h/o seeing psychiatry or therapy. Reports her current symptoms feel different than other panic attacks. No other chronic conditions or daily meds. Denies h/o serious allergic reaction to any medications (oral, intravenous, injections). Reports feeling dizzy with Excedrin PO 10 yrs ago. Never been given Epinephrine. H/o hay fever with weather changes - does not take medications. Pt denies swelling of the face, itching of the skin, rash, CP, dizziness, extremity weakness, HA, n/v, or abdominal pain.
41 2021-04-22 dry mouth Dizziness/light headedness, fatigue, chills, runny nose, dry mouth Rest, vitamin C, in bed with lots... Read more
Dizziness/light headedness, fatigue, chills, runny nose, dry mouth Rest, vitamin C, in bed with lots of blankets Outcome unknown
41 2021-04-22 mouth tingling The patient left the vaccine clinic after the 15 minute observation period. While driving home, abo... Read more
The patient left the vaccine clinic after the 15 minute observation period. While driving home, about 25 minutes post vaccination, the patient developed what she described as "tongue and throat felt funny and stuffy.' She drove to her PCP clinic and was evaluated by a physician. Vitals were normal/baseline (BP=96/68, HR=79, SpO2=100%, RR=14). She was treated with diphenhydramine 25mg by mouth, and Solu-Medrol 40mg intramuscular. Symptoms resolved following treatment and observation. The provider recommended that patient could proceed with 2nd dose.
41 2021-04-22 swollen tongue Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a... Read more
Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a contactable pharmacist. A 41-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN3518), via intramuscular route of administration in left arm on 02Feb2021 at 11:45 AM at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El1283), via intramuscular route of administration in left arm on 01Jan2021 at single dose for COVID-19 immunization and had no problem post 1st dose. Medical history and concomitant medications were not reported. The patient was allergic to shellfish anaphylaxis. On 02Feb2021 at 12:15 PM, the patient experienced tongue felt like it was swelling, tickle in her throat and itching. During observation period post second dose patient began itching and felt like she had a tickle in her throat. Patient began clearing her throat and asked for some water. RN noted she was rubbing throat and gave her water and benadryl 25 mg PO for itching. Patient noted that her throat was starting to feel funny like it might be closing up and her tongue felt like it was swelling. Epinephrine 0.3mg IM administered immediately after identifying these symptoms and patient wheeled down to ER for evaluation. Patient received IV benadryl in ER and famotidine. Observed for a couple of hours and then released. The outcome of the events was unknown.; Sender's Comments: A causal relationship between BNT162B2 and the reported events swollen tongue, pruritus and throat irritation cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .
41 2021-04-22 ringing in ears, ear discomfort tinnitus - pulsating swooshing in ears
41 2021-04-22 ringing in ears Since receiving my first Pfizer Covid vaccine on March 18th, 2021, I have experienced nearly non-sto... Read more
Since receiving my first Pfizer Covid vaccine on March 18th, 2021, I have experienced nearly non-stop tinnitus in both ears. I still went and received my second dose on April 9th, 2021. I am still experiencing the tinnitus and have an appointment with an ENT today, April 23rd.
41 2021-04-23 deafness 9 days after the vaccine I experienced sudden hearing loss in my right ear. There is a marked diffe... Read more
9 days after the vaccine I experienced sudden hearing loss in my right ear. There is a marked difference between the left and right ear, and I am relying on my left ear to hear and function. I am reporting this 48 hours after the onset of the hearing loss. Treatment - prednisone, zyrtec, flonase. Outcome - treatment only began 24 hours ago, so it's too soon to tell.
41 2021-04-23 ear discomfort, ringing in ears Tinnitus in left ear Pressure in left ear, left side of face
41 2021-04-23 mouth tingling, loss of taste Ninety minutes after injection, face and lips tingled and went a little numb, lost some feeling. Th... Read more
Ninety minutes after injection, face and lips tingled and went a little numb, lost some feeling. Throat went tight and tongue tingled and lost some taste. Throughout the three weeks since it started it comes and goes in severity but has not stopped. One dose of Benadryl was taken and the symptoms did not go away.
41 2021-04-23 smell distorsion, taste disorder For both of my vaccines, I had a noticeable dulling of my senses of taste/smell on the 3rd day follo... Read more
For both of my vaccines, I had a noticeable dulling of my senses of taste/smell on the 3rd day following vaccination. Symptoms did not last longer than 12-24 hours
41 2021-04-24 lacrimation increased Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma a... Read more
Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma attack, the nurse I seen took me to a curtain room and gave me 6 pumps of albuterol my bp was dropping at first and I was extremely weak and I took 2 more puffs and my BP went up now and the nurse wanted me to go to the ER and I got up and almost fell I was so dizzy I was given Benadryl at the hospital and received chest X-rays and was watched over and I was continuing to take Benadryl and albuterol around the clock, I was itchy all over and I?ve had to take my albuterol more often then usual now even though feeling better my heat rate is all over the place and and my period is extremely off as well clotting, tissue passing as the vaccine is now itchy again and swollen and hurting after 2 days as of your symptoms were gone
41 2021-04-25 inability to speak 24 hours after shot had hallucinations, then 3 days later started having sore throat, lost voice, an... Read more
24 hours after shot had hallucinations, then 3 days later started having sore throat, lost voice, and scratchy chest feeling. no fever, no cough, no sob.
41 2021-04-25 pain in jaw Patient woke up with jaw pain and left arm pain. When this didn't subside, she went to the ER and w... Read more
Patient woke up with jaw pain and left arm pain. When this didn't subside, she went to the ER and was found to have an NSTEMI. cath showed no abnomalitys echo showed inferior/infeobasal hypkinesis differential: takotsubo cariomyopathy, viral myocarditis, vaccine reaction Patient wore a heart monitor for a week which showed no abnormalities. Since this time, she has had occasional chest pains, squeezing sensations and pressure. A return visit to the ER because of continued chest pains showed a normal EKG and negative troponin. She is scheduled for a cardiac MRI tomorrow on 4/27/21. She is currently taking 10mg Amlodipine, 25mg metoprolol, a statin and a baby aspirin. The amlodipine seems to have done the most with respect to helping with her symptoms. She does not smoke. 1 glass of wine per week. She is not overweight. She has low cholesterol and low BP prior to this. Only other medical condition prior to this was occasional migraines (2 per year).
41 2021-04-25 ringing in ears Tinnitus
41 2021-04-25 visual impairment At 7:10 am on 4/14/21, I first started shaking uncontrollable because I was so cold w/ chills. Then ... Read more
At 7:10 am on 4/14/21, I first started shaking uncontrollable because I was so cold w/ chills. Then about 7:30 am I started breathing hard. My eye sight went black for a few minutes, I almost passed out. Both hands went numb for a few minutes. Then I got a fever, highest was 102.7. Had fever off and on all day and body aches then by 2 pm the fever was better. Then at 7:30 pm, I started shaking again and my fever spiked to 104.5. I got it down to 103 and it was like for about 3 hours then it broke. Then for about a week, I was very exhausted and had no energy and couldn't like normal, no appetite. It took me a week to get to feeling better.
41 2021-04-26 dry mouth Within 10 minutes of receiving her vaccine she developed dry mouth, nausea, lightheadedness, shakine... Read more
Within 10 minutes of receiving her vaccine she developed dry mouth, nausea, lightheadedness, shakiness, and then a tightness in her throat associated with "gagging."
41 2021-04-26 ear pain, ear discomfort, taste disorder Bell's palsy, abnormal taste, ear pain, fullness, vertigo
41 2021-04-27 dry throat, inability to speak A couple of hours later I had fatigue, cough, joint pain, muscle pain, change of appetited, brain fo... Read more
A couple of hours later I had fatigue, cough, joint pain, muscle pain, change of appetited, brain fog & lost of voice. I have not fully recovered from this symptoms. I seen several doctors. On 01/19/2021 I seen my doctor they tested me for covid & told me to rest & go back to work when I felt better. On 02/08/2021 got tested for covid again. On 02/26/2021 I was tested again for covid due to my cough and dry throat. On 03/02/2021, 03/9/2021, 03/15/2021 I was seen by raspatory doctor due to the symptoms that I was having. On 03/25/2021 continued cough anxiety and depression fatigue and pain. On 04/02/2021 I followed up with my pcp for my ongoing issues and she refer me with an ENT. On 04/26/2021 I was seen by ER because of migraines and I don't have a history for migraines. Today on 4/28/2021 I am seeing the ENT for the voice lost.
41 2021-04-27 lip swelling, mouth tingling it started about the 10 minutes after the shot.my lips started swelling up and my tongue started get... Read more
it started about the 10 minutes after the shot.my lips started swelling up and my tongue started getting tingly on the tip. my arm got swollen and was noticeable by the wrist area on the arm the shot was given on. my neck started to swell up on that side. then my cheak started getting numb like tingly feeling. it started coming up towards my face the numbness . they just gave shot of Benadryl. never had a reaction to a vaccine
41 2021-04-27 mouth swelling mouth swelling, itching,
41 2021-04-27 swelling around the eyes She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling ar... Read more
She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling around her eyes within an hour. After 24 hours, she turned red, developed swelling on her entire body, and itchiness on her entire body. Notes her joints were painful; unable to make a fist with her hands. Also had a fever. No asthma symptoms. She called Urgent Care for advice, was recommended to take cetirizine or other antihistamines and pain medications. Patient took cetirizine and ibuprofen, symptoms resolved within a few hours. Still has some residual swelling around her eyes but notes it isn't itchy.
41 2021-04-27 ringing in ears It?s made my tinnitus louder too point can?t ignore disrupts sleep and made my neck tighter.
41 2021-04-28 mouth numbness, ear itchiness Within 10 min left ear was warm and itchy, slowly progressed to left sides of neck and face. Waited ... Read more
Within 10 min left ear was warm and itchy, slowly progressed to left sides of neck and face. Waited full 30 min with no change. EMT advised me to take Benadryl at home after checking for rash. No trouble breathing. On the drive home, my left tongue and mouth went numb and left tonsil swelled slightly. I took 2 benadryl at home and felt better a few hours later. No recurrence as of today. With my first dose of the vaccine, I only noticed immediate nasal drainage.
41 2021-04-28 vision blurred, ringing in ears Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing lo... Read more
Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
41 2021-04-29 swelling of eyelid My eyelids and the area right below my eyes starting swelling and peeling about 48 hours after my fi... Read more
My eyelids and the area right below my eyes starting swelling and peeling about 48 hours after my first vaccine. After about 10 days, I went to my doctor just to make sure I shouldn?t be worried about a worse after the second dose, but he didn?t think there was much we could do except wait it out (symptoms are annoying but not debilitating). We agreed that I should get the second vaccine. I am still experiencing swelling, itching, and irritation of the area surrounding my eyes (not the eyes themselves) 16 days after my first shot. It is worst in the morning. I have had slight improvement since initial onset, but I am definitely still experiencing symptoms.
41 2021-04-30 smell distorsion didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a sp... Read more
didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unspecified date, and 5 minutes after she "didn't feel good". The patient was sick, blood pressure went high, smells smoke, pulse change and migraine up until 36 days later. She was on migraine medicine, and that she lost her job because of this. The patient already went to the hospital four times, and her doctor five times. The patient sought guidance on how to remove the vaccine from her system. The patient considered the events as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.
41 2021-04-30 swollen tongue arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; ... Read more
arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; This moved to swelling of the tongue; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in right arm, on 15Apr2021 16:15 (at the age of 41-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included PCOS (polycystic ovarian syndrome), allergies to sulfamethoxazole;trimethoprim (BACTRIM), metoclopramide (REGLAN) and amino acid base in iron infusion. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA, nasal spray). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Mar2021 16:00 (at the age of 41-year-old), at single dose, for COVID-19 immunization. On 16Apr2021 16:30 (reported as "initially within 5 minutes"), patient developed arm numbness and tingling. Physician prescribed diphenhydramine hydrochloride (BENADRYL) and prednisone. Within 30 minutes, began to feel burning in face and face began to tense up. This moved to swelling of the tongue and difficulty swalliwing. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. The patient underwent lab tests and procedures, which included COVID test (Nasal Swab) was negative on 17Apr2021. Therapeutic measures were taken as a result of events and included treatment with epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), famotidine (PEPCID) and diphenhydramine hydrochloride (BENADRYL). The outcome of the events was not recovered.
41 2021-05-02 visual impairment On April 4 (throughout the day) -- began to show symptoms of feeling abnormal / off-center (beginnin... Read more
On April 4 (throughout the day) -- began to show symptoms of feeling abnormal / off-center (beginning around 10am). by 5pm -- became uncoordinated / unbalanced (couldn't access phone, put on clothes, etc.). Advised by Neurologist to seek ER treatment and directed to local hospital. Initially, diagnosed as showing symptoms of a Stroke. Upon further analysis, hospital determined it was a MS Flare Up. Since April 4 -- patient lost use of left side (hands, legs). Right Side brain also affected. Currently in acute rehab (Since April 17) to regain functionality. As of May 3 -- still unable to walk on her own or use left hand. Still experiencing visual issues. Acute Rehab facility believes recovery may take up to a year. Patient's normal Neurologist was puzzled by diagnosis because the symptoms as well as the duration and acuteness of the episode is inconsistent with her MS condition. Patient was originally diagnosed with MS in 2009 and there have no MS flare-ups since the initial diagnosis. The normal Neurologist noted that the symptoms are inconsistent with her history. Believe it was proper to notify, given the recent vaccination. Can provide full medical records, if helpful
41 2021-05-07 blindness Increased intracranial pressure with vision loss requiring VP shunt placement; Increased intracrania... Read more
Increased intracranial pressure with vision loss requiring VP shunt placement; Increased intracranial pressure with vision loss requiring VP shunt placement; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 23Jan2021 at 12:00 (Lot Number: EK9231)(at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, all from an unknown date and unknown if ongoing. Known allergies: KEFLEX, LEVAQUIN, Penicillin. Concomitant medication included levothyroxine; lisinopril; trazodone and HCTZ, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 04Jan2021 at 15:00 (Lot Number: EL0140) (at the age of 40-year-old) as single dose for COVID-19 immunisation. On 26Jan2021 at 14:00, the patient experienced increased intracranial pressure with vision loss requiring VP shunt placement. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events for 2 days. The patient underwent lab tests and procedures which included intracranial pressure (CSF pressure): increased on 26Jan2021, SARS-COV-2 test (Nasal Swab): negative on an unspecified date. Therapeutic measures were taken as a result of the events and included 3 lumbar punctures and surgery for VP shunt. The patient outcome of the events was recovering.; Sender's Comments: The 41-year-old patient had medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, and was on multiple concomitant medications. Intracranial pressure increased and blindness were most likely due to concurrent disease, and unlikely related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
41 2021-05-07 hearing loss, ringing in ears This is a spontaneous report from a contactable consumer reporting for the daughter. A 41-year-old... Read more
This is a spontaneous report from a contactable consumer reporting for the daughter. A 41-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose maybe the right arm (reporter was unsure) at the age of 41-year-old for COVID-19 immunisation, administered through hospital. Medical history was none. There were no concomitant medications. In Apr2201 the patient experienced she can't hear right now and it won't go away, ringing in ears, she is extremely stressed out and this is affecting her life, she was so upset. The course of events was as follows: She has had ringing in her ears from this, started some time after the shot. She was extremely stressed out and this was affecting her life. She can't live like this. She recently divorced with 2 kids and trying to work. Went to the doctor twice and they sent her to ENT department. This is destroying her life. It was very stressful. Patient was having a severe problem. She had been to the doctor twice, including this week in Apr2021 and once the end of last week in Apr2021. They looked at her medications and sent her to counseling, to therapy. She had definitely not gotten better, has been persistent. She did not know on like a graph scale where it was. She received no treatment for ringing in ears. She was trying to take something for stress because this was horrible. She cannot hear right now and it won't go away. This is a serious problem. Reporter did not want her daughter to go deaf. She received a message from hospital, regarding her being scheduled for the second vaccine on Saturday and she said she was not going for that she wished she had not gotten the first one. Reporter stated she has a good friend who's daughter was a PA whom she has been corresponding to about this and she sent them links of how the Covid vaccine is linked to tinnitus. She has never had anyone report this. She sent it to her daughter and her daughter said can't read this, there is blogs with responses and she just said she can't read this, she was so upset that she can't hear right because of this with this ringing that won't go away. She had gotten a call from the Hospital Department stating that she was ready for the second shot. She was not getting the second shot and was sorry that she got the first one. The outcome of events was not recovered. Information on the lot/batch number has been requested.
41 2021-05-09 deafness, ringing in ears, ear discomfort Clogged feeling in ears, hearing loss, tinnitus
41 2021-05-16 ringing in ears Tinnitus in ears, starting loudly in the right ear at 16hrs after vaccination and softer in the left... Read more
Tinnitus in ears, starting loudly in the right ear at 16hrs after vaccination and softer in the left ears. Left ear became louder over the next week. Called primary care doctor twice over the next couple days and saw ENT on 4/28/21 after vaccination. No hearing loss detected and no cure available for tinnitus. ENT was unable to say if tinnitus will resolve over the next few weeks/months. Considering it has been nearly 4 weeks, I consider this to be permanent damage.
41 2021-05-17 ringing in ears The evening of the vaccine I noticed pulsatile tinnitus, which began as a low thudding sound in my h... Read more
The evening of the vaccine I noticed pulsatile tinnitus, which began as a low thudding sound in my head (with pulse). The next day the tone had changed to the high pitch, constant ringing of tinnitus. I also experienced persistent daily headaches for 8 days, which has resolved. The tinnitus has not resolved and ranges in intensity from so loud I cannot listen it focus to background noise.
41 2021-05-18 eye disorder Bell'sPalsy, left sided facial droop, inability to move the left forehead, left facial numbness, ina... Read more
Bell'sPalsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye
41 2021-05-19 taste disorder 5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed s... Read more
5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed shortness of breath, very sleepy, throat clearing, heavy post nasal drip. Weird taste in mouth. 5/18 - Neck Pain 5/19 - Felt a small moving ball on top of the left side of my collarbone, closer to my throat, it is painful and tender to the touch. My neck feels in pain, actually more like a burning sensation
41 2021-05-20 dry throat, thirst, visual impairment, deafness headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a sec... Read more
headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a second, difficult to find words for a second, felts as if she had a fever and kept coming in flashes, pain went down leg, but then quickly went away, index knuckle on left hand felt burning, but went away,2nd day- tiredness, hot flashes, thirsty, 3rd day sleep disturbances, night sweats on each day since vaccine, throat dry on second day, 3rd day throaty dry, lymph nodes swelling, tired, this morning pain in right axillary area, neck still sore, dizziness this afternoon, abdominal upset this morning, hot flashes today
41 2021-05-23 ear pain, ear discomfort, mouth tingling Approximately 3 hours after vaccine, I began to have tingling on my upper lip (area where I typicall... Read more
Approximately 3 hours after vaccine, I began to have tingling on my upper lip (area where I typically get a cold sore). Tingling continued to spread to the left side of my face, including my eyebrow, eye and temple area of my head. Tingling has persisted to both of my arms, hands, legs and feet. It comes and goes, and has continued through-out the day. Itching has now developed on my arms, right breast (nipple area) and feet. I have a general "internal" itch that I can't seem to scratch on my arms, legs and feet. On Saturday 5/22, Sunday 5/23 and Monday 5/24 I have also experienced strong nerve pain in my left eye and the lower right side of my head. The pain is sudden, strong but goes away fairly quickly. My left large tie also has developed a numbness, started off with a lot of tingling in that toe. My head generally has a fullness feeling, specifically my ears have a throbbing sensation that I also equate to a similar feeling when my cold sores are active. There is a dull ache behind my ears and the lower back of my head. I developed a headache starting on 5/20 (over the counter meds helped with that) Pain at injection site lasted for 3 days, but was manageable and did not interfere with daily activities. I have not had a cold sore develop as my dr told me to take Valtrex, I have taken one pill of that on 5/24. I also have taken Tylenol on 5/20, 5/21, 5/22 - 500mg 2 times a day.
41 2021-05-23 oropharyngeal discomfort Reported throat feeling "funny" and "hoarse" approximately five to six minutes post vac. Observed p... Read more
Reported throat feeling "funny" and "hoarse" approximately five to six minutes post vac. Observed pt x 51 minutes. No SOB, tachycardia, tachypnea, wheezing, hives, cyanosis observed. Vitals WNL x 2. BP 118/80, Resp 16-18, Pulse 80-88. A/O x3. Over the 51 minutes feeling in throat improved w/o intervention. Left w/o assistance and under no duress.
41 2021-05-23 tunnel vision Patient reported dizziness, lightheadedness, ascending warmth/tingling, tunnel vision, and that she ... Read more
Patient reported dizziness, lightheadedness, ascending warmth/tingling, tunnel vision, and that she "couldn't feel her hands" shortly after receiving her vaccine. She was highly anxious and stated "I never should have done this". On arrival to med obvs, her hands were in a contracted position and her arms/legs were shaking. Patient repeatedly asked if she was going to be paralyzed. The patient began to feel better after several deep, relaxed breaths. Patient was given water, apple juice, and crackers. Pt requested to use the restroom around 11:10. She was transferred there via wheelchair where she was able to urinate, and reported feeling better after doing so. On discharge, patient reported slight light headedness and "off" feeling, but was otherwise better. Vitals as follows: 10:50- BP 151/84, HR 144, RR 22, O2 97 10:52- BP 146/78, HR 144, RR 22, O2 97 11:00- BP 148/85, HR 125, RR 20, O2 100 11:07- BP 139/78, HR 116, RR 20, O2 100 11:26 (sitting)- BP 135/70, HR 104, RR 18, O2 100 11:36 (sitting)- BP 128/73, HR 98, RR 18, O2 100
41 2021-05-24 lip swelling right side facial swelling, right side lip swelling
41 2021-05-24 pain in jaw R jaw pain maxillary/mandibular with mouth symptoms in neuropathic pattern similar to V2/V3 trigemin... Read more
R jaw pain maxillary/mandibular with mouth symptoms in neuropathic pattern similar to V2/V3 trigeminal distribution, low concern for CNS event, saw urgent care, dentist, periodontist, PCP x 2, scheduled to see ENT; symptoms improving somewhat, supportive care with viscous lidocaine, ice/heat, APAP/NSAIDs
41 2021-05-24 visual impairment My vision became abnormal the following day after receiving vaccine. I could see fine, but felt lik... Read more
My vision became abnormal the following day after receiving vaccine. I could see fine, but felt like both eyes were not in sync with one another. It comes and goes. It can last for hours at a time. It has been ongoing, everyday for 4 weeks. I have never had any vision issues prior to the vaccine. I have seen an optometrist and eye specialists. So far, they have seen no signs or not detecting any eye condition or problem. I am to follow up with the eye specialists in 5 weeks. They recommended giving it a few extra weeks to see if symptoms improved or went away before looking into further/other testing.
41 2021-05-26 loss of taste, loss of smell 05/21/2021 Routine Covid-19 screening. later developed fever (subjective), cough, sore throat, short... Read more
05/21/2021 Routine Covid-19 screening. later developed fever (subjective), cough, sore throat, shortness of breath, Chills, headache, muscle aches, lost taste and smell, diarrhea and later developed chest congestion.
41 2021-05-26 loss of taste, loss of smell Pt states that she lost taste and smell since her first dose and it has only intermittently recovere... Read more
Pt states that she lost taste and smell since her first dose and it has only intermittently recovered. For example, ranch now burns her tongue.
41 2021-05-26 loss of smell 5/3/21-Contacted by individual to report that she has tested positive for COVID-19 test result with ... Read more
5/3/21-Contacted by individual to report that she has tested positive for COVID-19 test result with the following symptoms: cough, chills, headache, sore scratchy throat, congestion, runny nose, loss of smell, and fatigue. She has been Vaccinated x 2 with Pfizer COVID vaccine and denies any chronic conditions or medications.
41 2021-05-26 eye swelling Hives all over my body; Swollen eyes; Swollen knees elbows; Chills; This is a spontaneous report fro... Read more
Hives all over my body; Swollen eyes; Swollen knees elbows; Chills; This is a spontaneous report from a contactable Other Health Professional. A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266, expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 22Feb2021 14:30, 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264, expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 13.00, Single for COVID-19 immunization. The patient experienced Hives all over my body, swollen eyes, swollen knees elbows, chills on 22Feb2021 14:30. Patient was treated with Dosepk 4 MG. Adverse events resulted in Emergency room/department or urgent care. The clinical outcome of the events were not recovered.
41 2021-05-26 ringing in ears, hearing loss Hearing go out and tinnitus in one ear intermittently for 2 weeks; Hearing go out and tinnitus in on... Read more
Hearing go out and tinnitus in one ear intermittently for 2 weeks; Hearing go out and tinnitus in one ear intermittently for 2 weeks; Muscle jerking in arm, stomach, and one toe; Headache; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8731), via an unspecified route of administration in the left arm on 10Apr2021 at 00:00 (at the age of 41-years-old), 1st dose, single, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 11Apr2021 at 13:00, the patient experienced hearing went out, tinnitus in one ear intermittently for two weeks; muscle jerking in arm, stomach, and in one toe and headache. The patient underwent lab tests and procedures which included nasal swab COVID-SARS PCR test: negative on 21Apr2021. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.
41 2021-05-27 inability to speak, ear pain 5/19-injection site pain, muscle aches, sore throat, (Tylenol taken every four hours) 5/20-injection... Read more
5/19-injection site pain, muscle aches, sore throat, (Tylenol taken every four hours) 5/20-injection site pain, muscle aches (Tylenol administered every 4 hours) 5/21- sore throat, muscle aches, low grade fever, (Tylenol taken every 4 hours) 5/22- extreme sore throat (burning sensation), ear ache, cough, headache, low grade fever, lost voice,(Tylenol taken, hot tea, throat lozenges, gargle with warm salt water) 5/23-sore throat, headache, cough,(Tylenol taken, hot tea, throat lozenges, gargle with warm salt water)5/24- sore throat, runny nose, cough, facial pain, ear ache, voice returned,(Tylenol taken, hot tea, throat lozenges, gargle with warm salt water) 5/25- persistent cough, runny nose, 5/26-dry cough, 5/27- dry cough, 5/28-dry cough, I am currently having coughing uncontrolled dry coughing fits which last a few minutes in duration.
41 2021-05-27 eye pain Recurring pain around left eye. Probably sinus pain or migraine rather than true eye pain. Maybe be ... Read more
Recurring pain around left eye. Probably sinus pain or migraine rather than true eye pain. Maybe be related to the walk to and from the clinic, exposure to strobe lights en route, etc.
41 2021-05-28 hearing loss, swollen tongue, ringing in ears, swelling of eyelid, lip swelling throat felt like she had been talking all day and swollen; felt that they were giving a shot; couldn... Read more
throat felt like she had been talking all day and swollen; felt that they were giving a shot; couldn't get a full breath; right side of her face drooped a little; tongue was swelling; face, lips, eyelids and around them were swollen; intermittent chest pain; heart it felt achy at times; had a head rush; felt very hot suddenly; her ear started ringing and buzzing; she could not hear well; she felt immediately as if someone was trying to put her to sleep; She felt heaviness in her body, and in her chest and said it felt as if someone was lying on top of her.; her nose and mouth started to become gray and blue in color; numbness in her left arm; face, lips, eyelids and around them were swollen; face, lips, eyelids and around them were swollen; couldn't get a full breath because of the heaviness on her chest; fingers stay cold a lot; This is a spontaneous report received from a contactable consumer. This 41-year old female consumer (patient) received BNT162B2 dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: ER8730) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included allergic to shellfish and almonds from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced a head rush after the first dose of the Pfizer-BioNTech Covid-19 Vaccine and felt that they were giving a shot . Everything was normal but when she came home, within an hour and 20 minutes, she suddenly felt very hot, her ear started ringing and buzzing, and she could not hear well. She said she felt as if someone was trying to put her to sleep. When the caller went to wash her face, she noticed her face, lips, eyelids and around them were swollen. The right side of her face drooped a little, it looked different on the jaw than the other side. The caller's tongue was swelling and her throat felt like she had been talking all day and swollen. She felt heaviness in her body like a weighted blanket and in her chest and said it felt as if someone was lying on top of her, it was like she couldn't get a full breath because of the heaviness on her chest. She also noticed that her nose and mouth started to become gray and blue in color but she could still swallow. She also had residual symptoms such as numbness in her left arm , it,feels like its asleep and intermittent chest pain like her heart it felt achy at times. This has gone away but it would come and go and feel like it was lightning, like thunder in her chest. Her fingers stay cold to the touch a lot from where they bend down to the tips more on her left than anything. She did not take herself to the emergency room or the doctor for the events. The caller didn't seek medical care because she had some medications at home that were for allergies from her allergist and it helped with the swelling. The patient reported the medicine was a powder tablet that is dissolvable, unknown name, she thinks she may have used it once, it has numbers on it. The swelling went down to where she felt like she was fine after taking them. The swelling in her face and her eye lids were puffy for a few days. The patient had blood work done the day of the vaccine, prior to receiving the vaccine and an electrocardiogram (EKG). Therapeutic measures were taken as a result of throat felt like she had been talking all day and swollen, tongue was swelling, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen. The outcome of right side of her face drooped a little was unknown, recovered from head rush, felt very hot suddenly, ears started ringing buzzing, couldn't hear well, trying to put her to sleep, face was pounding, face, lips, eyelids and around them were swollen, tongue was swelling, felt like something was heavy on her body, heaviness on her chest, blue and gray around her nose and mouth, chest was hurting, trying to put her to sleep, and felt that they were giving a shot on 06May2021, recovered on 09May2021 from face, lips, eyelids and around them were swollen, recovered on 10May2021 from chest was hurting and recovering from fingers stay cold a lot and numbness in her left arm. No follow-up attempts are needed. No further information is expected.
41 2021-05-28 visual impairment, mouth ulceration, swelling of eyelid Heavy period Trouble with vision Eyelids swollen Erratic Heart rate Blood pressure Shaking Thr... Read more
Heavy period Trouble with vision Eyelids swollen Erratic Heart rate Blood pressure Shaking Throat swelling Tingling in feet/hands No appetite Weight loss Pressure on chest Cough Ulcers in mouth Neuropathy These symptoms have been going on and have not let up. Currently on Lyrica .
41 2021-05-30 eye twitching Chills, night sweats, fever of 103.5, brown urine, body aches, shortness of breath, rapid heart rate... Read more
Chills, night sweats, fever of 103.5, brown urine, body aches, shortness of breath, rapid heart rate, eye twitching
41 2021-05-30 vision blurred Vision blurriness 15 minutes later, subjective throat tightness 3 hours later, gone by next day. no ... Read more
Vision blurriness 15 minutes later, subjective throat tightness 3 hours later, gone by next day. no symptoms with second dose.
41 2021-05-31 eye pain The day after I received dose 2, 04/13/2021, I started having pain behind my eyes. I was feeling ver... Read more
The day after I received dose 2, 04/13/2021, I started having pain behind my eyes. I was feeling very fatigued. I had to take painkillers to help get through the day. I had a lasting headache for a whole week. My right armpit became swollen and sore. On 04/15/2021, I felt tingling on the left side of my body with mild dizziness and anxiety. I had a virtual visit with Dr. on 04/16/2021. I also had knee pain which is unusual for me. During my virtual visit, Dr. informed me that she felt fatigue for the week after she received her vaccine too. I was told that if my symptoms continue to follow up with the doctor. As of today, 06/01/2021, I can still see where I received the vaccination. I have a red bump there. It does not hurt, but it is noticeable.
41 2021-06-01 mouth numbness, taste impairment Immediately developed a metallic taste in her mouth that lasted for 4 days. Within 15-20 minutes of... Read more
Immediately developed a metallic taste in her mouth that lasted for 4 days. Within 15-20 minutes of receiving vaccine she developed tingling of her face and numbness of her tongue - this persisted for 10-15 minutes. She reports feeling drunk and disoriented for 3-4 days after vaccination.
41 2021-06-01 swelling of eyelid She got her vaccine, she had no reactions at all. On 5/12/21, she woke up 2 days with ankle and fee... Read more
She got her vaccine, she had no reactions at all. On 5/12/21, she woke up 2 days with ankle and feet swelling, hand and face swelling, eyelid swelling. She had a fever up to 100.5. Her swelling has not gone down on any of the locations. She cannot even take her wedding bands off. Her feet are extremely cramped in her shoes. Her allergies have gone tremendously. She has been throwing up and have been nauseous a lot. She has not been taking anything but Benadryl for the reactions. She also has gained 7# since the vaccine. Her hands have also been shaky. She has not notified her doctor of any of these symptoms.
41 2021-06-02 swelling around the eyes Orbital Swelling around the eye
41 2021-06-02 ringing in ears Tinnitus - constant ringing in both ears; This is a spontaneous report from a non-contactable consum... Read more
Tinnitus - constant ringing in both ears; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 03Apr2021 13:00 (Lot Number: EW0151) as 1st dose, single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with COVID-19 prior to vaccination The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced tinnitus - constant ringing in both ears which started within about a week of injection (09Apr2021) and has been going on for 7 weeks. The adverse event result in doctor or other healthcare professional office/clinic visit and the event was considered serious with seriousness criteria of disability. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment. The outcome of the events was not recovered. No follow-up attempts are possible, information on the lot/batch number cannot be request. No further information is expected.
41 2021-06-03 loss of taste Loss of taste; This is a spontaneous report from a contactable consumer (patient herself). A 41-year... Read more
Loss of taste; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies to sulfa. The patients concomitant medications were not reported. The patient previously took Zithromax and experienced drug allergy. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. It was unknown if the patient has been tested for COVID-19 post vaccination. On 05Mar2021 at 07:00, the patient experienced loss of taste and no treatment was received for adverse event. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-06-03 mouth numbness I got my second shot on 1/27/21, woke up Thursday morning and told my husband my tongue felt funny l... Read more
I got my second shot on 1/27/21, woke up Thursday morning and told my husband my tongue felt funny like it was numb. On Friday 1/29/21 went to work and as the day progressed I noticed it was difficult to eat lunch and then went home and noticed drooping of have my face. I called my employer and PCP, they told me to go to urgent care. They diagnosed me with Bells Palsy and prescribed and antiviral and steroid. I had a follow up with my PCP. It took about 3 weeks before my face returned to normal.
41 2021-06-03 lip swelling Swollen up lip; Very light chest tightening; This is a spontaneous report from a contactable consume... Read more
Swollen up lip; Very light chest tightening; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 14:00, (at age of 41-year-old) as a single dose for COVID-19 immunisation. The patient medical history included high blood pressure and pulmonary hypertension due to left heart disease. The patient was allergic to garlic. Concomitant medication included Atorvastatin (MANUFACTURER UNKNOWN), Lisinopril (MANUFACTURER UNKNOWN), vitamin-D (MANUFACTURER UNKNOWN), Iron (MANUFACTURER UNKNOWN), and Q10 for an unspecified indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 14:00, patient experienced swollen up lip for 10 mins and very light chest tightening. The patient did not receive any treatment for the events. The clinical outcome of the event swollen up lip recovered on 18Mar2021 14:10 and the event very light chest tightening was recovered on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-06-03 mouth tingling, taste impairment metallic taste in her mouth; lightheadedness; headache; nausea; tingling lips; This is a spontaneous... Read more
metallic taste in her mouth; lightheadedness; headache; nausea; tingling lips; This is a spontaneous report received from a non-contactable health care professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205), on unspecified date (at the age of 41-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included that patient mentioned having a history of anxiety and she took her duloxetine and WELLBUTRIN the day of the present report (05Mar2021). The patient's concomitant medications included duloxetine and bupropion hydrochloride (WELLBUTRIN), both from unspecified date for anxiety. She denied use of her lorazepam (ATIVAN) recently. It was reported that during her 15 minutes waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. Treatment included paracetamol (TYLENOL) and water. Response to treatment was good. She noted some lightheadedness prior to discharge but other symptoms were improved. Reporter walked patient around the bay area and she was feeling okay. Her vitals were stable. Patient was escorted out of the facility. As per patient discharge it was reported stable to go home and follow-up with primary care physician (PCP). The outcome of the events was resolved. No follow-up attempts are possible. No further information is expected.
41 2021-06-06 vision blurred Onset of dizziness and mild nausea shortly after her shot. Near syncope described by patient with bl... Read more
Onset of dizziness and mild nausea shortly after her shot. Near syncope described by patient with blurry vision briefly. Multiple prior V-V events including syncope described by her. No allergic type symptoms. BP, Pulse, O2 sat OK throughout 28 minute stay. Symptoms improved when supine and resolved on their own with time. No orthostasis.
41 2021-06-08 ear discomfort Missed dose of the Vaccine; shingles on her face including around the eyes; Shingles, rash, on her f... Read more
Missed dose of the Vaccine; shingles on her face including around the eyes; Shingles, rash, on her face, on her eyebrow near her; Ear bothering her; Persistent headaches; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received first dose of bnt162b2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot: number EN6207), via an unspecified route of administration, administered in Arm Left on 17Mar2021 as 1st dose, single dose for covid-19 immunization. The patient did not had any medical history. Concomitant medication(s) included vitamins nos (MULTIVITAMIN [VITAMINS NOS]) started taking about 5 years ago for good health, prenatal and general women's health vitamin. There was no prior Vaccinations within 4 weeks.On 01Apr2021, in the morning patient experienced persistent headaches, on 03Apr2021, early evening around 5 or 6 PM patient had ear issue started, ear started bothering her the pain started, patient thought she had an ear infection or something. On 06Apr2021, when patient woke up in the morning she had Shingles, rash, on her face, on her eyebrow near her eye. It was reported that patient got first Pfizer covid-19 vaccine injection on 17Mar2021 but then developed shingles 2 weeks later. She was wondering when she can get second injection, It has been about 7 weeks since the first. She had blisters that opened and then they scabbed. They are not visible but, she can still see what is left of them. It was a week or two ago they started to go away she believes. She went to Urgent Care and received an antiviral as treatment and was prescribed Valtrex as treatment and she is finished taking Valtrex. The eye doctor she went to see since she had the shingles on her face including around the eyes, told her to wait about 2-3 months to give her body time to heal and her immune system strong again before receiving her second Pfizer covid-19 injection. The patient reported that she needs to make a decision on whether she should get the next dose or not. The outcome of the event ear bothering her was resolved on 10Apr2021, persistent headaches resolved on 14Apr202 and event shingles on her face including, shingles, rash, on her face, on her eyebrow near her resolved on 21Apr2021 and outcome for missed dose of the vaccine was unknown. No follow-up attempts are needed. No further information is expected.
41 2021-06-08 mouth tingling Patient was given the first Pfizer COVID19 vaccine around 5:36pm. While waiting her 15 minutes patie... Read more
Patient was given the first Pfizer COVID19 vaccine around 5:36pm. While waiting her 15 minutes patient states that she is itchy, has blotchy skin, swelling in her feet and hands, and tingling in her face and lips. She is immediately brought back into theimmunization room for observation. Patient declined ice pack. After no signs of anaphylaxis and since patient was conscious and coherent, gave 25mg of diphenhydramine around 6:00pm. Told patient to remain seated for observation. Checked patient's bloodpressure at 6:12pm and it was 144/96 with pulse of 90. Patient states her blood pressure normally runs below 120/80. Brought patient back into immunization room for more monitoring. Patient states that symptoms are not improving. Recheck blood pressure at approximately 6:25pm and it was still elevated at 151/86 with pulse of 96. Patient declined ambulance ride and wanted to continue to be observed at the pharmacy. Continued to monitor patient and call pharmacy manager and market manager. Patient states that she has taken Benadryl and Zyrtec in the past for a previous allergic reaction and it did not lessen the symptoms. Discussed taking hydroxyzine and went over possible adverse reactions especially extreme drowsiness before giving to patient. Patient's husband was with her and would be driving her home. Gave hydroxyzine hcl 25mg approximately at 7:25pm and observed patient for additional 15 minutes. Patient felt comfortable enough to leave and go home with her husband. She stated that she has an epi pen and blood pressure monitor at her house and will continue to monitor symptoms and her blood pressure. Agreed if worsening symptoms to seek medical attention. Patient left pharmacy approximately at 7:40pm.
41 2021-06-08 toothache, pain in jaw Coughing, sneezing, runny nose, congested, bodyaches, teeth pain, jaw pain, neck pain, headache, che... Read more
Coughing, sneezing, runny nose, congested, bodyaches, teeth pain, jaw pain, neck pain, headache, chest pain, fever, chills/sweats, loss of appetite, fatigue????, sore throat, painful swallowing? All symptoms started approximately five hours after receiving the vaccine, after receiving the vaccine within seconds I got incredibly lightheaded and dizzy, almost like a drunk feeling?
42 2021-01-01 swollen tongue, dry mouth Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s... Read more
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
42 2021-01-03 deafness unilateral Left sided hearing loss; This is a spontaneous report from a contactable physician who was also the ... Read more
Left sided hearing loss; This is a spontaneous report from a contactable physician who was also the patient. A 42-year-old non-pregnant female patient received bnt162b2, lot number and expiration date were unknown, via an unspecified route of administration on 16Dec2020 , 8:30 at a single dose for covid-19 immunization. The patient's medical history included antiphospholipid antibody from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Dec2020, the patient experienced left sided hearing loss. It was unknown if patient received treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID-19 since vaccination. Patient has no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on the lot/batch number has been requested.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-03 ear swelling Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down ... Read more
Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down to wrist with little bumps, really red...had on left arm as well. next day on 12- 30 around 1:30pm co worker told me my neck was really red. I told her I was just hot from working, but by 3pm I had bumps, itchy, big raised red spots....right side was worse then left side but it did cross my whole neck. my arms cleared up but when I get hot it comes out enough to see where it was located. on sat Jan 2nd the bottom of my right ear swelled and had like a white like bump....but, as soon as I cooled off because I was hot it totally went away. today is Mon Jan 4th and my neck looks like the bad rash area has burned into my neck....I have been taking Benadryl crème on neck and Friday Dec 1st I started Benadryl pills but stop taking pills after sat Jan 2nd because I was just to tired.
42 2021-01-03 lip swelling Lip and facial area swelling tow days after receiving vaccine.
42 2021-01-03 oropharyngeal discomfort Patient complained of shortness of breath, chest tightness, and throat closure
42 2021-01-03 swollen tongue began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had fin... Read more
began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had finally noticed was swollen. EMS was called and I was sent to the ER.I was given benedryll by ems, at ER I was given a steroid, Claritin and another medication for the reaction. Discharged with epi pens, a round of steroids, benedryl initially which was changed to Claritin by follow up dr.
42 2021-01-04 loss of smell Loss of sense of smell, no other COVID symptoms; This is a spontaneous report from a non-contactable... Read more
Loss of sense of smell, no other COVID symptoms; This is a spontaneous report from a non-contactable other healthcare professional. A 42-year-old female patient started to received first dose of BNT162B2, intramuscular (left arm), on 17Dec2020 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history and was not taking concomitant medications. On 25Dec2020, the patient had loss of sense of smell; no other COVID symptoms. Outcome of the event was not recovered. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
42 2021-01-04 loss of smell had loss of sense of smell and tested positive for the virus; had loss of sense of smell and tested ... Read more
had loss of sense of smell and tested positive for the virus; had loss of sense of smell and tested positive for the virus; This is a spontaneous report from a contactable healthcare professional (patient). A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on 17Dec2020 at a single dose on the left arm, for Covid-19 immunization. The patient has no medical history and no concomitant medications (no other vaccines in four weeks and no other medications in two weeks prior to vaccination). The patient has no known allergies to medications, food, or other products. The patient had loss of sense of smell, no other symptoms on 25Dec2020 and tested positive for the virus yesterday, on 27Dec2020. The patient has no Covid-19 prior to vaccination. The patient underwent Covid test (Nasal Swab) and result was positive on 27Dec2020. The patient did not receive any treatment for the event. Outcome of the event was unknown. The events were assessed as non-serious by the reporter. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: A possible contributory role of BNT162B2 vaccine cannot be excluded for event based on available information.
42 2021-01-04 taste disorder, loss of taste Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of... Read more
Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
42 2021-01-04 tongue disorder, mouth numbness throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a sponta... Read more
throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date unknown) intramuscular at left deltoid on 28Dec2020 10:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in the workplace clinic. Medical history included allergies to shellfish, allergies to strawberries, and environmental allergies. Concomitant medications were not reported. On 28Dec2020 10:30 am (approximately 30 min post vaccine), the patient experienced that her throat feeling "hot" and her tongue feeling numb and thick. The patient denied ever feeling short of breath. The patient's vital signs were recorded on 28Dec2020. The patient was not tested for COVID-19 since vaccination. The outcome of the events throat feeling "hot", tongue feeling numb and thick was unknown. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.
42 2021-01-04 visual impairment, eye pain infection in L nostril and pain radiating to L eye, impacting vision
42 2021-01-04 visual impairment arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ... Read more
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
42 2021-01-05 mouth numbness tingling on left pinky warmth hot sensations moving up towards the cheek cheek and lips went numb
42 2021-01-05 mouth swelling had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within ... Read more
had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within one hour
42 2021-01-05 oropharyngeal discomfort she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from ... Read more
she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.
42 2021-01-06 lip swelling At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were sw... Read more
At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were swelling. I took 2 Benadryl and slept. At 6 am lip swelling went down but hives are all over still. At 8 am I took another Benadryl. It is now 12:30 and still there and itching.
42 2021-01-06 eye discomfort, ear pain Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a he... Read more
Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a headache, eye pane, and left ear pain. Around midnight, I started to experience severe chills along with the body aches. I woke up around 4:30 a.m. with a fever, 38.8?C orally. All other symptoms continued as well.
42 2021-01-07 lip itchiness, tongue itchiness After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the wait... Read more
After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.
42 2021-01-07 mouth tingling Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side o... Read more
Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.
42 2021-01-07 mouth tingling Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged t... Read more
Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged to PCP if sxs worsen. ED notes incomplete.
42 2021-01-07 thirst Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable othe... Read more
Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable other hcp, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL3246), intramuscularly on 02Jan2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 02Jan2021, the patient experienced headache, chills, bad dreams and excessive thirst. No therapeutic measures were taken as a result of the events. The clinical outcome of headache, chills, bad dreams and excessive thirst was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
42 2021-01-09 oropharyngeal discomfort I HAD SUDDEN MILD THROAT DISCOMFORT DIFICULTY SWOLLOWING THAT NEVER WENT ALWAY.
42 2021-01-10 taste impairment recipient had a metallic taste in her mouth after vaccine administration, states this had happen bef... Read more
recipient had a metallic taste in her mouth after vaccine administration, states this had happen before with other vaccines.
42 2021-01-10 eye swelling Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, alon... Read more
Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, along with fatigue. On 1/8 she reports new swelling started in her face (eyes and cheeks). Swelling has not improved today and fatigue has worsened.
42 2021-01-10 mouth numbness, tongue disorder, mouth tingling 5 minutes following tingling in my lips and tongue. Later that night my tongue felt thick and the t... Read more
5 minutes following tingling in my lips and tongue. Later that night my tongue felt thick and the tingling progressed from the tip to the back of by tongue.
42 2021-01-10 swollen tongue, mouth tingling lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, cl... Read more
lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, client seen at urgent care. Client treated with Prednisone 60 mg PO x1; client prescribed Benadryl Q 4-6 hrs. x2 days, Prednisone 20 mg PO BID x5 days. Client developed generalized pruritis and lip tingling approximately 12 hrs. post-vaccination. Tongue swelling improved but not fully resolved at this writing (72 hrs. post-vaccination).
42 2021-01-11 eye irritation, taste impairment Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face... Read more
Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face, burning of the eyes, and a metallic taste was noticed in the mouth. However, all of these sensations went away on their own within five minutes of onset, without any intervention.
42 2021-01-11 eye pain 1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w... Read more
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
42 2021-01-11 vision blurred While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she... Read more
While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm".   Pt stated that her heart felt like it was "pounding".   VS: 162/96, 99% RA, HR in the 70's.   Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home.   The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist.   Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications.  
42 2021-01-12 loss of smell Loss of smell
42 2021-01-12 taste impairment 1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted thro... Read more
1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted throughout the day. 1/9/21 - I woke up at 4am the follow day after receiving the vaccine and my left side of my face was numb, I could still taste metal in my mouth, I had a headache and pain in my right arm. I watch my symptoms and checked to see if I was having a stroke, but nothing pointed to that. 1/10/21 - I still was experiencing the same symptoms from 1/9/21 with not increased or decreasing of symptoms. Watched them throughout the day but nothing changed. 1/11/21 - I continued to have the same symptoms and reported to the ED after work for the symptoms listed above with no improvement. 1/12 & 1/13 - I continue to have the same symptoms with no changes.
42 2021-01-12 eye swelling 1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 ... Read more
1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.
42 2021-01-12 mouth numbness, feeling of choking, mouth tingling, mouth swelling 2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok... Read more
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
42 2021-01-12 mouth tingling patient experienced transient tingling of lips shortly after vaccine administration (within 15 minut... Read more
patient experienced transient tingling of lips shortly after vaccine administration (within 15 minutes but could not specify exact time after). Symptoms resolved on its own within 10 minutes of reporting to us (pharmacists). Declined oral diphenhydramine at time of reporting to us but said she would let us know if she had any changes. No further adverse events or symptoms returning >2 hours after initial report.
42 2021-01-12 mouth tingling Patient initially experienced tingling in left hand right after injection. This resolved but then sh... Read more
Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.
42 2021-01-12 mouth tingling Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM... Read more
Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM-108 14:00 p.m. symptoms continuing, symptom improvement beginning at 13:00 p.m.
42 2021-01-12 eye floaters The dat after the second dose just before noon I suddenly had eye floaties in my right eye. Unlike a... Read more
The dat after the second dose just before noon I suddenly had eye floaties in my right eye. Unlike a usual floatie that might come and go these have a shape that changes as I move my eye. There is no pain, they are a sudden annoyance that i hope will go away but I wanted to make sure I reported it.
42 2021-01-13 dry mouth 1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with e... Read more
1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
42 2021-01-14 lacrimation increased Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is... Read more
Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 06Jan2021 14:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme Headache, chills, sore throat, water eyes, runny nose, tiredness entire body aches on 07Jan2021. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19, the patient underwent lab tests and procedures which included Covid-19 test/Nasal Swab: negative on 05Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
42 2021-01-14 lip swelling My lip felt sore and swollen. I looked in the mirror and it?s moderately swollen. I had filler in my... Read more
My lip felt sore and swollen. I looked in the mirror and it?s moderately swollen. I had filler in my lips 2 years ago.
42 2021-01-14 feeling of choking Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and... Read more
Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and needs to tilt head up. Advised patient to sit under observation. At 11am continues to have throat soreness and light shortness of breath. Continues to need to tilt head up. Light tingling around throat. Has never felt this before. No dermatologic symptoms. Moved her for observation at ED at 11:30am
42 2021-01-14 swollen tongue, lip swelling 5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti... Read more
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
42 2021-01-14 swollen tongue, mouth tingling, lip swelling After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti... Read more
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
42 2021-01-15 eye pain Fever 101.8 Headache Pain behind eyes Aches Chills
42 2021-01-16 taste impairment On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigu... Read more
On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigue in the evening. On 1/16/21, day two I had nausea after eating breakfast, extreme fatigue, muscle aches and joint pain. I also had a sore throat and odd sour taste in the morning, both days following the shot. This morning, day 3 I feel tired with less aches.
42 2021-01-17 mouth numbness, mouth tingling Pt was given Pfizer vaccine dose #1 and patient's face became flushed within 1 minute of administrat... Read more
Pt was given Pfizer vaccine dose #1 and patient's face became flushed within 1 minute of administration. Pt has hx of multiple allergies. Pt was asked to take mask off and redness subsided within 5 mins. Pt then reported having numbness/tingling in tongue and lips. Pt was monitored for a total of 36 minutes per RN. Pt reported no further symptoms and noted improvement of symptoms. She was discharged to home with husband, who was also present for the event.
42 2021-01-17 lip swelling, swollen tongue About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB,... Read more
About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.
42 2021-01-17 eye discomfort, eye pain, ringing in ears couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind... Read more
couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-17 mouth discomfort 10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shor... Read more
10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER
42 2021-01-17 mouth tingling Employee reported palpitations 5 minutes after vaccine was administered then began having rash on ch... Read more
Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.
42 2021-01-18 loss of taste, loss of smell Developed myalgias on 1/12 which lasted until Friday and developed loss of sense of smell and taste ... Read more
Developed myalgias on 1/12 which lasted until Friday and developed loss of sense of smell and taste on Tuesday which lasted until Thursday
42 2021-01-18 deafness unilateral Body aches, joint pain, fever (tmax 101F), Mentally fog, fatigue Left sided Headache, dizziness, a... Read more
Body aches, joint pain, fever (tmax 101F), Mentally fog, fatigue Left sided Headache, dizziness, and I couldn?t hear out of my left ear. These symptoms peaked approximately 12 hours after the vaccine. They lasted for 24 hours. The next day, the fever was gone and the only symptom I had was fatigue. 48 hours after the vaccine all my symptoms had resolved.
42 2021-01-18 taste impairment c/o tingling of face and tongue, metallic taste
42 2021-01-18 eye swelling mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; Thi... Read more
mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering. Information on the lot/batch number has been requested.
42 2021-01-19 taste impairment EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting... Read more
EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
42 2021-01-19 taste impairment Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid... Read more
Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.
42 2021-01-19 mouth tingling Small hives around neck, face, tingling in lips.
42 2021-01-19 sensitivity to light Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until... Read more
Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.
42 2021-01-19 swollen tongue 5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins:... Read more
5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone
42 2021-01-19 vision blurred About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throa... Read more
About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throat, my lower face, and the tops of my shoulders. I had reduced sensation, but also felt as though I had no muscle control with movement. Examples of this are when I tried to flex my head forward as if in a nodding motion, or to elevate my shoulders like a shrug, or clench my jaw like when chewing. These were all extremely difficult and I felt as though I had no awareness of if I was even moving these parts of my body whatsoever when I tried to voluntarily do so. It was very strange and also upsetting. I also began to have blurred vision; it was difficult to focus or see properly, such as when you visit the eye doctor and they dilate your pupils and everything seems blurry and out of focus for a period of time afterwards. This all lasted for about exactly 1 hour post. I did not seek medical attention for this as it did not worsen. I never had any difficulty breathing. It then completely went away.
42 2021-01-21 sensitivity to light Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of... Read more
Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of 101.2 at highest temp recorded. Started on 1/20 at around 9 pm. Symptoms subsided early morning of 1/22.
42 2021-01-21 ringing in ears Body aches, chills, headache, dizziness, ringing in the ears, nausea, vomiting, and fatigue
42 2021-01-23 mouth tingling Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech, no left facial mo... Read more
Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech, no left facial movement Last approximately 1hr 1/2 then full function returned
42 2021-01-23 vision blurred Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, ... Read more
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
42 2021-01-24 eye twitching I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. ... Read more
I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. My lymph nodes swelled almost immediately and the eye twitching started days later. I'm still experiencing them a week later.
42 2021-01-24 taste impairment Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; m... Read more
Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.
42 2021-01-24 eye swelling, pain in jaw, toothache, ear pain left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j... Read more
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-25 loss of taste that evening HA, myalgia, arthralgia, cough, stuffiness, sore throat, loss of taste on sun
42 2021-01-25 dry eye Exceptionally dry eyes; This is a spontaneous report received from a contactable other healthcare pr... Read more
Exceptionally dry eyes; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown), via an unspecified route of administration in the left arm, on 12Jan2021 08:30, at single dose, for COVID-19 immunization, in the hospital. There were not medical history and concomitant medications. The patient has no known allergies and is not pregnant. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient experienced exceptionally dry eyes on 12Jan2021 at 20:30. Treatment included saline eye drops. The patient was not tested for COVID-19 post vaccination. The outcome of the event was recovered in Jan2021.
42 2021-01-25 eye pain 2 days after vaccine woke up with a fever of 102, severe headache, chills, eye pain upon movement, n... Read more
2 days after vaccine woke up with a fever of 102, severe headache, chills, eye pain upon movement, nausea--took until 1/22 to resolve
42 2021-01-25 pain in jaw, ear pain Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going ... Read more
Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3248), via an unspecified route of administration in left arm on 08Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included migraines, anxiety, arthritis, EOE, IBS, asthma, possible autoimmune disorder AS, and known allergies with caffeine. Concomitant medications included topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL), montelukast sodium (SINGULAIR), and multivitamin. The patient previously took scopolamine allergies. The patient experienced headache on the left side, left sided ear, jaw and neck pain going on 4 days, extreme fatigue going on 4 days, since 08Jan2021 22:00. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has no COVID prior vaccination, has not been tested for COVID post vaccination. Treatment for the events included MEDROL dose pack and TYLENOL. The outcome of the events was unknown.
42 2021-01-25 mouth tingling, tongue disorder 1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tig... Read more
1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tightness. All mild symptoms. tongue and Lip Issues resolved in abt 1 hour and chest tightness in abt 2 hours.
42 2021-01-26 mouth numbness Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept fo... Read more
Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept for 16 hours
42 2021-01-27 taste impairment Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the morni... Read more
Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the mornings; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3302), via an unspecified route of administration on 15Jan2021 07:30 in Left arm at single dose at Workplace clinic for COVID-19 immunisation. Medical history included Rhinosinusitis, Thoracic Outlet Syndrome, Polycystic ovarian syndrome (irregular menstrual cycles) and CBC issues: low white blood cell count, low lymphocyte count, high MCV (Mean cell volume) (under current care), all from an unknown date. Concomitant medication included Multivit, ergocalciferol (VIT D), folic acid (FOLIC), fish oil, magnesium, biotin. There was no other vaccine in four weeks. The patient did not have COVID prior vaccination and not had COVID tested post vaccination. The patient experienced Nausea, fatigue, muscle/joint aches and unusually sour taste in saliva in the mornings on 15Jan2021 11:00. The patient did not receive treatment for the events. The outcome of the events was recovering.
42 2021-01-28 taste disorder c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given... Read more
c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given benadryl 25mg , water, and ice pack, waited 30 minutes, rash subsided and pt feeling ok
42 2021-01-29 visual impairment 45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewha... Read more
45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewhat similar reaction to the first dose went down to the Emergency room on 12/31/20. They treated it as vertigo. gave zofran for nausea and valium to calm me down. Was sent home with Meclizine (motion sickness)meds. I am at 9 days after the vaccine administration and still having the vertigo and nausea due to being dizzy. I didn't go to the emergency room right away as I was treating it as they treated the first one. I fell asleep as soon as I got home from work at 130pm. I got the second dose at 0900 on 1/21/21. Fell asleep for several hours. Could barely wake up. Hands and feet were swollen. Couldn't make fists. Feet were tight. Stayed hydrated. since then for the past week I have been taking motion sickness meds the dizziness has not gone away. Went to the Emergency room on 1/28/21 as the symptoms still haven't gone away. They ruled me out for a stroke. I felt completely normal before the vaccine. I had CT scan done, MRI both came back normal. The diagnosis that was the outcome was vertigo.
42 2021-01-31 taste disorder Upper arm sore around injection site; Mild headache; Excessive tiredness; Bad taste in mouth. Sharp... Read more
Upper arm sore around injection site; Mild headache; Excessive tiredness; Bad taste in mouth. Sharp pain in collar bone around during the 15 min waiting period of after injection.
42 2021-01-31 thirst, loss of smell, loss of taste Intense thirst lasting 24 hours, abnormal bowel evacuation, mild loss of sensitivity to smells and t... Read more
Intense thirst lasting 24 hours, abnormal bowel evacuation, mild loss of sensitivity to smells and tastes
42 2021-02-01 ear discomfort, taste disorder, smell distorsion I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical obse... Read more
I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.
42 2021-02-01 ear pain 13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache,... Read more
13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach. All of Saturday these symptoms went on and I had a tightness in my throat, not pain. I was very delirious and speaking jibberish when awake. Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm. Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling. Today I woke and have a very upset stomach and achy feeling all over. The lump in my arm pit has gotten smaller but is still painful and visible.
42 2021-02-02 deafness unilateral She took the first Pzfier vaccine December 16 and 6 days later, she had complete hearing loss in lef... Read more
She took the first Pzfier vaccine December 16 and 6 days later, she had complete hearing loss in left ear. She first noticed the loss of hearing occurred after a run. The pt had a piercing headache and the next morning she could not hear out of left ear. She recalls having a slight headache and tingling on the left side of her face, just after the vaccine. MRI of the brain normal. Prednisone taper, starting at 60 mg and received intratympanic steroid injections. The steroid did not help her regain her hearing. She was then seen by doctor and underwent a dozen hyperbaric O2 therapy. Pt is beginning to get her hearing back in left ear.
42 2021-02-03 eye pain Left eye ball/socket soreness when moving side to side, up and down; Sinus pressure left eye; This i... Read more
Left eye ball/socket soreness when moving side to side, up and down; Sinus pressure left eye; This is a spontaneous report from a contactable other hcp. A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: El3248), intramuscular, in the left arm, on 08Jan2021 16:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced "left eye ball/socket soreness when moving side to side, up and down" and sinus pressure left eye on 10Jan2021 10:00. the outcome of events was recovering. Therapeutic measure taken as a result events included Sufdafed. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
42 2021-02-04 loss of smell, loss of taste Vaccine 1: flu like symptoms, severe headache, rash, severe body aches, fatigue for about 4 days. V... Read more
Vaccine 1: flu like symptoms, severe headache, rash, severe body aches, fatigue for about 4 days. Vaccine 2: Nausea, diarrhea, fatigue, severe body and muscle and joint aches, headache, temporary loss of taste and smell again. Lasted about 30 hours. Diarrhea persisted for 6 days.
42 2021-02-04 eye pain Report chills, HA, eye pain and muscle pain (leg). Treatment: none, Outcomes: continues to work, do... Read more
Report chills, HA, eye pain and muscle pain (leg). Treatment: none, Outcomes: continues to work, does not interfere with ADLs.
42 2021-02-05 mouth tingling TINGLING ON UPPER LIP FEW MINUTES AFTER VACCINATION
42 2021-02-06 mouth discomfort Patient complained of headache, nausea, dizziness, and burning sensation on upper lips 10-15 minutes... Read more
Patient complained of headache, nausea, dizziness, and burning sensation on upper lips 10-15 minutes post-injection.
42 2021-02-07 loss of taste Loss of taste; This is a spontaneous report from a contactable health professional, the patient. A 4... Read more
Loss of taste; This is a spontaneous report from a contactable health professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 22Jan2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported; however, it was reported that the patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 09:00, the patient experienced loss of taste. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of loss of taste was resolving. Information on the lot/batch number has been requested.
42 2021-02-07 loss of smell, loss of taste Intermittent loss of taste and smell. I was diagnosed with covid Nov 10, 2020 and lost my sense of s... Read more
Intermittent loss of taste and smell. I was diagnosed with covid Nov 10, 2020 and lost my sense of smell and taste through Nov 24, 2020, since then I have had full taste and smell. About 6 hours after my 2nd shot things began to taste like cigarette ash, but my smell was fine. Then that evening things returned to normal. The next morning through about 1pm I was fine, things began a bit off around 1pm. By 4pm my taste and smell was gone on Sunday. Monday I have some smell and taste but it comes and goes. For instance I could taste the arugula in my salad but not the tomato. I could not taste a tangelo, but could taste a blood orange, eaten one right after the other. I now have most smell back as of 2pm Monday, but taste is intermitten.
42 2021-02-07 ear swelling, ear pain 12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. ... Read more
12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.
42 2021-02-07 swollen tongue Client reports that she was feeling weird and was not a panic attack as she has had them before. Sh... Read more
Client reports that she was feeling weird and was not a panic attack as she has had them before. She states that she was lightheaded, dizzy and that her tongue started to well and she couldn't swallow. Client reports that she received Benadryl, and anti nausea medication. Client was transported to the local hospital. Client states that she could still breath through her nose and that she was only in the ER for approximately 2.5 hours.
42 2021-02-08 mouth tingling Red, itchy face with mild burning feeling, swollen throat with itch, and tingling in tongue.
42 2021-02-09 dry mouth, dry throat 15 minutes after received COVID 19 vaccine, developed shortness of breath, dry mouth and throat dysp... Read more
15 minutes after received COVID 19 vaccine, developed shortness of breath, dry mouth and throat dysphagia, high blood pressure and anxiety.
42 2021-02-09 lip swelling I had headaches, had a single event of lip swelling, upper lip. I had a cardiac issue, having PVC, p... Read more
I had headaches, had a single event of lip swelling, upper lip. I had a cardiac issue, having PVC, pre-ventricular contractions. I had work up done. I had to get an IV of magnesium. I still have those symptoms intermittently and I am being followed up with my cardiologist.
42 2021-02-09 feeling of choking -ADR: Allergic reaction (SOB and throat tingling/swelling -Inpatient - 0.9% NaCl Bolus, famotidine (... Read more
-ADR: Allergic reaction (SOB and throat tingling/swelling -Inpatient - 0.9% NaCl Bolus, famotidine (PEPCID) injection 20 mg ,diphenhydrAMINE (BENADRYL) injection 25 mg, methylPREDNISolone sod succ (SOLU-Medrol) injection 125 mg, diphenhydrAMINE (BENADRYL) injection ADS Med, famotidine (PEPCID) injection ADS Med -Treatment: discharged with Benadryl and Medrol Dose pack
42 2021-02-10 swelling of eyelid Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She to... Read more
Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She took medication which help dull the headache. She woke up the morning of 2/11/21 with hives on her face. She states her face was red and her eyelids swollen. The left eye lid more than the right. Employee took benedryl which helped, but her left eyelid remains red and swollen. Advised employee to contact her PCP.
42 2021-02-11 swollen tongue, feeling of choking Pt described a swollen tongue, racing heart, tingling throat.
42 2021-02-14 swollen tongue, mouth swelling woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all... Read more
woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; Mallampati score 4, not my baseline; Moderate fatigue rest of the day; Sore arm was experienced within 5 hours of administration; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at Left arm on 29Dec2020 17:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension (HTN), ablation corrected Wolff-Parkinson-White syndrome, pre-eclampsia. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), ibuprofen, naproxen sodium (ALEVE) and Women's multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took trolamine polypeptide oleate-condensate (CERUMENEX) and experienced allergy. The patient's sore arm was experienced within 5 hours of administration on 29Dec2020. Next morning 15 hours post, woke with swollen tongue, throat, and all mucosal linings. Mallampati score 4, not her baseline. Moderate fatigue rest of the day. Finally took Benadryl at 23-hours post vaccine, had to repeat Benadryl every 8 hours for 2 more days and monitor symptoms, events onset date was 30Dec2020 08:30. Adverse events result in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of Swollen tongue, Throat edema, Oral mucosa swollen, and Physical examination abnormal cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-15 visual impairment I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vom... Read more
I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vomited forcefully several times. My neck and upper back became stiff and painful. Then came chills, shaking, and more nausea. My throat felt like there was a lump in it that was closing me off. I felt very weak and easily fatigued. I started to have visual issues, confusion, and was unable to focus. Neck pain continued to be severe. The next morning I woke feeling good, but within 2 hour again I went downhill. Symptoms are only about half as bad as the day before. Very very tired.
42 2021-02-17 lip swelling Information provided by patient as follows. I do not have access to urgent care notes to provide th... Read more
Information provided by patient as follows. I do not have access to urgent care notes to provide that information. ALLERGIC REACTION TO VACCINE. SWELLING IN INNER AND OUTTER BOTTOM LIP. THROAT AND EARS ITCHY AND THROAT FELT TIGHT. DIFFUCULTY SWALLWING. WENT TO URGENT CARE AND RECEIVED STERIOD SHOT.
42 2021-02-17 smell distorsion smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had ... Read more
smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
42 2021-02-18 taste impairment, mouth tingling, swollen tongue could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ... Read more
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
42 2021-02-18 extreme sound sensitivity About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just... Read more
About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just bad. That evening, I noticed chills, pressure at the top of my head, sensitivity to sounds, and aching body. That night, I had trouble sleeping due to all of this. The next day, an additional thing I noticed was how much my lymph nodes hurt, especially in the throat and armpits. The left armpit in particular was more swollen and painful than at any other time in my life. I could not put my arm down without pain. The day after that, the feelings subsided. This 3rd day after the shot, my left armpit lymph node is a little sore, but I am able to do my daily activities. I took children's chewable aspirin tablets the first evening, day and 2nd evening.
42 2021-02-21 eye itchiness Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February... Read more
Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs.   At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though "somebody was breaking my bones" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime.   She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face.   Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope.   She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine.   No known history of allergy to polyethylene glycol.   No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection.   She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this.   She denies any recent medication changes or new over-the-counter medications.   She has not previously been diagnosed with COVID-19.
42 2021-02-22 mouth tingling, feeling of choking Client reported "tingling in back of tongue and throat." Sensation lasted 15-20 minutes. Resolved ... Read more
Client reported "tingling in back of tongue and throat." Sensation lasted 15-20 minutes. Resolved without medication intervention. Client reported, "Sensation is gone. I feel okay now."
42 2021-02-22 mouth tingling Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, ... Read more
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.
42 2021-02-23 mouth tingling, taste impairment anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue... Read more
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-24 pain in jaw Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only... Read more
Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only sore. After about 2 hours, I started to had a bad headache and pain and numbness under my left jaw.
42 2021-02-25 tongue itchiness Itching on neck, arms, face, ears, chest-burning. then tongue, throat itching client treated self wi... Read more
Itching on neck, arms, face, ears, chest-burning. then tongue, throat itching client treated self with 25ml of Atarax saw improvement after 10 minutes; left on own accord.
42 2021-02-27 bloodshot eyes Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives ... Read more
Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives traveled down the left side of my body. I sought treatment at Urgent Care. They prescribed 4 mg pack of 5 day steroid. On Saturday morning, the hives returned worse and covered my entire body except my face. The injection arm was swollen and red. I also begin to have shortness of breath. I went to the ER and they gave me an IV of benedryl and prednisone. I was released with another 4 day course but with 20 mg of steroid .
42 2021-02-28 swelling around the eyes, eye disorder sore left arm shot area chemosis- thought I had something in my eye, a cat hair since I had been p... Read more
sore left arm shot area chemosis- thought I had something in my eye, a cat hair since I had been petting put cat. skin around right eye slightly swollen. Realized the liquid was under clear part of eye. Looked like some bubbled coming from top of eye, so weird. Could feel the liquid moving in eye when moving head. Touched the eye, liquid spread around iris and pupil not going over it. Was so weird. No pain. Felt that it had to be a reaction to the shot. My body seems to be pretty sensitive. I have had cold sore a few times back to back due to stress. My youngest has Cystic Fibrosis that is what allowed us to get the vaccine, in home caregiver of medically fragile child. Went to urgent care, just needed a professional to say it would go away in a few days and note the reaction. The PA said it was not a reaction to the vaccine, that it is not listed as a reaction in the data. Blah blah blah. I disagreed and left it at that. Had a benedylt last night and put a pataday drop in eye as recommended by PA
42 2021-03-02 mouth tingling Lip tingling/fizzing; This is a spontaneous report from a contactable nurse (patient). A 42-year-ol... Read more
Lip tingling/fizzing; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3246), via an unspecified route of administration (at the age of 42-years-old) on 21Jan2021 10:00 at a single dose in right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included rosuvastatin calcium (CRESTOR), spironolactone, tacrolimus, and macrogol 3350 (MIRALAX). The patient experienced lip tingling/fizzing on 28Jan2021 19:00 with outcome of recovering. No treatment received for the adverse event. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event was considered as non-serious.
42 2021-03-02 ringing in ears ear crackling noises
42 2021-03-02 ringing in ears Ear crackling noise
42 2021-03-03 thirst 3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low gra... Read more
3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low grade fever and tired. 6:30 high fever 103 fever chills, shaking from chills. Lasted about 4 hours. No meds taken to offset. About 11 hot and tired. Hot with fever about 99-100.5. Up and down all night from being sore and not able to get comfortable. As well as feeling hot. Thirsty. Mental fog. 3/3/21: very tired. Wore out by simple tasks. Slept most of day. Achy body. A few slight fever times but not bad. Slept 18 of 24 hours. Times awake we?re just sitting. Mental fog. Even hearing someone else talk would wear me out. Went to bed at 6:30 pm. Was very tired but trouble falling asleep because could not get comfortable so took an Advil pm. Slept until 5:50 only getting up once to use bathroom. Did wake up in puddle of sweat when we to bathroom. 3/4/21: still tired feeling but feel much better. Mental fog way better. No fever. Feel alert and awake. Not feelingwore out by simple tasks. Location of injection: and arm response. Vaccine 1 given was about 2-3 inches down from shoulder joint. Very sore arm for 5 days. 3 days could raise arm or move without it hurting. Vaccine 2 given was no more than 1 inch down from shoulder joint. I was asked to pull T-shirt sleeve up further before getting it. It was much higher in arm than vaccine #1. 2 hours after vaccine arm was very sore. By 4 hours after arm hurt and not able to move it without pain. Did not use arm for even small normal tasks like taking a drink. By time fever broke around 11 pm, Arm felt much better. Sore but no pain to move it or use it for normal activities.
42 2021-03-04 eye itchiness, ear swelling 42 yr old female patient complaining of sensation of (L) inner ear swelling as with food and mold a... Read more
42 yr old female patient complaining of sensation of (L) inner ear swelling as with food and mold allergens. Area below (L) eye slightly itchy. No redness or swelling noted of ear or eye.
42 2021-03-05 swelling around the eyes About two days after my vaccine, the area under my eyes significantly puffed up. About 6 months ago... Read more
About two days after my vaccine, the area under my eyes significantly puffed up. About 6 months ago I had cosmetic fillers put under my eyes and the vaccine caused a reaction
42 2021-03-07 taste impairment 10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feel... Read more
10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feeling of being hot and cold, sheer panic. Symptoms were very strong for the first few hours after injection. Jittery, shaky, uneasy feeling persisted for about 48 hours.
42 2021-03-07 lacrimation increased, eye pain Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nau... Read more
Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nausea; eye ache and watery; eye ache and watery; This is a spontaneous report received from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9267, expiry date: unknown), via an unspecified route of administration in the left arm, on 13Feb2021 09:30, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and concomitant medications. The patient has no allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9261, expiry date: unknown) received at 42 years of age, via an unspecified route of administration in the left arm, on 23Jan2021 09:30, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 13Feb2021 at 18:00, the patient experienced fever, chills, soreness at injection spot, body and joint aches, headache, nausea, and eye ache and watery. No treatment was given for the events. The patient recovered on an unspecified date in Feb2021. The reporter assessed the events as non-serious. No follow-up attempts are possible. No further information is expected.
42 2021-03-08 eye swelling, swelling around the eyes Puffy, swollen eyes. Hives all over body. Every single part of my body. Been going on for 36 straig... Read more
Puffy, swollen eyes. Hives all over body. Every single part of my body. Been going on for 36 straight hours now. No relief. Treating with calamine lotion and round the clock benedryl. No breathing issues.
42 2021-03-09 mouth numbness 17 mins after the vaccine I had a weird feeling in both my legs and both my lips went numb (cheekbon... Read more
17 mins after the vaccine I had a weird feeling in both my legs and both my lips went numb (cheekbones down to my chin) and numbness in my fingertips.
42 2021-03-09 lip swelling Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen li... Read more
Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen lips
42 2021-03-09 sensitivity to light Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensi... Read more
Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.
42 2021-03-11 mouth tingling Shortly after receiving vaccine, experienced scratchy throat, difficulty swallowing and tingling of ... Read more
Shortly after receiving vaccine, experienced scratchy throat, difficulty swallowing and tingling of lips. EpiPen administered x 1 without improvement of symptoms. 911 called transferred to hospital by ambulance.
42 2021-03-11 vision blurred The logistician from station 3 alerted the observation area that a patient was not feeling well. Th... Read more
The logistician from station 3 alerted the observation area that a patient was not feeling well. The patient was sitting on the chair. She looked pale. She complained of feeling dizzy and lightheaded (went away 2 mins after getting the shot) and blurry vision (went away 5 seconds after getting the shot) Blood pressure: 118/76; Pulse 68. O2 sat unable to read d/t nail polish. Good capillary refill. She felt better after 20 minutes. She rested laying down with her feet elevated for 20 minutes. She sat down for 15 minutes and stood up for 5 minutes with no dizziness/lightheadedness. Patient texted that she arrived home safely and felt fine.
42 2021-03-11 visual impairment Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, f... Read more
Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, flu like symptoms, swollen red knuckles on left hand that were stiff and painful, fainted, dizziness, vision disturbances
42 2021-03-13 visual impairment Left side of my face doesn?t feel right. Almost numb and my vision to the left is off.
42 2021-03-14 ear discomfort 3-13-21 2:30PM RASH TO FACE & NECK. NO SOB/DYSPNEA, NO PAIN. 2:32PM BENADRYL 50MG PO. 2:36PM STATE... Read more
3-13-21 2:30PM RASH TO FACE & NECK. NO SOB/DYSPNEA, NO PAIN. 2:32PM BENADRYL 50MG PO. 2:36PM STATES SHE IS 'OK AND READY TO GO HOME'. NO ACUTE OR OBVIOUS DISTRESS. A/O X3, PINK, W/D, RESP REG WITH EASE. NO CHANGE IN RASH AT THIS TIME. AMBULATORY, GAIT BRISK AND STEADY. 3-15-21 9:30AM TC: STATES 'RASH IS GONE, EARS STILL FEEL RAW AND STILL TAKING ALLEGRA'. WILL CHECK WITH PCP R/T DOSE #2.
42 2021-03-14 lip swelling Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injec... Read more
Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injection site big red area showed up about 2 weeks after 1st dose
42 2021-03-14 pain in jaw Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontane... Read more
Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202), via an unspecified route of administration in the left arm on 25Feb2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history included diagnosed with COVID-19. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had other unspecified medications within 2 weeks of vaccination. On 25Feb2021 20:00, the patient experienced severe pain in her left jaw then it (jaw) locked up. Her face froze. She had difficulty swallowing. The patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events and included treatment with muscle relaxer, heat and ice, and rest. Outcome of the events was not recovered.
42 2021-03-14 mouth tingling 10 minutes after receiving second Covid vaccine, tongue and mouth felt tingly and scratchy. denies ... Read more
10 minutes after receiving second Covid vaccine, tongue and mouth felt tingly and scratchy. denies difficulty breathing or throat closing. Had similar symptoms with the first vaccine., Discussed with her PCP who gave her a note to have her second Covid vaccine but to take Benadryl 50 mg po one hour prior to shot which she did. Denies any drowsiness, stating she takes benadryl on a regular basis frequently. Ambulated with staff to med: Appears somewhat anxious, oropharynx patent, pink, moist mucus membranes, BP 128/62, T 98.6, Chest: CTA. RRR, HR 64. AAOx3, clear in conversation, ambulatory without difficulty. Declined transport to the ED or urgent care for continued care/follow up, although symptoms are not worsening but stable, and her anxiety decreased, during her 40 minute stay after the vaccine. Again, denied drowsiness and symptoms abating. She then left the unit for home at 2:40pm
42 2021-03-15 hearing loss 15: 47pmPt in post Covid vaccine waiting area, 1st dose administered. Pt c/o feeling hot and "my ear... Read more
15: 47pmPt in post Covid vaccine waiting area, 1st dose administered. Pt c/o feeling hot and "my ears are swelling like I'm on a plane". Pt reports having history of "severe allergies" Vital Signs: BP 162/75, HR 122, SPO2 99%. Reassessment 15:52 Vital Signs\ BP 138/84, HR 100, SPO2 99% Nurse alert alarmed, Pt transported via wheelchair
42 2021-03-15 lacrimation increased WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND... Read more
WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND I HAD A RIGHT SIDED FRONTAL HEADACHE. I TREATED WITH ICE PACK, TYLENOL, AND CLAIRITIN. 2 HOURS LATER I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS. tHE SWELLING BROKE DURING THE NIGHT WITH MASSIVE EYE TEARING AND POST NASAL DRIP. I CRAVED BLACK LIC0RICE LIKE MAD.
42 2021-03-16 loss of smell, loss of taste Patient had 2nd Pfizer COVID-19 vaccine on 1/11/2021. On 1/12/2021 developed loss of taste/smell,... Read more
Patient had 2nd Pfizer COVID-19 vaccine on 1/11/2021. On 1/12/2021 developed loss of taste/smell, rhinorrhea. Positive COVID test.
42 2021-03-16 taste impairment, taste disorder ~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min.... Read more
~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min. Taste was very proncounced, slightly metallic and very salty and lasted remainder of the day with associated nausea. Taste alterations resolved that day. Slight arm soreness and moderate fatigue for next 2 days, then resolved. On day 6, I developed fevers, the odd taste changes that I had post-vaccine returned, and fatigue. Felt "off," similar to when I had presumed COVID in March 2020. Fevers (100.5 on Advil), fatigue, felt "off." No cough/shortness of breath. Symptoms peaked on day 8, then I woke up feeling great on day 9. Minimal reaction to dose #2.
42 2021-03-16 vision blurred Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept f... Read more
Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept for the majority of the last 3 days. I wake up foggy and disoriented. Takes a while to focus and become alert. I use the restroom and maybe I'm able to be active for 15- 20 minutes then I'm back asleep, or too tired to keep my eyes open. Today is the first day I have been able to stay awake more than an hour. I had energy for about an hour and then felt like I was unplugged I'm just too tired to function. All I can do is go back to bed.
42 2021-03-18 loss of taste, thirst I have a big brain head aches from the outside in; Feel like I?m walking slanted when I?m walking st... Read more
I have a big brain head aches from the outside in; Feel like I?m walking slanted when I?m walking straight, can?t think in depth (it?s challenging to write graduate level papers); have to absolutely sleep 8-12 hours a night otherwise, I cannot function well with multi tasking as I did before the vaccine; Thirsty a lot more than usual, coughing sore throat (maybe this is normal w/the vaccine, I?m not sure). Today at 9:00pm, I realized that I lost my sense of taste. I ate a pizza and could not taste it. I am able to taste really sweet juice with my taste buds near the back of my tongue. This was something different today which is why I wanted to report. It does not feel like it is life threatening. Just uncomfortable to deal with. I?m so glad that I received the vaccine. If this is all that happens to me then , I am thankful for being alive and just having to deal with these discomforts while the vaccine is working through my system. Just note the symptoms maybe this is something in common with other people too.
42 2021-03-19 feeling of choking Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car an... Read more
Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car and as we continued to drive my face started tingling and feeling numb. I called the pharmacy at 3:50 and said I should take Benadryl or go to ER if symptoms worsen. I took liquid Benadryl 10ml at 3:55. The feeling continued for the next three hours. The feeling in my throat went away but the tingling feeling continued. On 3/20/2021 I went to urgent care at 9:40am due to continued tingling and numbness in the right side of my face and heaviness in my right arm . I was prescribed prednisone.
42 2021-03-21 extreme sound sensitivity lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, ... Read more
lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
42 2021-03-22 eye swelling Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated... Read more
Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated she started to have anaphylactic reaction to the Pfizer -Biotech COVID vaccine around 7:00 PM that same day. Her eyes swelled up and her throat started to feel like it was closes so she went to the ED at Hospital. At the hospital, she received an Epipen and a shot of benadryl. The reaction was taken care of and she was able to return home later that night with no lingering effect of the reaction.
42 2021-03-22 taste disorder Terrible taste in my mouth with certain foods. Toothpaste, meat, veggie chips, coffee and other thin... Read more
Terrible taste in my mouth with certain foods. Toothpaste, meat, veggie chips, coffee and other things all taste like an ashtray smells.
42 2021-03-22 ringing in ears Ringing in the ears. I have seen Primary care doctor, ENT and acupuncturist. Ringing still persists.... Read more
Ringing in the ears. I have seen Primary care doctor, ENT and acupuncturist. Ringing still persists. All doctors agree it will go away and is inflammatory response. It has NOT resolved as of today.
42 2021-03-22 vision blurred High Fever started at 9am on 3/21/21, got as high as 105 degrees by 3 pm. Chills, severe joint pain,... Read more
High Fever started at 9am on 3/21/21, got as high as 105 degrees by 3 pm. Chills, severe joint pain, dizziness and blurred vision.
42 2021-03-23 lip swelling, swollen tongue Tongue, lips swelling, hands and wrists (fingers) numb and tingling. Vaccine administered 1:38pm Be... Read more
Tongue, lips swelling, hands and wrists (fingers) numb and tingling. Vaccine administered 1:38pm Benadryl 50mg PO administered 1:50pm Epi pen given at 2:10pm
42 2021-03-24 swollen tongue Light headed and dizzy beginning approximately 10 minutes post vaccination. Swelling of tongue and i... Read more
Light headed and dizzy beginning approximately 10 minutes post vaccination. Swelling of tongue and itching in throat beginning approximately 20 minutes post vaccination. At this point patient notified observation nurse. Assessed by EMTs and nurse practitioner on site. Received injection of 25 mg of Benadryl. Began having relief of symptoms within 3 minutes. No Transported to hospital for observation. Received oxygen during transport. ER gave famotidine and loratadine via pills at 3:44 pm. Observation for approximately 70 minutes. At this point it had been approximately 4 hours since injection. BP and oxygen levels good. No itching. Released and returned home. Patient was cold and tired, which is typical for them when receiving a Benadryl injection. Slept for approximately 14 hours. Currently tired and achy, which is again typical for them after receiving a Benadryl injection.
42 2021-03-24 ringing in ears Sudden onset of continuous ringing in right ear.
42 2021-03-25 loss of taste, loss of smell Pt vaccinated. On 3/12 exposed . Symptoms of cough, loss of taste/smell, HA, runny nose. Tested + fo... Read more
Pt vaccinated. On 3/12 exposed . Symptoms of cough, loss of taste/smell, HA, runny nose. Tested + for and inconclusive for quest.
42 2021-03-25 ear pain Ear ache in left ear for several hours, tired, almost feverish feeling from late afternoon to evenin... Read more
Ear ache in left ear for several hours, tired, almost feverish feeling from late afternoon to evening the day of the vaccine and the late afternoon/evening the next day
42 2021-03-25 vision blurred I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath... Read more
I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath, blurred vision, light headedness, brain fog, nausea, fatigue, feeling of fainting and tightness in throat. These symptoms have been present and overwhelming for over 3 days presented themselves after day 2 of vaccine. The original symptoms of headache, body aches and chills subsided by day 3.
42 2021-03-26 ear discomfort Numbness of the face as if I was coming out of dentist office. Still able to move my face but can no... Read more
Numbness of the face as if I was coming out of dentist office. Still able to move my face but can not feel my skin. Ears felt as if I was underwater or going in plane (trying to pressurize)
42 2021-03-26 swollen tongue In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (s... Read more
In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am
42 2021-03-27 deafness unilateral, ringing in ears Extreme tinnitus beginning the day following vaccine and lasting about 48 hours. Within two days, ti... Read more
Extreme tinnitus beginning the day following vaccine and lasting about 48 hours. Within two days, tinnitus reduced but has remained persistent for now well over a month. For last 3 weeks, experiencing intermittent extreme tinnitus in left ear followed by muffled hearing/hearing loss. Overall tinnitus volume now seems to be increasing/worsening.
42 2021-03-28 swollen tongue After receiving dose, she began to feel warm, lightheaded, and nauseous. After ~15 min, she develope... Read more
After receiving dose, she began to feel warm, lightheaded, and nauseous. After ~15 min, she developed swelling in her tongue and took bendardyl (50 mg). Epinephrine was at bedside but not given. Reaction subsided. Vital signs were unremarkable. Physical exam was normal except for tongue swelling.
42 2021-03-28 ringing in ears tinnitus in both ears
42 2021-03-29 lip swelling Encounter Date: 3/23/2021 Hide copied text Hover for details 245PM Pifzer first dose Vacci... Read more
Encounter Date: 3/23/2021 Hide copied text Hover for details 245PM Pifzer first dose Vaccination given. 320 Complaining of not feeling well. States she stayed beyond her 15 minutes as did not feel well. BP 119/80 P86 R 18 Pulse ox 100%. When asked how she was feeling she stated she feels something in her throat. Complains of itching to her back. When examined, found many reddened areas with scratch marks over mid back near bra line. Consulted Dr. regarding giving Benadryl 25 mg po. She advised to administer. 325 Benadryl 25 mg given po. Denies difficulty swallowing but states not getting air as well. Lung sounds audible but diminished at bases. Unable to auscultate heart sounds per NP due to acoustics. 335 BP 125/85 P 132 R 22. Pulse ox 99%. States more difficulty getting air. Epinephrine 0.3 mg IM given complains of lip feeling tight. 337 Squad arrived and given report. BP 124/67 P138 R 22. Pulse ox 98%. Shivering from Epinephrine administration. Patient taken to Emergency Department, unable to see records from that facility.
42 2021-03-29 mouth tingling About ten minutes after the vaccine I had a strange feeling that something wasn?t right. Vaccine arm... Read more
About ten minutes after the vaccine I had a strange feeling that something wasn?t right. Vaccine arm started going numb with tingling. That hand then became completely numb. Then my throat went numb and face was tingling and couldn?t swallow properly. Found nurse at the vaccination site and reported not feeling well. She immediately noticed I was bright red and breaking out in hives. Nurse gave me an antihistamine shot and an oral antihistamine for an allergic reaction. I?ve never had an allergic reaction before or ever experienced any of these symptoms before. After a few minutes the symptoms started going away. I was advised to not drive myself home. About an hour later some milder symptoms came back, such as slight tingling of face and lips. Went away again gradually. Fell asleep (not sure how long) and woke up with swollen and numb lips so I took some more antihistamine. No more allergy symptoms after that.
42 2021-03-29 sensitivity to light, vision blurred Blurred vision, sensitivity to light, migraine headache 10 minutes after injection, heart palpitatio... Read more
Blurred vision, sensitivity to light, migraine headache 10 minutes after injection, heart palpitations within 4 hours of injection. Headache and heart palpitations still present now.
42 2021-03-29 visual impairment extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left s... Read more
extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
42 2021-03-30 taste impairment Metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not w... Read more
Metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; This is a spontaneous report from a contactable Other-HCP (patient reported herself). A 42-year-old non-pregnant female patient received BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration on 29Jan2021 12:00 PM at single dose to her left arm for Covid-19 immunization. She was allergic to Sulfa-thrush. No Covid was tested prior or post vaccination. Concomitant medications included (BENADRYL) every night and paracetamol (TYLENOL) 1-2 times a week bef. On 29Jan2021, the patient experienced metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food, very vivid dreams every night-sometimes nightmares, usually did not remember dreaming at all. She did not take any treatment in response to the events. Outcome of the events was not recovered.
42 2021-03-30 ear pain Vaccine 3/22/21, started with fatigue/generally feeling unwell 3/25/21, fever. Received Tdap vaccine... Read more
Vaccine 3/22/21, started with fatigue/generally feeling unwell 3/25/21, fever. Received Tdap vaccine 3/26/21. Persistent fever, pain around eye, ear and radiating into her head, nausea. Symptoms continued to worsen, developed chest pain and new onset seizure 3/31/21- Sent to ER for evaluation
42 2021-03-30 pain in jaw Moderate pain at injection site. Severe sinus headache, pain in jaw, nausea and fatigue. Took Acetam... Read more
Moderate pain at injection site. Severe sinus headache, pain in jaw, nausea and fatigue. Took Acetaminophen, drank lots of fluids and ate saltines and buttered toast, and took a nap. Started to feel better about 4PM.
42 2021-03-30 mouth tingling, mouth numbness Within minutes of receiving the vaccine, I felt tingling in my left arm at the shot injection site. ... Read more
Within minutes of receiving the vaccine, I felt tingling in my left arm at the shot injection site. About 20 mins later, I felt tingling and numbness in my upper lip as well as just above my lip. Consulted with the pharmacist who administered the shot as well as an on-line nurse about adverse side effect. I was instructed to take Benedryl, which I did (37.5 mg). It didn?t do anything to address the tingling. It has been four plus days since the vaccination and the right side of my upper lip feels swollen.
42 2021-03-31 taste impairment Metallic taste in mouth, itching on face and on skin along upper body and legs
42 2021-03-31 mouth swelling, mouth tingling Began experiencing right side of tongue and lips tingling within 30 minutes after receiving vaccine.... Read more
Began experiencing right side of tongue and lips tingling within 30 minutes after receiving vaccine. Took oral diphenhydramine but it did not improve. Visited urgent care the next day. No treatment was given, and patient was advised to follow up with primary physician. Four days later patient states she feels like her mouth is swollen on one side.
42 2021-03-31 feeling of choking Within 5 or so minutes of injection - Waves of warmth and nausea. Very slight tingling in throat. Sl... Read more
Within 5 or so minutes of injection - Waves of warmth and nausea. Very slight tingling in throat. Slightly elevated heart rate. Dehydration. Treated with benedryl and drank a lot of water and gatorade. Symptoms continued through next day. Body aches within 24 hours of vaccine in addition to tenderness at site of shot.
42 2021-04-01 eye bleeding blood in my eye;This is a spontaneous report from a contactable consumer (patient). A 42-year-old fe... Read more
blood in my eye;This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (BNT162B2, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 13:00 (at the age of 42-year-old) at single dose for COVID-19 immunization. The patient is not pregnant. Medical history included a leiden factor a blood disorder. The patient had no known allergies. Concomitant medications included ibuprofen (MOTRIN); ashwagandha; ascorbic acid (VITAMIN C); and an unspecified Pfizer vaccine on 12Mar2021 administered in the left arm. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. On 11Mar2021 12:00 AM, the patient experienced blood in her eye. There was no treatment for the event. No COVID prior vaccination and was not tested with COVID post vaccination. The outcome of the event was recovering. Information about lot/batch number has been requested.
42 2021-04-01 eye itchiness few hours after vaccine had headache, very mild sore arm that lasted an hour and red, itchy jaw, chi... Read more
few hours after vaccine had headache, very mild sore arm that lasted an hour and red, itchy jaw, chin neck for a couple hours, The evening after the vaccine was given I had chills, sweats, body aches, fever of 100, the next morning headache, body aches all day and the 2nd day after vaccine I had chills, cold sweats (mainly at night ) but body aches all day, both days very tried and weak. Then after those two days i was back to normal. Same thing happened with my 2nd shot and same timing. i did have covid in the past in august 2020
42 2021-04-01 lacrimation increased Very sore left arm, chills, runny nose, cold like symptoms, sore throat, body ache, eyes are waterin... Read more
Very sore left arm, chills, runny nose, cold like symptoms, sore throat, body ache, eyes are watering profusely
42 2021-04-01 pain in jaw headache, fever up to 101.8, severe body aches, jaw pain
42 2021-04-01 mouth tingling, feeling of choking Approximately 5 min following injection, pt reported that she felt her uvula was swelling with pruri... Read more
Approximately 5 min following injection, pt reported that she felt her uvula was swelling with pruritus of the throat, and that the back of her tongue was tingling. She reported feeling dizzy, with a flushed sensation in her chest, tingling progressed to entire tongue and to lips. No angioedema or rash on exam, airway clear, VS stable, 02 on RA 96-99% (02 sat increased following admin of epi) HR 106-109, BP 155/90. Administered 0.3mg epi via autoinjector and 50mg diphenhydramine PO. Pt noted sensation in the sensations in her throat, tongue and lips was beginning to subside approximately 10min after admin of medications. Transported via ambulance to CVMC ED for observation and further tx.
42 2021-04-01 mouth tingling Patient reported feeling hot, nauseated, heart palpitations, tingling around lips and discomfort and... Read more
Patient reported feeling hot, nauseated, heart palpitations, tingling around lips and discomfort and tingling/numbness/discomfort in left arm within 5 minutes after injection in left arm. (She was negative for lip or oral mucosa swelling, voice change, SOB, rash, visible flushing, urticaria) Her vitals remained stable and initial sx resolved spontaneously within 15-120 minutes apart from swelling (without erythema or induration) and tenderness on left medial anticube, which was treated with ice. Patient had normal ROM, strength of left arm. Patient was observed or 50 minutes and cleared by NP and MD to leave with instructions to FU with ED if return of symptoms. Arm swelling was resolving when called the next day.
42 2021-04-01 ringing in ears Sore arm for a couple days after shot 1. Sore arm for a few days after shot 2. Body aches, tired, a... Read more
Sore arm for a couple days after shot 1. Sore arm for a few days after shot 2. Body aches, tired, a little fuzzy headed the following day. Sometime in the past few weeks (I'm not sure when) I've developed pulsatile tinnitus in my left ear. It comes and goes. It's not very bad and usually only happens when I'm lying down in bed in the evenings. It feels like there's a little extra ear wax or cotton or something in that ear all the time though. I've never had tinnitus prior to this.
42 2021-04-01 ringing in ears Six days later developed rapid heart beat followed by dizziness and ringing in left ear. Rapid heart... Read more
Six days later developed rapid heart beat followed by dizziness and ringing in left ear. Rapid heart beat lasted three or four days. Dizziness 10 days. Still have ringing in ear on day 13. It has gotten louder.
42 2021-04-01 vision blurred Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?... Read more
Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?t feel right. I tried to lay down to see if I could feel better but this did not help. Even while in a relaxed state my blood pressure was up to 170/97 and heart rate of 220. I was very dizzy and felt like fainting but did not lose consciousness. I had a terrible pressure in my chest, in the left side of my neck and along the inside of my left arm. Also notable my vision was blurred. Called 911 ambulance took me to the Hospital ER and the ekg they performed was abnormal and also notable when they drew my blood my sodium level was below the normal threshold. I had taken 3 nitroglycerin tablets and my symptoms subsided enough for them to let me go home. Since coming home my bp has remained elevated much higher than normal at around 135/85. I continue to feel not quite normal and have the pressure in my left side of neck, chest and left arm. I feel very certain this is all due to the covid vaccine I received.
42 2021-04-02 loss of taste Loss of taste. After taking a nap, I discovered I had lost my sense of taste across most of my tongu... Read more
Loss of taste. After taking a nap, I discovered I had lost my sense of taste across most of my tongue. I was able to detect some tastes along the very outer edges of my tongue, but nowhere in the middle. This continued for 3 days, after which my taste fully returned.
42 2021-04-02 smell distorsion, taste disorder I had enhanced sense of taste and smell./a heightened sense of smell and taste; I had enhanced sense... Read more
I had enhanced sense of taste and smell./a heightened sense of smell and taste; I had enhanced sense of taste and smell.; I experienced lightheaded and dizziness,; and a headache that feels like pressure/headache; and a headache that feels like pressure, and sinus pressure at the bridge of my nose.; have mild to moderate body aches this morning in my legs and hip bones; have mild to moderate body aches this morning in my legs and hip bones; Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day.; About an hour after the injection I experienced nasal drainage in the back of my throat that lasted about 30 minutes.; 3 hours after my shot the arm pain at injection site began; followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued.; This is a spontaneous report from a contactable consumer (Non-healthcare Professional reporting for a patient). Follow-up received on 05Feb2021 reposted by a consumer was processed together with initial information. A 42-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Intramuscular injection), via an unspecified route of administration in the left arm on 26Jan2021 at 08:45 AM (Batch/Lot Number: EN5318; Expiration Date: Not provided) as a SINGLE DOSE for covid-19 immunisation at the clinic. Medical history included teenage asthma and allergic for Penecillin, mango skin (poison ivy-like contact) and dust mites. Concomitant medications were none. The patient did not receive other vaccines in four weeks. The patient did not have COVID-19 prior or since the vaccination. On 26Jan2021 after the shot in the medical observation area the patient experienced mild nausea that went away for the rest of the day. About an hour after the injection, she experienced nasal drainage in the back of throat that lasted about 30 minutes. 3 hours after the vaccination shot the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause to be sleepy or drowsy- simply fatigued. She had enhanced sense of taste and smell. On 27Jan2021 at 06:00 AM she woke up seeming okay and tried to work from home however she experienced lightheaded and dizziness, and a headache that feels like pressure, sinus pressure at the bridge of nose. She had to disengage from work. After lunch around 2 PM she had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. Dizziness and headache and nausea. On 28Jan2021 the patient woke up with nausea and ate breakfast with a heightened sense of smell and taste. She logged into work and the lightheadedness and dizziness began again. Clinical course of the event was as follows: On 28Jan2021, she woke up with nausea and ate breakfast with a heightened sense of smell and taste. Logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. She had no body aches, but that morning she had mild to moderate body aches, in my legs and hip bones. On 29Jan2021, she woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of nose remained same. She still had enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement). No treatment was received for the events. Outcome of events was not resolved.
42 2021-04-02 ringing in ears Loud tinnitus creating and achey head. Feels like I just left a loud concert all the time.
42 2021-04-03 ringing in ears, lip swelling, thirst i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusel... Read more
i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported. The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
42 2021-04-03 visual impairment Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Se... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Spoke with pt around 6:50pm (4/3/2021). she stated she was currently home and feeling a lot better. she denied anymore dizziness, flushing or feeling lightheaded. she is considering coming in with her husband when she comes for the second dose just in case she feels the same way
42 2021-04-04 bloodshot eyes, taste impairment Day 1 (4:30 pm vaccination day). Clammy hands and metal taste for 15 minutes, dizzy feeling for 1 m... Read more
Day 1 (4:30 pm vaccination day). Clammy hands and metal taste for 15 minutes, dizzy feeling for 1 minute. Later that day, overall feeling of unwell, short lived muscle weakness, tired, sore arm, anxiety, loss of appetite, odd, bubbling sensation in left leg, slight itchy skin mostly in legs and at injection site. Day two. Unwell, nausea, loose stool in morning, anxiety, tired, slight sore arm, odd bubbling sensation in left leg, slight itchy skin, loss of appetite, red eyes, red itchy chin, slight itchy skin in legs and at injection site Day three. Unwell, nausea, very slight sore arm, loose stool in morning, panic, tired, itchy red eyes, nausea, red itchy chin, slight itchy skin mostly in legs and at injection site, no appetite. Day 4. Loose stool in morning, more energy but still tired, itching continue slightly on chin and injection site and legs, appetite returning, slightly tired, very slight sore arm. Day 5. Woke up with indigestion, feeling unwell and tired, laid in bed and felt a jolt by means of noise in my head which only happened once and was quickly over, very slight sore arm, itchy at injection site, weird metal taste, upset stomach, leg and arm vein fullness Day 6. Woke up tired with overall feeling of slight unwell but gained a good bit of energy as the day progressed, leg and arm vein fullness. Day 7:. Leg and arm vein fullness Day 8:. Non localized Itchy skin Side note:. I'm beyond worried to get the second vaccination.
42 2021-04-05 dry mouth Brain fog a few hours post-injection 12 hrs to 36 hrs post-injection: Headache, muscle aches, stabbi... Read more
Brain fog a few hours post-injection 12 hrs to 36 hrs post-injection: Headache, muscle aches, stabbing and burning pains in most muscles, severe fatigue, dry mouth/ cracked lips not relieved by fluids, temp of 99.5, cold sweats, chills 36 to 48 hrs: fatigue, residual muscle aches, headache, nausea & belching
42 2021-04-05 drooling lightheaded, dizziness, "salivating" like she going to throw up. Evaluated by EMS-Cleared
42 2021-04-05 ringing in ears Intermittent ringing in both ears.
42 2021-04-05 vision blurred, taste impairment Initially (24 hours) I had fever 100.5, chills, aches. These resolved by 3/20. Arm was very sore f... Read more
Initially (24 hours) I had fever 100.5, chills, aches. These resolved by 3/20. Arm was very sore for about 3 days, but took almost a week to completely feel better. On 3/21 more concerning symptoms started to develop. Brain fog, spacenesses, trouble looking at books, computer tv. Very strange sensation. This resolved by 3/25. Other symptoms that developed beginning 3/21 were GI upset (diarrhea, stomach churning) as well as insomnia - very short and broken sleep all night with dreams and waking up each time after brief sleep with bad/sour taste in mouth. The insomnia has gotten progressively worse and unlike anything I've had before. I do not have a history of insomnia ( I sleep very well) . For the last week, I do not sleep more than a hour or two at a time and have the broken sleep, with dreams, not a good deep sleep at all, and sour/bad taste in the mouth. I also don't have any history of GI problems. I have been eating a bland diet to try and help with the stomach issues, which have improved somewhat but are still not resolved. The insomnia is very troubling. Also occurring is heat sensation in the right hand (this actually developed after my first shot which was 2/23) that would occur a few times a day where my knuckles are. In the last several days (starting 4/3) my right forearm and bicep have been feeling of weakness and numbness, almost like someone has been sitting on it. Not pins and needles feeling, but weak and numb. This is somewhat transient, and happens for a few hours each day. It seems to have improved as of today 4/6. My physician feels I could have had some kind of neurological response to the vaccine. I would like to know if this could be the case, or if there is any data showing these symptoms will go away, as I am obviously upset by them.
42 2021-04-07 eye strain, dry mouth After receiving the vaccine yesterday, I started filling amped up like a took a bunch of caffeine pi... Read more
After receiving the vaccine yesterday, I started filling amped up like a took a bunch of caffeine pills but I also had heavy eyes. Very dry mouth. Today I?m in pain from my neck to my hand. My entire arm feels swollen and burning. My hand is swollen and my finger tips are tingly. The severity of this pain started about 4 hours ago.
42 2021-04-07 burning mouth syndrome, ear discomfort Ears clogged, Cough, sore tongue
42 2021-04-07 oropharyngeal discomfort Patient received 1st dose of Pfizer Covid Vaccine. During post-vaccination monitoring period the pa... Read more
Patient received 1st dose of Pfizer Covid Vaccine. During post-vaccination monitoring period the patient reported that she was feeling discomfort in her throat. No shortness of breath. Given patient history of anaphylaxis from "red fire ants", she was administered diphenhydramine 25 mg liquid x 1. After 30 minutes of observation, patient reported resolution of throat discomfort and ambulated out of the vaccination clinic with her husband and family.
42 2021-04-07 oropharyngeal discomfort Patient provided information regarding history of asthma, previous allergic reations to animal, perf... Read more
Patient provided information regarding history of asthma, previous allergic reations to animal, perfume, dust, pollen. Also, reported anxiety when she see needle or syringe. When staff asked patient whether she is comfortable to complete her vaccination, patient replied that as long as she do not see the procedure she will be fine. After vaccine administration patient reported discomfort in her throat. Dr. and EMT team were notified. Patient's vital signs were BP 116/72 HR 103 O2 98% RR 18. Patient was monitored for forty minutes, no medications were administered. Patient left in stable condition (vita signs BP 121/70, HR 95, O2 99% RR 18). No hospitalization required.
42 2021-04-07 oropharyngeal discomfort Patient provided information regarding history of asthma, previous allergic reations to animal, perf... Read more
Patient provided information regarding history of asthma, previous allergic reations to animal, perfume, dust, pollen. Also, reported anxiety when she see needle or syringe. When staff asked patient whether she is comfortable to complete her vaccination, patient replied that as long as she do not see the procedure she will be fine. After vaccine administration patient reported discomfort in her throat. Dr. and EMT team were notified. Patient's vital signs were BP 116/72 HR 103 O2 98% RR 18. Patient was monitored for forty minutes, no medications were administered. Patient left in stable condition (vita signs BP 121/70, HR 95, O2 99% RR 18). No hospitalization required.
42 2021-04-07 ringing in ears Major headache starting just few hours after the vaccine. It was difficult to sleep. Treated with Ty... Read more
Major headache starting just few hours after the vaccine. It was difficult to sleep. Treated with Tylenol the next morning. Mild tinnitus in both ears. It's been almost 2 weeks post 1st vaccine and the ringing/humming/ shushing is still here....luckily it isn't unbearable but noticeable where I get to easily pay attention to it. I'm not sure if I should get the 2nd shot. I read reports of people's tinnitus getting worse after the 2nd shot. The headache also keeps coming and going, a lot more often than my normal range.
42 2021-04-07 vision blurred Chills, feverish, rash, spams in arm, hand trembling. possible diarrheas, headache, fatigue, blurred... Read more
Chills, feverish, rash, spams in arm, hand trembling. possible diarrheas, headache, fatigue, blurred vision, loss of focus, general malaise and body pain.
42 2021-04-08 taste impairment LIGHTHEADED, METALLIC TASTE IN MOUTH, MILD ITCHING ON LEFT SIDE, HEAVINESS IN CHEST AND GUT. NO SHOR... Read more
LIGHTHEADED, METALLIC TASTE IN MOUTH, MILD ITCHING ON LEFT SIDE, HEAVINESS IN CHEST AND GUT. NO SHORTNESS OF BREATH. TWO SYNCOPAL EPISODES, NO IMPROVEMENT IN SYMPTOMS AFTER 10 MINUTES, TRANSPORTED TO HOSPITAL.
42 2021-04-08 eye movement disorder PATIENT'S HUSBAND SAID SHE WAS FEELING REALLY SLEEPY. I ASKED IF SHE WAS NERVOUS BECAUSE SHE JUST S... Read more
PATIENT'S HUSBAND SAID SHE WAS FEELING REALLY SLEEPY. I ASKED IF SHE WAS NERVOUS BECAUSE SHE JUST SAW ANOTHER PATIENT FAINT AND SHE SAID YES. SHE FAINTED JUST AFTER THAT AND HER HUSBAND HELPED ME MOVE HER TO THE FLOOR. SHE WAS STILL BREATHING BUT SHE WAS IN AND OUT OF CONSCIOUSNESS SO WE CALLED 911. PATIENT WAS RESPONDING TO CONVERSATION BUT WOULD SLUR SOMETIMES AND EYES WOULD ROLL BACK AS SHE LOST CONSCIOUSNESS AGAIN. PLACED COLD COMPRESS ON FOREHEAD AND BACK OF NECK. PATIENT'S HEART RATE WFLUCTUATED THE WHOLE TIME. PARAMEDICS CAME TO ASSESS HER, BLOOD PRESSURE WAS HIGH 180 SYSTOLIC (DIASTOLIC WOULDN'T READ), AND SUGAR WAS 401. PATIENT DECIDED TO GO TO ER VIA AMBULANCE AFTER SHE ALMOST FAINTED AFTER STANDING.
42 2021-04-08 eye movement disorder heart rate was noted to be high in the 146-150 range.The patient was able to talk and respond to que... Read more
heart rate was noted to be high in the 146-150 range.The patient was able to talk and respond to questions but kept her eyes closed and was crying. She started heaving but was not vomiting. Benadryl and Solumedrol IM he was alert and coherent but kept her eyes closed and said ?she could not open them?. She started to have rigors at 2:40pm, her pulse ox dropped to 89%, heart rate again climbed to the 150?s. Taken to the ED
42 2021-04-08 mouth numbness The patient is a 42-year-old female with a history of extensive allergies who presents for a possibl... Read more
The patient is a 42-year-old female with a history of extensive allergies who presents for a possible allergic reaction status-post receiving her 1st dose of the Pfizer COVID vaccine 30 minutes ago. She notes symptoms of tongue numbness and an itchy throat. She reports a history of anaphylaxis secondary to a bee sting and contrast dye, but denies reactions to prior immunizations. The patient also has a history of Factor V Leiden blood disorder, but denies taking daily medications. She denies shortness of breath, nausea, vomiting, diarrhea, abdominal pain, chest pain or rash.
42 2021-04-09 dry eye -Recieved shot about 3pm -During the 15 min waiting period my eyes felt kind of dry and "weird". I ... Read more
-Recieved shot about 3pm -During the 15 min waiting period my eyes felt kind of dry and "weird". I honestly didn't even consider it could be a reaction, I thought the way I was breathing through my mask must have been drying my eyes out. -Left clinic after 15 mins, only symptom at this point was dry eyes -about 5 mins in to our drive home my face was feeling very funny and kind of numb. I was feeling worse and worse. -looked in mirror and noticed face was bright red and swelling up. Also my throat was fire red. -it was getting worse and worse, also was starting to get itchy. -My entire face was bright red -Stopped at Sister-in-law's house (cause it was on the way home and she is a nurse) and took two benadryl. Was observed for another 20 mins there and the reaction started to calm down. The redness was still there, but the swelling seemed to have stopped. -went home and kept a close eye on it the rest of the night. -became itchy, but no rash. The bright redness went away after about 20 mins, but my face stayed red (like a sunburn) most of the evening. Throat was red as well. -felt fine when waking up on 4/9 and no other instances of these symptoms -sore arm 4/8-4/10
42 2021-04-09 ringing in ears After the first shot I had tinnitus or ringing in my left ear for approximately two weeks. After th... Read more
After the first shot I had tinnitus or ringing in my left ear for approximately two weeks. After the second shot i developed a fever of 101 for 24 hours, severe headache and body aches and again tinnitus only in my left ear. I am four days post second dose and still have left ear tinnitus. I have not gone to my primary care doctor about this yet but plan to if the symptoms do not go away within two weeks.
42 2021-04-10 mouth numbness I was find after the 15 minute waiting period. By the time I had pulled out of the complex in my ca... Read more
I was find after the 15 minute waiting period. By the time I had pulled out of the complex in my car my cheeks were bright red and it continued down my neck. My right side of neck felt tight/stiff. By the time I got home I had a hive above the right clavicle. Right hand felt numb. Heart rate accelerated, face became puffy. Lips and gums felt numb, throat got red and swollen, hive on right gum and back of throat felt itchy. Never lost ability to breath or swallow. High anxiety, felt extremely uncomfortable in my body. Took Histaminum hydrochloricum via bioAllers Pollen Hayfever treatment several times between 6:30pm and 10pm. Took Skullcap via tea between 7pm and 8pm. Reaction started to calm down around 8:45pm, and I felt back in my body by 10pm. It took until about 2:30am until my heart beat regulated. I will see a PCP hopefully today (Sunday) if not tomorrow.
42 2021-04-10 mouth swelling, eye swelling, swollen tongue Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Fa... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: bilateral lower leg edema-Mild, Additional Details: Hx of asthma, previously diagnosed with COVID > 2 weeks ago, pt complained of bilateral lower leg edema 12 minuts after vaccine was given, pt given benadryl, 3 minutes later complained of throat tightening and tongue swelling, pharmacist administered epinephrine and called 911, EMS evaluated but pt refused transport
42 2021-04-10 swollen tongue, lip swelling Allergic reaction. Throat tightness and swelling of lips and tongue. Headache and pressure.
42 2021-04-11 dry throat Pt states she started to feel lightheaded, SOB and dry throat within 1 hour of vaccine.
42 2021-04-11 mouth tingling, mouth numbness Approximately 3-5 minutes after receiving shot, I experienced rapid heartbeat, rapid deep breathing,... Read more
Approximately 3-5 minutes after receiving shot, I experienced rapid heartbeat, rapid deep breathing, light tingly and numbness on my lips and feet and mild stomach weakness. I was immediately attended by the fire rescue on site who took my heart pulse and blood pressure. After leaving the location I experienced two more episodes of the same symptoms within 1 hour of receiving the vaccine. After that I have been okay. I would like to know if after having experienced these symptoms should I still receive the second dose.
42 2021-04-11 mouth tingling, mouth numbness An hour after I received the vaccine, I became light-headed and started feeling tingling in my upper... Read more
An hour after I received the vaccine, I became light-headed and started feeling tingling in my upper body. My lips were tingling and became numb. My throat also started to feel tight. I did receive Benadryl IVP 25mg within 5 minutes of reaction.
42 2021-04-12 ear pain, ear discomfort, toothache Received shot at 12pm. Symptoms started at 2pm and progressed rapidly, within an hour. Headache sta... Read more
Received shot at 12pm. Symptoms started at 2pm and progressed rapidly, within an hour. Headache starting on left side of forehead, moved across forehead to above right eye. Right ear then became plugged, and sharp ear pain in right ear when swallowing. Upper and lower teeth on right side of face began to ache. Right side of face became numb. Took Aleve and laid down in bed at 4:30pm, and fell asleep. Woke up at 8:30pm with all symptoms resolved except for the plugged ear (without pain), which was resolved the next morning when I woke up.
42 2021-04-12 mouth numbness patient reports sore throat and numb lip about 23 mins after vaccine. Benadryl given at 3:03p, pati... Read more
patient reports sore throat and numb lip about 23 mins after vaccine. Benadryl given at 3:03p, patient reports relief at 3:09p and symptoms completely resolved by 3:18p
42 2021-04-12 mouth ulceration hives, rash, gums swelling and bleeding, oral ulcers, joint swelling hands and wrist swelling, nause... Read more
hives, rash, gums swelling and bleeding, oral ulcers, joint swelling hands and wrist swelling, nausea, fever chills, lymph node swelling
42 2021-04-12 sensitivity to light, loss of taste, mouth discomfort Shot #1- Rushes of very intense anxiety, massive headache, extreme light sensitivity, loss of taste ... Read more
Shot #1- Rushes of very intense anxiety, massive headache, extreme light sensitivity, loss of taste & strange feelings in mouth, intense inability to rest, chills and then soaking my bedding with sweat, and then a crippling multi-day depressive bout which was extremely atypical for me. Shot #2- similar schedule, several hours after my shot I began to feel intense rushes of anxiety, a bit of a sore throat this time, this find the anxiety just completely took over in the night and I was writhing and thrashing, freezing cold but sweated through FIVE pairs of pajamas straight, absolutely could not get any rest or relief. Dizziness upon standing. The next day so utterly depressed and unable to move. No headache, no fever, but a very alarming ?cloud? or fog in my brain. Unable to communicate, dropping things, couldn?t complete a simple task, very frustrated and would burst into tears unprovoked. NOT AT ALL typical behavior for me. This went on for three days and I have not felt so low since the 90s when I was a pubescent teenager.
42 2021-04-12 thirst 4/9/21, just a sore arm and tired the same day Day 2-2.5: tired and little headache, sore arm, some... Read more
4/9/21, just a sore arm and tired the same day Day 2-2.5: tired and little headache, sore arm, some body aches Monday &Tuesday (4/12/21 --4/13/21) Had to miss work. Temp 99 on 4/13. VERY fatigued. Unable to regulate body temp. Hot and cold. Joint pain., body aches, excessive thirst, brain fog.
42 2021-04-12 vision blurred Blurred vision - I could see up close with my glasses off, but my vision blurred with them on.
42 2021-04-13 ringing in ears Severe headache, lasted about 1 week Chills, lasted about 1 day Fatigue, lasted about 1 day Tinnitus... Read more
Severe headache, lasted about 1 week Chills, lasted about 1 day Fatigue, lasted about 1 day Tinnitus, constant ringing, started 3/25/21 and has shown no improvement. As of today I have had this symptom for 3 weeks. It remains unchanged as of right now.
42 2021-04-14 deafness unilateral Sudden hearing loss in left ear
42 2021-04-14 sensitivity to light Dizziness. Nausea. Severe headaches. Sensitivity to light. Muscle pain all over; throughout body.... Read more
Dizziness. Nausea. Severe headaches. Sensitivity to light. Muscle pain all over; throughout body. The dizziness is causing an inability to function. Cannot stand or walk for periods of time.
42 2021-04-14 ringing in ears Tinnitus
42 2021-04-15 eye strain 1 st Vax- within 15min throat lymph nodes hurt/throat hurts, achy, sore sensation & achy chest, not ... Read more
1 st Vax- within 15min throat lymph nodes hurt/throat hurts, achy, sore sensation & achy chest, not fully chest pains but an ache upper chest. Blood pressure 99/70ish 98%O2 heart beats a bit high. Checked out by nurses at clinic By 3:53pm left clinic in stable condition. Symptoms didn't worsen. A bit of chest tightness and start of coughs. Took benadryl. It helped ease symptoms in about an hr. 4:20pm redness in face hands and chest. Tired feverish muscle aches. Eyes tired By 5pm the chest discomfort disappeared. By 1am April 16th the pain in throat had dimished, but a low ache and a sore sensation still persisted until 9am approx.
42 2021-04-15 dry throat Feels like throat is closing, dry throat (not mouth), feels like swollen throat, dizziness for 10 mi... Read more
Feels like throat is closing, dry throat (not mouth), feels like swollen throat, dizziness for 10 minutes, nausea
42 2021-04-15 swollen tongue, taste impairment Patient received the first shot of the COVID-19 Pfizer vaccine in the L arm on 4-6-21 at Hospital, a... Read more
Patient received the first shot of the COVID-19 Pfizer vaccine in the L arm on 4-6-21 at Hospital, and within 15 seconds reported a ?warmth? or ?burning? sensation in L arm, axilla, shoulder, chest, and stomach, and an almost immediate ?metallic taste? in her mouth. Shortly after she felt an increase in her heart rate. Approximately 30 minutes later she says she experienced nausea and like her ?tongue was swelling.? She went home and took a Benadryl and all symptoms had resolved within 30min-1hour. The following day (4-7-21), she was ?achey? and had low grade fever (Tmax 100.5F reported). That night (4-7-21), she felt like her axillary region was slightly sore or starting to swell, but woke up 4-8-21 to severe swelling, warmth , visible bruising, pain, tenderness, all in the L axillary region, so sought care at our office. She did have visible and palpable swelling under the L axilla, and it appeared her vaccine was given in the proper location and there was no local induration/warmth/tenderness at the injection site. She felt the same on 4-9-21, and by 4-12-21 all the axillary symptom had resolved and she only had sore lymph nodes under her jaw. By 4-14-21 all symptoms had resolved other than one small slightly tender lymph node under her jaw.
42 2021-04-16 ringing in ears Buzzing in ears began a week after 2nd dose.
42 2021-04-16 visual impairment Migraines resistant to OTC NSAIDs. Pain phases lasting multiple days, with multiple nausea, aphasia,... Read more
Migraines resistant to OTC NSAIDs. Pain phases lasting multiple days, with multiple nausea, aphasia, visual disturbance, and facial neuropathy phases. Pain phases will break after 3-4 days, followed by extreme tiredness, then onset of a new pain phase 1-2 days later.
42 2021-04-16 visual impairment dizziness; brain fog; vision issues; balance issues; This is a spontaneous report from a contactable... Read more
dizziness; brain fog; vision issues; balance issues; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraine from an unknown date and unknown if ongoing, kidney stones from an unknown date and unknown if ongoing. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included tizanidine hydrochloride (ZANAFLEX); amitriptilina [amitriptyline] (AMITRIPTILINA); and topiramate (TOPAMAX), all taken for an unspecified indication, start and stop date were not reported. Tizanidine, amitriptyline, and topiramate were taken within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 on 10Feb2021 at 12:00 (at the age of 42-years-old) for COVID-19 immunisation. On an unknown date after the second vaccination, the patient experienced dizziness, brain fog, vision issues, balance issues. Therapeutic measures were taken as a result of dizziness, brain fog, vision issues, balance issues included anti-inflammatory steroid. Clinical outcome of the events dizziness, brain fog, vision issues, balance issues was not recovered. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021284020 same reporter/ patient, different drug dose/ AE.
42 2021-04-17 taste impairment Pt c/o metallic taste in mouth with numbness and tingling in the lower jaw and at finger tips accomp... Read more
Pt c/o metallic taste in mouth with numbness and tingling in the lower jaw and at finger tips accompanied with dizziness.
42 2021-04-17 mouth numbness, dry mouth lump in throat/numbness to tongue, redness to face, dry mouth, pressure under eyes, evaluated by EMS... Read more
lump in throat/numbness to tongue, redness to face, dry mouth, pressure under eyes, evaluated by EMS, symptoms improved, pt. refused transport.
42 2021-04-17 visual impairment Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly ... Read more
Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly started a couple weeks after the vaccine and eventually worsened to the point of not being able to open my mouth. Symptoms included facial paralysis, Muscle weakness, fatigue, vision issues, Neuropathy issues. I was transfused with multiple doses of Immunoglobulin and IV steroids. Still currently in Physical therapy I have lost 3 months of not being able to work. Also had a blood clot
42 2021-04-18 loss of smell, loss of taste I received my Pfizer (1st shot) 4/12/21 @10:30 Am Later that evening around 8 PM I had a sore left ... Read more
I received my Pfizer (1st shot) 4/12/21 @10:30 Am Later that evening around 8 PM I had a sore left arm felt weak stayed that way of filling week that whole week. But I did notice that I cannot smell and still cannot as of today?s date 4- 19 -2021. I lost my sense of smell and taste but I can taste very little the flavor of any food. And I cannot smell. I was advised to report.
42 2021-04-18 mouth numbness Patient received COVID-19 vaccine today at 3pm. At 330pm patient requested to see a nurse. She state... Read more
Patient received COVID-19 vaccine today at 3pm. At 330pm patient requested to see a nurse. She stated the tip of her tongue felt numb. Had a similar reaction after her first vaccine, but more of the tongue was numb the first time. It went away after a day. She has not other numbness or deficits. She is requesting to have her vitals checked.
42 2021-04-18 lip swelling Pfizer- 1st shot- swelling of lips and fatigue- hydrocortisone, benadryl, claritin
42 2021-04-18 swollen tongue At 11:47 am (12 min. after receiving vaccination), I started to feel faint, dizzy and very, very wea... Read more
At 11:47 am (12 min. after receiving vaccination), I started to feel faint, dizzy and very, very weak like I was going to pass out, heart beat rapidly, started to get flush and sweaty, hard to talk because my tongue and cheeks started to swell. We had just been waved through the exit, so husband pulled car over for another 30 min. to see if I got worse. Then went home. Arrived home at 1:30 pm and was hit with the same symptoms. Felt very, very weak like I was going to faint until about 3:30/4 pm. Then I started to feel more normal again. At midnight, I started to feel very weak again. Have not experienced any further symptoms since then.
42 2021-04-18 vision blurred Extreme physical pain entire body, Enlarged lymph node under arm on side of injection, Blurry vision... Read more
Extreme physical pain entire body, Enlarged lymph node under arm on side of injection, Blurry vision, Intermittent fever/cold sweat.
42 2021-04-18 vision blurred Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get wo... Read more
Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get worse when I feel cold; I blurt out words for no reason; Eyes can't focus, when trying to read the words seem to be shaking; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Jan2021 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 21Dec2020 (lot number: EH9899) for covid-19 immunisation. The patient experienced body tremors, dizziness, headaches, balance issue, tremors get worse when she feel cold, she blurt out words for no reason, eyes can't focus, when trying to read the words seem to be shaking on 18Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Dec2020, sars-cov-2 test: negative on 27Feb2021. There were no treatment received for the events. The patient did not recover from the events.; Sender's Comments: Based on the available information, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-04-19 eye itchiness Nausea within 30 minutes, sleepiness within 1 hour, after 3 hour nap woke up with scratchy throat an... Read more
Nausea within 30 minutes, sleepiness within 1 hour, after 3 hour nap woke up with scratchy throat and eyes & muscle weakness. Chills, sweats, fatigue, nausea, muscle weakness, loss of appetite, and irritability lasted 2 days. Day 3 woke up with swollen toes on my left foot still irritable but less fatigued. Took Aleve, drank lots of fluids. No formal treatment sought at this time.
42 2021-04-19 eye swelling 12 hours after injection: chills, fever 101 F, headache, bone and body aches, nausea, severe stomach... Read more
12 hours after injection: chills, fever 101 F, headache, bone and body aches, nausea, severe stomach pain for about 3 hours, face and eyes hurt, swollen bags under eyes, fatigue. Still having headaches 4 days later.
42 2021-04-19 hearing loss, ringing in ears My wife is unable to hear, she has a constant ringing, she has vertigo/dizziness, and nausea. We di... Read more
My wife is unable to hear, she has a constant ringing, she has vertigo/dizziness, and nausea. We discovered this after visiting an ENT on Monday, 4/19/21. He said that my wife developed a viral infection in both of her ears, possibly due to the vaccination she received a week earlier.
42 2021-04-19 sensitivity to light The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full ... Read more
The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full body Aches set in, foggy head, headache. By around two I began running a light fever. By about 3 pm I felt overall horrible. By four-five I became incredibly nauseated and began vomiting about an hour later. I kept vomiting throughout the night until it was only acidic bile left. During this time I was burning up if I had even a sheet on my skin, but freezing if I didn?t. I was sweating late into the night. Vomiting stopped around 3 am. The next two days I managed rice, bananas and teaspoons of water but was always nauseated. Fever was gone, but headache and exhaustion remained. Daily nausea finally began to wane and was replaced by heartburn and gross feeling in my throat for about two days. About a week and half after the shot I finally regained my energy and had no stomach issues. Two weeks after injection today- The injection site still is bruised and burns/itches from time to time lightly.
42 2021-04-20 swollen lips Vax on Thursday. Friday morning fatigue, fever, severe headache, body aches and chills. Saturday: fa... Read more
Vax on Thursday. Friday morning fatigue, fever, severe headache, body aches and chills. Saturday: fatigue, fever, severe headache, worse body ache and chills, painful tongue ulcers. Monday: fatigue body aches and chills, joint pain, painful tongue ulcers, full body itching, severe headache. Tuesday: sores on lower lip, fatigue, nauseas, dizzy, headache, full body itching. Wednesday: sores on lower lip, full body itchinh, nauseas, dizzy, fatigue
42 2021-04-20 lip swelling Rash around neck, arm, chest. Upper lip swelling on right side
42 2021-04-20 mouth tingling, visual impairment I am reporting that I nearly fainted early in the morning. I woke up feeling uncomfortable and hot a... Read more
I am reporting that I nearly fainted early in the morning. I woke up feeling uncomfortable and hot and went to the kitchen for an ibuprofen. I immediately felt wobbly and nauseous. I sat on the floor a minute in the kitchen. Took the ibuprofen and walked back upstairs to my bedroom. Again I felt nauseous and then felt my face get hot, lips tingle, vision get grey, realized I was about to faint and lied down on the floor. A minute later I went back to bed feeling the chills, slept two hours and felt fine when I got up. Checked my Blood Pressure and it was normal. I don't normally faint. It was unexpected.
42 2021-04-20 smell distorsion, taste impairment very strong metallic taste and smell.
42 2021-04-20 swollen tongue Swollen tongue
42 2021-04-20 ringing in ears, permanent deafness, deafness unilateral I had the vaccine on 4/5 and on 4/8 I experienced sudden sensorineural hearing loss, unilaterally le... Read more
I had the vaccine on 4/5 and on 4/8 I experienced sudden sensorineural hearing loss, unilaterally left ear... I am now profoundly deaf in my left ear. Suffering tinnitus and vertigo.
42 2021-04-21 taste disorder Pt stated the back of her tongue, feels like it is swelling, but stated that her throat doesnt feel ... Read more
Pt stated the back of her tongue, feels like it is swelling, but stated that her throat doesnt feel bad. denies SOB. At 1403, pt stated that she had a strange taste in her outh and her tongue feels tight against her teeth. at that time EMTs were paged. pt talking with EMTs reguarding medical HX and allergies. at 1440 pt is drinking water 1450 pt stated that she is ready to go home and that she is feeling better. Pt was abulatory upon leaving and walked out of the tent and drove off.
42 2021-04-22 ear pain, pain in jaw Patient received 1st Pfizer vaccine at 3:10pm on 4/20/21 and felt only numbness/tingling in arm with... Read more
Patient received 1st Pfizer vaccine at 3:10pm on 4/20/21 and felt only numbness/tingling in arm within the first hour, then felt fine rest of day into the following day 4/21/21, until about 2:00pm when she developed a headache that got worse with time. Headache turned into pain that radiated to her ears, jaw, and neck. When patient got home close to 6pm that evening (4/21/21), she looked in the mirror and noted her face looked droopy. She went to go speak to her husband, who realized immediately that her speech was slurred. He took her to hospital where she was admitted for observation and tests were run.
42 2021-04-22 ringing in ears Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart p... Read more
Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart palpitations, tinnitus
42 2021-04-23 bloodshot eyes, eye irritation Can My eyes are burning and red
42 2021-04-23 sensitivity to light 99.9 fever taken at 2am 4/21/21, noted again above 99 evening of 4/21/21. Chills, aches, fatigue, ... Read more
99.9 fever taken at 2am 4/21/21, noted again above 99 evening of 4/21/21. Chills, aches, fatigue, headache, lower back pain, pain at site of injection / left arm, increase in sensitivity to light and sound observed until 9am Friday 4/24/21.
42 2021-04-24 deafness, ringing in ears Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a cont... Read more
Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 16:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history included blood clot from an unknown date. Patient is not pregnant. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. No other vaccine in four weeks. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. The patient experienced cannot hear out of it at all and have tinnitus in her left ear on Mar2021 (reported as 02:30), 24 hours after the first dose. Took 2 weeks to return after the first dose. Outcome of cannot hear out of it all was recovered on an unspecified date while unknown for tinnitus.
42 2021-04-24 deafness, ringing in ears fever of 101; headache; muscle soreness and stiffness; muscle soreness and stiffness; extreme fatigu... Read more
fever of 101; headache; muscle soreness and stiffness; muscle soreness and stiffness; extreme fatigue; Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a contactable consumer (who is also the patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration in the left arm, on 06Apr2021 15:00, as single dose, for COVID-19 immunisation. Medical history included blood clot. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, therapy dates not reported. The patient did not have COVID-19 prior to vaccination and had not tested for COVID-19 post vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) received at age 42 years, via an unspecified route of administration in the left arm, on 12Mar2021 16:45, for COVID-19 immunization, and within 24 hours, the patient experienced tinnitus in left ear and cannot hear out of it at all which took two weeks to return after the first dose. The patient did not receive other vaccines in for weeks. On 06Apr2021, the patient received the second dose. On 07Apr2021 at 02:30, the patient had tinnitus in his left ear and could not hear out of it at all. On 07Apr2021 at 03:00, 12 hours after the injection, the patient had a fever of 101 along with headache, muscle soreness and stiffness, and extreme fatigue. No treatment was given for the events. The outcome of the events was not recovered.
42 2021-04-24 ear discomfort, ringing in ears, hearing loss, double vision main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick succ... Read more
main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; has kept her up nights three nights; vision was double; fatigue; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Mar2021 (at the age of 42-years-old; not pregnant), at 10:00 AM (Lot Number: ER2613) as a single dose in the left arm for COVID-19 immunisation. Medical history included eosinophilic oesophagitis and known allergies: sulfa drugs both from an unknown date and unknown if ongoing. Concomitant medications included finasteride (PROPECIA), lorazepam (ATIVAN) and fluticasone propionate (FLOVENT (reported as FLOVENT 200)); all taken from an unspecified date for an unspecified indication. On 18Mar2021 at 5:00 PM, the patient reported that the main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise and has kept her up nights three nights since vaccine. After the dose, the patient's vision was double, but she thought it was just because of fatigue. Patient also reported that arm soreness was going away. No treatment was received by the patient for the reported adverse events. Post vaccination COVID test: polymerase chain reaction (PCR) COVID test/ nasal swab was conducted on 18Mar2021 and the result was negative. The outcome of the event "arm soreness" was recovering and not recovered for all other events. No follow up attempts are needed. No further information is expected.
42 2021-04-25 oral mucosal blistering got shot on 4/13 tues evening. the following monday 4/19, i got blisters in my mouth. the next day ... Read more
got shot on 4/13 tues evening. the following monday 4/19, i got blisters in my mouth. the next day on Tues 4/20 i got a major headache like someone hit me on the head. wed 4/21, i got rashes on my forearm.
42 2021-04-25 pain in jaw Shoulder pain at sight of injection at first - then spread to entire shoulder joint. Pain started n... Read more
Shoulder pain at sight of injection at first - then spread to entire shoulder joint. Pain started night of injection and caused limited mobility as well. This was very intense for the first four days. After that, it started to improve - day by day- for the next six days or so. However, at that point (about 10 days post injection) the pain in the shoulder started increasing - day by day- and now is very painful again. Ice the first day, then switched to heat after that. Not much improvement or relief. Also took Tylenol but it barely helps at all. The intensity of the shoulder pain is causing related pain in my neck and jaw because I find myself clenching my teeth in pain - which causes jaw/face pain and now headaches. They are tension type headaches because of the grinding/clenching.
42 2021-04-25 thirst Radiating heat all over body. Sweats with 99.8 fever. horrible pain in all joints especially back.... Read more
Radiating heat all over body. Sweats with 99.8 fever. horrible pain in all joints especially back. extreme thirst. brown urine. head ache. All began around 2am on Saturday and the most severe lasted until approximately 7am. From 7am to 8pm was able to start advil and tylenol rotation which helped stop the joint pain and the radiating heat. the sweats continued along with the thirst.
42 2021-04-26 loss of smell, loss of taste Received Pfizer COVID vaccine 12/26/2020 and 1/16/2021. On 4/25/2021 developed loss of taste/smell... Read more
Received Pfizer COVID vaccine 12/26/2020 and 1/16/2021. On 4/25/2021 developed loss of taste/smell, fever, and nasal congestion. Tested positive for COVID.
42 2021-04-26 taste impairment Metallic taste in mouth immediately - sill having symptoms
42 2021-04-26 bloodshot eyes, eye irritation, eye pain, eye itchiness, eye swelling, lacrimation increased, sensitivity to light On 4/9, let eye turned red along with burning, itching, swelling, tearing in the eye. Swelling in t... Read more
On 4/9, let eye turned red along with burning, itching, swelling, tearing in the eye. Swelling in the armpit. On 4/11, the pain in the eye became quite severe. Eye was also sensitive to light and touch. On 4/13, elevated ESR levels (67) were detected and Prednisone (60mg daily) s was prescribed. On 4/14, optometrist diagnosed iritis and prescribed Prednisone eye drops. On 4/19, further tests ruled out other possible causes for iritis and Prednisone was stopped.
42 2021-04-26 oropharyngeal discomfort Patient presented for second dose of Pfizer Covid Vaccine. Has history of anaphylaxis to red bee ve... Read more
Patient presented for second dose of Pfizer Covid Vaccine. Has history of anaphylaxis to red bee venom and experienced throat discomfort with first dose Covid Vaccination and received Diphenhydramine susp 25mg by mouth with improvement in her throat discomfort within 5 minutes of administration. Water proved. Patient physically examined by physician. Pulse Ox 99% at discharge home with husband who was driving. Patient was advised on appropriateness of repeat dosage of 25mg Diphenhydramine if need later in the evening.
42 2021-04-26 ringing in ears Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, we... Read more
Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, went away after about 4 days, then came back around day 12 with chills and feeling run down/sick, but as more of a pins and needles/cold burn feeling, again mostly around legs, went away after a few days, came back again 4/26 as pins and needles and cold burning feeling with chills every now then, also experiencing off and on vertigo since vaccine and tinnitus, as well as painful lymph nodes in chest mostly on vaccine side starting in day 12ish post vaccine.
42 2021-04-27 burning mouth syndrome, lip swelling, bloodshot eyes 4/16 - rash, lip swelling, tongue pain, temperature, chills, body aches, lymphadenopathy, 4/23 - ch... Read more
4/16 - rash, lip swelling, tongue pain, temperature, chills, body aches, lymphadenopathy, 4/23 - chest pain (same day as cortisone injection) 4/24 - worsening swelling, pain with swallowing 4/25 - admitted to the hospital through the ED with erythemic rash to bilateral palms, bilateral feet, back; painful, not itchy; eye red; lip swollen; tongue pain and pain with swallowing
42 2021-04-27 mouth tingling At about 2:30 started feeling funny. Thought I was possibly hypoglycemic but my blood sugars were 12... Read more
At about 2:30 started feeling funny. Thought I was possibly hypoglycemic but my blood sugars were 123. Then about 3:00 tasted feeling tingling in my arm and finger tips and legs. 3:30 my legs felt like they were swollen but the weren't. Noticed I was coughing more to clear my throat. And felt a little itchy on different parts of my body. Around 4:30 my husband noticed I had something on my face. Turned out to be hives. My throat area velt wierd a little numb but not completely. I felt big lumps on both sides of my neck. I then started to feel tingling on my nose and left side of my tongue. I noticed it felt a little uncomfortable to swallow almost like a sore throat but without pain. I did not feel short of breath at any time. I took 50mg of benadryl at 6pm. The symptoms started to subside. Still had occasional itching. By the morning I felt better. Throat felt better and itching was gone. I did end up taking more benadryl at about 8pm because I noticed my throat feeling swollen again. By the morning I was back to normal again.
42 2021-04-28 ear discomfort At about 3:50 PM client was given vaccine. 10 min or so later reported lips feeling fuzzy. No troubl... Read more
At about 3:50 PM client was given vaccine. 10 min or so later reported lips feeling fuzzy. No trouble with breathing. At 1610 B/P 130/94 P 80. At 4:16 PM 911 was called. About 4:20 PM client reported something is happening to me. Client brought up both hands to head & stated feeling pressure behind both ears & in both ears. Pulse not racing. 2nd nurse speaking with client to support, calm, said she was having trouble finding words. EMS assessed & had client walk with them to the ambulance. RN
42 2021-04-28 tongue disorder After 30 minutes receiving the vaccine pt felt itching of the tongue, feeling flushed & itching of b... Read more
After 30 minutes receiving the vaccine pt felt itching of the tongue, feeling flushed & itching of both cheeks, after an hour, slight difficulty swallowing & talking, tongue felt thick & funny, also itching of whole body no rashes, Took liquid Benadryl & Liquid Zyrtec per instructions of immunologist with some relief.
42 2021-04-30 dry eye Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the mid... Read more
Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs; Dizziness; At the time she was given her COVID-19 Vaccine shot, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back; dry eyes; she was coughing more; the increase in coughing had made her voice huskier sounding; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 08:45 Arm Left (Lot Number: EP6955, Expiration Date: 30Jun2021) single dose for covid-19 immunisation. Medical history included ongoing Crohn's disease from 1999, ongoing Hidradenitis suppurativa at the end of 2019, ongoing Small Fiber Peripheral Neuropathy diagnosed at the end of 2019. She said her doctor was not sure of the Small Fiber Peripheral Neuropathy's cause, or if the Small Fiber Peripheral Neuropathy was associated with any of her other medical conditions. She said she had symptoms for sometime, and was diagnosed with a lot of things at the end of 2019 because she was finally able to see a specialist. Concomitant medications included adalimumab (HUMIRA AC) from in Feb2020 at 40mg injection pen once a week for her Crohn's disease. Reported she has had no reactions to flu or pneumonia vaccines for immunisation in the past. She said she had her first COVID-19 Vaccine dose on Thursday, 18Mar2021. She said on Saturday morning (20Mar2021), she had shortness of breath, dizziness, and chest pressure. She said her shortness of breath, dizziness, and chest pressure has been lasting for 20-something days, and she doesn't know why. She said she had taken two (different) week long prescriptions of Prednisone. She said she had 2 EKGs, 2 chest x-rays, and blood work, which were all normal on 13Apr2021 and 2021. She said her doctors don't know why she was having the shortness of breath, dizziness, and chest pressure. She said she was using inhalers, medications, and everything, and still had her symptoms. She asked if what she was experiencing was a side effect of the COVID-19 Vaccine, or due to her 2 autoimmune diseases because her doctors were grasping at straws at this point. Reported she had so many medical conditions, and was taking so many different medications. Reported she has had shortness of breath and chest pressure every day, but the dizziness wasn't constant, and had lessened. She said she has never had the shortness of breath and chest pressure before. She said she has never had anything last that long either. She said she was wondering if her shortness of breath and chest pressure were caused by the COVID-19 Vaccine. Clarified the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, saying it was an odd feeling. Reported she was coughing more, and she believed the increase in coughing had made her voice huskier sounding in 2021. She said she had a cough associated with outdoor allergies, but the cough she had now didn't feel like her normal allergy cough. She said she had no mucus. She said she was not sneezing, or coughing out anything. She said the cough she had now was different. Reported at the time she was given her COVID-19 Vaccine shot 18Mar2021, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her fingertips. She said the warmth feeling also went to the left side of her back. She said she was kept longer after she got her COVID-19 Vaccine for monitoring. She said the warmth feeling in her left arm, left fingertips, and left back didn't last long, and went away. Reported she had gone to the Emergency Room on Tuesday, 13Apr2021, because she had palpitations, and a weird feeling under her skin. She said while at the Emergency Room, she had an EKG, chest x-ray, and blood work. She said the doctor was looking for a blood clot. She said all her testing came back negative for a blood clot. She said earlier that day (13Apr2021) was her 3rd visit to her doctor since her symptoms had started. Reported she had started Restasis on 19Mar2021, the day after her first COVID-19 Vaccine. She said she was prescribed Restasis for dry eyes, and didn't have the dose, NDC, Lot, and Expiration Date because she was not at home. AEs require a visit to Emergency Room and Physician Office. Treatment included Stated she had taken 2 different week long doses of Prednisone to treat her symptoms. She said she first took Prednisone 40mg, once a day, for 7 days. She said she was off the Prednisone 40mg for 2 days, and had instructions to call her doctor if she wasn't feeling better. She said she went back to her doctor, and was prescribed Prednisone 60mg for 3 days, then Prednisone 40mg for 3 days, and then Prednisone 20mg for 3 days. She said she did not have the 2 Prednisone prescription NDC, Lot, and Expiration Dates. She said she was also put on a 10-day Azithromycin 250mg tablet prescription. She said she took a Azithromycin 500mg (2-250mg tablets) dose the first day, and then Azithromycin 250mg, once a day, for the next 9 days. She said she did not have the Azithromycin 250mg tablet NDC, Lot, and Expiration Date. She said she was also prescribed an Albuterol (90mcg per actuation) inhaler, providing: NDC Number: 66993-019-68, Lot Number: A63H, Expiration Date: Jan2022. She said she didn't feel like the Albuterol inhaler was doing the rescue part, and that she could take the Albuterol inhaler every half hour. Reported she was prescribed an Albuterol inhaler (90mcg per actuation) for shortness of breath. Outcome of the event Shortness of breath, the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, coughing more, the increase in coughing had made her voice huskier sounding was not recovered. Outcome of the event Palpitations, a weird feeling under her skin was unknown. Outcome of the event Dizziness was recovering. Outcome of the event had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back was recovered on 18Mar2021. No follow-up attempts are needed. No further information is expected.
42 2021-04-30 ringing in ears The tinnitus I have in both ears that I recently developed (potentially due to an early Covid infect... Read more
The tinnitus I have in both ears that I recently developed (potentially due to an early Covid infection became much louder and screeching.
42 2021-05-05 deafness unilateral, ringing in ears Moderate/Severe Tinnitus and hearing loss in left ear, unsuccessfully treated with medrol dose pack... Read more
Moderate/Severe Tinnitus and hearing loss in left ear, unsuccessfully treated with medrol dose pack and 18 day course of prednisone
42 2021-05-06 eye pain shakes, body aches, fever, pain in arm pit of the same arm vaccine was administered, neck pain, pai... Read more
shakes, body aches, fever, pain in arm pit of the same arm vaccine was administered, neck pain, pain shooting down arm with tingling in fingers (if arm vaccine was administered), pain in eyes, fatigue, headache
42 2021-05-07 ringing in ears Sudden Hearing loss and tinnitus
42 2021-05-12 deafness unilateral, ringing in ears Left ear: Ringing in ear, hearing loss, tinnitus Steroid shot injection in eardrum Not resolved
42 2021-05-12 ringing in ears 8 days after first shot in The Pfizer Covid vaccine series, I developed very horrible tinnitus. Had ... Read more
8 days after first shot in The Pfizer Covid vaccine series, I developed very horrible tinnitus. Had not been around any loud sounds. Just woke up with it roaring in my ears. Never had COVID.
42 2021-05-13 visual impairment, ringing in ears Hospitalized for severe vertigo, nausea and disrupted eye sight. Dizziness and tinnitus continuing p... Read more
Hospitalized for severe vertigo, nausea and disrupted eye sight. Dizziness and tinnitus continuing past hospital stabilization.
42 2021-05-19 loss of smell, loss of taste Pt is a 42 YO female who has received her full Pfizer vaccination: first dose on 1/23 and second dos... Read more
Pt is a 42 YO female who has received her full Pfizer vaccination: first dose on 1/23 and second dose on 2/13. She developed headache, congestion, and loss of taste and smell on 5/12. Tested positive for COVID-19 on 5/13.
42 2021-05-19 mouth ulceration Developed sores (Ulcer) in both nostrils, mouth and lip exactly 1 week after receiving first shot.
42 2021-05-21 ringing in ears Sudden hearing loss and tinnitus; Sudden hearing loss and tinnitus; This is a spontaneous report fro... Read more
Sudden hearing loss and tinnitus; Sudden hearing loss and tinnitus; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jan2021 (at the age of 42-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included known allergy to Sulfa. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: unknown), administered in left arm on 09Jan2021 for COVID-19 immunisation. The patient experienced sudden hearing loss and tinnitus on 11Mar2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included oral steroids, injected steroids and hearing aid. The outcome of the events was not recovered. Seriousness criteria of both events was reported as disabling/incapacitating. Information on the lot/batch number has been requested.
42 2021-05-23 ringing in ears tinnitus
42 2021-05-24 ear pain dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congest... Read more
dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congestion; loss of appetite; Headaches; fatigue; right axillary lymph node swollen; Dizziness; Room spinning; nausea; body and face tingling; chills; body aches; insomnia; This is a spontaneous report from a contactable nurse reporting for herself. This 42-year-old female nurse (Patient) reported that: A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE for COVID-19 immunization. Patient also received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 09:30 AM, (Batch/Lot Number: EK9231) as SINGLE DOSE for COVID-19 immunization (time interval between two doses: 18 days). Medical history included drug hypersensitivity, to Penicillin, tetracycline. Concomitant medication included cetirizine hydrochloride (ZYRTEC) 1x/day and Multivitamins. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 22Jan2021 10:00 PM, the patient experienced dizziness, room spinning, nausea, body and face tingling, chills, body aches and insomnia. Also, it was reported that, the patient had fatigue, right axillary lymph node swollen on 23Jan2021, on 24Jan2021: dizziness had nausea. On 26Jan2021: Dizziness, nausea, loss of appetite, tingling face and body and headache. On 27Jan2021: Dizziness, nausea, tingling face and body, cough, congestion and on 28Jan2021: Cough, congestion, earache. On 29Jan2021, the patient presented with dizziness, tingling face and body, cough congestion, and headache. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for adverse events. The patient was recovering from all the event at time of reporting. Follow-up attempts are completed. No further information is expected.
42 2021-05-24 eye pain Numbness in left hand. Left arm heavy and sore.Fever. Chills. Cough. Heart palpable. Shortness of br... Read more
Numbness in left hand. Left arm heavy and sore.Fever. Chills. Cough. Heart palpable. Shortness of breath. Stomach cramps. Nausea. Diarrhea. Pain behind eyes. Burning itchy skin. Uterine bleeding.
42 2021-05-25 loss of taste, loss of smell The day after the shot I was nauseous and fatigued! Full body aches continued throughout the day, bu... Read more
The day after the shot I was nauseous and fatigued! Full body aches continued throughout the day, but were managed with ibuprofen and Tylenol. I lost my sense of taste and smell as well! Two weeks out and I can smell some, but I still have no taste!!
42 2021-05-25 loss of taste Lost sense of taste
42 2021-05-25 lacrimation increased, dry throat Dry nose and throat; Dry nose and throat; Weepy eyes, a lot of tears, water coming from her eyes; Fe... Read more
Dry nose and throat; Dry nose and throat; Weepy eyes, a lot of tears, water coming from her eyes; Fever; Cough; Cold-like symptoms; Body pain; inflammation under her armpit; Pain under her armpit; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 12May2021 (at the age of 42-years-old ) at 1ST DOSE, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had dry nose and throat; weepy eyes, a lot of tears, water coming from her eyes and had fever; a lot of coughing; cold-like symptoms; body pain; felt inflammation and pain under her armpit in May2021 after the first dose. She mentioned that because of symptoms she could not go to work for 2 days i.e. 13May2021 and 14May2021. The events were reported as non serious. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-05-25 lacrimation increased MY EYE BROWS SWELLED; DIZZINESS; CRAVED BLACK LICORICE LIKE MAD; MASSIVE EYE TEARING; HAD A RIGHT SI... Read more
MY EYE BROWS SWELLED; DIZZINESS; CRAVED BLACK LICORICE LIKE MAD; MASSIVE EYE TEARING; HAD A RIGHT SIDED FRONTAL HEADACHE; POST NASAL DRIP; I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS.; This is a spontaneous report from a non-contactable non-health care professional. A 42-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine) (Lot/batch no: EN6199) dose number 1 via unspecified route of administration on left arm as a single dose for COVID-19 immunisation on 04Mar2021 at 06:30 PM (at the age of 42-year-old). Medical history included allergy to gold. Concomitant medication was not provided. Reported patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced dizziness within the first 15 minutes. Within the first hour her eye brows swelled and she had a right sided frontal headache. 2 hours later she felt like she was at high altitude which lasted for 36-48 hours. The swelling broke during the night with massive eye tearing and post nasal drip. She craved for black licorice like mad on 04Mar2021. The action taken was not applicable. Therapeutic measures were taken as a result of events and included self-treatment with ice pack, tylenol, and clairitin from an unknown date. The patients recovered from the events dizziness, eye brows swelled, frontal headache, massive eye tearing and post nasal drip was recovered. No follow-up attempts are needed. No further information is expected.
42 2021-05-26 taste disorder I now have a 2" by 4" welt on my arm that is warm to the touch; This was in addition to a small welt... Read more
I now have a 2" by 4" welt on my arm that is warm to the touch; This was in addition to a small welt I got on my arm a few hours after injection, which lasted 2-3 days; I got a weird taste in my mouth that lasted about 3 days; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown and expiration date was not reported) via an unspecified route of administration in left arm on 10Feb2021 at 14:00 (at age of 42-years-old) as unknown dose, single for covid-19 immunization. Medical history included thalassemia, high blood pressure, allergies to pet dander and pollen. Concomitant medication included lisinopril and ciprofloxacin (CIPRO). Patient did not receive other vaccine in four weeks of vaccination. Patient has not COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 10Feb2021, (almost immediately after injection), got a weird taste in mouth that lasted about 3 days and small welt got on her arm a few hours after injection, which lasted 2-3 days. On 17Feb2021, (day 7 after injection) have a 2" by 4" welt on her arm that was warm to the touch, which she believed called COVID arm. No treatment was received. The outcome of events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-05-28 mouth numbness Facial numbness especially lips and tongue; Facial numbness especially lips and tongue; This is a sp... Read more
Facial numbness especially lips and tongue; Facial numbness especially lips and tongue; This is a spontaneous report from a contactable consumer (patient). This 42-Year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included cat allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient had no concomitant medications. The patient reported that on 08Apr2021 at 16:00 she experienced facial numbness especially lips and tongue which lasted a few weeks. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of facial numbness especially lips and tongue were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
42 2021-05-28 ringing in ears Ringing in my ears started about the same time that I left the clinic parking lot. As of writing th... Read more
Ringing in my ears started about the same time that I left the clinic parking lot. As of writing this at 7:23 am the following morning it has not gone away.
42 2021-05-28 tongue discomfort Persistent nausea; tongue often feels different; This is a spontaneous report from a contactable hea... Read more
Persistent nausea; tongue often feels different; This is a spontaneous report from a contactable health care professional (patient). A 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 24Feb2021 as an unknown dose number, as a single dose for COVID-19 immunization. Medical history included familial hypercholesterolemia and hashimotos antibodies both from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included trazodone (manufacturer unknown) and hydroxyzine (manufacturer unknown), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced persistent nausea and tongue often feels different on 27Feb2021. The events resulted to a doctor or other healthcare professional office/clinic visit. As treatment for the events, the patient's gall bladder was removed (as reported). The events were reported with a seriousness of disability. The outcome of the events was not recovered. The patient had a nasal swab SARS-COV-2 test on 07May2021 with a result of negative.; Sender's Comments: Events represent intercurrent medical conditions and unrelated to BNT162B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-05-29 ear discomfort, ear pain Fatigue, headaches and unusual sensations in head/scalp/neck area (pressure, numbness, tingling) sta... Read more
Fatigue, headaches and unusual sensations in head/scalp/neck area (pressure, numbness, tingling) started day after shot and continued for weeks before finally seeking medical help two weeks post vaccination. Have since experienced blood pressure fluctuations, anxiety, vertigo, nausea, light-headedness, heart palpitations, ear pressure/throbbing, chest pain and sensations of weakness/numbness on left side of face/head/neck/chest/arm. Two weeks post-vaccine (on 5/11) I met with my endocrinologist to check on my Hashimoto's condition and thyroid/iron bloodwork since I was still feeling fatigued and generally unwell post vaccine.
42 2021-05-29 eye discomfort One day after injection on 5/14/21, got intense painful ache under right ear. It went away after abo... Read more
One day after injection on 5/14/21, got intense painful ache under right ear. It went away after about a day. But then on the evening of 5/24, I found that my right eye was very scratchy. On 5/25, I realized it?s because the right eye would not close all the way. On the evening of 5/25, I found my food kept falling into my right cheek when I ate. On 5/26, I found that my right eye would not blink at all. And my right cheek was numb. My right eyebrow would not raise as high as the left and my smile was crooked. I went to urgent care and they diagnosed me with Bell?s Palsy.
42 2021-05-29 visual impairment Vision change
42 2021-05-31 eye pain dizziness; injections site reactions including: swelling itchiness, and warm to the touch; Swelling,... Read more
dizziness; injections site reactions including: swelling itchiness, and warm to the touch; Swelling, itchy, hot to touch at injection site; injections site reactions including: swelling itchiness, and warm to the touch; fever of 103 at highest; her eyes hurt; weak; lethargic; headache; slight aches/Achy/whole body hurt; skin was sensitive; she felt like she had the flu; felt very sick; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via intramuscularly in left arm on 29Jan2021 at 10:50 am as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246), via intramuscularly in left arm on 08Jan2021 at 10:50 am as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30Jan2021 at 00:00, patient experienced achy, weak, headache, eyes hurt, lethargic, whole body hurt, fever of 103 at highest. She also said on Saturday around 12:00 am, is when she felt very sick, her skin was sensitive. It was reported that Today, she still feels slightly dizzy, has a headache and slight aches. Patient also experienced dizziness. Sunday, her temperature went down to 99.2 degrees Fahrenheit. On 31Jan2021 at 07:00, patient experienced Swelling, itchy, hot to touch at injection site. She stated she doesn't typically have reactions to vaccines, and that symptoms are improving from peaking on Saturday 30Jan2021. She's wanting to know if these are normal and how long AEs might last. Today she still feels dizzy, has HA and slight aches. No duration is reported for other AE's. Referred to MD for treatment. She wanted to know if it was normal not to feel right after having the shot on Friday. She is a dental hygienist. She provided her weight as being between 145-150. NO ER or physician's office required. Patient medical history was reported as provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was reported as none. The outcome of the event dizziness, felt very sick, felt like she had the flu, skin was sensitive was unknown and outcome of the events injections site reactions including: swelling itchiness, and warm to the touch was not recovered and outcome of the other events was recovering. Follow-up attempts are completed. No further information is expected.
42 2021-05-31 hearing loss, ringing in ears pulsatile tinnitus - constant - whooshing sound in ear correlating to the beat of my heart - hard ti... Read more
pulsatile tinnitus - constant - whooshing sound in ear correlating to the beat of my heart - hard time hearing
42 2021-05-31 ringing in ears Tinnitus since second vaccine shot!
42 2021-06-02 smell distorsion She got her vaccine, she had a sore arm, but otherwise had no reaction. The next morning at 10:00 ... Read more
She got her vaccine, she had a sore arm, but otherwise had no reaction. The next morning at 10:00 AM she felt extremely tired as if she had not slept in days. Then she got extremely cold and had to wrap up with a blanket. She started making lunch for the children, and had made chicken nuggets for one of them, and the smell made her extremely nauseous and was throwing up 4 different times, and felt like she had morning sickness. She had to call the parents to pick up the children, and went to bed at 4:00 PM yesterday and woke up at 6:00 AM this morning. She has extremely aching of joints, low back in the waist area. She had a temp of 100.0, and when she took it this morning it was 97.9. She did not eat yesterday, and the smells again have given her dry heaves and has not eaten anything since the vaccine. She is still having the nausea and the queasy feeling, as well as back aches. She has been taking OTC Motrin for the symptoms.
42 2021-06-02 vision blurred Pain at injection site; pain in rib cage and thoracic spine; pain in rib cage and thoracic spine; st... Read more
Pain at injection site; pain in rib cage and thoracic spine; pain in rib cage and thoracic spine; stiffness; chills; rash on my face and injection site; rash on my face and injection site; blurred vision/cloudy; digestive issues; headache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0171), via an unspecified route of administration, on 23May2021 at 12:30 (at the age of 42-years) as single dose in left arm, for covid-19 immunization. Medical history included: allergies, meningitis, low back pain, SI joint disfunction, IBS and known allergies: Sulfa drugs, soaps, detergents, and other household products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included: ibuprofen, multivitamin, antioxidants, leaky gut r. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 23May2021 at 22:30, the patient experienced pain at injection site, pain in rib cage and thoracic spine, stiffness, chills, rash on my face and injection site, blurred vision, cloudy, digestive issues and headache. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
42 2021-06-03 taste impairment I've experienced swollen lymph nodes on Left side only; a bad taste in my mouth/ metallic taste; Thi... Read more
I've experienced swollen lymph nodes on Left side only; a bad taste in my mouth/ metallic taste; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered in in arm left on 01Feb2021 07:30 AM (at the age of 42-year-old), as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included atenolol, lisinopril, tizanidine hydrochloride (ZANAFLEX), and omeprazole. Patient previously took BNT162B2 first dose administered in in arm left for covid-19 immunization. Patient did not have COVID prior vaccination. Patient did not have other vaccines in four weeks. Patient has not tested covid post vaccination. No known allergies. On 01Feb2021 07:45 AM the patient experienced adverse event and reported that "I have experienced swollen lymph nodes on Left side only. But a bad taste in my mouth since the 2nd shot on 01Feb2021. over 4 weeks. It is a terrible metallic taste". Patient did not receive treatment for the adverse events. Outcome of the events was not resolved. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
42 2021-06-03 sensitivity to light 101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymp... Read more
101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymph node pain, migraine, photophobia, lack of appetite, fatigue, malaise
42 2021-06-03 swollen tongue Increased heart rate to 131 at 11:29 am; dizziness; muscle weakness; swelling of tongue; This is a s... Read more
Increased heart rate to 131 at 11:29 am; dizziness; muscle weakness; swelling of tongue; This is a spontaneous report from a contactable consumer. This 42-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 11:15 (Batch/Lot Number: EN6206; Expiration Date: Jun2021) as Ist dose, single dose for covid-19 immunisation. Medical history included chronic sinusitis, ventricular extrasystoles, covid-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. Concomitant medications included azelastine (AZELASTINE); fluticasone (FLUTICASONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took pseudoephedrine and experienced drug hypersensitivity. On 05Mar2021 11:30 the patient experienced increased heart rate to 131 at 11:29, dizziness, muscle weakness, swelling of tongue. The patient underwent lab tests and procedures which included heart rate: 131 on 05Mar2021. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was recovered.
42 2021-06-06 swollen tongue Anaphylaxis sharp pain left side by chest swelling in nape of neck by thyroid extreme sinus pressur... Read more
Anaphylaxis sharp pain left side by chest swelling in nape of neck by thyroid extreme sinus pressure between eyes tongue swelled glands under ears swelled throat swelled. Epi pen given by HCP in pharmacy
42 2021-06-08 mouth numbness, mouth tingling This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient ... Read more
This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiration date: unknown), via intramuscular route, administered in upper left arm on 19Mar2021 (at the age of 42-year-old) as 1st dose, single dose for COVID-19 immunisation. She was given vaccine between 15:00 pm and 16:00 pm. The patient medical history includes asthma, gastroesophageal reflux disease, covid -19 and migraine. Concomitant medications included Breo, Singulair, Flonase and Azelastine. The hospital advised to stop taking Flonase. She had rabies vaccine for work, and she must be checked every 2 years for titers. There was no family history. She was not HIV positive or syphilis positive. The patient experienced within 15 minutes of receiving the vaccine, her left side of face went numb, and the left arm went heavy. By the next day, the thumb and pinky on left hand were numb and had pain in left arm pit. The patient experienced migraines on 18May2021. The inside of her mouth has been persisting on left side of face. The rest of her face was getting better, but then 2 weeks ago she had another full episode, and it went back numb again on the left side of her face and has been numb since. Now it has traveled into left eye up towards the eyebrow, towards her ear, down to her chin, and straight up the middle. Half of her tongue feels tingly numb, and the other half was fine. Her lips are numb. It was like when you get dental work, get home, and the Novocaine wears off. And that was what the whole left side of her face feels like. Did not feel as heavy as the first couple of days, but she feels like she cannot use her arm because it was weak. Left thumb and pinky were numb was on and off. Since she relapsed 2 weeks ago, it has been numb ever since. The left-hand grip was weak. Numbness of left thumb and pinky has gotten worse. Her left-hand grip has gradually worsened as time has went on. She had pain every once in a while, but pain was not constant like it was. She was been having headaches since she got Covid. Asthma, reflux, and Covid that should be all of her medical conditions. The patient saw on a group to call this number if she had a reaction to the Pfizer vaccine. She did VAERS online reporting back in Mar. She states people are like they never heard of what happened to her before. The patient was 216 or 218 pounds. She had been waiting since Mar since the adverse reaction. She stated it takes about a month to get her fully on the medication. She just started on medications and was told it will take about 2-3 months before she starts feeling better if medications works. She saw EMTs at site and told her if face was still numb next day to go to the ER. She woke up and more of her face was numb, pinky and thumb were numb, and her arm pit was hurting. She went to the ER on 20Mar2021. She was discharged the next day on 21Mar2021 with no diagnosis and told to follow-up with neurologist. On 11May2021 while at work, she had a weird feeling come over her body. She went clammy and was weak, she could barely stand. The numbing of the face was just in her mouth but that night, her whole face went numb on left side. She could barely walk; it was super weird. They did head CT, cervical CT, and bloodwork, but they could not really find anything. She was admitted back into the hospital on 12May2021, and they did more brain MRIs and bloodwork. She was discharged on 14 May with really no diagnosis and to follow-up with the neurologist. Lab test included Covid negative on 13Jan2021 and 4 brain MRIs. Two were regular MRIs, a brain MRI with contrast, and she thinks it was a MRA where they looked at the blood vessels flow in and out of the brain. She also had brain CT, cervical spine CT, and a ton of blood work. She was hospitalized twice. And they still do not know what was wrong with her. She will 2 more brain MRIs and a cervical MRI left to go in 2 more weeks, Covid 19 Test (positive in Dec2020 and negative in 13Jan2021). The outcome of the events left side face went numb and left thumb and pinkie numbness was not recovered/resolved. Left arm heaviness and axillary pain was recovering /resolving. The outcome of feeling abnormal, difficulty in standing, Tingling tongue, Numb lips, migraine, cold sweat(clammy) and asthenia was unknown. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-06-08 ringing in ears Within 24 hours of my 2nd Pfizer shot, I had some moderate level dizziness, lightheadedness and brai... Read more
Within 24 hours of my 2nd Pfizer shot, I had some moderate level dizziness, lightheadedness and brain fog. Then on May 8th, I woke with debilitating vertigo. I was unable to walk without help, and over the next two weeks, I had severe dizziness, brain fog, cognitive decline, and was unable to work, drive or watch my kids. After about two weeks, I noticed I was experiencing ringing in my ears, which I learned was tinnitus. The tinnitus has steadily increased in volume/intensity, and now I have insomnia because the noise is so bad. The vertigo, dizziness and brain fog have since gone away, but the tinnitus has not. I strongly believe that my tinnitus is related to the covid vaccine.
42 2021-06-09 vision blurred, ringing in ears A couple weeks after the 2nd shot I had blurriness of vision and had bouts of light headed dizzine... Read more
A couple weeks after the 2nd shot I had blurriness of vision and had bouts of light headed dizziness . 4 weeks after the shot I began getting non-stop tinnitus in both ears. It is non-stop and cannot sleep
42 2021-06-10 eye swelling, tongue itchiness, swollen tongue So on 2/23/2021 I have hives at 1:30AM and took Clariton. 3AM tongue was still itchy. I woke up unco... Read more
So on 2/23/2021 I have hives at 1:30AM and took Clariton. 3AM tongue was still itchy. I woke up uncomfortable both times. I went to the DR 2/23/2021, just took Benadryl. On 3/12/2021 in the evening I had my eyes and tongue swollen at about 9PM. I have consistently had intermittent swelling on m tongue. I have been seen by an allergist as well on May 27th , I had a skin prick test and allergy tests. I now have to carry Benadryl, steroid pills and an EpiPen wherever I go. There was tongue on 2/23/2021 that was really bad, I did not have eye swelling or anything like that. Starting 2/24/2021 I was on steroids and 2x a day Benadryl but none of that really alleviated the swelling either.
43 2020-12-31 mouth tingling Mild tingling of the right upper lip, no swelling no respiratory issues. Tingling resolved at 9:53am... Read more
Mild tingling of the right upper lip, no swelling no respiratory issues. Tingling resolved at 9:53am and the patient was discharged to home.
43 2021-01-03 mouth numbness, eye disorder, pain in jaw Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I ha... Read more
Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I had numbness and weakness in the right of my tongue which I quickly realized included the right portion of my face. Included tongue was numb and I couldn't move it. An Er trip and CT scan confirmed it was Bells Palsy. Today, My symptoms continue. Top of my head all the way to the way to bottom of neck is experiencing paralysis. Can move tongue now and it's partly numb but it's cooperating a bit more now. Nerve pain has worsened all over all the right side of face. Feels like someone has kicked face and I have a deep bruise. It's a deep ache. Nothing will take away the ache away. My eye doesn't lubricate like it should. So I have to either manually close it and wet it manually or tape it closed.
43 2021-01-03 swelling around the eyes, lip swelling My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but... Read more
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
43 2021-01-03 swollen tongue Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post inje... Read more
Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell
43 2021-01-04 dry mouth About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; Abo... Read more
About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth. She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
43 2021-01-04 ear discomfort Not feeling well; chills; muscle aches; headache; ears bothering; stuffy/runny nose; stuffy/runny no... Read more
Not feeling well; chills; muscle aches; headache; ears bothering; stuffy/runny nose; stuffy/runny nose; This is a spontaneous report from a non-contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), intramuscularly in the right arm, on 18Dec2020 at 06:00 (at the age of 43-years-old) at a single dose for COVID-19 immunization. Medical history included hypothyroid, breast cancer, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included levothyroxine (MANUFACTURER UNKNOWN) and tamoxifen (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose on 25Dec2020 at 20:00. The events were reported as non-serious. No therapeutic measures were taken as a result of the events. The clinical outcome of not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
43 2021-01-05 taste impairment, lip swelling, mouth tingling Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamet... Read more
Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamethasone and Benadryl . Symptoms resolved
43 2021-01-05 taste impairment 5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt ... Read more
5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt throat swell. Not lymph nodes. Swelling sensation Inside throat. Had a mild headache. Was given 50mg of Benadryl. Taken to ER for observation. Swelling resolved couple hours later without any further reactions. Swelling never impeded my ability to breathe.
43 2021-01-05 sensitivity to light extreme headache with sensitivity to light, low grade fever (99.8), large muscle body ache, fatigue ... Read more
extreme headache with sensitivity to light, low grade fever (99.8), large muscle body ache, fatigue lasted from around 2am 1/6 until 5pm 1/6.
43 2021-01-06 mouth numbness, taste impairment metallic taste, numbess tonque and left arm, no treatemnt at present
43 2021-01-06 mouth tingling First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mil... Read more
First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mild pain arm. 12/17-12/18 arm pain got worse every day. 12/19 couldn't sleep at night. 12/20 limited motion in arm. Called doctor12/21. Took 400mg ibuprofen. Took Medrol for shoulder pain. 12/22 not able to sleep. Dr. wrote rx for Flexerol. Continued to take meds. Went back to work 12/23 with some pain. By 12/26 much better.
43 2021-01-07 mouth numbness, mouth tingling Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with va... Read more
Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with vaccine clinic to report symptoms and be monitored for 30 minutes.Took 50mg Benedryl. Symptoms resolved 12/28/2020.
43 2021-01-07 vision blurred Temporary blurred vision; increased her nearsightedness from -1.25 to -1.75; corneal edema/ Corneal ... Read more
Temporary blurred vision; increased her nearsightedness from -1.25 to -1.75; corneal edema/ Corneal topographies showed swelling in the cornea; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140), intramuscular (left arm, dose number 1) on 01Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa antibiotics, hormonal migraines, and gluten intolerance from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC), and spironolactone from unspecified dates for unspecified indications taken within two weeks. No other vaccine was taken within four weeks. Patient has not COVID prior vaccination. Patient has not been tested for COVID post vaccination. The patient experienced temporary blurred vision in the right eye on 02Jan2021. Patient stated that she is an optometrist so she performed a variety of tests and determined she had corneal edema. Corneal topographies showed swelling in the cornea, increased her nearsightedness from -1.25 to -1.75. By the time she left work 7 hours later, her vision and corneal topographies returned back to normal. Treatment was not given for the events. Event outcome was recovered on 02Jan2021. The reporter assessed the event was non-serious.
43 2021-01-07 visual impairment Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.;... Read more
Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER, Lot number: EL1284, expiry date not reported), via an unspecified route of administration on 04Jan2021 09:00 at a single dose on Left arm for COVID-19 immunisation. Medical history included Migraine, asthma, seasonal allergies, RLS (Restless legs syndrome). Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), sumatriptan succinate (IMITREX), fluticasone propionate (FLONASE ALLERGY RELIEF). The patient previously took Amoxicillin, codeine and experienced allergies. The patient experienced ocular migraine, onset at 14:00, took 1 dose of Imitrex (25 mg) at 14:15. Vision began to improve at 14:40. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.
43 2021-01-08 taste disorder Generalized edema, shortness of breath, change in taste
43 2021-01-09 taste impairment Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg... Read more
Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg Benadryl with improvement. Nausea/vomiting, metallic taste resolved after 24 hours. Headache and muscle aches lasted 48 hours and improving.
43 2021-01-09 ear discomfort, eye swelling, lip swelling Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swol... Read more
Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swollen lips; Hard Ears; Warm Skin; Itching; Wheezing.
43 2021-01-09 sensitivity to light Moderate to sever Joint pain HA PHOTOPHOBIA Moderate soreness and swelling at injection site
43 2021-01-10 dry mouth Headache started then I developed dry mouth that turned to ulcers on tongue
43 2021-01-10 eye itchiness Severe itching (not at injection site), but on eye, forehead, and scalp. Mild itching sensation on ... Read more
Severe itching (not at injection site), but on eye, forehead, and scalp. Mild itching sensation on the day of vaccination, but it got worse the next 2 days. The only medication I am allergic to is Neosporin, so I don't know if the vaccine has components of this in it.
43 2021-01-10 eye itchiness Itching (not at injection site) on eye, forehead, and scalp. Mild on day of shot, but worse the fol... Read more
Itching (not at injection site) on eye, forehead, and scalp. Mild on day of shot, but worse the following 2 days. The only thing I am allergic to is Neosporin, so I don't know if any of those ingredients are in the Pfizer vaccine.
43 2021-01-10 drooping eyelid L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose ... Read more
L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose #2 of the Pfizer-BioNTech vaccine
43 2021-01-11 eye pain, loss of smell, loss of taste lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; ... Read more
lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
43 2021-01-11 eye swelling 1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 07... Read more
1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 0700-Facial swelling, mostly around eyes, forehead, and nose 1/11/2021 0700-Continued facial swelling limited to around eyes only 1/12/2021 0530-Continued facial swelling limited to around left eye only
43 2021-01-11 lip swelling, mouth tingling Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and... Read more
Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and tingling to the roof of her mouth, tongue, and upper lip. Vital signs with mildly elevated blood pressure at 132/80, oxygen saturation 99%, and pulse 72. She was given diphenhydramine (Benadryl) 50 mg by mouth as a single dose and water to drink. She was observed for 30 minutes and symptoms gradually improved. Vital signs after 30 minutes of observation with blood pressure 120/78, oxygen saturation 100%, and pulse 61. She had her husband come to drive her home due to receiving a dose of Benadryl and due to the potential for drowsiness with this medication. She was instructed to take another dose of Benadryl in 6-8 hours if her symptoms continue to persist. She states that her husband will be home with her for the remainder of the day and will observe her and seek medical attention if needed. She was also instructed to follow up with her primary care provider if symptoms persist beyond the next few hours today and certainly if they persist following a second dose of Benadryl in 6-8 hours. She expressed understanding. She stated that she was comfortable going home and continuing to monitor her symptoms.
43 2021-01-11 mouth tingling After my first vaccination, I had tingling all the way down to my fingertips. While I was driving ho... Read more
After my first vaccination, I had tingling all the way down to my fingertips. While I was driving home that night, my face, mouth, tongue, and cheeks became tingling. I got my second dose and and the same symptoms happened. Last night I felt feverish and was achy.
43 2021-01-11 toothache I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the v... Read more
I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the vaccine the pain began increasing to the whole left side of my face and neck and increasing in intensity. I was unable to sleep 12/24 and 12/25 and ended up going to urgent care on 12/26. Despite not having sinus fullness/drainage they diagnosed it a sinus infection and gave me antibiotics. At the end of the 5 day course my symptoms had improved some but were not gone and I was still requiring frequent Tylenol for pain so the course of antibiotics were extended. I do not know if this was caused by the vaccine, but it coincided with the vaccine.
43 2021-01-11 visual impairment, tunnel vision I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and sta... Read more
I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and started feeling woozy and seeing spots. By the time I got back into my house, I had tunnel vision and could not see directly in front of me. I went to lay down, but ran into a piece of furniture because I was so disoriented and hit my shin on it. I collapsed on my bed. I stayed there for few hours and then I was ok. I had severe, flu-like symptoms for most of the day - fever, chills, low energy, joint pain (specifically back and hip) - that waxed and waned. I finally felt almost back to normal approximately 50 hours after the injection.
43 2021-01-12 loss of smell I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I w... Read more
I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I was tired, and had no smell and slept all weekend. My arm was very, very sore. The rash lasted until 12/23/2020.
43 2021-01-12 ear pain Fever up to 102.9 Chills Nausea and vomiting Earache Headache Backache For
43 2021-01-12 eye pain Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took ... Read more
Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took 1 aleve at 3pm. at 4pm noticed some left undereye tenderness to palpation. at 11pm noticed left undereye swelling and bruising. took zyrtec and iced. in the morning 1/10 swelling was worse. continued to ice. I contacted my dermatologist who felt it was a reaction to the previous underye filler i had >2.5 years ago. she started me on a medrol dose pack. swelling resolved by 1/11 in the morning.
43 2021-01-12 eye discomfort, eye swelling I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9... Read more
I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9 and took an aleve at 3pm. at 4pm i noticed mild left undereye tenderness to palpation. at 11pm i noticed left undereye swelling and and bruising. i iced and took a zyrtec. by morning on 1/10 the swelling was worse and i called my dermatologist. she felt it was a reaction to the undereye filler i had >2.5 years ago. she started me on a medrol dose pack. the swelling resolved by the morning on 1/11.
43 2021-01-13 taste impairment arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne... Read more
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-13 eye disorder She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried ... Read more
She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried for a long time; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# either GL0140 or EL0140, Expiry date and NDC number were not written), via an unspecified route of administration in left arm on 23Dec2020 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient pregnant: No. She has had No positive test for covid before the vaccine, and No Antibody test before the vaccine either. She has had No issues with vaccines in the past. The patient had the vaccine on 23Dec2020 and then on 01Jan2021 she began to experience eye twitching and it hasn't gone away and it's very bothersome. It's still happening. Her first dose was on 23Dec2020. The eye twitching began on 01Jan2021, it's just the left eye, she can see the eye lid moving when it twitches, she felt it, like the eyeball itself was twitching or spasming. There were no issues with the vision in that eye. She did feel she was getting sleep, she was conscious about seeing if she was tired, both eyes felt as if she had cried for a long time but she had not cried at all and the eye that was twitching she felt it more in. She thought it was getting better in the morning because at that time she didn't feel it, but by mid-afternoon it was consistent. The twitching happened often sporadically every couple of minutes, and she was annoyed of it. Investigation Assessment: No. The outcome of the event left eye twitching was not recovered, outcome of other events was unknown.
43 2021-01-13 mouth tingling reported uriticaria and lip/tongue tingling. po benadryl administered.
43 2021-01-13 tongue itchiness, mouth itchiness, mouth tingling Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog... Read more
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
43 2021-01-14 taste impairment Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensatio... Read more
Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ejko85, intramuscular on 22-DEC-2020 11:45 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history had known allergies to latex. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 01:15AM, the patient experienced metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. The metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Outcome of the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
43 2021-01-14 mouth tingling Approximately 30 minutes after receiving the vaccine, pt. c/o itching and redness on neck and arms. ... Read more
Approximately 30 minutes after receiving the vaccine, pt. c/o itching and redness on neck and arms. Pt. also c/o "tongue tingling." Blood pressure: 192/96, Heart Rate: 78, O2 sats: 97% on room air. Assessed by APN. No Epinephrine or Benadryl given at POD. EMS took patient via ambulance to be evaluated at Medical Center.
43 2021-01-14 mouth tingling 15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in ... Read more
15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in face, lips, and tongue. She was sent to the ER from the COVID clinic.
43 2021-01-14 swelling around the eyes HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does... Read more
HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does not interfere with ADL's continue to work. No improvement in symptoms will continue to monitor.
43 2021-01-14 sensitivity to light Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Co... Read more
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
43 2021-01-16 thirst, swollen tongue, lip swelling, mouth tingling I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole l... Read more
I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.
43 2021-01-17 ear itchiness, ear discomfort, vision blurred, eye pain Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per... Read more
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
43 2021-01-17 mouth tingling Itching started at vaccination site about 20 mins after vaccination, then progressed to scratchy thr... Read more
Itching started at vaccination site about 20 mins after vaccination, then progressed to scratchy throat, face itching, tongue tingling. This was the individual's second dose, she had no issues with the first dose. She has history of allergy to IV contrast dye, but no previous issues with vaccines. Provided 50 mg Benadryl onsite and had no further issues, monitored for over one hour, symptoms improved, and drove herself home from vaccination event.
43 2021-01-18 loss of taste Body ache, muscle pain, severe headache, fever(102.0) dizziness chill, loss of taste
43 2021-01-18 deafness unilateral Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy... Read more
Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
43 2021-01-18 eye swelling Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts wo... Read more
Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts worse on chest, bilateral arms, neck & back, left sided headache from behind eye to base of neck
43 2021-01-18 eye swelling Rash on both arms and swelling in eyes
43 2021-01-18 swollen tongue Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pe... Read more
Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pepcid and observation in ER for 3 hours. Rash, hives, burning and itching continue which worsen when exposed to someone with Covid.
43 2021-01-19 dry mouth 1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl ... Read more
1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl 50mg 1505: BP: 134/88, HR: 91, SpO2: 100% 1510: BP: 122/81, HR: 80; SpO2: 100% 1545: BP 135/84, HR: 80, SpO2: 100%
43 2021-01-19 eye swelling, bloodshot eyes Patient stated that she received the 2nd dose of the Pfizer vaccine on 1/13/2021. At 5:00 am on 1/14... Read more
Patient stated that she received the 2nd dose of the Pfizer vaccine on 1/13/2021. At 5:00 am on 1/14/2021, she noticed her right eye was swollen and red. Patient also complains of a headache. Patient took Benadryl and Ibuprofen without resolution of symptoms. Denied any problems with breathing or swallowing. Patient advised to see PCP or go to Urgent Care.
43 2021-01-19 eye swelling 24 hrs later of vaccination on 1/14/2021 my right eye got swollen until 1/16/2021 I went to the doct... Read more
24 hrs later of vaccination on 1/14/2021 my right eye got swollen until 1/16/2021 I went to the doctor on 1/15/2021 & I got steroid.
43 2021-01-19 visual impairment Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ... Read more
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
43 2021-01-21 taste impairment Ran a fever for 24 hours, joint pain, metallic taste in mouth x 4 days and blisters on tongue.
43 2021-01-21 mouth tingling, feeling of choking 20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches i... Read more
20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches in hands, rapid heartbeat, and rash. I returned to vaccine clinic and was referred to ER. I was observed for several hours and symptoms resolved.
43 2021-01-21 ringing in ears Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pal... Read more
Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pale and diaphoretic. Seen in the ED and was given fluids and monitored a couple hours and released. On 1/21/20 she continued to feel poorly with dizziness and ringing in her ears. She was seen by her physician and given a steroid injection and a meclizine prescription. Physician believes her symptoms are a continued reaction to the vaccine.
43 2021-01-21 tongue discomfort, mouth tingling Within 1 minute of my injection of the 2nd Pfizer dose, my throat started feeling itchy and scratchy... Read more
Within 1 minute of my injection of the 2nd Pfizer dose, my throat started feeling itchy and scratchy, I couldn't clear it, this was at 2:30. I was given a Claritin 10mg, 1 1/2 hrs later the sensation seemed to have cleared up. But 20mins later around 4:10pm my tongue started burning and tingling and within 15mins that sensation traveled to the back of my throat. Within 20mins from that I broke out in a rash on my chest, this was around 4:40. I was taken to ER and given 50mg Benadryl through the IV. My rash on my chest started going away but my throat and tongue still felt tingly and burning. It started barely clearing up around 8:45pm but it did not go away entirely, it is still here today 1/22/21 1:54pm, but not bothersome. It seems to be fading away as time goes. I will continue to take Benadryl at home every night until symptoms completely resolves.
43 2021-01-21 vision blurred Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later t... Read more
Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later that day/evening patient developed rheumatoid arthritis flair up that resolved over the course of two days and use of prescription medications (diphenhydramine and prednisone). Patient has a long standing history of rheumatoid arthritis.
43 2021-01-22 eye discomfort High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in should... Read more
High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in shoulders and back and throughout body. Fever lasted almost 48hours, fever would be about 101.8 to 104.6. would only go down a few points after tyelenol given, then motrin 2-3hrs later given, then back to tylenol, then back to motrin.....ect. I was drinking plenty of fluids, then resorted to cool showers, baths, and popsicles and freeze pops. Even yesterday 1.22.2021, had a low grade fever 99.2F. Arm is still currently sore, with giant red rash where injection was given, and extremely warm to touch. I tried to report, and it continually told me, my time has expired and comments were not accepted. 1.22.2021 took motrin and tylenol again due to eye pressure , headache and low grade fever. Finally felt better 130p.m 1.22.2021.
43 2021-01-24 oropharyngeal discomfort, mouth tingling Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper b... Read more
Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper body, and then tachycardia. Became very nervous with the strange sensation and took pulse which was initially in normal range. This however progressed to a rapid heart rate. Overall symptoms lasted 3-4 minutes. Pulled over and exited a busy highway. Called 911 (2:22 pm) during symptoms and they said they could only call an ambulance. Had some confusion when speaking to operator, as I couldn't tell them which exit I was at although I know the exit. Ultimately, drove myself to the hospital parking lot (about 4-5 min away) as heart rate had started to return to normal. Heart rate was in normal range when I rechecked in hospital parking lot. Sat in car for about 5 minutes before deciding to drive back to vaccine clinic to report my symptoms. Clinic about 3-4 minutes away. Pulse ox was normal x 2. BP was actually elevated x 2. Waited 30 minutes before being released home.
43 2021-01-24 sensitivity to light Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fev... Read more
Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills. Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs. Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
43 2021-01-24 ringing in ears Worsened tinnitus. I had tinnitus that had largely resolved and since the vaccine, it's been extrem... Read more
Worsened tinnitus. I had tinnitus that had largely resolved and since the vaccine, it's been extremely loud - more loud than ever before. I don't have any other lifestyle issues that would've aggravated the tinnitus.
43 2021-01-25 mouth numbness NUMB TONGUE ON RIGHT SIDE FOR TWO DAYS; RESOLVED ON ITS OWN WITHOUT FURTHER INCIDENT
43 2021-01-25 mouth tingling chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetir... Read more
chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable
43 2021-01-26 ear pain, eye pain Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick... Read more
Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears. Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me. There was no comfortable position to alleviate any of that. I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure. I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen. It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night. I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
43 2021-01-26 eye pain, ear pain 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j... Read more
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-26 mouth numbness I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, howe... Read more
I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, however my symptoms did start within 72 hours of receiving the vaccination. As of today, my symptoms remain, but seem to be improving.
43 2021-01-26 mouth itchiness Soon after receiving this vaccination, she started reporting that her mouth was itching. The itchin... Read more
Soon after receiving this vaccination, she started reporting that her mouth was itching. The itchiness progressed to various places mostly around her head and upper torso. She took 50 mg diphenhydramine about 10 minutes after first reporting the symptoms. She reported feeling fine about 1 hour later.
43 2021-01-27 taste impairment 10 minutes post vaccination developed metallic taste in mouth, then scratchy throat and throat began... Read more
10 minutes post vaccination developed metallic taste in mouth, then scratchy throat and throat began to close up and was given PO Benadryl - no relief. Required Epinephrine and transport to ER
43 2021-01-27 taste impairment constant metallic taste that started approximately 1 hour after receiving the vaccine that has now e... Read more
constant metallic taste that started approximately 1 hour after receiving the vaccine that has now exceeded 24 hours for duration.
43 2021-01-27 bloodshot eyes intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, ... Read more
intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
43 2021-01-27 ringing in ears Pfizer-BioNTech Covid-19 Vaccine . Ringing in Right ear and loss of hearing for approximately 5 hou... Read more
Pfizer-BioNTech Covid-19 Vaccine . Ringing in Right ear and loss of hearing for approximately 5 hours, fever, headache and pain on left arm where vaccine was inserted.
43 2021-01-27 tongue itchiness Pt had vaccine on Friday 1/22 and then had dermal filler on Monday 1/25. Patient had previously had... Read more
Pt had vaccine on Friday 1/22 and then had dermal filler on Monday 1/25. Patient had previously had filler with no reaction and at this treatment has significant swelling and pain in treated area along with itching of treated area and throat and tongue.
43 2021-01-28 taste impairment Metallic taste in mouth about an hour after receiving the vaccine - lasted about 5 hours. Body Ache... Read more
Metallic taste in mouth about an hour after receiving the vaccine - lasted about 5 hours. Body Aches, Fatigue all over starting 24 hours after receiving vaccine. Lasted for about 8 hours. Fully recovered by next morning.
43 2021-01-28 oropharyngeal discomfort 1:15 PM: pt received vaccination. 1:18 PM: pt states her throat feels "thick" and "uncomfortable to ... Read more
1:15 PM: pt received vaccination. 1:18 PM: pt states her throat feels "thick" and "uncomfortable to swallow". Oxygen saturation: 100% and HR: 85. 1:30 PM: Oxygen saturation : 98%, HR: 69 1:35 PM: Oxygen saturation: 98%, HR: 70. Reports feeling better. Sensation is improving. 1:40 PM: Oxygen saturation: 99%, HR 65, pt reports she feels okay 1:45 PM: Oxygen saturation: 98%, HR 67. 1:50 PM: Oxygen saturation: 98%, HR 70. Pt states she is ready to go and is feeling better. She had no difficulty talking or breathing.
43 2021-01-28 mouth tingling Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report... Read more
Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 14Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. 25 minutes after the vaccination on 14Jan2021 (16:55), the patient's face was tingling around her mouth. It lasted for about 30 minutes. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events on 14Jan2021 at 17:25.
43 2021-01-28 smell distorsion, taste disorder taste/smell alteration within 1 hour of vaccine / facial twitching 3 days later / CNS depression
43 2021-01-31 inability to speak A couple of days later after the vaccine, I started with a runny nose, sneezing, nausea, itchy throa... Read more
A couple of days later after the vaccine, I started with a runny nose, sneezing, nausea, itchy throat, painful cough, chills. No fever. On 01/01 I woke up and had no voice. I went straight to the UC and they diagnosed me with upper respiratory infection, I was treated with azithromycin and something else for nausea. About days later I was totally fine.
43 2021-01-31 sensitivity to light 01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout t... Read more
01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.
43 2021-02-01 loss of smell Tested positive for COVID-19 this week; COVID-19; This is a spontaneous report from a Pfizer-sponsor... Read more
Tested positive for COVID-19 this week; COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer. A contactable consumer (patient) reported that a 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3249), via an unspecified route of administration in left arm on 07Jan2021 13:30 at single dose for covid-19 immunization (vaccination). Medical history included pleurisy. Family medical history was none. There were no concomitant medications. Historically she felt like she had the flu when she had gotten the flu vaccine (years not specified); but she did not feel like she had the flu after getting flu vaccine this year in 2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no additional vaccines administered on same date of the Pfizer suspect. The patient received the Pfizer COVID-19 vaccine 07Jan2021; and she tested positive for COVID-19 this week. Then clarified that she was administered first dose of Pfizer COVID-19 Vaccine 07Jan2021. She had onset of COVID-19 around 15Jan2021 when she became unable to smell. She had 2 COVID-19 tests performed on 16Jan2021, one was a rapid COVID-19 nasal swab test with positive result; the other was a COVID-19 nasal swab test that they had to send off to test which was also positive. No medications were taken prior to vaccination/event. She asked if she should still get the second dose as scheduled relative to this event. Second dose was scheduled for 27Jan2021. No emergency room visit required, physician office visit (urgent care) required for event COVID-19. She mentioned she was not the only patient to test positive for COVID-19 that received Pfizer COVID-19 Vaccine same date she received Pfizer COVID-19 Vaccine on 07Jan2021. She declined to provide any further information regarding those patients/events/products/report. The sample of product was not available to return. The outcome of events was unknown.
43 2021-02-01 ear pain Backache and back spasms; Backache and back spasms; Ear pain on right side of head; I have Trigemina... Read more
Backache and back spasms; Backache and back spasms; Ear pain on right side of head; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; This is a spontaneous report from a contactable Other Health Professional reporting for herself A 43 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 18Jan2021 at 12:15 at single dose intramuscular on arm left for COVID-19 immunization. Medical history included Trigeminal Neuralgia, asthma, High blood pressure, CSF leak out of my nose (which has spontaneously healed), Seasonal allergies, milk allergies to lactose, Allergy to arthropod sting (tongue swelled up once from a hornet sting on hand) and allergic reaction to antibiotics (hands swell up). Concomitant medications included propranolol. On 18Jan2021 soon after vaccination (reported as 18Jan2021 at 12:15), patient experienced backache and back spasms. Ear pain on right side of head. Patient had trigeminal Neuralgia and it made her face temporarily flare up with the side face pain (as reported). Patient didn't received treatment. At the time of the reporting the patient was recovering from the events. information on the lot/batch number has been requested.
43 2021-02-02 dry mouth Hives, Rash, itching, chest tightness, throat tightness, dry mouth, difficulty breathing
43 2021-02-02 gaze palsy Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness... Read more
Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness, fever 100.4
43 2021-02-02 mouth numbness felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi... Read more
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
43 2021-02-03 loss of taste, loss of smell Woke up with fatigue the next day. On Jan 1, 2021 I started running a temperature - it got up to 102... Read more
Woke up with fatigue the next day. On Jan 1, 2021 I started running a temperature - it got up to 102.1 - had temperature all weekend and tried to bring it down with Tylenol. Went to work on Monday, Jan. 4, and was sent right home after taking a COVID test (result was negative). Follow up with my Doctor on Thursday, the 7th, and had another COVID test was a positive result. Friday, the 8th, my family went to clinic to test and so I tested again that day and my result was negative for that test. My symptoms were body aches, headaches, lost sense of taste and smell and fatigue. These lasted 5-6 days.
43 2021-02-03 taste impairment, lip swelling Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, redd... Read more
Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly
43 2021-02-03 taste impairment METALLIC TASTE IN MOUTH, ITCHINESS / RASH TO LATERAL APECTS OF TONGUE TOWARDS TONGUE'S APEX BEGINNI... Read more
METALLIC TASTE IN MOUTH, ITCHINESS / RASH TO LATERAL APECTS OF TONGUE TOWARDS TONGUE'S APEX BEGINNING 1/30/2021 GENERAL MALAISE 2/2-2/3/2021; TEMP ON THESE DAYS 99.4 DEGREES AND 99.7 DEGREES RESPECTIVELY I TOOK ACETAMINOPHEN ON 2/2/2021 BENADRYL 2/4/2021 - ITCHINESS SUBSIDED POST (1) DOSE TONGUE RASH PERSISTS AT THIS TIME
43 2021-02-03 eye itchiness Allergic reaction; Itchiness on right side of head, forehead, and eye; Itchiness on right side of he... Read more
Allergic reaction; Itchiness on right side of head, forehead, and eye; Itchiness on right side of head, forehead, and eye; Cluster headaches; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1686) via an unspecified route of administration in the left arm on 08Jan2021 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included migraines. Concomitant medications included magnesium, vitamin B12 and vitamins NOS (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took neomycin sulfate/polymyxin b sulfate (NEOSPORIN) and experienced allergy. On 08Jan2021 at 20:00, the patient experienced allergic reaction, itchiness on right side of head, forehead, and eye and cluster headaches. The events resulted in Doctor or other healthcare professional office/clinic visit. Corrective treatments taken as a result of the events included diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) and sumatriptan. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.
43 2021-02-03 ringing in ears Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringi... Read more
Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringing in ear, and nausea. Blood pressure was elevated.
43 2021-02-03 tongue itchiness, taste impairment METALLIC TASTE IN MOUTH, RASH ON LATERAL ASPECTS OF BOTH SIDES OF TONGUE TOWARD APEX AND ITCHY TO... Read more
METALLIC TASTE IN MOUTH, RASH ON LATERAL ASPECTS OF BOTH SIDES OF TONGUE TOWARD APEX AND ITCHY TONGUE. GENERAL MALAIASE 2/2/2021 AND 2/3/21. TEMP TAKEN ON BOTH DAYS WITH READINGS BETWEEN 99.4-99.7 DEGREES. TOOK ACETAMINOPHEN 2/2/21 AND BENADRYL ON 2/4/21. TONGUE ITCH SUBSIDED POST 1 DOSE (2 CAPS) OF BENADRYL. RASH PERSISTS AT THE TIME OF THIS WRITING.
43 2021-02-04 gaze palsy Fever (100.3), joint and muscle pain and HA. Treatment: Tylenol with moderate improvement . Outcome... Read more
Fever (100.3), joint and muscle pain and HA. Treatment: Tylenol with moderate improvement . Outcome: Does not interfere with ADLs.
43 2021-02-05 taste impairment Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomit... Read more
Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomiting. Began alternating Tylenol and Ibuprofen 800mg. 6 hours to the following day- severe headaches, chills, body aches, all over joint pain. Around midnight on 1/6/21 pain in the arm that radiated up her neck. 1/7- fever of 101. Small rash around injection site and slightly down arm. Stiff neck and arm pain.
43 2021-02-06 swollen tongue, mouth numbness Received the second dose of her Pfizer COVID vaccine today when she started feeling hot and felt lik... Read more
Received the second dose of her Pfizer COVID vaccine today when she started feeling hot and felt like her tongue was numb / swelling
43 2021-02-08 ear discomfort, ringing in ears I developed tinnitus and a fullness in my left ear one week after receiving my first dose of the COV... Read more
I developed tinnitus and a fullness in my left ear one week after receiving my first dose of the COVID vaccine. The symptoms have remained persistent and consistent. All day I have tinnitus and a fullness in my left ear which has not subdued since the symptoms first started one week after receiving the COVID vaccine.
43 2021-02-09 mouth numbness Patient complained of numbness around mouth post vaccine. Oral diphenhydramine 25 mg x 1 dose was a... Read more
Patient complained of numbness around mouth post vaccine. Oral diphenhydramine 25 mg x 1 dose was administered and symptoms resolved
43 2021-02-09 mouth tingling Lip tingling, throat tight, cough, flushing, jittery sensation
43 2021-02-09 vision blurred Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist.... Read more
Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular on 25Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included hypertension and Hypertension, allergies to peanuts. Concomitant medication included amlodipine, estradiol. The patient experienced Patient experienced Hypertension (BP 140/103), dizziness and blurred vision immediately after vaccine administration. All AE's resolved within 2 hours with dizziness and blurred vision resolving first (HTN took longer to resolve) on 25Jan2021 11:00. Outcome of events was recovered.
43 2021-02-10 mouth numbness felt like she was going to pass out; face started to tingle/tingling returned but this time it was d... Read more
felt like she was going to pass out; face started to tingle/tingling returned but this time it was down her chest; lips started going numb; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration, in the right arm, on 27Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 27Jan2021, after getting the vaccine, the patient experienced face started to tingle and felt like she was going to pass out. On 27Jan2021, vitals were taken and showed normal. The patient reported that on her way home on 27Jan2021, lips started going numb and the tingling returned but this time it was down her chest. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL). Outcome of all the events was recovered on unspecified date in Jan2021.
43 2021-02-10 mouth tingling Tachycardia (140s initially); tightness in neck; tingling lips and under tongue; tightness in throat... Read more
Tachycardia (140s initially); tightness in neck; tingling lips and under tongue; tightness in throat; sweating. She takes Allegra 180mg daily and took 12.5 mg Benadryl prior to injection. After symptoms began, she was treated with Pepcid 40 mg, Benadryl 25 mg, prednisone 40 mg. Symptoms of tachycardia and tightness in neck began almost immediately after injection. Other symptoms began 5-10 minutes later. Symptoms persisted in waxing/waning fashion for about 1.5 hours. Oxygen level remained at 100% on room air. Lungs were clear- no wheezing. She was observed for about three hours. Heart rate was in 80-90 range for the last 1.5 hours. She was released to home with husband. To continue prednisone 40 mg next three days, then taper off. Continue Pepcid 40 mg daily for 5 days. Benadryl 25 mg every 6 hours as needed for breakthrough symptoms. Continue her usual Allegra 180 mg daily. She has f/u on 2/15/21 or sooner if symptoms return and not controlled with above.
43 2021-02-10 smell distorsion fatigue; chest congestion; chills; altered smell; This is a spontaneous report from a contactable he... Read more
fatigue; chest congestion; chills; altered smell; This is a spontaneous report from a contactable health professional reporting for herself. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot#EJ1686 via intramuscular route at the left arm on 20Jan2021 01:00 PM at single dose for COVID-19 immunization. Medical history included Hypothyroidism and allergy to codeine and sulfa. Concomitant medications were not reported. The patient had received the first dose of the same vaccine on 30Dec2020 01:00 PM from lot#EL1284, via intramuscular route at the left arm. On unknown date the patient experienced fatigue, chest congestion, chills and altered smell. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the events. Prior to vaccination, the patient was diagnosed with COVID-19 on unknown date. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 26Jan2021 and the result was negative. The outcome of the events was not recovered.
43 2021-02-14 swelling around the eyes Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunothe... Read more
Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunotherapy. Pt presented with rash/itching on chest, tingling around ears and runny nose 20 minutes after vaccine administered.(0828) Doctor notified and Benadryl 25mg PO given VS at time 169/98, 60, 100%. 0847 pt c/o slight chest tightness, slight labored breathing, feeling of periorbital swelling,VS at time 173/91, 51, 99% Doctor again notified and an RN stat called, pt taken to the ER and report given to ER RN, pt appeared to be comfortable and feeling somewhat better
43 2021-02-14 tongue discomfort, mouth tingling Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redne... Read more
Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
43 2021-02-15 vision blurred Facial flushing, asthma, blurred vision
43 2021-02-16 lip swelling, swelling around the eyes, swollen tongue, mouth tingling pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongu... Read more
pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongue & throat & some difficulty swallowing approx 30 - 45 min following vaccine Had also eaten a english muffin with plain cream cheese just prior to symptom onset She was noted to have mild swelling of her tongue & very sl lower lip She was administered 50 mg of diphenhydramine, 20 mg famotidine & 60 mg Prednisone & cold compress to face Was able to take all orally with water & had no difficulty -- after approx 30 minutes her s/s had much improved & her facial erythema & swelling had reduced no resp distress and O2 sat was 99%
43 2021-02-16 swollen tongue, lip swelling, swelling around the eyes My lips started swelling and my tongue swelled and throat got all itchy. My eyes were really puffy. ... Read more
My lips started swelling and my tongue swelled and throat got all itchy. My eyes were really puffy. I took Benadryl - I took 2. It made me sleep. I slept for about 1 hour and went back to sleep. I went back to sleep for 9 hours and the next day I I was a little tired and had some aches. Was fine after that.
43 2021-02-17 lip swelling Dose #2 pfizer; Pt reported onset of chest pain and SOB within 5 min of vaccine. Followed by nausea,... Read more
Dose #2 pfizer; Pt reported onset of chest pain and SOB within 5 min of vaccine. Followed by nausea, vomiting, and feeling of swelling of lips, . Pt used her own albuterol, 2 puffs. RRT called. BP 166/99, HR 90, pulse ox 100, airway intact, lungs clear, cardio tachy but regular, skin warm and dry with no diaphoresis. Concern for anaphylaxis as pt symptoms continued and some increase in disorientation Epi Pen administered, O2 via NC. IV access attempted but unable to obtain. EMS called. Pt monitored with resolution of CP, SOB, nausea, lips swelling and disorientation. Pt continued to have feelings of swelling of tongue and transported to ED
43 2021-02-17 pain in jaw, toothache, eye floaters After the first dose, developed floaters that resolved after 24hr. After the second dose, I develope... Read more
After the first dose, developed floaters that resolved after 24hr. After the second dose, I developed severe jaw pain, teeth pain and back pain that resolved after 2-3 days.
43 2021-02-18 tongue itchiness PATIENT COMPLAINS OF HEADACHE AND TONGUE ITCHING. PATIENT MONITORED AN ADDITIONAL 15 MINS. PATIENTS ... Read more
PATIENT COMPLAINS OF HEADACHE AND TONGUE ITCHING. PATIENT MONITORED AN ADDITIONAL 15 MINS. PATIENTS COMPLAINTS SUBSIDED.
43 2021-02-19 eye bleeding 8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint,... Read more
8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint, right wrist joint. The joints that do normally hurt were way worse (my back, and right big toe joint). There was a pain in my right eye, and that eye had blood vessels burst in it. 36 hours after the shot= started bleeding from my vagina. My last menstruation was 2 weeks ago and this is VERY unusual for me. Normally my periods are 30-32 days apart.
43 2021-02-19 mouth itchiness, tongue itchiness 10 minutes after injection felt extreme dizziness to the point of feeling faint, tightness in throat... Read more
10 minutes after injection felt extreme dizziness to the point of feeling faint, tightness in throat, severe itchiness in throat, tongue, ears, mouth and all over my body, and felt nauseous. Had to be treated in Urgent Care for these symptoms, Benadryl was administered, and seemed to help the itchiness and tightness of throat
43 2021-02-21 smell distorsion Parosmia foul smelling odors no one else smells that makes me very nauseous
43 2021-02-22 permanent deafness Acute sensorineural hearing loss right ear
43 2021-02-22 lip swelling Swelling of the lips- angioedema
43 2021-02-22 mouth itchiness Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping.... Read more
Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping. Received 20 mg IV Famotidine, 10 mg IV Dexamethasone, 0.3 ml sub Q Epinephrine, 25 PO Benadryl and 1 liter Normal Saline. RN documents that blood pressure did drop to 107/64, but did not become hypotensive. Discharged in stable condition at 1500. Doctor recommended that she not receive second dose.
43 2021-02-22 oropharyngeal discomfort Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throa... Read more
Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throat fullness for 2 weeks following first dose of vaccine.
43 2021-02-22 swollen tongue, lip swelling pt initially noted palpitations and shortness of breath. After several minutes improved and then pt ... Read more
pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
43 2021-02-22 tongue itchiness, swollen tongue, lip swelling, lip itchiness numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; ... Read more
numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
43 2021-02-22 tongue itchiness Within minutes of receiving the first dose of the vaccine, my tongue became itchy. As the evening we... Read more
Within minutes of receiving the first dose of the vaccine, my tongue became itchy. As the evening went on, my neck became sore. I took an antihistamine that evening when I got home. The itchy tongue continued for approx 10 days, following the injection.
43 2021-02-23 dry mouth Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely ... Read more
Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
43 2021-02-23 ear pain "Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination... Read more
"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination" TM was hospitalized 3xs after vaccination. On 1/24/21 TM was hospitalized and kept overnight for tachycardia and SOB and has to f/u with cardiology this week. The second time TM went to the hospital for a headache where an MRI was done. The third time she was also treated for a headache
43 2021-02-23 eye swelling, swollen tongue, mouth swelling Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
43 2021-02-24 eye pain Extreme shooting pains left side of head. Tenderness above ear. Left eye pain. Lethargic. Neck pain.... Read more
Extreme shooting pains left side of head. Tenderness above ear. Left eye pain. Lethargic. Neck pain. Muscle pain.
43 2021-02-24 drooping eyelid Bell's Palsy right side of face. Right upper eyelid droop, righ cheek numbness on palpation, slight ... Read more
Bell's Palsy right side of face. Right upper eyelid droop, righ cheek numbness on palpation, slight smile effected/off from left, no ringing in ear, able to raise eye brow. Mental status WNL, able to hold conversation, made proper eye contact.
43 2021-02-24 lip swelling, taste impairment Right after injection, patient complaints of metallic taste and scratchy throat. 10 minutes after i... Read more
Right after injection, patient complaints of metallic taste and scratchy throat. 10 minutes after injection, patient developed mild swelling of lips. VS was stable, a dose of Benadryl 50 mg by mouth given. Patient was taken to ER.
43 2021-02-24 oropharyngeal discomfort About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt lik... Read more
About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg - twice a day
43 2021-02-24 swollen tongue A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vacc... Read more
A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 100% Physical Exam--Vitals and nursing note reviewed. Constitutional -- General: She is not in acute distress. Appearance -- Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal -- Cervical back: Neck supple. Skin -- General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; Thought Content: Thought content normal; Judgment: Judgment normal. Assessment/Plan -- Treatment included: water and snacks. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.
43 2021-02-24 vision blurred Blurry vision, neck pain, patient refused to be seen by EMS.
43 2021-02-26 eye itchiness, swelling around the eyes, vision blurred, eye pain I immediately felt skin and eye itchy after I received the vaccines. Stayed in the waiting room for ... Read more
I immediately felt skin and eye itchy after I received the vaccines. Stayed in the waiting room for 30 mins, felt better. Next day skin itch got worse. Specially around my eyes.Eye itchy, rubbing, pain, vision blurry, puffiness, discharged, I bought some allergy drops but it didn?t get better. , on the 7 days after the vaccine, it was a Saturday, it got so much worse that I could barely open up my eyes. So I went to a clinic. The nurse practitioner gave me eyes drop for infection, it did not get better. She prescribed another eye drop, still not working. Now my eyes feel horrible,.
43 2021-02-27 mouth itchiness New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built ... Read more
New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built some immunity to certain foods. Since I received my vaccine I have had strong reactions to foods I usually tolerate with mild oral itching in very small portions. The first increased reaction was around 2 weeks after my first shot. About 2 hours after eating a very small portion of avocado, I woke up with a start with extreme tightness of my chest and gasping for air. I caught my breath after a few seconds then projectile vomited. Treated with 50mg Benadryl and returned to sleep after 45 minutes. I have never had any respiratory symptoms with a food allergy reactions. About 2 weeks after my second shot I accidentally ate a few bites of tomato which has not been a problem for over 10 years. After vomiting in my car and pulling off the road I saw my cervical lymph nodes were swollen to about 1.5 inches in diameter. I have never seen any thing like it. My airway was clear. I took 25mg of Benadryl, waited for 30 minutes, then drove home. I had a similar experience 3 weeks after my second shot with a fresh/homemade pickle that apparently was too raw. Vomiting with mildly swollen cervical lymph nodes treated with 25 mg Benadryl
43 2021-02-27 pain in jaw, ear pain Substantial pain in jaw on my right side. Pain radiates to ear. Hurts to open my mouth and chew. My ... Read more
Substantial pain in jaw on my right side. Pain radiates to ear. Hurts to open my mouth and chew. My jaw was clicking yesterday. Pain is way worse today Vs yesterday. I?ve never had this hurt so bad.
43 2021-02-28 eye pain, dry eye, eye swelling On 2/28 around 6pm. I started feeling some flu like symptoms start. Mild headache, fatigue, chills, ... Read more
On 2/28 around 6pm. I started feeling some flu like symptoms start. Mild headache, fatigue, chills, slight runny nose, mild sore throat. My left eye suddenly felt awful. I told my husband my eye is stuck (open). It was very scary and I felt like I had to hold my hand against it tightly. Meanwhile my right eye just wanted to stay closed, so then I couldn?t see at all. My husband guided me into the kitchen and I tried to flush my eye with water to see if that would help whatever was going on with my eye lid. My husband gently rubbed the skin above my eye. He couldn?t see my eye lid at all. All that was visible to him was the tip of my eyelashes. He was able to grab the tip of my eyelash and release my eyelid. It was very uncomfortable and scary. After the eyelid was released the eye was very sore . I called the nurse line and they recommended I be seen within 24 hours. I saw the doctor this morning not related at all to the vaccination facility. She said it sounded like an ocular muscle spasm. She said she didn?t see anything in the vaccine literature about this type of response but recommended I report it in case it?s a rare response. I have never had that happen before and I hope to never have it happen again.
43 2021-02-28 eye itchiness Patient stated eyes were itchy and throat itchy. Stated she felt funny. Given 25mg oral Benadryl. R... Read more
Patient stated eyes were itchy and throat itchy. Stated she felt funny. Given 25mg oral Benadryl. Resolution of symptoms before leaving vaccine site
43 2021-03-01 vision blurred heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous rep... Read more
heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer. A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.
43 2021-03-01 vision blurred Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by E... Read more
Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by EMS. 1:09PM -Jaw slightly tight. 1:20 pm pain, stiffness traveling to mid back. 1:25 pm neck feeling better, no nausea, tinling in hands, no change in sensation in legs. 1:30pm remains lightheaded, vision remains blurry, c/o left sided chest discomfort when pressure applied, pain and stiffness in neck returning. 1:42 pm transported to Hospital by rescue squad.
43 2021-03-02 loss of smell, loss of taste Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphy... Read more
Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.
43 2021-03-02 eye swelling, dry mouth Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; faci... Read more
Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
43 2021-03-02 lacrimation increased Fine after administration during the observation period. At 7 or 7:30 pm patient started itching on... Read more
Fine after administration during the observation period. At 7 or 7:30 pm patient started itching on face, back , arms and left leg. patient says the itching was mild to moderate. No visible rash. Patient compared the itching to what happened after she took codeine. Then throat started itching, no shortness of breath or difficulty breathing. Eye also started watering. At midnight the patient took a Benadryl and this help relieve the itching. all the patient noticed was the injection site pain. Today she is still itching, but it is mild and did not warrant Benadryl. Advised patient if she experiences any form of shortness of breath to go to the emergency room.
43 2021-03-03 loss of smell, loss of taste Patient developed rhinorrhea and loss of taste/smell. She had a positive PCR for COVID-19 on 3/1/2... Read more
Patient developed rhinorrhea and loss of taste/smell. She had a positive PCR for COVID-19 on 3/1/2021. Received Pfizer vaccine on 1/20/2021 (lot EL3248) and 12/30/2020 (lot EL0142).
43 2021-03-03 dry throat, dry mouth This 43 yo ADSM received first Pfizer COVID vaccine Lot EL9264 on 1/29/2021 to left arm about 1440pm... Read more
This 43 yo ADSM received first Pfizer COVID vaccine Lot EL9264 on 1/29/2021 to left arm about 1440pm. Staff monitored her for 30 min due to past hx of "allergies" and 28 min post vaccine she c/o difficulty breathing in (described as sensation of heavy breathing/was taking deeper breaths than usual), a dry mouth/throat, and a very faint dull pain to her forehead. She denies any cp, mouth/throat swelling, angioedema, rash, myalgia, weakness, fever/chills, difficulty swallowing, no wheezing, cough or other systemic symptoms. Nurse came over and gave her epi pen at 1515 and sent to ER. In ER: VS 160/83, HR 103, Resp 28, O2 sats room air 100%, T98.9F. Lungs CTA in ER. Headache worsened, but no difficulty breathin
43 2021-03-03 mouth tingling Developed hives on my neck and back and extreme itchiness - took 2 benedryl and it cleared up with... Read more
Developed hives on my neck and back and extreme itchiness - took 2 benedryl and it cleared up within 30 minutes, Have never had hives before. Some weird tongue sensation is lingering as well that has been lingering. Emailed Dr who said to avoid taking benedryl or steriods after second dose but it was ok to proceed with second dose.
43 2021-03-05 sensitivity to light, lacrimation increased, pain in jaw, mouth tingling, loss of taste, extreme sound sensitivity 5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to... Read more
5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to just below the ear. Pain traveled directly from site of vaccine in arm and up through neck. 10 min after vaccine: Nerve pain down began in a line down right arm and into pinky and ring fingers of right hand. 20 min after vaccine: Tongue tingly (entire right side only, left side normal), pain in jaw, headache beginning in right temple. OTC Tylenol and then Ibuprofen taken 1 hour, 15 min after vaccine helped dull headache but not other symptoms. Nerve pain was intermittent until bedtime. The next morning, woke to right eye crusty from tearing, right eye tearing at corner (clear, like tears), consistently drippy right nostril (clear), loss of taste in tingly right side of tongue (could taste on left side of tongue), tingly right side of lips, slight drool right side mouth, outside of ear slight tingly. Headache returned, only in right temple extending to above right eye. Right side of face felt heavier than left side. Sensitivity to light, sound. Took Tylenol and Ibuprofen. Over 9 hour period (24-28 hours after vaccine given), most symptoms resolved, including taste. The next day (48 hours after shot), symptoms remaining are right eye has very slight tearing, right side of face feels a little "heavier" than left side, but drastically different from day before. I have NEVER had anything like this happen before after a vaccine or otherwise.
43 2021-03-06 ear pain 2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next t... Read more
2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next to it painful, itchy, hurts when push on toenails, awoken from sleep needing Tylenol Both got better without medical treatment.
43 2021-03-08 loss of taste Loss of taste
43 2021-03-08 mouth tingling About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strang... Read more
About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strange swelling feeling around the backsides of my tongue, like the numbing feeling after a dentist visit. Then about 15 or 20 minutes later someone noticed a red slightly bumpy rash on my chest below my neck. It did not progress. I took Benadryl about 40 minutes after my shot and the rash and tongue feeling went away. I took Benadryl again 6 hours later . After that I had a mild headache and fatigue for two days. With some occasional nausea that would come and go for three days.
43 2021-03-09 mouth numbness Numbness in lips and tongue, lightheaded and headache after 15 mins of getting vaccine. Fluids given... Read more
Numbness in lips and tongue, lightheaded and headache after 15 mins of getting vaccine. Fluids given at 1030am
43 2021-03-09 mouth tingling Patient returns to vaccine location two hours after vaccine, stating within minutes she had sensatio... Read more
Patient returns to vaccine location two hours after vaccine, stating within minutes she had sensation of tingling on the left side of her face and tongue. No other symptoms. Vaccine clinic was closed for the day, encouraged to seek care at an acute care. Confirms understanding.
43 2021-03-09 swelling of eyelid eye lid swelling; Pain in left eyelid that felt like a bruise about 24 hours after shot; This is a s... Read more
eye lid swelling; Pain in left eyelid that felt like a bruise about 24 hours after shot; This is a spontaneous report from a contactable consumer reporting for herself. A 43-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EM9810) vaccine , via an unspecified route of administration in the left arm on 05Feb2021 14:45 at single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included doxycycline (DOXYCYCLINE), loratadine, pseudoephedrine sulfate (CLARITIN-D). The patient experienced pain in left eyelid that felt like a bruise about 24 hours after shot on 06Feb2021 15:00 with outcome of recovering , eye lid swelling on 07Feb2021 02:45 with outcome of recovering. Both the events were considered non serious. The patient received Cold compress and Benadryl on advise from on call to treat the events. Follow up information has been requested.
43 2021-03-09 swollen tongue 16:53 Pt states head, legs itchy 17:00 Given Zyrtec, 10mg PO 17:18 Benadryl 50mg, IM BP 125/63 HR 7... Read more
16:53 Pt states head, legs itchy 17:00 Given Zyrtec, 10mg PO 17:18 Benadryl 50mg, IM BP 125/63 HR 75 02 99% RA, 17:27 pt staes tongue starting to swell, 17:32 epi 1:1000 .5ml IM left thigh 17:39: tongue improving 02 sat 99% RA 17:58 pt stable for discharge home, provided transport to car pt
43 2021-03-10 loss of taste, loss of smell Loss of taste and smell and felt congestion
43 2021-03-10 mouth numbness After receiving the pfizer covid vaccine pt c/o having an itchy throat and c/o dizziness. Pt was pl... Read more
After receiving the pfizer covid vaccine pt c/o having an itchy throat and c/o dizziness. Pt was placed supine on cot and vs obtained. VSS on RA. Color pink throughout. Pt continued to c/o itchy throat and then stated her lips where becoming numb. Epi 0.3 mg given via auto-injector per protocol. Ambulance called. Arrived within 6 minutes and took pt to the hospital for further evaluation.
43 2021-03-12 ear discomfort Patient complained of feeling a burning sensation in her throat and ears 30 minutes after receiving ... Read more
Patient complained of feeling a burning sensation in her throat and ears 30 minutes after receiving the vaccination. The burning sensation subsided within 10 minutes.
43 2021-03-13 ear discomfort, deafness unilateral, ringing in ears Tinnitus in right ear Partial hearing loss Feeling of fullness in right ear Fatigue
43 2021-03-13 eye swelling, lip swelling, swollen lips Face swelling (cheeks,, lips, eyes); Scratchy throat; Lips and face tingling; Heavy tongue.
43 2021-03-13 eye swelling, oropharyngeal discomfort Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with... Read more
Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with mild discomfort.
43 2021-03-13 mouth tingling, mouth numbness, feeling of choking Numbness and tingling in throat and tongue.
43 2021-03-14 mouth itchiness, mouth swelling Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing... Read more
Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing deeply, itchiness in mouth, blotching of skin
43 2021-03-15 taste impairment Notes Expand AllCollapse All Patient: ... Read more
Notes Expand AllCollapse All Patient: DOB: 6/11/1977 Date: 3/15/2021 MRN: Subjective Patient is a 43 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and "head rush", feeling dizzy and had a metallic taste in mouth (shortly resolved). Sensation of chest tightness as reported upon her arrival to bay. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Medical hx includes asthma and allergies, pvcs and IgG deficiency ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and headaches R arm pain where injection site is. Ice pack given for site.: Previous Reactions: flu vaccine 20 years ago. She's done well with flu vaccines since then. Objective Vitals Vitals: 03/15/21 1244 03/15/21 1254 03/15/21 1310 BP: 128/85 122/65 Pulse: 86 86 86 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Hyperventilating upon arrival to bay. Pt improves with deep breathing. Pt did take her levalbuterol as well during her stay which did help her chest tightness. No wheezing heard pre/post administration. O2 sats 100% Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) R arm pain; injection R arm. Ice pack placed. Anxiety: hyperventilating, relieved with instructed deep breathing and removal of mask for short time. Lightheaded/dizzy: related to anxiety and systemic stress response. She reponded well to zyrtec, water and snack. Pt able to recover and stand w/o symptoms. She was ambulated out to the front w/o difficulty accompanied by this provider. She's to follow up with pcp/allergist. Pt voiced appreciation of care today.
43 2021-03-15 mouth tingling 43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DE... Read more
43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DENIES OTHER C/O TO INCLUDE DIFFICULTYBREATHING, SWALLOWING, SPEAKING, DENIES SWELLING IN OR AROUND FACE/MOUTH, NAUSEA, OR OTHER C/O. PT INITIALLY WAS WILLING TO GO TO ER BUT HER SXSUBSIDED WHILE WAITING FOR AMBULANCE AND SHE DECIDED TO AMA AND FOLLOW UP ON HER OWN. FOUND ABOVE PT A/O X4, NO OBV DISTRESS, NO OBVIOUS ANGIOEDEMA, SPEAKS IN FULL SENTENCES, CLEAR LS BILAT ALL, SOME HIVE LIKE RASH ON ANTERIOR CHESTBELOW THE CLAVICLES, EXTREM - PWD, GOOD PMS X4, MOVES ALL WITH PURPOSE
43 2021-03-15 ringing in ears My ears have been ringing since receiving the shot.
43 2021-03-15 vision blurred Day 1 - Within 30 minutes of injection I felt dizzy and my vision was unfocused (almost blurry). D... Read more
Day 1 - Within 30 minutes of injection I felt dizzy and my vision was unfocused (almost blurry). Day 2 - The ocular disturbances continued and I had a huge headache. Almost felt as if my eyes were dilated. Day 3 - The back of my head and neck ached like whiplash from a car crash if I moved my head up and down; head felt stiff and heavy; ocular disturbances continue Day 4 - Same symptoms as Day 3 continue
43 2021-03-16 mouth numbness First 20 minutes fine. Next hour-extreme energy/adrenaline. More than ever experienced. Next 3-4 ho... Read more
First 20 minutes fine. Next hour-extreme energy/adrenaline. More than ever experienced. Next 3-4 hours- Severe brain fog, confusion, lack of concentration and mental dysfunction. Lack of clarity, rational thinking and precise understanding. Felt like an inability to talk, make sound decisions or focus. Also feelings of eyes bulging and short temporary numb bottom lip. Feelings of brain abnormality and being drugged. Hour to two after-Feelings of coming down from days of an extreme caffeine high with no sleep. Worried, is mildly putting my reaction to the vaccine reaction/side effects. It was terrifying. I thought, I may not return from the negative adverse effects I was having. Something was certainly not right. It is something, I?m not sure I can go through again. Especially, with the second shot being stronger than the first. I was incapable of doing anything!
43 2021-03-16 vision blurred Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and ... Read more
Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and vision was blurry"; nausea-began having dry heaves (had not eaten), CBG 123, HR bradycardic and erratic, developed pounding HA, EMT stated "throwing PVCs"; then went to ER in POV
43 2021-03-18 eye twitching My left lower eyelid began to spasm after the onset of a severe headache just after 12 pm. Fatigue, ... Read more
My left lower eyelid began to spasm after the onset of a severe headache just after 12 pm. Fatigue, nausea, body aches, and heaviness in my chest began around 4:30 pm. Eye spasms stopped after taking ibuprofen but began again 7 hours later.
43 2021-03-18 ringing in ears Ringing in my ears/head. A loud high pitched ring. Making me crazy. Started around March 10th. Is no... Read more
Ringing in my ears/head. A loud high pitched ring. Making me crazy. Started around March 10th. Is not getting better.
43 2021-03-19 dry mouth Fever, aches, muscle spasms, pain, headache, dizziness, fatigue, dry mouth Started about 12 hours af... Read more
Fever, aches, muscle spasms, pain, headache, dizziness, fatigue, dry mouth Started about 12 hours after vaccine received, lasted 24 hours
43 2021-03-19 ringing in ears Sore arm, headaches, tinnitus
43 2021-03-21 mouth tingling VR stat burning from arm through chest, tingling tongue
43 2021-03-22 taste impairment After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 m... Read more
After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 minutes passed out. For the next three weeks, I had migraines more frequently than my usual migraines and a new pain behind my eye. After receiving my second doses, I felt extremely tired and within 3 hours of receiving got shooting pain on left side of my face. I was diagnosed with Trigeminal Neuralgia by Dr on March 22, 2021. This pain has been constant since receiving the second dose on March 8.
43 2021-03-22 mouth numbness, oral mucosal blistering, taste disorder pt stated she immediately had a taste inside her mouth. Her mouth became numb and she developed bum... Read more
pt stated she immediately had a taste inside her mouth. Her mouth became numb and she developed bumps like blisters on the inside of the mouth. Pt contacted PCP and was told to go the ER if she got any worse. So today 3/23/2021 she went to the Urgent Care. She was given a steroid shot and prescribed famotidine 20mg x 2 days for 7 days. Pt still has these symptoms but waiting for the injection to help. Pt will FU w/ PCP.
43 2021-03-22 mouth tingling Tingling in the cheeks on both sides of the face. More minor tingling in lips and tongue. Mostly r... Read more
Tingling in the cheeks on both sides of the face. More minor tingling in lips and tongue. Mostly resolved after 2 hours, though still felt around 6pm
43 2021-03-23 lip swelling, mouth tingling 3/23/21 - pt called the call center to inquire about J&J vaccine availability and to cancel 2nd dose... Read more
3/23/21 - pt called the call center to inquire about J&J vaccine availability and to cancel 2nd dose appointment. Pt reported that she had a reaction w/ pfizer vaccine. Received Pfizer vaccine on 3/2/21. From review of available outside records, pt called PCP (outside provider) on 3/5/21 reporting itchiness, lip swelling, tongue felt enlarged but no trouble swallowing or SOB 2 days post-vaccine. Pt was advised to continue benadryl and if s/sxs worsen to go to ED. Per pt, they later developed SOB and went to outside ED where she received epi-pen and prescribed prednisone course. Pt followed up with PCP on 3/11/21 and pt report improvement in symptoms. Pt was advised by PCP not to get 2nd dose of pfizer.
43 2021-03-23 mouth tingling Recurrence of left side facial Bells Palsy. tingling of left lower and upper lip and slight droop of... Read more
Recurrence of left side facial Bells Palsy. tingling of left lower and upper lip and slight droop of left side of mouth.
43 2021-03-23 feeling of choking, mouth tingling, lip swelling 20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage ... Read more
20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage in my airways and could breathe easily through my nose, but did feel constricted in my throat for about 40 minutes.
43 2021-03-23 ringing in ears 18hrs of solid sleep commenced after approx 7hr or wakefulness following vaccination. Ive been diag... Read more
18hrs of solid sleep commenced after approx 7hr or wakefulness following vaccination. Ive been diagnosed with mild tinnitus for about a decade. I mostly ignore it. However, about 48hr after shot#1 the volume began increasing... somewhere between 5 and 6 days after it was an 11 out of 10 on volume... so loud I couldn't find words to answer the phone. It comes and goes in waves, I have moments of tolerable racket, and hours of piercing ringing. Caffeine has no apparent effect for me. I eat a healthy diet, and exercise a couple days per week. I know aspirin can make it worse, but Excedrin has been the only OTC that's ever cut headaches for me, in my life. Right now I waver between crushing head plain, and undecipherable ringing. Any constant hum like a fan or fluorescent lights is like nails on a chaulkboard to me. Today is day 7, after a short night, i woke up to crushing head pain, showered and went back to bed, the head pain (without Excedrine) has subsided, giving way to fierce high pitched ringing. My neck muscles are tired... i just realized Ive been holing the "shudder" pose, shoulders raised to my ears, like one does to protect from a sudden loud noise.
43 2021-03-24 taste impairment I did not eat before my appointment, and had taken 325mg of aspirin before the vaccine due to my chr... Read more
I did not eat before my appointment, and had taken 325mg of aspirin before the vaccine due to my chronic chest pain (undiagnosed). My other meds were taken the night before. Approximately ten minutes after receiving the vaccine, I developed a metallic taste in my mouth. After being observed for 45 minutes, I left and got something to eat. After I ate the metallic taste lasted another hour before diminishing.
43 2021-03-24 mouth tingling Patient called clinic with complaints of possible reactions to the second dose of the vaccine today.... Read more
Patient called clinic with complaints of possible reactions to the second dose of the vaccine today. States that after she was observed for 15 minutes following the second dose of the Pfizer vaccine, she went home and noticed some slight tongue tingling that lasted for a few minutes then went away. She had her second dose today at 0945. Denies any reactions after her first dose. States now she has bumps on her skin similar to a skin rash with some pruritus. Denies wheezing, dyspnea, SOB, lip/tongue swelling, throat tightness, dysphagia, chest pain, nausea, vomiting. States she did take Zyrtec 10 mg this morning which is normal for her as she has allergies. She was currently at work when calling. Advised Pt of the following for treatment: 1. Topical hydrocortisone 1% cream to affected areas for the itch. Cool compresses for swelling and the itch. 2. OTC Zyrtec-- advised her to take a second dose of 10 mg tonight when going to bed. Also advised her to take Benadryl 25 - 50 mg every 4-8 hours as needed, max 300mg daily. Can be sedating, do not take with driving or operating machinery. Decided it would probably be best for her to leave work and go home in case she gets sleepy. She denied needing a work note at this time. 3. Advised to call 911 if signs and symptoms worsen at any time. Advised Pt not to follow up at \center if having any red flag symptoms but rather go to the ED immediately. Red flag symptoms: SOB, wheezing, lip/tongue swelling, throat tightness, chest pain. Discussed reaction with collaborating physician who was also the clinical observer for the vaccines today. Also made clinic manager aware
43 2021-03-25 taste impairment Metallic taste in mouth
43 2021-03-25 eye itchiness, lip swelling Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. L... Read more
Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. Lips and lower face are becoming more swollen. I have no access to Health insurance so I will take a shower and some Benadryl, my only attainable recourse at this time.
43 2021-03-25 swollen tongue Heart palpitations and labored breathing within 10 minutes of getting vaccine. Swollen tongue withi... Read more
Heart palpitations and labored breathing within 10 minutes of getting vaccine. Swollen tongue within 45 minutes
43 2021-03-26 thirst Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with... Read more
Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with Tylenol for 48 hours Extreme muscle pain- not ache, it hurt to lay still Bones would hurting, especially if pressure was applied to move or walk Shallow breathing Extreme thirst Sharp stabbing pain in head: bottom left toward back of neck Large Swollen spot under left arm under arm pit Increased heart rate- approx 130 bpm Went to emergency room in around 8:30 PM on Thursday March 25th. Was given via UV: fluids, Benedryl, medicine for pain & swelling. Discharged around 11:00 PM. Have Remained sick with normal side effects, feeling flu like, and a low temp around 100. Much more manageable. Today is Saturday & I still feel very unwell but no longer feel like I?m dying.
43 2021-03-27 bloodshot eyes Red rash on both arms, chest, and face. Red eye.
43 2021-03-28 mouth tingling, swollen tongue, lip swelling 43 year old female with a past medical history significant for asthma, anxiety, DM, migraines, thyro... Read more
43 year old female with a past medical history significant for asthma, anxiety, DM, migraines, thyroid papillary carcinoma who is presenting to the ED with an allergic reaction. She received her COVID vaccination at 1700. At approximately 1715 she felt a lump in her throat. Shortly after she felt as if her tongue/lips were tingling/becoming swollen and then she developed nausea. No rash or abdominal pain. No dyspnea or chest pain. All symptoms are consistent with prior episodes of anaphylaxis. She has had anaphylaxis to vaccinations in the past but was advised by her allergist to get the COVID vaccine today. On arrival patient is quite anxious. Vital signs are stable. Her tongue is enlarged/mildly edematous, additionally appreciated mild lip/perioral swelling. There is no stridor or wheezing, no evidence of respiratory distress. Given examination findings, symptom description, findings concerning for anaphylaxis. As such, epinephrine promptly administered as well as solumedrol, famotidine, and benadryl. Shortly after the epinephrine she endorsed improvement in her swelling, though during benadryl administration she endorsed a sudden onset of subjective throat swelling/felt as if she could not breathe. Patient was reassessed, no change in initial examination findings, within a few minutes she felt her symptoms improve without intervention.A short while later she again felt as if her throat swelling was worsening, as such epinephrine dose re administered. Following a 2.5 hour period of observation she endorsed continued improvement in her allergic symptoms, requested discharge home though continued observation offered. A course of prednisone prescribed, patient already with epi pen. Patient discharged home.
43 2021-03-28 sensitivity to light, eye twitching Nausea, chills, light sensitivity, migraine, pain radiating through left arm ( couldn't move arm af... Read more
Nausea, chills, light sensitivity, migraine, pain radiating through left arm ( couldn't move arm after several hours), loss of appetite, emotional mood swings, twitching in left hand and eyes, lethargic,
43 2021-03-29 ringing in ears Tinnitus after 4 hours shot one. It went away after two weeks. Shot two it came back again. Golf ... Read more
Tinnitus after 4 hours shot one. It went away after two weeks. Shot two it came back again. Golf ball size knot in lymph nodes
43 2021-03-29 ringing in ears Tinnitus in left ear.
43 2021-03-30 loss of taste, loss of smell Loss smell and taste for a week.
43 2021-03-30 loss of taste, ear pain Quickly progressing facial paralysis after extreme ear pain on same side of face. Diagnosed as Bell'... Read more
Quickly progressing facial paralysis after extreme ear pain on same side of face. Diagnosed as Bell's Palsy. Extreme case per doctor. Some loss of taste. Persistent extreme pain in and around ear and traveling down neck; all same side. Eye won't close. Difficulty drinking, and difficulty eating without choking. Numbness on entire right side of face with full paralysis. Treatment is Valacyclovir, Gabapentin, Prednisone, Tramadol. And keeping eye covered at all times.
43 2021-03-30 taste impairment, smell distorsion Four hours after the vaccine, I started to experience a metal taste in my mouth. This lasted for abo... Read more
Four hours after the vaccine, I started to experience a metal taste in my mouth. This lasted for about 2 days. The day after the vaccine I started smelling a burning smell. However, nothing was burning. It is 4 weeks later and I still experience this. Today, I am in day 2 of smelling something like burnt toast. It drives me a little crazy and it is disorientating.
43 2021-03-30 ear pain, mouth pain swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report ... Read more
swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report from a contactable consumer (patient himself) of 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified roue of administration on 07Feb2021 at 11:30 AM (at the age of 43-years-old) in the right arm and first dose BNT162B2 (lot number: EM9809) via unspecified route of administration in the right arm on 21Jan2021 at 02:00 PM both as single dose of Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not having known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 and Nasal swab and rapid antigen result was negative, On 13Feb2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on any other medications within 2 weeks of vaccination. On 08Feb2021 at 02:00 AM, the patient experienced body aches, swollen glands, sores in mouth, earache, pain swallowing. No therapeutic measures were taken. The outcome of event was not recovered. Information on the lot/batch number has been requested.
43 2021-03-30 mouth numbness, mouth tingling pt c/o numbness of her tongue; tingling of her lip
43 2021-03-30 vision blurred back of head and neck hurts, felt like whiplash; back of head and neck hurts, felt like whiplash; He... Read more
back of head and neck hurts, felt like whiplash; back of head and neck hurts, felt like whiplash; Headache/ back of head and neck hurts/ walking too much and looking up/down and left/right causes headache; Dizziness; blurry vision; sensation of eyes wanting to cross; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiry date were unknown), via an unspecified route of administration in the left arm on 11Mar2021 13:00 (at 43 years old) at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included glaucoma, asthma, and allergies to topical iodine, penicillin, and latex, all from an unknown date and unknown if ongoing. The patient was not pregnant. Concomitant medications included brimonidine tartrate (ALPHAGAN), brinzolamide (AZOPT), latanoprost (XALATAN) and an unspecified Inhaler; therapy dates and indications were unknown for all. The patient took these medications within two weeks before the event onset. The patient did not receive other vaccination within 4 weeks prior to the BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. It was reported that on day 1 (11Mar2021), the patient experienced dizziness, blurry vision, and sensation of eyes wanting to cross. On day 2 (12Mar2021), the patient experienced headache, blurry vision, and sensation of eyes wanting to cross. On day 3 (13Mar2021), patient experienced back of head and neck hurts, felt like whiplash; walking too much and looking up/down and left/right causes headache. On day 4, the symptoms from day 3 continued. No treatment was received in response to the events. The adverse events involved hospitalization. The outcome of the events was not recovered. Information on batch/lot number has been requested.
43 2021-03-31 taste impairment Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: metalic taste in mouth, heart racing
43 2021-03-31 feeling of choking Develops cold feeling throughout body ad tingling sensation in throat. Denies SOB or trouble swallow... Read more
Develops cold feeling throughout body ad tingling sensation in throat. Denies SOB or trouble swallowing. Given benadryl 25mg PO x 1. Discharged home with family under stable condition. SPO2 97% RA HR 95 RR 14 even and unlabored
43 2021-04-01 ear pain At site after got vaccine began shakes n feeling unwell was taken to tent dr said blood pressure and... Read more
At site after got vaccine began shakes n feeling unwell was taken to tent dr said blood pressure and pulse high stayed for 30 minutes and felt better. Over weekend experience dizziness and pain in ear unwell feeling fast heart rate spike to pcp Monday on Tuesday had called dispatch health heart rate high n fast they called ambulance cuz I was tachycardia and high blood and having tremors. Was released under this was anxiety related pcp n cardio dr increased my metoprolol but currently still suffering wit tremors or tics of body . I have no control over movement and not sure when or if this will end. This was only my first dose and not comfortable with getting second and not sure what to do to manage these symptoms.
43 2021-04-01 hearing loss, deafness, ringing in ears Pfizer-BioNTech COVID-19 Vaccine EUA I was vaccinated yesterday and woke up with morning with tinnit... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I was vaccinated yesterday and woke up with morning with tinnitus in both ears, although it appears to be worse in the left ear than the right. I also think I've got a bit a hearing loss, but that may just be the interference of the high pitched tone. Everything sounds a bit muffled today, though, as well.
43 2021-04-01 mouth tingling Tingling around lips that started about 45 minutes after the vaccine. Lasted about 1/2 hour. Sorenes... Read more
Tingling around lips that started about 45 minutes after the vaccine. Lasted about 1/2 hour. Soreness around injection site the next 2 days.
43 2021-04-03 loss of smell, loss of taste After 3 days of the Pfizer first dose I got covid-19. I didn't have fever or difficulty breathing, ... Read more
After 3 days of the Pfizer first dose I got covid-19. I didn't have fever or difficulty breathing, but I had: Extremely fatigued Body aches Headache loss of taste and smell Runny nose Nausea Diarrhea
43 2021-04-03 eye swelling, mouth tingling Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. ... Read more
Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. Eyes and throat began swelling. Doctor told me to use the epipen on myself since I was salivating a lot. Called the ambulance and was taken to Hospital. Doctor told me that they thought the Lisinopril allergic reaction was activated. It is now Sunday (four days later) and I am experiencing muscle aches in my right arm and nerve pain in my right hand/fingertips. On Saturday, my right arm was twitching and cramping. Felt chills on Friday.
43 2021-04-04 swelling of eyelid, eye swelling I developed facial swelling approximately 3.5 weeks after the first injection. My eyelids swelled, a... Read more
I developed facial swelling approximately 3.5 weeks after the first injection. My eyelids swelled, and my cheeks and under eye area as well.
43 2021-04-04 ringing in ears I had an initial bad reaction about 3 minutes after the injection almost passing out, severe nausea,... Read more
I had an initial bad reaction about 3 minutes after the injection almost passing out, severe nausea, dizziness overheating. Now I am experiencing terrible ringing in my ears (tinnitus).
43 2021-04-05 taste impairment Metallic taste, nausea. Symptoms improved.
43 2021-04-06 loss of taste Dizziness, extreme fatigue, chills, loss of taste, nausea
43 2021-04-06 taste impairment It started three days after the first dose of the vaccine. I had a metallic taste in my mouth which ... Read more
It started three days after the first dose of the vaccine. I had a metallic taste in my mouth which lasted five weeks. It was there all the time. I was thirsty and trying to get rid of it all the time. It did not go away until after I got the second dose of the vaccine. It went away about a week after getting the second dose. It just went away suddenly.
43 2021-04-06 eye disorder Left eye began feeling odd the next morning, face pins and needles, eye feeling weird
43 2021-04-06 ringing in ears Received dose on 3.30.21. Patient reported on 4.6.21 (at 23:57) that she has had tinnitus in both e... Read more
Received dose on 3.30.21. Patient reported on 4.6.21 (at 23:57) that she has had tinnitus in both ears (since vaccination?) that has not subsided.
43 2021-04-06 toothache At time of shot, felt stinging pain in the elbow and wrist of left arm, later 5 mins. At some point... Read more
At time of shot, felt stinging pain in the elbow and wrist of left arm, later 5 mins. At some point the next day, I developed Spinal pain. Pain in SI joins, several distinct spots along the spine and the base of my skull, spinal stiffness, difficulty touching knees or putting chin to chest. Lasted 2 days. Night of 3/292021, I woke up with tooth pain in multiple teeth on both upper and lower and right and left sids of mouth. Pain great enough to wake me up and caused difficulty returning to sleep, after 600 mg ibuprofen, able to get to sleep and completely gone in the am. Starting 3/30, pain along nerve paths in upper right side back around scapula, felt like burning, intermittent. Now resolved to tingling / numb feeling and some tingling / decreased sensation in upper lip left side and under eye left side
43 2021-04-07 ringing in ears Tinnitus dizziness
43 2021-04-07 visual impairment The patient presented to the Emergency Department several hours after receiving their first dose of ... Read more
The patient presented to the Emergency Department several hours after receiving their first dose of Pfizer's COVID-19 vaccine. EMS evaluated at the vaccine site, but the patient refused transport and elected to drive themselves. In the ED, the patient reported heart palpitations, "seeing spots", chest discomfort, itching on their chest, and HTN. On presentation, the patient was tachycardic (120bpm) and hypertensive (185/95). The patient's labs and tests were not concerning, and the physician stated the patient was well-appearing and in no acute distress. The patient was discharged with diagnoses of possible reaction Pfizer COVID vaccine, Possible anxiety response, and Hypertension. The physician instructed the patient to regularly check their blood pressure and follow-up with their PCP.
43 2021-04-08 deafness unilateral, ringing in ears Tinnitus, hearing loss left ear
43 2021-04-08 taste impairment IMMEDIATE METALLIC TASTE IN MOUTH RIGHT AFTER VACCINE. THE FOLLOWING DAY WOKE UP STILL WITH TASTE BU... Read more
IMMEDIATE METALLIC TASTE IN MOUTH RIGHT AFTER VACCINE. THE FOLLOWING DAY WOKE UP STILL WITH TASTE BUT HAD A FAINTING SPELL AROUND 9AM THEN ANOTHER AROUND 530PM. THE METALLIC TASTE LAST LIKE 5 DAYS BUT THE FAINTING SPELLS HAVE CONTINUED SINCE. HAVE DECIDED TO SET UP APPOINTMENT WITH A FAMILY DOCTOR DONT KNOW IF ITS NORMAL FOR THIS TO BE ONGOING.
43 2021-04-08 extreme sound sensitivity, sensitivity to light Headaches; migraines; Light and noise sensitivity.; noise sensitivity; This is a spontaneous report ... Read more
Headaches; migraines; Light and noise sensitivity.; noise sensitivity; This is a spontaneous report from a contactable consumer or other non hcp. A 43-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 05:15 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history included hashimotos thyroid, drug hypersensitivity, food allergy unknown if ongoing, drug hypersensitivity from unknown if ongoing, allergies to medications, food, or other products Cipro, doxycycline. Concomitant medication(s) included sertraline hcl (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported. On 09Feb2021 the patient experienced headaches, migraines, light and noise sensitivity, noise sensitivity. The outcome of the events was not recovered.
43 2021-04-08 hearing loss, ringing in ears About 24 hours after the injection, I developed a very sudden, loud ringing in my ears to where I co... Read more
About 24 hours after the injection, I developed a very sudden, loud ringing in my ears to where I could barely hear anything else for about two minutes. The intensity subsided, but now two days later, I still have a faint ringing that I hear anytime I'm in a quiet place, which is extremely distracting when trying to fall asleep or when I wake up. I feel like I can no longer hear silence. The ringing is always there. I did contact my doctor, and if it doesn't go away by next week, she will refer me to an ENT.
43 2021-04-08 mouth tingling, taste impairment Pt stated "Funny Feeling in her tongue" Pt states feeling warm and nauseated. Pt states she has a ... Read more
Pt stated "Funny Feeling in her tongue" Pt states feeling warm and nauseated. Pt states she has a "metallic taste in her mouth" BP 132/76 Pulse ox 97% resp rate 20 HR 106
43 2021-04-08 ringing in ears, ear pain Left ear is pinging with slight pain- tinnitus.
43 2021-04-09 ear pain Severe headache and earache
43 2021-04-09 eye bleeding eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; hea... Read more
eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; head/face is tingly/cold; eye had a hemorrhage - it got worse the next day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnant patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 08:30 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included gastric bypass from Jul2018, high blood pressure prior to gastric bypass but has had regular BP (blood pressure) since then, and allergy to penicillin. The patient's concomitant medications were not reported. The patient previously received the first dose of the same vaccine in left arm on 03Mar2021 at 08:30 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 05:00 PM, a day after she received the Pfizer vaccine (2nd dose), her eye had a hemorrhage - it got worse the next day (26Mar2021). She felt light headed and head/face was tingly/cold. Took her blood pressure and it's in a normal range (109/77 111/77). She spoke with a relative that was a nurse practitioner and was advised hemorrhage could be related to vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. Information about batch/Lot number has been requested.
43 2021-04-09 ringing in ears Tinnitus. Ringing in left ear.
43 2021-04-11 ear discomfort 3/24/21 - Spreading heat up left shoulder to left side of Neck 5 mins 3/24/21 - pricking on left elb... Read more
3/24/21 - Spreading heat up left shoulder to left side of Neck 5 mins 3/24/21 - pricking on left elbow slightly itchy 3/24/21 - 5:05PM - Intense pricking around browbone and cheeckbone on face - tightening of skin on cheeks with heat feelings 3/24/21 - pricking on elbows Left and Right- skin sensitization over body- random pricking on varius areas of body 3/25/21 - Continues - tingling begins in both forearms and legs; Chest pain right pectoral area 3/26/21 to date - numbness on face; tingling of entire left leg; pinpricks across shouldrs upper chest Pain on forerms ; fullness in ears Weakness and heaviness in both arms; fatigue
43 2021-04-11 mouth numbness Patient did not disclaim that she had a previous reaction to the pneumococcal vaccine and answered n... Read more
Patient did not disclaim that she had a previous reaction to the pneumococcal vaccine and answered no on the questionnaire and told the vaccinator that she had no prior reactions. She was instructed by the vaccinator to wait 15 minutes. Client stayed in observation room for 20 minutes and had no symptoms. She then left the building and went to her car. She was in her car for 10 minutes on the phone. She stated that at this time her lower lip started to feel heavy and numb, and her left arm started to feel itchy. She came back into the building and reported her symptoms. Vital signs were taken at 1325 (blood pressure 120/50 and pulse 70). Client given 50mg liquid oral solution of Diphenhydramine (Benadryl) at 1325. Vitals signs retaken at 1330 (Blood pressure 110/50 and pulse 70). Patient stated at this time that ?the itching is feeling better,? but also complained of a headache. Patient offered water. Continued to monitor. Patient sated that her headache was gone at 1337 and that her ?arm was only slightly itchy now,? and her ?lip feels better.? Vital signs taken at 1340 (Blood pressure 110/60, pulse 68, and SPO2 99%. Patient advised to follow up with primary care provider within 24 hours, or call 911 if symptoms return more severe. Patient walked out of facility unassisted with steady gait.
43 2021-04-11 ringing in ears Tinnitus, joint pain, sudden onset of seasonal allergies ( never experienced before)
43 2021-04-12 mouth numbness Within 10 minutes facial numbness to the left lip and cheek area. Felt like rubber and lasted for ab... Read more
Within 10 minutes facial numbness to the left lip and cheek area. Felt like rubber and lasted for about an hour. Reappeared 2 days later and lasted a few hours.
43 2021-04-12 swelling around the eyes After the vaccine: 10 minutes - small headache started 30 minutes - swollen throat, pale color 40 mi... Read more
After the vaccine: 10 minutes - small headache started 30 minutes - swollen throat, pale color 40 minutes - shaky legs was administred two pills of benadryl following day, 9h30am - area around right eye swollen and rugged (consistent with previous allergy case - 10 years ago) tooke 1 pill of Cetirizine Hydrochloride 10mg
43 2021-04-13 dry throat Arm turned deep red purple after a few minutes, felt has ants all over me, felt Rush of cold freezin... Read more
Arm turned deep red purple after a few minutes, felt has ants all over me, felt Rush of cold freezing through stomach up through chest and back lower to upper back, felt as if cotton was being packed into my throat. After a few more minutes difficult to swallow. Dr. administered Epi shot, was sent to ER where was administered IV meds, prescribed at home allergy meds. ER follow-up last Thursday with primary Dr. , extended prescribed allergy meds for additional month due to ongoing symptoms.
43 2021-04-13 eye movement disorder, pupils dilated This nurse was called to the monitoring area to assist a patient that was passing out. Patient calle... Read more
This nurse was called to the monitoring area to assist a patient that was passing out. Patient called out she felt dizzy at which time her eyes rolled back and she started to go limp. EMS was called immediately. Patient was assisted to the floor by multiple staff. Patient lost consciousness for 15-20 seconds. Patient regained consciousness spontaneously. Pupils were enlarged. BP 110/70, HR 65, Pulse ox 99%. Patient was s/p covid vaccine # 1 (Lot ER8727, exp. 7/31/21). Ice pack applied to patient's neck. Patient laid on floor and remained awake, alert, and oriented. Patient stated she felt better. She was sat upright and given water. Patient stated she has not had anything to eat or drink since last night. Patient was assisted to chair slowly. EMS arrived @ 12:24. Patient then had a second episode where she felt dizzy and started to pass out. She was again lowered to the floor. Patient was placed on a monitor by EMS, BP 74/44. EMS inserted IV line into her Left AC and started fluids. BS via fingerstick was 104. Patient was transported to ED without further incident.
43 2021-04-13 eye pain Costochondritis began March 23. March 26 terrible migraine set in. It was the worst one I?ve ever ha... Read more
Costochondritis began March 23. March 26 terrible migraine set in. It was the worst one I?ve ever had. Head felt like it was being crushed on both sides, extreme nausea, dry heaving, and pain all over head, back of eyes, neck, shoulders, and face. This migraine continued on and off for almost two weeks, required ER visit, Dr visits, IV steroids, IV NSAIDs and injections, and other migraine medications. The headache continued for over 2 weeks, specifically on left side of head and face near temple and side of head and left side of forehead. I?ve been on prednisone between 30-20mg daily for this. I am 24 days passed receiving first shot and still have mild pain on left side. I am still recovering.
43 2021-04-13 lip swelling Pt with known anaphylaxis to various things presented for 1st Pfizer with the advise of her physicia... Read more
Pt with known anaphylaxis to various things presented for 1st Pfizer with the advise of her physician. Pre-medicated herself (also with MD advise) with 50mg Benadryl, took additional 50mg post vaccine (again at MD advise). within 5 min post vaccine became symptomatic with lips puffiness, throat itch. 5 min later administered Epi pen and called 911. Airway remained patent, some scratchiness but trach sounds clear. Sats wnl--left site on stretcher, airway intact to local ED
43 2021-04-13 vision blurred Immediately after the shot, I started to have blurry vision, dizziness, rapid heart beat and sweatin... Read more
Immediately after the shot, I started to have blurry vision, dizziness, rapid heart beat and sweating, almost collapsed in the arms of the nurse although I was seated. Could not stand or walk. The nurses attended to me, by giving me water and sugar and calming my breathing. After a few minutes one of the nurses took me for a walk around the facility and recommended I take Benadryl. They kept an eye on me for about 1h and a half until I was in some shape to drive back home. Driving was very difficult, as I was still fairly dizzy and weak. During the day I would get bursts of dizziness, tingling in the face and unusual heart palpitations. In the evening I got shivers and dizziness. I was fine the next day.
43 2021-04-14 taste impairment, loss of taste Extreme headache, body ache, arm sore, my mouth has a metallic taste and can not taste salt.
43 2021-04-14 lacrimation increased, drooling, eye pain This was my second dosage of the Pfizer vaccine. Upon the first vaccine, I did feel symptoms of thro... Read more
This was my second dosage of the Pfizer vaccine. Upon the first vaccine, I did feel symptoms of throat swelling and difficulty swallowing that subsided without intervention and quickly. For the second vaccine that I received today, I experienced dizziness in the store and began to sweat. I left because the pharmacy staff did not seem to want to be bothered. Upon driving home, within about 15 minutes of getting the vaccine, I began to have nausea to the point that I had to stop and pull over. I vomited a small amount of my breakfast. Continued to feel shaky, dizzy, faint, excessive saliva and tearing of eyes. Upon arriving in my driveway, it was hard to walk up stairs. The nausea continued for about 1.5 hours but the weakness and feelings of faintness continue still after 2 hours after the vaccine. I had some tachycardia. It's hard for my eyes to look up and my eyes hurt when I move them. I had moments of feeling like I had a parietal vice on my head. I called the pharmacy to report all of this and only spoke with a pharmacy assistant. No pharmacist called to check on me. I am an RN so I have the knowledge needed to care for myself and seek medical attention if needed, but I have sympathy for those that are not and have their report of symptoms dismissed just as I did from the vaccine provider.
43 2021-04-14 lip itchiness, lip swelling, mouth tingling swelling to lips tingling around lips itching around lips redness to lips and around lips
43 2021-04-14 lip swelling Pain and swelling lips, and several areas of the face (swelling and pain in lips, pain only in face)... Read more
Pain and swelling lips, and several areas of the face (swelling and pain in lips, pain only in face) both sites, only where she has had filler (filler name unavailable Restylene or Juvaderm??).
43 2021-04-14 ringing in ears After receiving the first shot I had normal side effects - a headache that went away in 24 hours and... Read more
After receiving the first shot I had normal side effects - a headache that went away in 24 hours and a sore arm that lasted 36-48 hours. I did notice a slight jitter/shaky feeling and a little tinitus. One week later the tinitus became much louder and continual. This has continued for a week. I also have moments of vertigo and an overall achy/tired feeling that I have been in bed for the past 4 days.
43 2021-04-14 vision blurred Patient reported nervousness prior to receiving vaccine. Patient reported blurred vision, possible v... Read more
Patient reported nervousness prior to receiving vaccine. Patient reported blurred vision, possible vertigo, slight nausea. Patient never lost consciousness. Patient was moved to fresh air, given ice pack, bottle of water. Left without issue.
43 2021-04-14 visual impairment Migraine with aura without headache (diagnosed by medical professional). Visual disturbance for abou... Read more
Migraine with aura without headache (diagnosed by medical professional). Visual disturbance for about 20 minutes. Slightly elevated blood pressure.
43 2021-04-16 swelling around the eyes Swelling under both eyes, first noticed when I woke up the morning after vaccine, gradually decrease... Read more
Swelling under both eyes, first noticed when I woke up the morning after vaccine, gradually decreased over the next few days; swelling left cheek, gradually decreased over the next week; chest tightness, started the day after vaccine, intermittent throughout day, decreased in frequency & severity 8 days post vaccine. Currently 14 days post vaccine and still have mild chest tightness, intermittent throughout day.
43 2021-04-17 taste impairment Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; he... Read more
Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; her body started to feel strange/ just felt weird; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in left arm, on 12Mar2021 at 02:30pm (at age of 43 years old), as a single dose, for COVID-19 immunisation. Medical history included migraine and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ondansetron (ZOFRAN) and oxymetazoline hydrochloride (CLARITIN ALLERGIC), Nurtec and allergy immunotherapy; all started on an unspecified date and for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 12Mar2021 (at 6:00pm), the patient experienced a metal taste in her mouth, mild on first afternoon but stronger tasting on next two days. On Day 2, it was reported that her body started to feel strange, could not quite describe feeling, further described as it was not really a tired feeling or a painful feeling, just felt weird. On 25Mar2021, the patient experienced Bells palsy. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the events metal taste in her mouth, body started to feel strange/just felt weird. The clinical outcome of the events, metal taste in her mouth, body started to feel strange/ just felt weird, was recovered on an unspecified date. The clinical outcome of the event Bells palsy was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
43 2021-04-17 mouth tingling, mouth numbness Lips tingling numbness left side face tongue, pin and needs hands feet
43 2021-04-18 ear discomfort At approximately 11:47, patient presented with syncope, nausea and vomiting, headache, and ear press... Read more
At approximately 11:47, patient presented with syncope, nausea and vomiting, headache, and ear pressure. EMS was notified at approximately 11:49 and arrived at 11:54. Pt agreed to transport to hospital.
43 2021-04-18 eye swelling I have a dermal filler under my eyes and two days after getting the second shot of the Pfizer vaccin... Read more
I have a dermal filler under my eyes and two days after getting the second shot of the Pfizer vaccine I woke up with eyes very swollen .
43 2021-04-18 mouth numbness, swollen tongue, lip swelling, mouth tingling within 5 minutes developed numbness/tingling in lips and tongue with swelling. received prolonged mo... Read more
within 5 minutes developed numbness/tingling in lips and tongue with swelling. received prolonged monitoring at the site with resolution of symptoms within 3 hours
43 2021-04-18 mouth numbness Felt fine for 15 min waiting period. Began drive home and started to feel slight sensation on left j... Read more
Felt fine for 15 min waiting period. Began drive home and started to feel slight sensation on left jaw, almost like novocaine, then my heart began extreme racing and lurching, with irregular rhythm. I looked for a place to pull over-I was on the highway, but luckily it subsided after 4-5 min.
43 2021-04-18 swollen tongue Swelling of tongue and throat. BP 209/115 (pulse 104). Given Epi-Pen, then sent to hospital. Was at ... Read more
Swelling of tongue and throat. BP 209/115 (pulse 104). Given Epi-Pen, then sent to hospital. Was at hospital for 1 day, and received IV Solumedrol, Pepcid, IV Benadryl.
43 2021-04-19 ear pain, ringing in ears Was dizzy after recovering the shot. Lasted 24 hours and then I started getting ringing and sharp pa... Read more
Was dizzy after recovering the shot. Lasted 24 hours and then I started getting ringing and sharp pains in the right ear. This lasted for hours.
43 2021-04-19 mouth tingling Patient reported tingling and funny feeling in lips and tip of tongue. Patient had no other symptom... Read more
Patient reported tingling and funny feeling in lips and tip of tongue. Patient had no other symptoms of swelling, pain, or trouble swallowing or breathing.
43 2021-04-20 dry mouth, mouth numbness My tongue went numb, my left arm went numb, my throat tightened up, my blood pressure and heart rate... Read more
My tongue went numb, my left arm went numb, my throat tightened up, my blood pressure and heart rate went way up, I had a hard time swallowing, dry mouth, tight chest
43 2021-04-20 eye discomfort, ear discomfort Hands and feet felt arthritic, nausea before eating, all over body & joint pain, then a debilitating... Read more
Hands and feet felt arthritic, nausea before eating, all over body & joint pain, then a debilitating migraine that lasted all day, sinus pressure in ears, around eyes, lethargy
43 2021-04-20 eye discomfort I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to ... Read more
I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to where I got the shot/ like whenever I take a step to walk it's feels like my head is going to explode; really bad back ache; My face and my back started getting like hot, like heat, like very hot reaction/like radiating heat in my back it is like surrounding my spine, its right in the middle of my back; It feels like heat and pressure around my spine area; high pressure behind the right eye; My arm started hurting; the arm I got the shot in; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733), intramuscular (reported as in the muscle) in left arm on 01Apr2021 (at the age of 43-year-old) at 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that initially, right afterward she meant her arm started hurting which was normal the arm she got the shot in, she wasn't worried about that. But then her face and her back started getting like hot, like heat, like very hot reaction. She did not know how to describe it, it was like radiating heat in her back it was like surrounding her spine, it was right in the middle of her back. It felt like heat and pressure around her spine area. And in her head, it had not lit up. She had headache so badly that her right eye which was to the opposite side to where she got the shot. She had very high pressure behind the right eye. It was literally like whenever she took a step to walk it was felt like her head was going to explode. It was for her a headache and really bad back ache. When paraphrased the above concern, patient stated It was for days at the time of this report. First adverse reaction was on the actual day that she received the vaccine that was 01Apr2021. Second shot was reported as 29Apr2021. When probed for if patient still experiencing adverse event patient stated that she was still experiencing. As per outcome of event patient stated for its persisting. As per treatment she took an ibuprofen (ADVIL) for the first-time last night before the present report. Just because she needed to get sleep. She had not slept in days. So, she took ADVIL to get rid of the pain last night that was only the things she had done since Thursday 01Apr2021. But it didn't even work. She woke up and felt the exact same. Dose of Advil was reported as 200 mg, she took one 200 mg tablet. She just took it the day before the present report (04Apr2021). The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
43 2021-04-21 eye twitching, dry eye Right eye lower lid twitching started about a week after vaccine and still continues to this day - 3... Read more
Right eye lower lid twitching started about a week after vaccine and still continues to this day - 3 months after second vaccine. I have seen an optometrist and neurologist. I have tried eye drops for dry eye and for allergies with no relief. I also have a tingling that comes and goes on my right cheek.
43 2021-04-21 mouth numbness Client complained of Numbness on the right side of her face/tongue approximately 15-18 minutes after... Read more
Client complained of Numbness on the right side of her face/tongue approximately 15-18 minutes after injection. Client described it as "like going to the dentist". Blood pressure 170/100 during episode. O2 sat 100%, HR 69. She denied shortness of breath and had ho stridor or compromised breathing. Client sat with observer for another 15-20 minutes, and stated that the symptoms were going away. She stated that her mother is a nurse and she would have her mom bring her to the ER if symptoms worsened.
43 2021-04-21 bloodshot eyes, eye pain, eye swelling Day 1: Symptoms of fatigue, malaise develop at 12pm. Symptoms of fatigue, malaise worsen, headache d... Read more
Day 1: Symptoms of fatigue, malaise develop at 12pm. Symptoms of fatigue, malaise worsen, headache develops. Go right to bed after work at 4:30pm Day 2: Extreme fatigue, malaise, brain fog. Severe joint pain, immobility. Inability to go to work, bedridden. Later that evening, Redness, pain, and swelling of right eye (iritis) begin to develop, indicating beginning of lupus flare. Day 3: Iritis increase in severity, Moderate to severe aches and joint pain, moderate fatigue, malaise, brain fog. Contact rheumatologist & ophthalmologist. Prednisone therapy withheld to prevent inhibiting immune response to vaccine. Day 4-14: All symptoms persist, then dull to functional levels by Day 14. Rheumatologist recommends this flare be reported to VADERS. 3/17: Given 2 wk prednisone taper for Lupus flare that developed days earlier. (Extreme fatigue, malaise, brain fog. Severe joint pain, immobility. Inability to perform most daily activities, occasionally bedridden & inability to go to work, Iritis (Redness, pain, and swelling of right eye) 4/5: Given 2 wk prednisone taper for Lupus flare that developed days earlier. (Extreme fatigue, malaise, brain fog. Severe joint pain, immobility. Inability to perform most daily activities, occasionally bedridden & inability to go to work, Iritis (Redness, pain, and swelling of right eye) 4/18: Redness, pain, and swelling of right eye (iritis) begin to develop, indicating beginning of lupus flare. 4/19: Inability to go to work, bedridden due to extreme fatigue, malaise, brain fog. Severe joint pain, immobility. Inability to perform most daily activities, occasionally bedridden & inability to go to work, Iritis (Redness, pain, and swelling of right eye) 4/20: Some spotting. At this point menstrual cycle delayed 20 days
43 2021-04-21 ringing in ears, ear discomfort, ear pain Weakness, nausea, extreme dizziness, vertigo, pain in ear, tinnitus, fullness in ear, chills and 99.... Read more
Weakness, nausea, extreme dizziness, vertigo, pain in ear, tinnitus, fullness in ear, chills and 99.6 temperature.
43 2021-04-21 ringing in ears About 10 minutes after shot I felt a bit flushed and light headed, then my face felt numb for a coup... Read more
About 10 minutes after shot I felt a bit flushed and light headed, then my face felt numb for a couple hours. I was then just tired on and off with a sore arm. On day 3 I started feeling congested with pulsing in my right ear followed by ringing tinnitus which continues to this day. I have taken Tylenol and ibuprofen a couple times, which doesn?t help much. I am currently over the 7 day mark from first dose.
43 2021-04-21 ringing in ears Constant ringing of the ears that has not subsided.
43 2021-04-22 mouth numbness Tounge and front upper teeth and jaw became very numb, as if I had a shot of Novocain.
43 2021-04-22 lip swelling Face and lip swelling. Tightness in throat under jaw. Went to Urgent Care 3 days later, prescribed S... Read more
Face and lip swelling. Tightness in throat under jaw. Went to Urgent Care 3 days later, prescribed Steroids.
43 2021-04-22 mouth tingling Patient complain of tongue tingling and itchy throat, on assessment noted small raised bumps on tong... Read more
Patient complain of tongue tingling and itchy throat, on assessment noted small raised bumps on tongue, redness of face, patient denies any shortness of breath, Benadryl 25mg po given, tolerated well . Was reassessed after 20 minutes, denies any discomfort in throat, no raised bumps noted, member was notified to pick up patient for home, Left at 9:28 accompanied by staff to car with family, no shortness of breath noted.
43 2021-04-22 taste disorder, swollen tongue Weird taste in mouth after 5 minutes, within 15 minutes throat tightness, and back of tongue swellin... Read more
Weird taste in mouth after 5 minutes, within 15 minutes throat tightness, and back of tongue swelling. Some difficulty swallowing. Kept having to clear my throat. Hoarseness in my voice began soon after. Was treated with liquid benadryl 50mg po and used my albuterol inhaler. Vitals were taken by vaccination center clinicians and staff. Symptoms began to alleviate once po benadryl began working. Took a longer acting antihistamine, Allegra when I got home. Had to take another dose of Benadryl later this afternoon. Started itching all over body.
43 2021-04-23 ear pain Starting around 1:00 am (almost exactly 12 hours following vaccination), patient experienced chills ... Read more
Starting around 1:00 am (almost exactly 12 hours following vaccination), patient experienced chills (alternating hot/cold sensations, sometimes hot/cold at the same time in different body parts), violent shaking/shivering, fever ranging from 99.9 to 102 degrees F (even after taking 400-600 mg of ibuprofen every 6 hours), body aches / pains in virtually all bones and muscles, and some organs (painful ear drums, eyelids, swallowing room temperature liquid felt painful in esophagus but no throat soreness); moving muscles to change position felt like bones would break and/or muscles / ligaments would tear; unable to find a singular comfortable position; unable to sleep; heart racing while in resting / reclined position - watch showed 15+ minutes of "fat burning" heart rate and "5 floors climbed", despite lying reclined and trying to sleep for more than 8 hours (having not walked more than about 1000 steps in the day to use the bathroom and drink fluids). The following day, fever broke, but patient woke sweating with a temperature of 96.6 degrees F (lower than the patient's average temp in the 97s-98.6 range). Body aches were mild to moderate, but mild nausea and diarrhea were experienced for all waking hours, and appetite was less than normal. Exhaustion still experienced in the third day (today 4/24), and body aches mild. No known fever at this time.
43 2021-04-23 ear itchiness throat tightness; throat clearing; throat clearing difficulty swallowing; coughing with drink of wat... Read more
throat tightness; throat clearing; throat clearing difficulty swallowing; coughing with drink of water; unable to eat (beans and rice); generalized swelling at left arm; pain in left arm referring into back and neck; pain in left arm referring into back and neck; pain in left arm referring into back and neck; limited ROM; unable to lift arm; itchy ears; This is a spontaneous report from a contactable Other HCP (reported herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201 and expiry dates were not provided) via unspecified route of administration on 18Feb2021 17:45 as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient's medical history was not reported. The patient was allergic to amoxicillin, azithromycin, doxycycline, sensitive to caines and walnut. Concomitant medications included ergocalciferol (VIT D) daily, vitamin b complex daily, melatonin as needed. Patient did not receive other vaccines within 4 weeks or prior vaccination. The patient did not have COVID 19 prior to vaccination and no COVID-19 test post vaccination. On 18Feb2021 17:45, the patient throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears. Therapeutic measures were taken with 50 mg Benadryl for throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), after 15-30 minutes later able to eat and no treatment received for rest of the events. The outcome of the events throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice) was recovered on an unspecified date on 2021 and generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears was not recovered.
43 2021-04-23 lip swelling, mouth numbness Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left sid... Read more
Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El3302), via an unspecified route of administration in left arm on 13Jan2021 10:00 as single dose and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: En5318) via an unspecified route of administration in left arm on 04Feb2021 11:00 as single dose for COVID-19 immunization. Patient age was 43-years-old and was not pregnant at the time of vaccination. Vaccine was administered at the military facility. Patient medical history included sleep apnoea syndrome. The patients concomitant medication included melatonin taken for an unspecified indication, start and stop date were not reported. The patient experienced cheek swelling on left side of face with numbing of lip due to swelling with numbing of lip due to swelling on 25Jan2021. No other vaccine in four weeks. Emergency room/department or urgent care. No COVID prior vaccination. No covid tested post vaccination. Therapeutic measures were taken as a result of the event. The outcome of the events was recovering.
43 2021-04-23 ringing in ears Severe ringing in left ear and I was vaccinated in left arm.
43 2021-04-24 eye itchiness tightness in chest; joint pain; headache; nausea; swollen lymph nodes; fatigue; itchy eyes; bacteria... Read more
tightness in chest; joint pain; headache; nausea; swollen lymph nodes; fatigue; itchy eyes; bacterial vaginosis; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication,phentermine (PHENTERMINE) taken for an unspecified indication,metoprolol tartrate (METOPROLOL TARTRATE) taken for an unspecified indication, ascorbic acid (VIT C) taken for an unspecified indication, ergocalciferol (VIT D) taken for an unspecified indication. The patient experienced bacterial vaginosis with outcome of recovering. The patient had tightness in chest, joint pain, headache, nausea, swollen lymph nodes, fatigue, itchy eyes on 09Feb2021 with outcome of recovered. Information on the lot/batch number has been requested.
43 2021-04-24 mouth tingling Tingling in lips, requesting Benadryl. Vitals wnl. Benadryl PO given.
43 2021-04-24 ringing in ears, deafness Experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus an... Read more
Experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus and possible sudden hearing loss in left ear following vaccination; Experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus and possible sudden hearing loss in left ear following vaccination; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 03Apr2021 10:30 (Batch/Lot Number: ED7533) as single dose for covid-19 immunisation. Medical history included AV block, colitis, optic neuritis, previous hearing loss in right ears and pre-existing tinnitus in right ears all from an unknown date and unknown if ongoing. Concomitant medications included montelukast; clarithromycin (CLARITIN) and bisacodyl (DULCOLAX); all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and vancomycin and experienced allergies. The patient experienced experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus and possible sudden hearing loss in left ear following vaccination on 03Apr2021 13:00. Contacting doctor, the patient was hesitant to receive second vaccination. No treatment was received for the events. The patient did not recover from the events.
43 2021-04-24 ringing in ears Tinnitus
43 2021-04-25 ear pain Started with right ear pain, which became within several days severe Bell?s palsy. I had complete r... Read more
Started with right ear pain, which became within several days severe Bell?s palsy. I had complete right sided facial paralysis, including the right side of my mouth, throat and eye not closing. I had extreme fatigue, facial pain, ear pain, throat pain, difficulty swallowing. This took 1 month to have improvement. Also had some elevated heart rate.
43 2021-04-25 ringing in ears Intense ringing in ears(tinnitus), unable to sleep-nightmarish flash images during rest- first 2 nig... Read more
Intense ringing in ears(tinnitus), unable to sleep-nightmarish flash images during rest- first 2 nights, joints swollen and aching (over 1 week), onset of seasonal allergies for 1st time( sneezing 20x row, sinus pressure-over 1 week).
43 2021-04-26 mouth numbness, taste impairment, feeling of choking Patient stated she could feel tingling in throat, metallic taste/numbness in tongue several minutes ... Read more
Patient stated she could feel tingling in throat, metallic taste/numbness in tongue several minutes after injection. No facial/mandible tongue swelling. Gave water, tolerated PO well. Patient felt better, no more tingling/numbness in throat/tongue. Stable & released from vaccination site.
43 2021-04-26 ringing in ears Tinnitus for 3 days No treatment Went away with time
43 2021-04-27 loss of smell, loss of taste neck pain, back pain, body aches, loss of smell/taste
43 2021-04-27 lacrimation increased, toothache My first vaccine was on a Tuesday. The following Saturday I woke up, around 8:15 am, and the right s... Read more
My first vaccine was on a Tuesday. The following Saturday I woke up, around 8:15 am, and the right side of my face was numb. My right eye kept tearing, nose was running, teeth and gums made it hard to eat. My face did not look droopy and my eyes were not crossed. I was scared and checked for other symptoms that could indicate stroke, eventually thought it could be the start of MS or something serious. Around 10 pm the numbness was gone. It has not returned but I am not sure if I should get the second dose. I called my pcp but office did not pick up so I just let it go, until I read that it could possibly be related to the vaccine (a few days ago).
43 2021-04-27 vision blurred I started experiencing throat swelling within the first five minutes of receiving the vaccine. withi... Read more
I started experiencing throat swelling within the first five minutes of receiving the vaccine. within ten minutes, my vision was blurry and I started to experience light headedness and vertigo. I tried to notify the staff within 15 minutes but had to wait 5 minutes before being acknowledged.
43 2021-04-28 dry mouth, ringing in ears She got her vaccine, she had no side effects other than her mouth being really really dry. She went... Read more
She got her vaccine, she had no side effects other than her mouth being really really dry. She went to bed, and was awakened at 3:00 AM with ringing in her ears. She is living on 3 hours of sleep a day due to the persistent ringing in the ears. She went to the tinnitus center who gave her some medication for the swelling and to wait and see if it goes away or if this is permanent. Right now she is very upset that the public is not being informed of this information.
43 2021-04-28 ear pain Outbreak of shingles on the left side of my face and scalp involving pain around my temple, cheek, f... Read more
Outbreak of shingles on the left side of my face and scalp involving pain around my temple, cheek, forehead, and ears and a rash on my upper temple and scalp.
43 2021-04-28 mouth tingling Tingly feeling in face 45 min after shot and continued but lightened a bit around 4:15 pm and just l... Read more
Tingly feeling in face 45 min after shot and continued but lightened a bit around 4:15 pm and just lips and cheeks tingly Called an spoke with nurse at dr office and they said if not better in 24 hours to call back
43 2021-04-29 thirst, light flashes or floaters in the eye Five minutes after injection, felt nauseated, face went cold and tingly, started rapid breathing, bl... Read more
Five minutes after injection, felt nauseated, face went cold and tingly, started rapid breathing, blood pressure elevated, felt very parched, hands tingly, thought I was going to pass out. This happened with the first Covid vaccine shot as well, so I lied down immediately after this shot, but it didn't help. I've never had this reaction to any other vaccine. Symptoms improved after 10-15 minutes, but I had to move very slowly. Felt very parched the rest of the evening and now as well (the next day). Had hallucinations of bright lights in my right peripheral vision that evening (which I've never had).
43 2021-05-04 eye bleeding A blood vessel burst in my right eye; headache; tired; This is a spontaneous report from a contactab... Read more
A blood vessel burst in my right eye; headache; tired; This is a spontaneous report from a contactable nurse. A 43-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 08:15 (Batch/Lot Number: 20921163) as a single dose for COVID-19 immunisation Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient had not received any other vaccinations within 4 weeks. Concomitant medication(s) included chlorthalidone (CHLORTHALIDONE) taken for blood pressure measurement, start and stop date were not reported. The patient reported that a blood vessel burst in her right eye on 10Apr2021 at 0600, she also reported a headache and was tired. The patient states that she got her first dose of the Pfizer COVID vaccine on Friday 9Apr2021. Patient states that the next day a blood vessel burst in the right eye. Patient states that at first she was thinking she didn't know what to think. Patient states that she didn't know what to do. Patient looked online to see how long the eye would take to heal. Patient states that the redness has gone away, the side part of patient's eye looked like something happened. Patient states that it was a lot when it happened. Patient states that the following morning on the 10Apr2021 she had a headache in the morning. Patient states that on or around 6:00 AM or 7:00 AM on 10Apr2021 she woke up with the headache and noticed the burst blood vessel. Patient states that the headache woke her up. Patient states that she took something for the headache but it still kind of lingered and patient felt kind of off all day long. Patient states that it lasted then kind of gradually went away and she didn't feel that way after a couple of days. Patient states that was the first vaccination and she is set to get the second vaccination on 30Apr2021. Patient states that with having that reaction of the blood vessel in the eye, she wants to get on with her life. Patient states that she wants the other portion of the vaccination but is nervous about getting it. The outcome of the events for tbe blood vessel burst in her right eye was recovering and the remaining events was recovered on 10Apr2021. The patient was not tested for COVID-19 before or after vaccination.
43 2021-05-10 mouth swelling, lip swelling, swollen tongue, eye swelling Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient recei... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient received Pfizer covid vaccine, experienced some lip swelling on the way home and stopped by another pharmacy and was given 2 pills of benadryl 25mg. Swelling went down, patient is fine. Reported by pharmacy manager.
43 2021-05-14 loss of smell, loss of taste congestion, poor appetite, fatigue, of taste and smell
43 2021-05-15 ringing in ears tinnitus, ringing in the ears
43 2021-05-18 bloodshot eyes, eye swelling, eye itchiness It was itchy like hives but looked like measles; broke out in a rash on trunk that quickly spread fr... Read more
It was itchy like hives but looked like measles; broke out in a rash on trunk that quickly spread from chin to toes that evening; It was itchy like hives but looked like measles.; It was itchy like hives but looked like measles.; left eye swelled shut and was itchy and red; left eye swelled shut and was itchy and red; left eye swelled shut and was itchy and red; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 43-year-old female patient (no Pregnancy at time of Vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 at the age of 43 years old (Lot Number: ER8730) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient never had allergic reaction before. On 08Apr2021 (day 9 post vaccine), the patient's left eye swelled shut and was itchy and red. She assumed she had pink eye and was treated accordingly. It did not go away. On 15Apr2021 (Day 16), she broke out in a rash on trunk that quickly spread from chin to toes that evening. It was itchy like hives but looked like measles. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Eye drops and steroid creams and antihistamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
43 2021-05-19 ringing in ears fainted; hit my head; I woke up disoriented moments later; ears are ringing from my head hitting; He... Read more
fainted; hit my head; I woke up disoriented moments later; ears are ringing from my head hitting; Headache; Feel dizzy; noticed muscle aches; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 11:15 (at 43 years old, not pregnant) as 2nd dose, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC); mometasone furoate (NASONEX). The patient took Fioricet before and had allergies. The patient had her first dose of bnt162b2 vaccine on 13Apr2021 for Covid-19 Immunisation on left arm at 43 years old. All events reportedly started on 05may2021 03:00. Patient woke up in the middle of the night to use the bathroom. She thought she was feeling fine, but then noticed muscle aches as she walked. She decided to take Motrin. She walked to the sink and felt dizzy. She got so lightheaded, She sat on the edge of the tub with my head between her legs. That was the last thing She remembered. Based on the evidence the next morning, she must have stood up put Motrin in my mouth and poured a glass of water. Then she fainted and hit her head on the bathroom floor. She had never fainted before in her life. She woke up disoriented moments later with two Motrin still on her tongue and having no idea where she was. She had to crawl back to bed. The next morning, she found the spilled a glass of water and Motrin pills all over the floor. She now had a persistent headache and her ears are ringing from her head hitting the bathroom floor. She did not know that dizziness was a potential side effect or she may have taken precautions. The outcome of the events was recovering. No other vaccine in four weeks.No Covid prior vaccination.Not Covid tested post vaccination. Information about the Lot/batch number has been requested.
43 2021-05-25 eye itchiness, swelling of eyelid 7 days after vaccine, "face episodes" erupt; "face episodes" = 7-10 days of eyelids swelling; upper ... Read more
7 days after vaccine, "face episodes" erupt; "face episodes" = 7-10 days of eyelids swelling; upper and lower lids; entire face is burning; tiny red bumps / burning rash on face; THIS ONLY OCCURS ON MY FACE AND EYELIDS. "episode" each episode follows same phases = begins with itching of eyes, skin and eyelids weep or seem to be shiny and oily; then affected areas start to harden and dry over, face feels like alligator skin on top of it; then, affected area chaffs or peels off and reveals somewhat new skin; looks like had a chemical face peel. I have had FOUR major episodes since first Pfizer shot on 04/08/21; affected a total of 30 days on and off, so far. Latest episode ended 05/25/21. *Have pictures!
43 2021-05-26 ringing in ears Headache; Dizzy; had a hemorrhagic stroke in her left pontine/diagnosed with Pontine hemorrhage; whi... Read more
Headache; Dizzy; had a hemorrhagic stroke in her left pontine/diagnosed with Pontine hemorrhage; white blood cell count was a little elevated; her ear was ringing; This is a spontaneous report from a contactable consumer (patient's husband). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 43 years old on 24Apr2021 14:00 (lot number EW0171) given in her left arm at single dose for COVID-19 immunization. Medical history included slightly elevated blood pressure. Concomitant medication included amlodipine besilate (NORVASC) for slightly elevated blood pressure. Historical Vaccine included first dose of BNT162B2 (lot number ER8734) at the age of 43 years old given in her left arm on 03Apr2021 between 14:00-16:00 for COVID-19 immunization. Caller said his wife was in the hospital right now. He said she got the Pfizer COVID-19 vaccine on 24Apr2021 and then on 06May2021 she had a headache and was dizzy, then was admitted to the hospital and they found out she had a hemorrhagic stroke in her left pontine. Caller said that he was asked to report it due to proximity of this happening to getting the vaccine. Caller said his wife's headache and feeling dizzy started on 06May2021 at 2:30. He said that there was no treatment done for the headache. Patient described the headache she was experiencing feeling like she was a little dizzy, and said her ear was ringing, so he took her to go to bathroom and she said she didn't think she was able to stand anymore. He said he was holding her. He called the ambulance and they took her to the hospital where she was admitted 06May2021. This was within an hour or so, since she went by ambulance. Patient was diagnosed with pontine hemorrhage, which they could not treat, a pontine hemorrhage was not treatable, it had to stop bleeding on its own. He said for treatment they have let her rest, there was no surgical option for it, and no interventions that could be done. Caller said his wife's white blood cell count was a little elevated, but nothing came to his mind right now. The outcome of the events were unknown. Information on Lot/Batch number was available. Additional information has been requested.
43 2021-05-27 lip swelling, mouth discomfort, eye swelling dizzy spells; lips swollen & burning; lips swollen & burning; inside cheeks covered with hive like s... Read more
dizzy spells; lips swollen & burning; lips swollen & burning; inside cheeks covered with hive like sores; hives on legs, arms, face; eyes swollen nearly shut/Day 8 swollen eyes/Day 14, 15, 16 random eye swelling; wheezing; Coughing; hard time breathing; all consuming itch in tips of fingers and toes/ hand/foot itch; swollen throat-hard to swallow; swollen throat-hard to swallow; chest spasm; sleepy; Days 2,3,4 lower back and uterus pain; uterus pain; extreme exhaustion; stiffness in joints; This is a spontaneous report received from a contactable consumer, the patient. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 13:00 (NDC Number: ndc 59267-1000-01) as a single dose (at the age of 43 years old) for COVID-19 immunisation. The patient medical history included unspecified allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 16Apr2021 at 07:30 the patient experienced lower back and uterus pain, extreme exhaustion and stiffness joints on 18Apr2021 swollen throat-hard to swallow chest spasm, sleepy; on 19Apr2021 eyes swollen nearly shut, wheezing/coughing, hard time breathing-used inhaler, all consuming itch in tips of fingers and toes, lips swollen & burning, inside cheeks covered with hive like sores, hives on legs, arms, face, took Allegra but no relief; on 20Apr2021 the patient experienced dizzy spells. The events resulted in Doctor or other healthcare professional office/clinic visit. The clinical course is as follows: Days 2,3,4 lower back and uterus pain; Day 5 same plus swollen throat-hard to swallow, chest spasm, sleepy; Day 6 same plus eyes swollen nearly shut, wheezing/coughing, hard time breathing-used inhaler, all consuming itch in tips of fingers and toes, lips swollen & burning, inside cheeks covered with hive like sores, hives on legs, arms, face, took Allegra but no relief; Day 7 same as day 6 + dizzy spells; Day 8 swollen eyes, hand/foot itch less severe but still consuming; Day 9 eyes less swollen, feet/hand itch less consuming; Day 10 manageable itchy feet/hands; Day 11 swollen eyes, itchy hands/feet increased intensity; Day 12 swollen eyes, itchy hands/toes less severe; Day 13 nothing; Day 14, 15, 16 random eye swelling, itchy feet/hands. About a week after last symptoms the patient started getting lower back pain, cramping in her chest and uterus again, it had been intermittent. The patient had been dealing with extreme exhaustion and stiffness in her joints since this all began. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative on 19Apr2021. Therapeutic measures were taken as a result of events wheezing/coughing, hard time breathing for which patient used inhaler, and hives on legs, arms, face for which patient took Allegra. No therapeutic interventions were taken for all other events. The clinical outcome of all events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
43 2021-05-27 mouth tingling, mouth numbness, ear pain sore throat/her throat started hurting very bad and it does not have any signs of stopping; concerne... Read more
sore throat/her throat started hurting very bad and it does not have any signs of stopping; concerned about signs of Bell's palsy; numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips went numb/numbness was all over her face bilaterally/numbness tongue down her throat; numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips numb; numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips numb; lip and right cheek got very tingly/tingling in cheeks and lips; lip and right cheek got very tingly/tingling in cheeks and lips; pounding headache; lightheadedness and dizziness; severe left ear pain; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13May2021 at 09:30 am (at the age of 43 years old) (Lot Number: EW0162; Expiration Date: Jul2021) as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient reported that she got the first dose of the Pfizer COVID-19 vaccine on 13May2021 at 09:30am. At 09:54am, she noticed her lip and right cheek got very tingly/tingling in cheeks and lips and at 10:04 am she had numbness that goes under her chin and down throat then from her tongue to the back of her throat/both cheeks and lips went numb. Then at 12:00 noon, the intense numbness was all over her face bilaterally and had numbness tongue down her throat. At 13:45, her throat started hurting very bad and it does not have any signs of stopping and so she is concerned about signs of Bell's palsy. The patient confirmed that she did not have loss of muscle control, she can still swallow and breathe. She confirmed that she has no signs of stroke. But had severe left ear pain since the vaccine. The patient did not think this is an emergency. She was told to report these to Pfizer. The patient was not sure if she should get the second vaccine and wondered if these were all normal. She declined to provide primary care provider details stating she hasn't been seen by one in a while. She stated that the soreness/hurting of throat was not there at first but is getting worse and also her tongue is also going numb and it's going down the throat. She did not have any weakness, but has pounding headache, some lightheadedness and dizziness, and sore throat on 13May2021. She has not been seen by provider and has not been to emergency room. She did call her family doctor and was instructed to go to the emergency room, but she wanted to see if the symptoms would subside first and notify Pfizer. No other vaccines given the same time on 13May2021 and no other vaccines 4 weeks prior. No problems with vaccines in the past. Outcome of the event severe ear pain was unknown, while not yet recovered from the remaining events. The events Bell's palsy, lip and right cheek got very tingly/tingling in cheeks and lips, numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips went numb/numbness was all over her face bilaterally/numbness tongue down her throat, sore throat/her throat started hurting very bad and it does not have any signs of stopping, pounding headache, and lightheadedness and dizziness were assessed as serious (medically significant). Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
43 2021-05-28 deafness, tunnel vision next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I c... Read more
next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; Hearing loss; tunnel vision; After a couple of minutes, started feeling faint/dizziness; weakness; nausea; got hot; started sweating excessively; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 07Apr2021 20:15 at age of 43-year-old (Batch/Lot Number: Ew0151) at single dose for COVID-19 immunization. Medical history included know allergies to wheat. The patient is not pregnant at the time of report. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks or other medications in two weeks. After a couple of minutes on 07Apr2021 at 20: 30, the patient started feeling faint. Hearing loss, tunnel vision, dizziness, weakness, nausea, got hot and started sweating excessively. The patient was able to walk with assistance after 20-25 minutes. The patient also developed sore arm on 07Apr2021, then the next night of 08Apr2021, she couldn't sleep because she was itchy and feeling ticking all over her body. The events did not result in emergency room visit or physician office visit. There was no treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr2021.
43 2021-05-28 oropharyngeal discomfort At 10:12am, this nurse notified that attendee had complaints of dizziness and lightheadedness. On-si... Read more
At 10:12am, this nurse notified that attendee had complaints of dizziness and lightheadedness. On-site fireman notified. Fireman at side and vital signs at 10:14am: blood pressure 148/82, pulse 99, temperature 97.4F, respirations 22, O2 sats 100% on room air. At 10:14, attendee had complaints of "throat feeling weird" and "upper lip quivering" and "fingertips tingling". Attendee states she has a history of anxiety and has these same symptoms with anxiety attacks. Fireman encouraged patient to slow her breathing. Vital signs at 10:30am: blood pressure 135/80, pulse 81, respirations 20, O2 sats 99% on room air. Daughter present with patient. Attendee stating she was feeling better and more calm and that she did not feel the need to go to the hospital and that sensation of lightheaded and dizzy have passed. Attendee instructed to have her daughter drive home and to contact urgent care or her primary physician if she had any other concerns/issues upon leaving the vaccination site or upon returning home or later in the day. Attendee ambulated out of facility with daughter at about 10:42am. No acute distress noted.
43 2021-05-28 ringing in ears Tinnitus constantly since the day following the second dose. Worse at night and when tired. Never ... Read more
Tinnitus constantly since the day following the second dose. Worse at night and when tired. Never experienced it before vaccinations. It affects ability to relax and sleep.
43 2021-05-29 ear pain Fever, aches, chills, headaches, nausea, exhaustion, sore throat, ear aches, drainage, coughing
43 2021-05-31 ear pain Sharp pain in ear that comes in goes morning after shot that lasted two days. Slightly swollen front... Read more
Sharp pain in ear that comes in goes morning after shot that lasted two days. Slightly swollen front inner part of right shoulder (NOT the arm that was injection) just outside bra strap, two days after shot up to present. Right arm also felt tingly. I took Ibuprofen once last week as well as yesterday and today to see if that would help with inflammation; so far it has not.
43 2021-05-31 swollen tongue, lip swelling, eye swelling Swollen lips, tongue, eyes, or face.
43 2021-06-01 eye irritation sharp shooting pain; she can barely walk; felt like she was hit with a cannonball; bedridden; to be ... Read more
sharp shooting pain; she can barely walk; felt like she was hit with a cannonball; bedridden; to be isolated in part of her lower back and her glutes/back is destroyed/it dissipated to her lower back and glutes and is extremely painful; She can barely move/can barely move, barely get in and out of cars, barely stand up from sitting position; Arm is not sore anymore at all; transverse myelitis; barely stand up from sitting position; panic; inflammation of my lower spine; kind of distracted; difficulty with normal everyday functions; She had muscle aches/All caller's muscle are sore/she had muscle pain in all of her body; fever; Eyes weren't burning anymore/burning eyes; to be isolated in part of her lower back and her glutes/it dissipated to her lower back and glutes and is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the arm left on 11May2021 at 15:00 as single dose for COVID-19 immunisation. Medical history included stomach issues, ongoing lyme disease (this condition started and diagnosed about 10 years ago), hay fever, dust allergy, pollen allergy, animal dander allergy, motion sickness (this condition started probably before Lyme), patient said she got sick when she goes on boat; every time she was on a boat she lost her lunch. Family medical history included diabetes, but the patient has never had diabetes. Concomitant medications included ongoing promethazine for stomach issues (it is antihistamines, nothing radical and taking it since got Lyme disease about 10 years ago), ongoing Belsvia. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 43 years old) as single dose for COVID-19 immunization. The patient previously also received the flu shot several months before. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The patient got her second Pfizer covid vaccine on May 11 and felt like she was hit with a cannonball and was bedridden for a day. She had muscle aches on 12May2021 which she expected but now they seem to be isolated in part of her lower back and her glutes and it seems to be getting worse. Patient can barely move, sit down or stand up and it was a sharp shooting pain. All her other muscle pains have resolved. On 12May2021, patient had muscle aches which though was normal for the first couple of days and so most of the muscle aches went away except the patient back was destroyed that reported as worsened. Stated it was that side of the body in pain. The patient was trying to sit up right now and was having really sharp shooting pain on back. The patient figured this would have resolved itself by now. Stated she was kind of scared this might not go away. On 12May2021, patient arm was not sore anymore at all and eyes weren't burning anymore. The arm was sore day the day after receiving the second dose Pfizer Covid Vaccine, 12May2021. On 12May2021, patient had a fever and about 24 hours the fever lasted; could barely move; burning eyes that back to normal and also lasted for 24 hours. The patient can barely move after receiving second dose Pfizer Covid Vaccine, sharp shooting pains, really, really bad. The patient can barely move, barely get in and out of cars, barely stand up from sitting position. The patient assumes this was a side effect of the second dose Pfizer Covid Vaccine and was it would dissipate by now, but it was getting worse and worse. The patient stated the pain was now isolated to the lower part of her back on the gluts. All muscles were sore, started to get worse, all muscles in whole body were sore but it was now isolated to that area. That was a really big deal, patient can barely function. Thought it would get better, thought it would resolve but it is getting worse. The patient can barely stand up or sit down, that's how bad the pain was. Patient stated it was a pure, really sharp pain and the patient got stuck. The patient got stuck taking a piddle on the toilet for like 15 minutes after the patient first received the second dose Pfizer Covid Vaccine. Patient thought it would go away. All patient's muscle were sore. Noticing it was isolated in that specific area. Pretty much the patient's whole body function was like lower back, whole gluts almost, mainly on injection side. Stated all soreness in whole body, like hit by a cannon ball. The pain in rest of muscles dissipated, they felt normal but the muscles above the gluts, patient's whole function, whole body function was obliterated right now. Whenever the patient tries to move, had a sharp piercing pain. The patient tried to make sure she slept good and in good positions and everything. The patient states she was kind of distracted. Patient can barely walk, she's experiencing sharp shooting pain and difficulty with normal everyday functions (she's been bedridden because even going to the toilet was a big deal, she got stuck and was unable to get up and sit down), she's concerned because the other side-effects resolved but she got the vaccine a week ago and it's getting worse, she had muscle pain in all of her body and it dissipated to her lower back and glutes and was extremely painful. Patient also had burning eyes but this symptom went away and fever. She would like to know if anyone else has experienced anything like this and if it's normal to experience these side-effects, particularly the severe debilitating muscle pain 7 days after the second dose of the vaccine because she still has this symptom and it's getting worse. Patient said she was stuck lying in bed. She said if she switches sides she got the sharpest pain and it was like she gets it in her organs, like her lung was being punctured. Her primary care didn't know her well enough to give her anything for the pain for a couple of days. The pain was sharp, shocking. She felt like its in her hips; she can't even use toilet on her own, it takes forever. She was un-functionable and obliterated. The walking issue started a couple days after the vaccine. It was with all the muscles in her body, she was bedridden. She expected it to resolve. She said it isolated to that area, ironically her arm wasn't sore anymore, nothing else, but she was extremely sore in that area in her glutes. It was getting worse and it made her panic, she was not walking, she was handicapped, she was completely crippled. Also said the muscle pain started the day after her vaccine and went for 7 days after. The difficulty walking start day was hard to say; it was a gradual manifestation and it was not like all of the sudden she got the shot and can't walk. It was several days getting worse and now was is sort of in demise. Clarified these events occurred after her second vaccine, she had no problems with the first. Patient also stated she thought she had developed transverse myelitis, inflammation of her lower spine from the vaccine, from second Pfizer vaccine, side effect, she can barely move. AE(s) did not require a visit to emergency room, for events not being able to barely walk and being in extreme pain that resulted in physician office visit and she went to the doctor's on 17May2021. No surgeries to report. Lab data included body height was 160 cm or 5 feet, 3 inches; patient weight was like 145 pounds. The outcome of events fever, burning eyes was recovered on 13May2021. The outcome of events transverse myelitis, feeling abnormal, bedridden, Movements reduced, Pain in arm, Panic disorder, Spondylitis, Distractibility was unknown; while of the other events was not recovered.
43 2021-06-01 eye pain Within a half hour to 45 minutes post injection, I started having a sharp pain in my left eyebrow. o... Read more
Within a half hour to 45 minutes post injection, I started having a sharp pain in my left eyebrow. over the next hour or so, the pain worsened around my left eye, and I noticed a numbness in my forehead and upper cheeks (Similar feeling to botox but also slightly tingly). The discomfort lasted throughout the evening. By bedtime, I was extremely fatigued and having feverish symptoms (chills, aches, headache, fatigue) though my body temp was not elevated much. When I woke up the next morning, my temperature was increasing, chills and body aches were worse. I was somewhat expecting that, given accounts from others. Highest temp was 102.8 over the next 24 hours. But most concerning was my resting heartrate was elevated all day (tracked via apple watch). My resting HR even while sleeping was from the upper 80s and as high as 103 bpm. After bedtime that night, I started having pretty severe body aches in my torso. Most of the other aches had lessened but these got worse, preventing sleep, and lasted through most of sunday 5/30. By evening, I felt much better, and by Monday, I was back to normal, all symptoms gone.
43 2021-06-01 bloodshot eyes, sensitivity to light, vision blurred My eyes became very blood shot, blurry vision, light sensitive for a couple weeks now.
43 2021-06-01 ringing in ears Ringing in ears; This is a spontaneous report from a contactable consumer (patient) via medical info... Read more
Ringing in ears; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, lot Number: EW0176, expiration date: unknown), via an unspecified route of administration in the right arm on 28Apr2021 at 11:45 (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history included Asthma (diagnosed when 2 years old). Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, lot Number: EP7533, expiration date: unknown), via Intramuscular route of administration in the right arm on 07Apr2021 at 11:45 as a single dose for COVID-19 immunization. On 05May2021, her ears are ringing so loud, she can't sleep or hear, this started one week after she received the second dose of the Pfizer COVID-19 vaccine and she has an appointment tomorrow with ENT. The ringing was a little bit in her right ear, but it was more in the left ear. She wants to know why she feels tinnitus, why ringing in ears, hissing, and weird sounds are not listed as a side effect. She feels like it should be listed as a side effect since hundreds of people are saying it was a side effect. She stated, "it has ruined her life". The outcome of the event was not resolved.
43 2021-06-02 loss of taste, loss of smell I had the vaccine and I got sick immediately after like 4 hours after and each day I got sicker and ... Read more
I had the vaccine and I got sick immediately after like 4 hours after and each day I got sicker and sicker, I had fever, chills, sore throat, and each day I felt crappier, the head ache, stomach ache, diarrhea, we assumed it was from the vaccine and Friday I woke up with a rash all the way from my arm to my hand, and that day I kind of knew this was not because of the vaccine and I called my doctor and he said this does not seem like from the vaccine but he had me go to his office and when he saw my arm he said we should get you tested for Covid. On Saturday I woke up and we were supposed to go to our friends house and I felt miserable and I could not smell her essential oils. For dinner we were having chicken tacos and I could not taste anything. By then I knew I had Covid and I still went and got the test on Saturday morning, and tested positive. I did not have apetite and I wanted every blanket on me. My boss called and he had Covid too. I insisted my client got tested too. I was scared to sleep because I was shocking in the mucus. They recommended a chest x-ray but I was too sick to get it done. Even now I still have a hard time. Now I have bronchitis and I am going to the doctor on Friday to see if this is a result of Covid or something not related. Right now I am on antibiotics, steroids, and inhaler.
43 2021-06-02 deafness unilateral Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade... Read more
Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
43 2021-06-03 dry mouth Tingling in arm, arm sore to touch, dry mouth, nauseous, headache
43 2021-06-03 eye swelling Left eye got swelled up; Stye; Vaginal infection; This is a spontaneous report from a contactable co... Read more
Left eye got swelled up; Stye; Vaginal infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the first of two reports. This report is for the events related to the first vaccine dose. A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration in the right arm on 05Apr2021 at 09:45am (Batch/Lot number: Unknown, at the age of 43 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included migraines. The patient has no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were reported as none. The patient did not receive any other medications within 2 weeks of vaccination. Clinical course included: On 05Apr2021 at 09:45am the patient received the first dose of BNT162B2. On 08Apr2021, 3 days after the first dose of BNT162B2, her left eye swelled up. She went to the ophthalmologist and was told she had a stye. She was prescribed Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic. The same day she woke up with what she thought was a vaginal infection. She went to the gynecologist and was prescribed Diflucan. The patient fulfilled both treatments and was fine. The events resulted in a visit to physician or other health professional office, urgency or emergency room/department. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events left eye swelled up, stye and vaginal infection was recovered. Information on the lot/batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021577114 same report/patient/vaccine, different dose/AE.
43 2021-06-03 ringing in ears Immediately after receiving my first shot, blood pressure shot up to 148/60 (normally 120/60 or less... Read more
Immediately after receiving my first shot, blood pressure shot up to 148/60 (normally 120/60 or less), heart racing, felt dizzy, and legs felt funny, heavy. This higher heart rate persisted throughout the first day and evening, and on day 2 I woke up with wheezing and was sent to the ER. Blood pressure readings there were the same. Had a headache for three days also. On day 3, started feeling slightly better, but then awoke with lightheadedness, brain fog, tinnitus, and the feeling of a tight scalp. This persisted for two more days. On 6/1 was seen in outpatient care with blood pressure still higher (138/60), and tinnitus, with lower legs feeling like they were in cold water.
43 2021-06-03 vision blurred At approximately 1442, client reports to nurse feeling dizziness, sweating, shakiness, palpitations ... Read more
At approximately 1442, client reports to nurse feeling dizziness, sweating, shakiness, palpitations and blurred vision and stated ? it feels like my sugar is low.? Patient reported she did not have glucometer and had been feeling like this for 10 minutes. EMT assessed patient vitals: blood pressure 140/90 mmHg, pulse 110 beats/minute and SpO2 99%. Patient reported history of diabetes mellitus type 2, asthma, leukemia, and ovarian cancer. Patient reported taking metformin, insulin, and an inhaler. At 1443, nurse activated EMS. At 1451, paramedics arrived and assumed care. Patient blood sugar was 123. Patient declines transport to hospital and signed Against Medical Advice form. At approximately 1500, paramedics left facility. Patient vitals reassessed at 1505: blood pressure 130/90 mmHg, pulse 102 beats/minute, and SpO2 99%. Patient stands up and reports feeling dizzy again. Nurse offered crackers. Patient consumed crackers and stated she felt better and was not dizzy anymore. At 1316 lead nurses assisted patient who is pushing her mother in a wheelchair to her vehicle. Patient left facility with steady gait and unlabored respirations.
43 2021-06-06 deafness unilateral Sudden hearing loss, left ear, onset 6/2/2021. On 60 MG prednisone taper, starting 6/6/2021
43 2021-06-07 taste disorder, ringing in ears Vertigo and dizziness onset about 2 minutes of receiving 2nd shot. Sudden tingling in nose and weird... Read more
Vertigo and dizziness onset about 2 minutes of receiving 2nd shot. Sudden tingling in nose and weird taste in mouth. Racing heart. Pharmacist administered Epi Pen, and I was transported to the ER via Ambulance. Vertigo, dizziness, giddiness ever since. Shortness odd breath, not resolved yet either. Developed Atypical Pneumonia 6 weeks after second shot. Leg pain when resting. Heart palpitations, and heart pounding. Unusual heavy, long and incredibly painful Menstruation after first shot. Feeling of difficulty swallowing after second shot for several days. Feeling of "electrical" mini shots in random places of my left side (inner thigh, underside of arm, in my eye etc.). Off and on ear sounds left ear. Joint/foot pain left foot after first shot.
43 2021-06-07 vision blurred, eye disorder, eye swelling, eye pain Severe headache; Blurred vision; Unable to move left eye; Lost vision in left eye due to swelling; L... Read more
Severe headache; Blurred vision; Unable to move left eye; Lost vision in left eye due to swelling; Left eyelid is drooping; Left eye pain; the vision loss is most likely temporary; Orbital Maltumor; This is a spontaneous report received from a contactable consumer (Patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Apr2021 13:00 (Batch/Lot Number: ER8736; Expiration Date: 31Jul2021) (at age of 43-year-old) as 1ST DOSE 0.3ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took Vaccine Tdap and experienced Sore arm, headache, and fever; took Flu shot and experienced Headache, Fever, and gets sick. There was no other vaccine in four weeks. Caller reported that she gets sick each time after she gets the flu shot. The patient experienced severe headache on 01May2021 , blurred vision, unable to move left eye , orbital maltumor, lost vision in left eye due to swelling, and left eyelid is drooping, and left eye pain, all on May2021 . The patient underwent lab tests and procedures which included blood glucose: normal on 12May2021, computerised tomogram: normal on 12May2021, magnetic resonance imaging: normal on 12May2021, magnetic resonance imaging: orbital maltumor left eye on 16May2021, multiple sclerosis: normal on 12May2021, myasthenia gravis: normal on 12May2021, thyroid releasing hormone challenge test: normal on 12May2021 . Clinical details: Caller reported that she got the first dose of the Covid-19 vaccine on 30Apr2021. Caller reported that the next day, 01May2021, she had a severe headache. Caller reported that the headache carried on for almost 3 weeks. Caller reported that she also experienced blurred vision and is unable to move her left eye. Caller reported that her physicians have run tests and informed her that there is a known side effect of the Covid-19 vaccine where the muscles in the face get attacked. Caller reported that she had a CT, MRI, and blood work performed to rule out everything else. Caller reported that the severe headache, blurred vision, and inability to move her left eye are a really weird and unusual things to happen and it is coinciding with the Covid-19 vaccine.Caller reported that she has been to the ophthalmologist and neurologist to figure out what's going on. Severe headache: Caller reported that the pressure behind her eye is causing her headache. Caller reported that the headache is in the back of her head and eye. Caller reported that her headache has improved. Caller reported that her headache is no longer running at a 7 and is now more like a 4. Blurred vision: Caller reported that the blurred vision started about a week and a half after she received the first dose of the Covid-19 vaccine on 30Apr2021. Caller reported that after 2 weeks, the blurred vision had escalated to where she went to the emergency room. Unable to move left eye: Caller reported that the inability to move her left eye began about a week and a half after she received the first dose of the Covid-19 vaccine on 30Apr2021. Orbital maltumor: Caller reported that the orbital maltumor is what is restricting the movement in her eye as well as giving her the severe headache and blurred vision. Caller reported that her physician informed her that it could be a rare side effect of the Covid-19 vaccine. Caller reported that her neurologist did not seem too concerned about it. Caller reported that she is following up with her neurologist in 2 weeks. Lost vision in eye because of swelling: Caller reported that the vision loss is most likely temporary and that her vision will most likely return after the swelling decreases. Eyelid drooping: Caller reported that her eyelid is drooping slightly more this week than last week. Caller reported that her drooping eyelid is not very obvious, but it's noticeable when her eyes are closed. Left eye pain: Caller reported that she was trying to move her eye just to see better when the blurred vision began and her eye started hurting if she was looking up or to the left. Caller reported that the swelling behind her eye has gone down and the pain in her eye has gone down.Caller reported that she was prescribed steroids for the orbital maltumor and swelling in her eye. Caller reported that she has been on steroids for 3 days and that her eye is improving. Investigations: Caller reported that bloodwork was performed in order to determine what was causing her symptoms. Caller reported that she was tested for myasthenia gravis and multiple sclerosis. Caller reported that her thyroid and glucose level were also checked. Caller reported that all of her blood work came back fine. events Blurred vision, unable to move left eye, orbital maltumor require a visit to: Emergency Room and Physician Office. Caller reported that blood work was drawn to test her thyroid and blood glucose levels as well as to check for myasthenia gravis and multiple sclerosis. Caller reported that the blood work all came back fine. The outcome of events were resolving.
43 2021-06-08 loss of taste Update: 1st day 5/27/2021 afterwards I had to leave work early bc I was dizzy, nauseous, body aches,... Read more
Update: 1st day 5/27/2021 afterwards I had to leave work early bc I was dizzy, nauseous, body aches, very weak. Day 2 was better in the morning but as the day went more body aches and headaches. Towards the end of day 2 I can?t taste anything. Day 3 sinus is all the getting on my last nerves. Nose running, head congestion, body aches, and still can?t taste anything. Now I don?t know if it?s just my allergies bc I was in pollen a little bit yesterday. PLEASE understand that I am sensitive to foreign things and have had reactions to other vaccines.
43 2021-06-08 eye swelling, bloodshot eyes Today, 2nd after the second shot, my eyes are almost totally swollen and red as if I were sunburned.... Read more
Today, 2nd after the second shot, my eyes are almost totally swollen and red as if I were sunburned. I've never had any allergic reactions in the past, so it's a little new to me. Ice patches and Benadryl are helping a little bit.
43 2021-06-08 eye swelling early menstuation within 48 hours and extremely heavy, extreme fatigue, extreme swelling around eyes... Read more
early menstuation within 48 hours and extremely heavy, extreme fatigue, extreme swelling around eyes, joints and face, pain in joints and back. symptoms subsided after 60 days
43 2021-06-08 pain in jaw Second dose of Pfizer 4/9/21 and was admitted with low level positive troponin after symptoms for 1 ... Read more
Second dose of Pfizer 4/9/21 and was admitted with low level positive troponin after symptoms for 1 week (posterior neck discomfort radiating to jaw and shoulder along with nausea, feeling uncomfortable, discomfort in upper chest).
43 2021-06-08 tongue disorder Patient received Pfizer vaccine, before sitting in waiting area. Almost immediately complained of S... Read more
Patient received Pfizer vaccine, before sitting in waiting area. Almost immediately complained of SOB and tongue feeling thick. Epipen given. BP 180/68 HR163 POX 93% on RA. Stat Team called. BP down to 158/42, HR 137, Pulse ox 99% on 2L, tongue feeling better and less SOB. Move to ER with stat team.
43 2021-06-09 ringing in ears Exactly two weeks after I developed severe chills, and a horrible headache. Around this time I also... Read more
Exactly two weeks after I developed severe chills, and a horrible headache. Around this time I also developed a rash on the right/back side of my midsection I thought was poison Ivy because I spend a lot of time outdoors exercising. I am not allergic to poison Ivy however, and it was not very itchy (just a little). I took a picture. Then developed a small painful rash on the front of my right/back midsection with little pustules. The headache got worse over days and severe lower back pain and gas. When I laid down I could hear blood pumping in my ears. I missed two and a half days of work despite working from home and needing to be present online. The whole thing lasted a week, but I have a mark from the second rash still on me despite that is it is a month or so later.
43 2021-06-09 vision blurred, blindness, oropharyngeal discomfort, eye pain migraine headache disease; her eye is producing gunk; Almost kind of like pink eye; felt like a thou... Read more
migraine headache disease; her eye is producing gunk; Almost kind of like pink eye; felt like a thousand needles are in the patient's eye; losing her vision; Blurriness; maybe allergies; arm started hurting worse than it did after the caller received the first dose; throat is all scratchy; spot where the caller received the second dose Pfizer Covid Vaccine was sort of hard to the touch; This is a spontaneous report from contactable consumer (patient herself). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right upper arm on 19May2021 (Batch/Lot Number: EP6955) as 2nd dose, single for COVID-19 immunisation. The patient had no relevant medical history and no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right upper arm on 28Apr2021 (Batch/Lot Number: EW0176) as 1st dose, single for COVID-19 immunization and experienced arm started hurting, felt like had a flu, started losing voice, had a hard spot, being lethargic, and had a hoarse voice. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 19May2021, the patient received her second dose Pfizer Covid Vaccine and her arm started hurting worse than it did after she received the first dose Pfizer Covid Vaccine. The patient has started losing her voice. The worst thing of it was, the patient was now losing her vision. She cannot see anything close up, all blurry. This began the next day after receiving the second dose Pfizer Covid Vaccine, 20May2021. She probably wouldn't have thought much of it, mentioned it to her husband, who was a medic. The patient's husband said something like allergies increase. She ignored it and the next day she had an online appointment with someone and that person mentioned the patient was clawing at her eyes. That was when the blurriness started. The white of her eye was not red, but during the day her eye was producing gunk. Almost kind of like pink eye. She wakes up in the morning and has gunk in her eye. The patient had been putting Visine Red Eye Comfort (lot numbers: KAB6601, expiration date: Jan2023) in her eye and it was not helping. She read online and searched and found a woman who lost her vision after receiving the Pfizer Covid Vaccine. She said Pfizer's list stated inflammation may be possible and a list of more serious side effects listed was eye blurriness. Sher stated her vision was getting worse every day. The worst thing of it was now losing vision. If she closes her eyes like a little bit more than just blinking, closes where put eyelids together, this felt like a thousand needles are in the patient's eye. Everyday her eyes have gotten worse. For example, while watching a program on television, she could not tell the faces of the people and said she didn't know what was going on. Because it was so blurry, she thought maybe it was screen time and she tried everything. Today, the patient was quiet worried and it seemed like it has progressed. It had multiplied, everyday it gets worse by 20%. It was twice as bad today as it was yesterday. The patient was a little frightened. The patient's throat was all scratchy. She had a headache but said that was kind of normal. She gets headaches on a daily basis, but the headache was not going away. She had migraine headache disease and doesn't think she had headaches because of the second dose Pfizer Covid Vaccine. The patient stated she has quarantined and hasn't gone anywhere, no group stuff, nothing. She was afraid it's from the Pfizer Covid Vaccine, it was maybe allergies, even though she has never had allergies her whole life. If it was not pink eye, the patient did not want to take antibiotics. She only takes antibiotics for what was needed. She was confused if her eyes get worse, if it was more difficult to blink or more blurry. She knew one of the things she looked at said a very strained side effect was Covid Eye or whatever after receiving the Pfizer Covid Vaccine, but it blurs vision and may clear up after a few days. If she goes to the doctor and he says this might be a side effect, she doesn't know that the doctor will do anything or know what to do. If better or worse the patient stated she will call Pfizer back to report. She does not know how many people got this batch of the Pfizer Covid Vaccine. The events did not require visit to the emergency room or the physician's office. The patient stated she thought she better call because she doesn't want other people getting the Pfizer Covid Vaccine if maybe it was off or the pharmacy was not handling the medication right. The outcome of the event 'arm started hurting worse than it did after the caller received the first dose' was recovered on 25May2021, of losing her vision and blurriness was not recovered, and of remaining events was unknown. No follow-up attempts are needed. No further information is expected.
43 2021-06-10 eye twitching BELLS PHALSY, PARTIAL FACE PARALYSIS, RIGHT EYE & LIP TWITCH
44 2021-01-02 swollen tongue numb pockets on face, a little swelling of tongue and a little tired/flushed
44 2021-01-03 eye irritation first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong ... Read more
first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.
44 2021-01-04 ear pain, mouth tingling, mouth numbness Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin... Read more
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
44 2021-01-04 ear pain, toothache pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; te... Read more
pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.
44 2021-01-04 lip swelling, mouth tingling Tingling of top lip with mild swelling
44 2021-01-04 feeling of choking, mouth numbness, mouth tingling lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips... Read more
lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; developed a cough once the numbness and tingling reached my throat; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 15:30 at a single dose for COVID-19 immunization. Medical history included thyroidectomy for thyroid cancer, anaphylaxis to mangoes and allergic to multiple medications. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine and liothyronine. The patient received the vaccine at 3:30pm, ten minutes later her lips, tongue and throat became numb and tingly. She developed a cough once the numbness and tingling reached my throat. She was given Benadryl at the time, 15 minutes after injection. She was still having numbness and tingling to the back of her tongue currently (8 days after injection). The patient was not hospitalized for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.
44 2021-01-06 taste impairment Following administration of the first dose of COVID-19 vaccine (Pfizer), pt reported feeling tired a... Read more
Following administration of the first dose of COVID-19 vaccine (Pfizer), pt reported feeling tired and having a "metallic taste" in her mouth. Pt reported very little fluid or food intake prior to the vaccine. Given Gatorade and crackers; monitored for 30 min. Symptoms resolved. Patient received 2nd dose of vaccine on 1/6/2021 and no adverse reactions were reported during the 30 minute monitoring period.
44 2021-01-06 taste impairment Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hur... Read more
Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face
44 2021-01-06 mouth tingling Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccin... Read more
Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccination. Patient was provided 50mg Benadryl and observed for 15-20 minutes at which point they began improving. Patient was checked in on after about an hour and was doing okay.
44 2021-01-07 loss of smell slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positiv... Read more
slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.
44 2021-01-07 blindness in both eyes I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning... Read more
I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning it was pounding, spread to the right half of my head, nausea, photo sensitivity, vertigo. It took 36 to 48 hours before I could function. 48 to 72 hours later I had another headache with vertigo. I had complete vision loss in my left eye.
44 2021-01-07 ear pain Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5... Read more
Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5/21 both negative. Symptoms continued ear infection 1/6/21, nausea and chest pain. 1/7/21 vomiting and diarrhea started. Going in for COVID swab this am. And seeing a provider.
44 2021-01-07 ear itchiness Redness and itching on the left ear lobe and nose, lasted for about 1 hour and symptoms resolved on ... Read more
Redness and itching on the left ear lobe and nose, lasted for about 1 hour and symptoms resolved on its own in 1 hour. Did not need to call physician.
44 2021-01-07 eye irritation, taste impairment Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; m... Read more
Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; metallic taste in the mouth; burning in the eyes; chills; shaking; This is a spontaneous report from a contactable physician, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection on 24Dec2020 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020 at 07:00, the patient experienced sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking which lead to doctor or other healthcare professional office/clinic visit. Treatment was provided for the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking with NSAIDs. The outcome of the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking was not recovered. Since the vaccination, the patient has been tested for COVID-19 on 30Dec2020 via Nasal Swab and Antigen test and both were negative.
44 2021-01-07 eye swelling I am a physician and received 2 doses of the Pfizer COvID vaccine. First dose 12/20/20. Second dose ... Read more
I am a physician and received 2 doses of the Pfizer COvID vaccine. First dose 12/20/20. Second dose 1/6/2021. Forty- eight hours after second dose I had moderate to severe under eye swelling at site of dermal fillers I received May 20,2020 requiring steroids and antihistamine. I also had severe myalgias and fever 12 -36 hours after my second dose.
44 2021-01-07 mouth numbness Myalgia bottom lip feels heavy, jaw feels heavy, bottom lip and jaw numbness Narrative:
44 2021-01-07 thirst Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became ha... Read more
Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.
44 2021-01-08 dry mouth 1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelli... Read more
1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelling, chills and dry mouth
44 2021-01-08 ear discomfort, mouth tingling 1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my l... Read more
1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my lips (right side only). This turned into an icy, burning sensation that traveled up my right cheek, ear and scalp and stayed for 2 hours. The feeling returned that night at an unknown time and I felt fine the next day.
44 2021-01-09 eye swelling I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face ... Read more
I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face and mainly my eye lids were extremely swollen. Later in the day, ~noon I spiked a fever of 102.4. I had overall body aches and chills.
44 2021-01-10 oropharyngeal discomfort about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even ... Read more
about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even with Bendryl. End of second day had sore "fiery" throat. Felt like throat was on fire lasted for a week. Nothing made it better.
44 2021-01-10 oropharyngeal discomfort Dec 17th, my throat felt scratchy, 45 minutes later I was wheezing.
44 2021-01-10 feeling of choking Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tin... Read more
Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tingling on her face and then after 5 more minutes she said she felt her throat tingling. Our safety officer who is a DR was called ans ordered a dose of epinephrine 0.5 ml to be given and then call the EMS.
44 2021-01-11 eye itchiness, taste disorder Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild f... Read more
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells. Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
44 2021-01-11 eye itchiness, taste disorder 1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a... Read more
1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home
44 2021-01-11 mouth numbness About one hour after receiving the vaccine, my tongue went numb for about 12 hours. I had taste and ... Read more
About one hour after receiving the vaccine, my tongue went numb for about 12 hours. I had taste and smell, but tongue was numb.
44 2021-01-11 mouth numbness Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult brea... Read more
Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult breathing. Patient also reported numbness of the lips. Symptoms occurred within 5 minutes of vaccine administration. Epinephrine 0.3mg pen was administered at 11:05 per protocol. One diphenhydramine 50mg capsule was administered at 11:07 per protocol. Patient reported easier breathing and increased heart rate almost immediately. Her throat felt like she "swallowed an ice-cube sideways". Within 10 minutes, the patient reported that her lips and throat felt better, but still tingles. States that it was "like she had recently shaved". A wheelchair was provided by the long-term care facility staff, and the patient was wheeled to the ER within the facility. Patient arrived at ER at 11:18 and pass-off to the ER team was completed around 11:20.
44 2021-01-11 swollen tongue Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured fo... Read more
Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured for 3 minutes.
44 2021-01-12 eye pain Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/202... Read more
Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/2021. Rashes started on 06/09/2021. On 06/10/2021, I went to the emergency room, diagnosis with Shingles, and the doctor prescribed Valacyclovir.
44 2021-01-12 eye pain Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Ras... Read more
Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Rashes started on 01/09/2021. I went to the emergency room on 01/10/2021, diagnosed with shingles, started treatment with Valacyclovir.
44 2021-01-12 lip swelling @0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also re... Read more
@0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also reporting numbness to lips as well. Same reaction to the initial dose. Patient stated it did not feel worse than the initial time. By 0735, symptoms resolved.
44 2021-01-12 vision blurred 10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was swea... Read more
10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was sweating and short of breath. My peripheral vision was cloudy. This lasted approx ten minutes.
44 2021-01-13 loss of smell Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I ... Read more
Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I lost my sense of smell which lasted about 1.5 week and my arm was sore, heavy and red at the injection site. The soreness and the feeling of heaviness ended the next day but the redness stayed for about 5 days and changed to a bruise which then stayed for about 1 another week. On the 29th I was given a COVID-19 test which came back positive. I noticed when I lay flat I cough alot but when I prop myself up I dont.
44 2021-01-13 taste impairment Voiced metallic taste/nausea. Inintal compliant began @ 1340. Left observation @ 1400. Denies any... Read more
Voiced metallic taste/nausea. Inintal compliant began @ 1340. Left observation @ 1400. Denies any other s/s of distress. No SOB/Trouble breathing as well.
44 2021-01-13 ear pain Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck),... Read more
Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck), and muscle aches in upper back. This continued through the weekend. On Wednesday, 1/6/2021, she saw a provider for ear pain, chest pain (radiating to right arm). She was not prescribed/given treatment regimen. On Thursday, 1/7/2021, night, she started to have vomiting diarrhea, and chest pain. On Friday, 1/8/2021, she went in to be seen for chest pain and r/o PE. States she has a history of PE and had a CT performed, no clots found. EE states does not have vomiting and diarrhea from 1/13/2021 for the first time since the start of this symptoms. Continues to have GI issues: decreased appetite and upset stomach. Also states she feels very fatigued.
44 2021-01-13 burning mouth syndrome Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness imme... Read more
Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness immediately after getting her first dose of the Pfizer COVID-19 vaccine at 1030 this morning. 26 minutes later the symptoms are followed by cold sweats. She feels much better now, does not now, did not have shortness of breath, nausea, vomiting, wheezing, change in voice, difficulty swallowing. Patient reports the symptoms are similar to but much milder than the symptoms she gets during rituximab infusion for her myasthenia gravis. Patient notes that she took Zyrtec and acetaminophen at 9:00 as premedication. Prior to this patient had been well, no fevers, nausea, vomiting, diarrhea, chest pain, shortness of breath, cough, sore throat, urinary problems, or other problems. Patient did not receive any additional therapy in the ED. She was observed for 2 hours in the ED and was subsequently discharged home.
44 2021-01-13 burning mouth syndrome "my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild ... Read more
"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild soreness to back of tongue. sent for obs. took zyrtec, tylenol prior to getting vaccine. eupneic, a/ox4, skin w/d. no distress" Blood pressur 160/91
44 2021-01-14 dry mouth Nausea, Dizziness, anxiousness, elevated Blood pressure, dry mouth, tachycardia
44 2021-01-14 bloodshot eyes, eye discomfort Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c... Read more
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
44 2021-01-14 swollen tongue After the administration of the COVID-19 vaccine, during the observation period, the patient showed ... Read more
After the administration of the COVID-19 vaccine, during the observation period, the patient showed a swollen tongue and shortness of breath
44 2021-01-16 vision blurred 1/9/2021: 0230: Woke with headache and generalized muscle aches 1200: Generalized muscle aches, seve... Read more
1/9/2021: 0230: Woke with headache and generalized muscle aches 1200: Generalized muscle aches, severe headache and blurry vision
44 2021-01-17 ear discomfort My face started to go numb and feel tingly. My ears also felt plugged, as if I were changing elevat... Read more
My face started to go numb and feel tingly. My ears also felt plugged, as if I were changing elevations. The effects lasted for a little over an hour.
44 2021-01-17 mouth tingling Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis ... Read more
Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis on arms and rash erupted - fine; erythema, warmth, HR 8, R 18, Pulse ox 97%, lungs clear. At 11:45, she noted tingling of the tongue, but no enlargement. Benadryl 25mg given PO at this time. At 12:00, she noted fingers tingling. At 12:20: HR 98, pulseox 97%. At 12:25: Rash, pruritis on right leg just below knees and behind the left knee.
44 2021-01-18 eye pain fever, joint pain, muscle pain, eye pain. called in sick to work.
44 2021-01-18 feeling of choking, oropharyngeal discomfort The patient received the COVID-19 vaccine at approximately 10:00 and within 10 minutes stated that h... Read more
The patient received the COVID-19 vaccine at approximately 10:00 and within 10 minutes stated that her throat was tingling and scratchy and she felt like she had something in her throat. She proceeded to try to clear her throat. These symptoms worsened and the patient was sent to the ED for observation/treatment. Benadryl 25mg IVP, Pepcid 20mg IVP, Solu-Medrol 125mg IVP and Zofran 4mg IVP was administered at 10:54. Then a GI Cocktail was also administered PO (contains Donnatol, Lidocaine and Maalox) immediately following. Ativan 0.5mg IVP was administered at 11:28. The patient was discharged home at 12:27 and was stable. Take home prescription from the ED was for Prednisone 40mg daily for 5 days.
44 2021-01-19 lip swelling Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team ... Read more
Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team of previous allergic reactions to H1N1 vaccine (anaphlyxis - swelling of mouth, lips and tongue) and flu vaccine (head to toe hives). Patient was counseled by lead pharmacist regarding risk and and data related to vaccine. Patient agreed to receive vaccine. Informed patient that we would monitor for potential reaction for 30 minutes, patient agreed to stay. Patient was observed by nursing. At approximately, 1850 patient reported that she felt her lips swelling, and noted to have difficulty in her speech. She has administered 50mg Benadryl suspension. Vital signs taken: 1900: 147/92; 82; 97% room air 1905: 132/101; 84; 97% room air 1910: 145/104; 84; 97% room air. 1915: 147/104; 81; 97% room air RN observer called vaccine physician on call at 1915 regarding patient status. Patient was then observed to have hives around her neck, upper chest and arms. RN then called again at 1924. Was advised to send patient to the ED. RN called ambulance and was advised to administer epinephrine. Pharmacist pulled up 0.3mL of epinephrine. Administered injection in right thigh at 1934. Ambulance called and arrived on site at 1936. Patient was assessed, IV access secured and transferred to ED for further observation. Observed for 4 hours with improvement in symptoms. sent home with prednisone. Patient contacted the next day and reported hives on arms, face, back, hands as well as swollen lips and fever to 101.6. Contacted again the following day and symptoms were resolving. Patient is tracking symptoms in VSAFE
44 2021-01-20 loss of smell, loss of taste near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for C... Read more
near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
44 2021-01-21 eye swelling Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye... Read more
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
44 2021-01-21 mouth itchiness, eye itchiness 48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes... Read more
48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes, mouth, and throat, coughing, and slight constriction in my lungs. Within 30 minutes of taking Benadryl the symptoms began to subside. After the allergic reaction, I developed the normal symptoms of the vaccine with chills, fever, body aches and a headache. Injection site had increased soreness for the rest of the day.
44 2021-01-21 thirst, dry mouth Dry mouth, extreme thirst, digestive distress. Onset approximately 12 hours post injection. Lasting ... Read more
Dry mouth, extreme thirst, digestive distress. Onset approximately 12 hours post injection. Lasting until the next day. Resolved over time.
44 2021-01-21 ringing in ears I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my... Read more
I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my left arm all the way to the finger was swollen. I had pain in the wrist arm, joints and fingers. I determined it was due to the swelling. I had some lymph node enlargement, and was really fatigue and slept most of the day. (36 hours). I did not have a fever. I'm a doctor and did some evaluations on myself. I didn't have trouble breathing of swallowing. If I wasn't medically trained I would have gone into the doctor. I did see an ENT for hearing test to make sure there was no damage and there was not.
44 2021-01-24 mouth tingling After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later pa... Read more
After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later patient was C/O tight throat, Solumedrol 60mg IM administered to Rt buttocks by this nurse. Pt then escorted to ER for further evaluation. On 1/25/21 at 1359: Patient reported tingling of lips and throat felt tight. SPO2 via finger with a result of 99%. Emergency room provider's note: 44-year-old female patient presents ED after allergic reaction. Patient received her first COVID-19 vaccination and during the 15-minute observation period began to feel as if she had some tightness in her throat and difficulty swallowing. She has a scratchy sensation to her posterior pharynx. She denies specifically shortness of breath, nausea vomiting, dizziness or near syncope. She was medicated with 50 mg of Benadryl p.o. as well as 60 mg of Solu-Medrol IM prior to arrival. She states she has never previously had allergic reactions to vaccinations in the past
44 2021-01-24 mouth tingling Tingling around the mouth, throat swelling, and bronchospastic cough
44 2021-01-24 sensitivity to light Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck,... Read more
Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck, behind eyes, and top of head) throbbing pain. Hurt to move eyes. Photosensitivity (eyes must remain shut at all times) Nausea, fever (102.3), sweats, chills Severe body aches (most prominent in lower back, hips, and legs/knees) Tylenol/ibuprofen alternating (reduced pain down to 4/10) 1st applied ice to lower back and surrounded head. This allowed me to sleep for almost 4 hours. Then applied heat to lower back. Continued to drink normally and eat bland diet These symptoms lasted all day. Around 11:30pm on 1/25 symptoms resolved with the exception of a headache requiring ice packs again throughout the night and tylenol. 9:22am today, still mild headache and get dizzy or a vertigo feeling if I change position too quickly or rotate my head too quickly
44 2021-01-24 toothache Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur... Read more
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
44 2021-01-25 taste disorder Patient presented with possible allergic reaction described as feeling "tingles everywhere" and "wei... Read more
Patient presented with possible allergic reaction described as feeling "tingles everywhere" and "weird taste" in mouth. The symptoms began about 15 minutes ago after receiving the Pfizer COVID vaccine dose #1 Patient was treated with Benadryl, Solu-medrol and NS 1L bolus. Symptoms improved. Normal lung sounds. No signs of further reaction
44 2021-01-25 vision blurred Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision.... Read more
Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision. Patient almost fell while walking and was sat down. Patient was clammy and diaphoretic and blood pressure was elevated from her normal but O2 was normal. No swelling but patient reported drainage in her throat, a thick mucus like feeling. Ambulance was called and patient was taken away on stretcher, was not able to stand to get on stretcher.
44 2021-01-25 vision blurred Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizzines... Read more
Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.
44 2021-01-26 mouth tingling, taste impairment Metallic Taste / Tingly lips. Observed for 30 minutes. Only reported symptoms at 15 minute mark in... Read more
Metallic Taste / Tingly lips. Observed for 30 minutes. Only reported symptoms at 15 minute mark in observation and reported improving. denies any symptoms of throat swelling. Released to home.
44 2021-01-26 ringing in ears Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing... Read more
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
44 2021-01-26 tongue itchiness surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue... Read more
surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue; Headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the vaccine, patient had hives and an itchy tongue on an unspecified date in Jan2021. Patient received some Benadryl at site. She spoke for about two hours and it seemed to ease a little bit. Patient came home and slept a quite a bit. As soon as she woke up, patient had the itchy tongue and hives again, so she took another the Benadryl. She woke up and then had a blistering rash all over on Jan2021. But the blisters were like surface blisters, like deep blisters all over her body. She went to the urgent care and received some IM steroid and Benadryl as treatment. Patient also had the headache on Jan2021. Outcome of the events was unknown. Patient was asking if she should get her second dose as back in the emergency room, they said they would not suggest to get the second dose.; Sender's Comments: Based on the time association, the blistery rash is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-01-26 vision blurred Complained of blurred vision, and feeling lightheaded and dizzy. Vital signs were within normal limi... Read more
Complained of blurred vision, and feeling lightheaded and dizzy. Vital signs were within normal limits. O2 saturation normal. Started about 15 minutes after vaccination and lasted another 15 minutes. No medications or other interventions needed. Will follow up with their physician.
44 2021-01-27 inability to speak Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Sy... Read more
Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Symptoms lasted 2 days.
44 2021-01-27 dry throat 40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to ... Read more
40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to forehead, to right ear and to right side neck, followed by sudden throat dryness. BP 165/122, HR 120, Pts normal BP 90-100 systolic 80's diastolic, Hr usually 80's. about 1 hr later mild headache, left arm soreness. 2nd day after sensation of palpitations, day 3 sensation of palpitations, HR 108 on one measurement.
44 2021-01-27 eye swelling, eye irritation bilateral eye irritation; edematous right eyelid since day of 2nd vaccine; This is a spontaneous rep... Read more
bilateral eye irritation; edematous right eyelid since day of 2nd vaccine; This is a spontaneous report from a contactable nurse reported for herself. This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at single dose in the left arm on 12Jan2021 10:15 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), paracetamol (TYLENOL). Previously the patient received the first dose of BNT162B2, intramuscular in the left arm on 24Dec2020 02:00 PM for Covid-19 immunisation. On 12Jan2021 12:00 PM, the patient experienced bilateral eye irritation, edematous right eyelid since day of 2nd vaccine. No treatment was performed. The outcome of the events was not recovered. The vaccine was administered at Hospital Facility. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post the vaccination. Information on the lot/batch number has been requested.
44 2021-01-27 eye swelling her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; T... Read more
her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
44 2021-01-27 lip swelling 1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swel... Read more
1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swelling. Took Tab.Benadryl and Tab.Pepcid .Tab Benadryl continued 3 times. 1/17/21 @9.30pm developed more hives on thighs and lower lip swelling. Centracare was closed. continued Tab.Benadryl and Pepcid. The following day while woke up in morning@8.30am, noted all my face swollen with hives all over the body more on the trunk. seen by PCP. Inj.Solumedrol 125mg IM given, and a Medrol pack given. symptoms started to subside by the following day and took almost 4 days for the complete recovery. Took a call off from work.
44 2021-01-27 feeling of choking Lightheaded, dizziness, throat tingling
44 2021-01-27 swollen tongue, lip swelling Edema in both hands and arms. Swollen face Lower lip swelling and tongue swelling
44 2021-01-28 eye pain, swelling of eyelid Per Client on 1/27/2021 at 6:00 am awaken to left under eye lid swollen and tender. Per Client no me... Read more
Per Client on 1/27/2021 at 6:00 am awaken to left under eye lid swollen and tender. Per Client no medication taken for symptoms. Currently have not been seen by medical provided regarding symptoms. Per Client symptoms have not resolved and is planning to follow up with PCP today.
44 2021-01-28 mouth tingling, mouth discomfort Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure
44 2021-01-28 feeling of choking Within 5-10 minutes injection, tingling back of throat and increased mucus that lasted less than a m... Read more
Within 5-10 minutes injection, tingling back of throat and increased mucus that lasted less than a minute; Within 5-10 minutes injection, tingling back of throat and increased mucus that lasted less than a minute; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El0140, expiry date: unknown), intramuscular on 23Dec2020 18:00 at single dose (left arm) for COVID-19 immunization. Medical history included hypertension and allergies to medications, food, or other products: Shellfish, phenergan, possibly sulfa. Patient was not pregnant at the time of vaccination. Concomitant medication included melatonin, amlodipine, fluticasone propionate (FLONASE); medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient, within 5-10 minutes injection, had tingling back of throat and increased mucus that lasted less than a minute on 23Dec2020 18:15. The outcome of the events was recovered on an unspecified date. Treatment was not received for the adverse event. Patient received second dose of bnt162b2 (lot number El3248) intramuscular on 14Jan2021 17:00 (vaccine location: Left arm). Events were reported as non-serious.
44 2021-01-28 swelling of eyelid No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the thr... Read more
No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the throat, ears, and armpits. She developed three hives on her abdomen. She took diphenhydramine and Claritin then was able to go back to bed. She did not use the EpiPen but had it available. When she woke up in the morning she had swelling of the eyelids and face.
44 2021-01-28 thirst My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thi... Read more
My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thirsty
44 2021-01-28 ringing in ears This is a spontaneous report from a contactable physician. A 44-year-old female patient received sec... Read more
This is a spontaneous report from a contactable physician. A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration on 08Jan2021 08:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. The patient is not pregnant. There were no concomitant medications. The patient received first dose of BNT162B2 on 18Dec2020 08:00 AM at left arm lot number= EJ1685. On 09Jan2021 11:00, the patient experienced right tinnitus. The patient did not receive treatment for the event. The outcome of the event was not recovered.
44 2021-01-29 loss of smell At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid o... Read more
At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid on couch. Fell asleep, per family hallucinated. About 1 to 2 hours later I could not smell.
44 2021-01-31 eye pain Approximately three hours after injection the lymph node in the armpit closest became swollen and ar... Read more
Approximately three hours after injection the lymph node in the armpit closest became swollen and arm was sore. Administered Tylenol. At approximately midnight woke up with severe chills, fever (103) , Body pain, Severe eye pain and nausea. Developed a headache and sweating throughout the night. Continued to administer Tylenol at regular intervals. Sweating was profuse in that pajamas needed to be changed twice. At this point it has been more than 24 hours and though the symptoms have reduced in severity, eyes are still very sore and still experiencing chills and low-grade fever off and on. I would?ve gone into urgent care but there was a huge snowstorm. The reaction was quite concerning and very surprising. There was literally only a sore arm and mildly at that from the first injection .
44 2021-01-31 vision blurred 10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN ca... Read more
10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN came to assist. 10:04am Benadryl 25 mg liquid given PO BP121/73 P 104 PO 97%. Left arm injection site asymptomatic. Pt states this is her 2nd Covid vaccine and did not react to the first one. Pt states she had anaphylactic reactions to PCN, ASA, Sulfa, Keflex and Codeine in the past. C/O blurred vision. 10:10am BP 132/81 p 112 PO 98% with same symptoms. RN present and we discussed going to ER, vs stable and patient declined going. 10:15am BP 133/82 P-114 PO 96%, pt states her breathing is better, thinks the Benadryl caused the dizziness, continued blurred/fuzzy vision, not double vision, A & O x3. 10:20am BP 127/83 P-108 PO98% denies SOB and chest tightness, states she feels better. Crackers, juice and water given. 10:25am BP 123/83 P 105 PO 98% pt states blurred vision has gone. 10:30am BP 129/70 P 105 PO 97% continue to feel better. Talking to her co-worker about getting a ride back to work with her after she receives her vaccine. 10:55am BP 120/72 P 105 Sat 99% went to restroom with another nurse and states she feels fine standing. 11am BP 126/75 P98 PO 98% denies arm numbness, blurred vision and SOB/chest tightness. Report off to 11am Volunteer RN for the monitor room.
44 2021-02-02 sensitivity to light, extreme sound sensitivity Migraine with nausea, sensitivity to light and sound for 10 days that is only minimally lessened wit... Read more
Migraine with nausea, sensitivity to light and sound for 10 days that is only minimally lessened with 12-16 Motrin daily. Had injection of Toradol and started imitrex this morning after going to my doctor, but still no change.
44 2021-02-03 ear pain RECEIVED VACCINE ON WEDNESDAY JAN,20. JANUARY 21,2021 I HAD MUSCLE ACHES AND TEMPERATURE OF 101. SY... Read more
RECEIVED VACCINE ON WEDNESDAY JAN,20. JANUARY 21,2021 I HAD MUSCLE ACHES AND TEMPERATURE OF 101. SYMPTONS GOT WORSE NEXT DAY WITH INCREASED BODY ACHES,FEVER,SNEEZING, EAR PAIN,GLANDS SWOLLEN. TESTED FOR COVID 19 ON 01/26/2021. RESULTS WERE NEGATIVE AND WAS TOLD TO FOLLOW UP WITH PCP AND COULD NOT RETURN TO WORK TILL SYMPTONS IMPROVING. WENT TO PRIMARY DOCTOR AND WAS SWABBED FOR FLU,BACTERIAL.FUNGAL INFECTION. RESULTS CAME BACK AS BACTERIAL INFECTION AND AM NOW ON BACTRIM DS. STILL HAVING HEADACHE AND TIREDNESS.
44 2021-02-03 mouth tingling Tiredness; headache; felt out of it; tingling tongue and lips; tingling tongue and lips; body spasms... Read more
Tiredness; headache; felt out of it; tingling tongue and lips; tingling tongue and lips; body spasms in abdomen throughout the night; This is a spontaneous report from a contactable other healthcare professional, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3248, via an unspecified route of administration on 18Jan2021 at 10:15 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Fluoxetine hydrochloride (PROZAC), valaciclovir hydrochloride (VALTREX), Cetirizine hydrochloride (ZYRTEC ALLERGY) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took iodine and experienced drug allergy. On 18Jan2021 at 12:00, the patient experienced tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night. The patient did not receive any treatment for the events. The clinical outcomes of tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
44 2021-02-04 eye twitching, mouth tingling 15 min after vaccine administered patient stated she had a frontal headache radiating to her right s... Read more
15 min after vaccine administered patient stated she had a frontal headache radiating to her right side of head and tinglinig around her lips. She was instructed to stay for an additional 15 min for observation. She was placed on a stretcher to lie down. She was conversing and her S/S went unchanged. At approx 1 pm she became unresponsive, she did not wake with touch or verbal command Her eyelids were fluttering as if she was experiencing a seizure. A condition was called. Pulse ox 100 % blood sugar 90. Monitor NSR. She remained unresponsive and was taken to the ED. Upon arrival to the ED at approx 1:17 pm, the ED nurse stated she was awake. Evaluated by physician, labs and CT head ordered. Patient stated all lab work and CT scan was normal. Employee was discharged with a diagnosis of vasovagal near syncope.
44 2021-02-06 mouth numbness, mouth tingling About a half hour after receiving my second vaccine shot I began to feel tingling and numbness on th... Read more
About a half hour after receiving my second vaccine shot I began to feel tingling and numbness on the right side of my face. The sensation was located under my cheekbone and expanded to my jaw. It gradually spread to my chin and lips. It lasted for approximately four hours. When I woke up the next morning it was gone. The day after the vaccine I had more common side effects.
44 2021-02-07 loss of smell tested positive for COVID/stuffy nose/couldn't smell; tested positive for COVID/stuffy nose/couldn't... Read more
tested positive for COVID/stuffy nose/couldn't smell; tested positive for COVID/stuffy nose/couldn't smell; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 44-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Lot Number: ER5730 or EK5730), via an unspecified route of administration at Arm right on 18Dec2020 17:00 at the 44 years old at single dose for COVID-19 immunization. The medical history was none. The Family Medical History Relevant to adverse events was none. The concomitant medication was none. The patient was supposed to work the day she tested positive but had a stuffy nose on 01Jan2021. She wasn't sure if that was what it was but when she took a shower she couldn't smell the body wash and so she knew she had COVID. She had a rapid test used for the positive test for COVID on 01Jan2021. There was no hospitalization due to testing positive. The events did not require a visit to Emergency Room and Physician Office, but she did go to the urgent care to get the rapid test.There was no Prior Vaccinations (within 4 weeks). There was none additional Vaccines Administered on Same Date of the product. The patient underwent lab tests and procedures, which included tested positive for COVID on 01Jan2021. The outcome of the events was unknown.
44 2021-02-07 lacrimation increased Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, w... Read more
Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, watery eyes. 3-6pm felt recovering. Friday 9pm-Sunday 4pm abd pain got added to the mix with bloating and abd distension. Friday?s symptoms lessen. Took meds and alkaline products to balanced things out. Ate bread crackers constantly to help with acid buildup and damage of mucosal lining. Protonix 40mdg only alleviate pain for 30 minutes. Could not sleep for over 24 hrs. Pale white stool. Axillary lymph nodes pain. Monday and pain better. Felt lethargy and numbness to hand and feet. Mild Headache still persist.
44 2021-02-08 feeling of choking On 2/9/21, The associate had a tingling sensation in her throat and forehand and it felt like her th... Read more
On 2/9/21, The associate had a tingling sensation in her throat and forehand and it felt like her throat was closing up. The associate stated to the nurse that she had the same issue with the first dose and she did not notify anyone of the that reaction. She just went home and took benadryl and it resolved. The associate received diphenhydramine (50 mg per ml IM once ) on 2/9/21 .
44 2021-02-08 swollen tongue, lip swelling Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was adminis... Read more
Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was administered and rapid response called. Patient was transported to the ed . Per providers note, developed sensation of Facial swelling, lip swelling, tongue swelling and difficulty breathing
44 2021-02-09 eye itchiness I received the second dose of my vaccine yesterday morning. I waited 15 minutes and then left to go... Read more
I received the second dose of my vaccine yesterday morning. I waited 15 minutes and then left to go home. It took me 25 minutes to get home. As soon as I walked in the door, I noticed itching all over my body. I looked in the mirror and noticed a red rash with some hives, that covered my throat and chest area. My eyes were itching as well. I have had severe anaphylactic reactions in the past that required several hours in the emergency room, so I knew to take an antihistamine right away. The rash took at least a couple of hours to fade away; however, the itching of the eyes and body lasted until this morning. I did experience some occasional wheezing until 3 or 4 this morning. I am okay now.
44 2021-02-09 swelling of eyelid fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. b... Read more
fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. bp 129/93 heart rate 115. Headache with flush face and arms and legs super heavy feeling on Sunday. Tuesday night experienced facial and head swelling, started in the middle of my forehead gradually filling up my entire head and face. Wednesday my whole face/eyes and head swollen, with tightness on my chest. My primary care provider prescribed methylprednisolone tablets USP Dosepak 4mg. I did take Benadryl and tylenol Tuesday. I also applied ice packs to my head and face. Headache still comes and goes with brain fog. Slight swelling remains on my forehead and eyes.
44 2021-02-10 eye pain, ear pain Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't k... Read more
Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't keep mouth closed shut tight to swish after brushing teeth same night. Headache above right eye, right ear pain and right side neck pain all starting 2/6/21 morning. Had televisit on 2/8/21 who advised me to be further checked out. At the er they did an head ct without contrast which was normal did a neuro exam and determined I had bell's palsey. Prescribed prednisone 20 mg tid x 7 days and valacyclovir 1 gm tid x 7 days. They also advised to tape my eye shut when sleeping. My eye hurts when I drive or focus on pc or tv so I had to miss 2 days of work thus far.
44 2021-02-10 mouth tingling, lip swelling, swollen tongue Within 5 minutes of receiving covid vaccine #1: Tingling lips, swollen tongue, swollen lips. All s... Read more
Within 5 minutes of receiving covid vaccine #1: Tingling lips, swollen tongue, swollen lips. All symptoms resolved in 1hour
44 2021-02-11 dry mouth PATIENTS TIME IS UP FOR 15 MIN OBSERVATION TIME AND STATES FELLS ITCHY WITH DRY IRRITATION TO MOUTH.... Read more
PATIENTS TIME IS UP FOR 15 MIN OBSERVATION TIME AND STATES FELLS ITCHY WITH DRY IRRITATION TO MOUTH. PATIENT STATES SAME REACTION LIKE WHEN SHE HAS PEANUTS. PATIENT TOOK 25 MG OF HER BENADRYL AND STATES IS GOING TO MED CENTER NORTH FOR FURTHER TREATMENT. PATIENT DID NOT WANT ANY FURTHER TREATMENT FOR SYMPTOMS HERE AT THIS TIME.
44 2021-02-11 eye itchiness Received 2nd dose of Pfizer vaccine on 1/29/2021. The day after the vaccine patient started experien... Read more
Received 2nd dose of Pfizer vaccine on 1/29/2021. The day after the vaccine patient started experiencing bilateral itchy eyes. She went to urgent care and they gave her eye drops (unknown medication) but they made her sleepy so she discontinued. Patient presented to employee health and was recommended to take 10 days of oral anti-histamine without improvement. Re-presented to employee health 2/9/21 reports of increased eye itching and that itching was migrating down to her neck. She denied itchiness of the throat, rash, or redness. Employee health sent patient to urgent care.
44 2021-02-11 oropharyngeal discomfort Patient received 1st dose of Pfizer Covid19 vaccine today at approx 10:45 AM; pfizer lot number EN53... Read more
Patient received 1st dose of Pfizer Covid19 vaccine today at approx 10:45 AM; pfizer lot number EN5318. Patient has history of severe head to toe rash within minutes of receiving Vancomycin/Gent IV. Order obtained from APRN to give dose and monitor for 30 min. Patient alerted monitoring nurse at 10:59AM that she was experiencing a "scratchy" throat and difficulty swallowing. BP 130/88 O2 99% room air, P84. Epi 0.5mg 0.5ml (Lot 339384) administered LD IM at 11:02 AM. Patient hesitant with receiving Benadryl, does not respond well, has to take allegra instead; Benadryl not given. EMS arrived at 11:08AM and assumed care of patient. Patient transported to Hospital. Attempted phone call on 2/11/2021 with no answer.
44 2021-02-11 swollen tongue Vaccination between 1:00 PM Five minutes after was itchy, numb, swelling up tongue 50 Mg Benadryl,... Read more
Vaccination between 1:00 PM Five minutes after was itchy, numb, swelling up tongue 50 Mg Benadryl, itchy to left hand, back head, and neck forty to fifty minutes. Take a dose of Benadryl around 8:00 pm . Itching lasted a week. Scratched the right lower leg and this created a raised bruise to that was sensitive to touch and lasted a week.
44 2021-02-14 taste impairment, loss of taste, ear discomfort Within 45 minutes, had an overwhelming metallic taste in mouth. Lost ability to taste food for 36 h... Read more
Within 45 minutes, had an overwhelming metallic taste in mouth. Lost ability to taste food for 36 hours. Also had a fuzzy feeling in ears. Next day had fatigue, headache, aches, shortness of breath. Subsided within 48 hours.
44 2021-02-15 burning mouth syndrome, swollen tongue Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. ... Read more
Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. Started at home for there days from work. Tongue and throat are still sore.
44 2021-02-18 loss of smell, loss of taste Aches Exhaustion Sore throat Loss of appetite Loss of taste/smell Headache Diarrhea Stomach p... Read more
Aches Exhaustion Sore throat Loss of appetite Loss of taste/smell Headache Diarrhea Stomach pain Chills Fever Extreme swelling on left arm / injection site
44 2021-02-21 loss of taste, ear pain Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migrai... Read more
Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain
44 2021-02-21 inability to speak 1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. ... Read more
1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.
44 2021-02-21 tongue discomfort About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that... Read more
About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.
44 2021-02-22 loss of smell, loss of taste, deafness, drooping eyelid Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; Th... Read more
Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
44 2021-02-22 swollen tongue, eye swelling, mouth swelling, lip swelling Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and ... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and redness in cheeks. Patient described feeling swelling in lips but no swelling was visible. She was given 25mg Benadryl and monitored for approximately an hour with no additional swelling seen and was driven home by a relative.
44 2021-02-23 oropharyngeal discomfort, taste impairment Patient reported metallic taste in mouth feeling flushing in throat and chest. HR 113, 96% o2 RA was... Read more
Patient reported metallic taste in mouth feeling flushing in throat and chest. HR 113, 96% o2 RA was checked by paramedics and cleared refused treatment.
44 2021-02-24 mouth numbness, mouth tingling Initial symptoms numbeness and tingleness in mouth anf face; hour after vaccine both hands dark blue
44 2021-02-25 swollen tongue I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to ... Read more
I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support. A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D). The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
44 2021-02-26 visual impairment, eye itchiness, eye discomfort The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, ther... Read more
The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, there were halos on the lights, itchy eyes, itchy throat, and her body felt warmer. She had an increased blo0od pressure of 150/100mmHg.
44 2021-02-27 ear pain Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes ... Read more
Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes 10 minutes after injection Chest pain and tightness 15 minutes after injection Brain fog delayed movement thyroid meds left my system 20 minutes after injection
44 2021-02-28 ear pain 01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching a... Read more
01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching along the mandibular branch of the facial nerve. This lasted ~ 4 hours 01.26.21: fever 99.2, nausea & dry heaving, left sided ear and throat pain, coughing, body aches, fatigue. These symptoms lasted ~ 12 hours
44 2021-02-28 eye pain, swollen tongue, tongue disorder Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with ton... Read more
Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with tongue that felt thick or swollen. Then the next am woke up with aches, headache, chills, hot (suspected fever but did not get up and check) tiredness. Spit up yellow fluid (thought it might be from GERD) and laided around all day. Did not eat as stomach felt nauseated. At 3 pm I ate half a sandwich and at 4 ate half a banana and drank some water and 1/4 of cup of sweet tea. By 6pm I was really sick to my stomach got up and threw up sandwich and banana. I thought I saw some blood but was not sure. I continued to throw up and it became all blood (bright red) mixed with water. This occured twice and then I called doctors office and the dr on call advised me to go to ER since urgent cares were closed. I went to ER about 8:30pm with continued headache, nausea, lightheadedness. I tried to tell ER dr that I was there mainly for throwing up blood. I sat in waiting room. ER dr saw me at 3am and gave me Zofran for nausea as i thought I was going to be sick and gave me EKG, Blood panel and Blood Pressure readings. Told me I was mildly dehydrated. My BP was higher than I think I have ever seen it.
44 2021-02-28 eye pain injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tyle... Read more
injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old) at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
44 2021-02-28 mouth tingling, swollen tongue One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell.... Read more
One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell. The swelling lasted for 4 hours. 16 hours after the vaccine I had a fever of 101 degrees Fahrenheit, chills, muscle aches, a headache, and I was vomiting. This lasted for 36 hours.
44 2021-02-28 mouth tingling Tongue and lips tingling 10-15 mins after vaccine, the nurse on site took pulse/ox, blood pressure,... Read more
Tongue and lips tingling 10-15 mins after vaccine, the nurse on site took pulse/ox, blood pressure, blood sugar, and looked at my face and neck to see if she could see a reaction from the outside. These symptoms stopped 1 hr after vaccine. Then, very slight rash on neck and chest the next day (2/28) red spots (no itching), no treatment. Today (3/1) the rash is lighter and many spots are gone.
44 2021-02-28 mouth tingling 1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hour... Read more
1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hours. 30 minutes after receiving the vaccine I felt confused and in a fog. That lasted 2 days. The following morning I also had flu like symptoms. Those lasted 24 hours.
44 2021-02-28 ringing in ears Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin... Read more
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
44 2021-03-01 lip swelling, swollen tongue S: Adverse reaction following administration of COVID-19 vaccine B: Patient received COVID-19 vacc... Read more
S: Adverse reaction following administration of COVID-19 vaccine B: Patient received COVID-19 vaccine at 1630 and was monitored for 15 minutes post vaccination. A: Before leaving following appointment, patient reported that her throat "felt scratchy" and "didn't feel right." Patient denies shortness of breath and stated that her scratchy throat was her only symptom and stated that maybe it was not a big deal. She was given a cup of water and took a drink. She then stated that she felt it was getting worse. She stuck her tongue out and stated that she felt like it was swelling up. Her lips appeared to be swelling as well. R: At 1648, epi pen was administered to patients right thigh. Patient was transported to the ER via wheelchair. Call placed to ER and report was given. Patient was not seen in the ER, reason unknown.
44 2021-03-01 mouth tingling, taste impairment, tongue discomfort While eating lunch, tongue started burning and tingling with odd taste in mouth. The bitter taste, ... Read more
While eating lunch, tongue started burning and tingling with odd taste in mouth. The bitter taste, almost like soap, and the tingling sensation lasted until bedtime that evening. All ingedients in lunch have been tolerated before, had eaten from this same batch of vegetables and meat the day before with no issues. Per advisement of physician in my work office, i took 50mg Benadryl when i got home. Ate from the same batch of food 2 days later and no odd taste or tingling sensation.
44 2021-03-02 loss of taste Tested for SARS COV-2 on 3/1/21 prior to travel, asymptomatic at the time of test. On 3/1/21, after ... Read more
Tested for SARS COV-2 on 3/1/21 prior to travel, asymptomatic at the time of test. On 3/1/21, after the test, she began having nasal congestion, body aches, achey at the base of her lungs and intermittent loss of taste. PCR test resulted evening of 3/1/21 was positive.
44 2021-03-02 double vision Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double v... Read more
Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
44 2021-03-02 eye swelling 2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side... Read more
2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side of her face feels fine, tight through, light bumpy rash on her chin) increased over the last hour and now do not seem to be getting worse. She is able to breathe without difficulty. She will take 50 mg Benadryl and if symptoms progress she will go to the ER for further treatment and evaluation of an allergic reaction to COVID vaccine. She will call Dr. back later and may need note for work. 2/26 11:30 AM Received text message from patient. "I woke up with trouble breathing, hives on my neck and jaw and swollen face. Nausea and diarrhea. Trouble swallowing so I took Benadryl. Swelling went down on face but still tight in throat. . Dr. "instructed her to go to ER if symptoms worsen and told her I would check on her on Monday. I asked her if her symptoms were not changed, worse, or improved. She answered: "They got worse this am from 5 to 10 and feeling better now. As far as swelling and breathing feels better. 3/1 10:21 AM Dr. Spoke with patient 10:21 am. She states that she is feeling much better and no longer has difficulty breathing or feeling of throat tightness. She does still have nausea, with occasional vomiting, and diarrhea. She felt well enough to return to work today. 3/3 11:09 AM Dr. spoke with patient. She stated that she is finally feeling "back to normal". We discussed severity of side effects and recommendation to defer 2nd Pfizer vaccination. She stated that at one point she was "close to going to the ER".
44 2021-03-04 mouth tingling, mouth numbness Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower l... Read more
Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
44 2021-03-05 oropharyngeal discomfort During pt observation after receiving COVID-19 vaccine, pt complained of feeling as if her chest was... Read more
During pt observation after receiving COVID-19 vaccine, pt complained of feeling as if her chest was feeling tight. RN requested on site MD to come over and evaluate. After several minutes of MD speaking with pt, pt stated she felt as if her chest tightening was getting worse and it was painful and that her throat was "feeling weird". MD stated to alert on site Medics and have them complete further evaluation. Medics completed their eval and had on site first responder request an ambulance to further evaluate pt. EMS arrived at 1028 and after completing their evaluation of pt, it was determined to take pt to the hospital for further evaluation. Pt significant other drove their personal vehicle home. Pt was transported via ambulance at 1045 in stable condition to the hospital.
44 2021-03-06 lip swelling, swelling of eyelid, mouth numbness Fever, body aches, arm pain (at injection site); bilateral eyelid swelling, lip numbness/swelling
44 2021-03-09 eye itchiness Body aches; itching eyes & body; itching eyes & body; chills; headache; This is a spontaneous report... Read more
Body aches; itching eyes & body; itching eyes & body; chills; headache; This is a spontaneous report from a contactable other health professional (Patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, Right arm on 05Feb2021 at single dose for covid-19 immunisation (Age at vaccination 44 years) at hospital. Patient was not pregnant at the time of vaccination. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received other medications received within 2 weeks of vaccination. Medical history included ehlers-danlos syndrome (EDS), mast cell activation syndrome (MCAS), postural orthostatic tachycardia syndrome (POTS). Allergies to medications, food, or other products included Latex allergy. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COVID 19, Pfizer, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration, Right arm on 15Jan2021 at single dose for covid-19 immunization (Age at vaccination 44 years). On 06Feb2021, the patient experienced body aches, chills, headache, itching eyes & body. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No treatment was received for the events. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-03-09 feeling of choking Tingling in throat, numbness of ankle and toes
44 2021-03-09 swollen tongue, dry mouth Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea... Read more
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
44 2021-03-10 lacrimation increased, mouth tingling Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ... Read more
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
44 2021-03-10 mouth tingling Client is 12 weeks pregnant and has family history of cardiac issues. Client complained of "heart ra... Read more
Client is 12 weeks pregnant and has family history of cardiac issues. Client complained of "heart racing" and complaints of tingling of the tongue. No shortness of breath or distress. Vitals were taken twice. ECG monitor was placed due to family cardiac issues. ECG was normal sinus rhythm.
44 2021-03-11 mouth tingling Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site.... Read more
Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site. Temperature 99.8
44 2021-03-11 swollen tongue Swollen throat, swollen tongue. Swollen trachea. Respiratory difficulty
44 2021-03-12 deafness unilateral Acute hearing loss unilaterally (right ear) beginning D7 after dose 1, peaking at D10-13 after dose ... Read more
Acute hearing loss unilaterally (right ear) beginning D7 after dose 1, peaking at D10-13 after dose 1 with moderate recovery by D15. Again, acute hearing loss after second vaccine (R>L) beginning on D7, peaking on D11-16. Today is D16 with no recovery whatsoever.
44 2021-03-12 tongue itchiness, swollen tongue Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presen... Read more
Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presents with anaphylaxis & hypertension. Staff gave ALS care and administered 50mg Benadryl IM & EPI 0.3 mg IM. Due to no improvement, staff gave O2 prior to 2nd EPI dose. Staff transported pt to Hospital. EOR.
44 2021-03-13 mouth swelling Immediate intense deep itching at injection site. Itchy throat and mild swelling of mouth. Treated ... Read more
Immediate intense deep itching at injection site. Itchy throat and mild swelling of mouth. Treated with Benadryl
44 2021-03-13 swollen tongue, mouth swelling, dry mouth, thirst, lip swelling Felt very dizzy and chest started to hurt. I was very thirsty and my mouth felt like it was full of ... Read more
Felt very dizzy and chest started to hurt. I was very thirsty and my mouth felt like it was full of cotton. My lips swelled. This happened within a few minutes of getting the vaccine. I was already being observed in a 30 minute seat, 20-30 minutes were added and three different professionals addressed the issue including a nurse practitioner. About 20 minutes after leaving the facility, about 1.5-2 hours after getting the vaccine, I noticed I was easier to breathe and I hadn?t realized how much my tongue and inside of mouth had been swollen previously. After these 2 hours, I felt fine. The following day I experienced a headache and was tired. Otherwise was fine.
44 2021-03-14 mouth tingling PATIENT STATES HAS NAUSEA AND DIZZINESS ALONG WITH TINGLING SENSATION TO FACE AND LIPS. PULSE IS 100... Read more
PATIENT STATES HAS NAUSEA AND DIZZINESS ALONG WITH TINGLING SENSATION TO FACE AND LIPS. PULSE IS 100 AND REGULAR. PATIENT HAS NO SHORTNESS OF BREATH, NO RASH OR ITCHING. PATIENT WATCHED AND EXTRA 15 MINS BUT REFUSED TO GO FOR FURTHER TREATMENT.PATIENT INSTRUCTED TO FOLLOW UP WITH EMERGERGENY DEPARTMENT OR CLINIC IF HAD FURTHER NEDDS OR ISSUES DID NOT RESOLVE.
44 2021-03-14 toothache Headache Injection site pain, odontalgia Narrative: Patient experienced odontalgia without Bells pa... Read more
Headache Injection site pain, odontalgia Narrative: Patient experienced odontalgia without Bells palsy Other Relevant History:
44 2021-03-15 burning mouth syndrome, feeling of choking, dry throat I felt like I was stung by something on the far back part of my tongue. I then felt like my throat a... Read more
I felt like I was stung by something on the far back part of my tongue. I then felt like my throat a dry, scratchy and tingled. This continued for several hours. I took benadryl at 230 and after 45 minutes it subsided a bit. Still there but not as strong. I also got a headache on the left side of my head.
44 2021-03-15 lip swelling Swelling of lips, redness. Rash on wrist of lower arm
44 2021-03-16 lacrimation increased, eye disorder, vision blurred, sensitivity to light, eye pain I just wanted to pass along my vaccine experience. So, I got the first dose on 25 Jan. Within a da... Read more
I just wanted to pass along my vaccine experience. So, I got the first dose on 25 Jan. Within a day or two I developed a cold sore. I had not had one in years but it wasn't a big deal. I just figured the foreign vaccine had triggered it from being dormant. Well, I got my second dose on 16 Feb. Within days my eyes started feeling weird...specifically my left eye. It was achy all day, red when I woke up, watery, and it was difficult to focus when I first turned on the lights. This morning I went to the eye doctor and he told me that I had developed a blister (like a cold sore) in my eye. I had never ever ever experienced this. But like the first cold sore on my lip, he said it was dormant in my body and the vaccine just triggered it. There are only two eye drops that treat this and they are pretty expensive but he told me that if I had not come to see him, this virus would have just lingered in my eye. Just thought I would share my experience.
44 2021-03-17 taste impairment Light headed and slight dizziness along with string metallic taste in mouth almost immediately follo... Read more
Light headed and slight dizziness along with string metallic taste in mouth almost immediately following injection. These symptoms dissipated after about 15 minutes and I was able to drive home. An hour later I started to have intense muscle and joint aches all over my body with slight dizziness. My left arm, regardless of continued movement, became increasingly sore. The next morning only slight aches and dizziness remained and I was able to go to work. By the end of the eight hour work day, the joint and muscle aches and fully returned accompanied with intense pain in my left arm, hand, and neck. Today I feel no symptoms at all.
44 2021-03-17 ear pain, pain in jaw Chronic, intense pain in left jaw, behind the left ear, and neck pain and headache related to the le... Read more
Chronic, intense pain in left jaw, behind the left ear, and neck pain and headache related to the left side.
44 2021-03-17 eye swelling every where she had had filler injections are swollen except the left eye, her left eye is not swoll... Read more
every where she had had filler injections are swollen except the left eye, her left eye is not swollen; every where she had had filler injections are swollen except the left eye/her doctor believes she is having a reaction with her fillers/bump on her right eye; under her right eye there was a large bump that was swollen; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration in the left upper arm, on 07Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included Hashimoto's disease from 2017 and ongoing, cosmetic filler injections got in her face within the last year and half or 2 years. Patient said that she knew that Allergan asked her doctor about her ongoing Hashimoto's as well. She takes medication for that. Patient also said that her white blood cell count runs low, like around 2 if they want to note that as an immune system thing and she confirmed that was an issue for her prior to receiving the COVID 19 vaccine. Family medical history included that her daughter has Hasimotos as well. Concomitant medications included unspecified medications for Hashimoto's disease. The patient previously received first dose of BNT162B2 (lot number: EI1685) via an unspecified route of administration in the left upper arm on 18Dec2020 at the year of 44 years at single dose for covid-19 immunisation. She said her doctor believes she is having a reaction with her fillers. She clarified fillers were like cosmetic injections got in her face. She thought the filler was called Allergan but she didn't have any other information about it. She did know her doctor did call Allergan and did a report with them. She thought it was like a big deal because it was not documented with Pfizer just with Moderna. She said the doctor was also going to call and report this as well. The doctor has not called yet but he said he was going to, she just left their office. Basically the places she had had filler injections within the last year and half or 2 years not have, under her right eye there was a large bump that was swollen and then the places that were called labial folds, the marionette lines where she had had filler there were all swollen and that was on the right side of her face and then on the left side the marionette lines were swollen as well so basically everywhere she had had filler injections were swollen except the left eye, the left eye is not swollen. And the places were swollen and hard. She first noticed the swelling yesterday 25Jan2021. The bump on her right eye was yesterday around 15:00 and then this morning (26Jan2021) it was much worse under her eye and she noticed the bumps on the right side at about 6 am this morning and around 9 am she began feeling it on the left side and it progressively has gotten worse since it started in all of those areas (26Jan2021). This case reported as serious. Patient did not visit Emergency Room, but she has been to 2 different physicians in physician office. No other vaccines administered on the same day as either dose of the suspect product. Patient did not have prior vaccinations within 4 weeks. Outcome of the events was not recovered. Reporter assessed event everywhere she had had filler injections are swollen except the left eye, her left eye is not swollen as related to BNT162B2.; Sender's Comments: Based on available information a contributory role of BNT162B2 to reported events cannot be fully excluded. Consideration should also be given to the contribution from the cosmetic filler injections. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
44 2021-03-17 mouth numbness Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the ... Read more
Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the right side of my body.
44 2021-03-17 feeling of choking, mouth tingling Patient reported tingling in tongue and throat approximately 15 minutes after vaccine administered. ... Read more
Patient reported tingling in tongue and throat approximately 15 minutes after vaccine administered. Patient was given diphenhydramine.
44 2021-03-19 lip swelling Patient experienced swelling of lips and itching sensation in her throat 20 minutes after receiving ... Read more
Patient experienced swelling of lips and itching sensation in her throat 20 minutes after receiving her 2nd dose. Called EMS to her vehicle. Transport ambulance was called to bring patient to ER. Benadryl 50mg IM given by onsite EMS prior to transport.
44 2021-03-19 mouth tingling, mouth numbness Bottom lip numb/tingly.
44 2021-03-19 thirst Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I a... Read more
Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I also felt tired and body aches. The next day I was exhausted, could hardly keep my eyes open and could not get enough water. My arm began to hurt, I had chills/fever, and my shoulders/back of my head hurt a LOT. I also was congested, coughing and sneezing, and my chest felt tight. My knuckles and toes hurt as well. Tylenol, day-quil, aspirin, - none of these worked. I had COVID back in June/July 2020 and the symptoms are all the same ones I had.
44 2021-03-20 mouth tingling 25 min after the vaccine I had left the hospital and was already home. I was unable to swallow. I co... Read more
25 min after the vaccine I had left the hospital and was already home. I was unable to swallow. I could breathe and talk, but could not feel the Babcock of my throat. My tongue felt like it was swelling but it wasn?t! I tried to drink but couldn?t. This lasted approx 5 minutes and started to subside. All effects cleared 45 -50 min later. The following day I nauseous, throwing up, headache, tired, body aches. Today is totally fine!
44 2021-03-21 dry throat Approximately 6 hours after injection I began to feel as if my skin was burning and itching. Had cr... Read more
Approximately 6 hours after injection I began to feel as if my skin was burning and itching. Had crawling sensation throughout body and throat felt a little tight/dry. The burning, itching and crawling feeling continued for a couple weeks. Had to take Allegra and Benadryl and currently am still taking it to ward of symptoms.
44 2021-03-21 taste impairment Patient had a metallic taste in her mouth. Her entire left arm felt itchy. She was also dizzy. Ga... Read more
Patient had a metallic taste in her mouth. Her entire left arm felt itchy. She was also dizzy. Gave patient one Cetirizine 10mg tablet. Patient refused benadryl and said that she was allergic.
44 2021-03-22 taste impairment I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea... Read more
I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea; diarrhea; headache; I have been having vivid nightmares during this time as well; metallic taste; This is a spontaneous report from a contactable consumer (patient). The 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 09:45 AM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic fatigue syndrome, Epstein barre. The patient was not pregnant. No other vaccine in four week. No covid prior vaccination. The patient did receive other medications in two weeks. The patient experienced i have epstein barre and it feels like it has been reactivated, waves of dizziness, fatigue, nausea, diarrhea, headache, i have been having vivid nightmares during this time as well, metallic taste on 24Feb2021 14:00. Reported as: I have Epstein barre and it feels like it has been reactivated. I have waves of dizziness , fatigue, nausea, diarrhea, headache and metallic taste. I have been having vivid nightmares during this time as well. I developed a metallic taste in my mouth. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.The patient had covid tested post vaccination via Nasal Swab on 03Mar2021 and was negative. It's unknown if the patient received treatment. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.
44 2021-03-22 taste impairment metallic taste in mouth starting around 11:30 and lasting for 3 hours. Metallic taste went away aft... Read more
metallic taste in mouth starting around 11:30 and lasting for 3 hours. Metallic taste went away after 3 hours.
44 2021-03-22 feeling of choking Shortly after vaccination patient reported feeling hot and dizzy with tingling in throat and legs. ... Read more
Shortly after vaccination patient reported feeling hot and dizzy with tingling in throat and legs. IV was started and patient was given Solumedrol and Benedryl before being taken to ER by EMS.
44 2021-03-22 ringing in ears The morning after my dose I woke up feeling like I would pass out while laying in my bed. I believe ... Read more
The morning after my dose I woke up feeling like I would pass out while laying in my bed. I believe I did since I know the feeling after waking up. Ringing in ears and sweaty. I then began to vomit and contributed vomiting most of the day if I stood up I got dizzy. I could not hold anything down in my stomach. I had fever of 100.0 about 6 pm I began to be able to have a small amount of food in my stomach.
44 2021-03-23 ear discomfort Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left whe... Read more
Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left when she passed out and fell in shower; Ear completely clogged up only on the left side; Headache; Tired; Soreness on my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included underactive thyroid. Concomitant medication included unspecified thyroid medication. The patient was asking if her symptoms were normal following the vaccination. She got the second dose of the COVID vaccine yesterday, 07Mar2021 at around 11:00 (also reported as 10:00 to 10: 15 or 10:30). Throughout the day, she was fine and mentioned that she had soreness on her arm later. At around 22:00, she was driving home and started feeling a slight headache and reported that she didn't take anything. She was tired, so when she got home, the patient fell asleep. She woke up and did feel a slight headache and couldn't sleep on her left arm because it was killing her, but it was fine. At 5:30 this morning (08Mar2021), the headache was still there. She then stood and sat up, took her thyroid pill because she has an underactive thyroid and was on the highest dose of thyroid replacement. The patient stated that the events happened so fast, as soon as she got into the shower. She got out of bed and started walking, grabbed her stuff to shower and started feeling that her headache was building up more than it had all morning so far. She thought maybe it was just because she had just physically gotten up and started walking. She got into the shower, and for about 2-3 minutes into getting into the shower, she remembered she had started putting shampoo into her hands; grabbing the shampoo bottle; but she suddenly got so nauseous and the headache that came on was extreme. She did not have a lot of time to react. She thought she would throw up in the shower, she had no time to get out of the shower to the toilet to throw up; she suddenly felt dizzy, passed out in the shower and fell to her left side on the floor. All she could remember before she passed out was that she had the shampoo bottle in her hands and she said out loud, she heard herself say "What is happening to me". Then she lost all the strength in her arms and legs. She remembered for a split second she tried to hold on, she dropped the shampoo bottle on the floor and grabbed the rail or edge of the shower and tried to hold on because she felt herself when she went down. Her left ear was completely clogged up only on the left side. When she passed out, thankfully she thought by trying to hold on to the rail or edge of the shower that she kind of eased her fall down, so she did not fall hard or hit her head. She did not know if she passed out for seconds or minutes because she has no idea exactly when she went into the shower, maybe around 05:45; but when she woke up she realized she was on the floor, she was not flat on the floor but on her knees, having fallen to the left side with her head off to the side on the shower wall; the glass door to her shower was wide open and all the water was coming out of the shower; it scared her when she woke up. The outcome of the event passed out was recovered on 08Mar2021, not recovered for headache, and unknown for all other events. Information on the lot/batch number has been requested.
44 2021-03-23 swollen tongue Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130... Read more
Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130/80. HR: 66. Pt appeared pale and gray. At 14:20. Epinephrine 0.3mg adm x 1 IM (L vastus Lateralis) by the RN. at 14:22, pt sts feeling better. At 14:25, pt sts throat feels as if closing and tongue swelling again. EMS has arrived at that time and pt agreed to be transported and they took over her care.
44 2021-03-24 mouth numbness My upper lip began to spasm and became numb. I also had some slight numbness on the tip of my tongue... Read more
My upper lip began to spasm and became numb. I also had some slight numbness on the tip of my tongue.
44 2021-03-25 eye twitching I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had di... Read more
I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had difficulty breathing for 2 weeks. I have had eye twitching in my left eye for 3 days. I have had tightness in my chest and tingling in my chest.
44 2021-03-25 burning mouth syndrome Gum sensitivity and swelling, oral mucosa swelling, tongue sensitivity and irritation.
44 2021-03-25 mouth numbness Dizziness; numb tongue; difficulty swallowing; difficulty breathing; inability to move arms and legs... Read more
Dizziness; numb tongue; difficulty swallowing; difficulty breathing; inability to move arms and legs; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6199 and expiration date unknown), via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 as a single dose for COVID-19 immunization. Medical history included depression, pre-diabetes and known allergies: bee stings. Concomitant medications included loratadine (LORATADINE), metformin (METFORMIN), paroxetine (PAROXETINE), and bupropion hydrochloride (WELLBUTRIN), and "Mul". The patient had no other vaccine in four weeks. On 09Mar2021 at 15:15, The patient experienced dizziness, numb tongue, difficulty swallowing, difficulty breathing, and inability to move arms and legs. The patient had no COVID prior vaccination and had not tested post vaccination. Therapeutic measures were taken as a result of the events which included Epinephrine, ER treatment, and Prednisone. The outcome of the events was resolving. The events resulted in: Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event).
44 2021-03-25 lip swelling pt noticeably antsy, asked if she was ok. she stated that she was trying to power through but couldn... Read more
pt noticeably antsy, asked if she was ok. she stated that she was trying to power through but couldn't. Nurse asked her to see the injection site. When she took off her sweatshirt, stating she felt on fire, the site and her arms were extremely red. She was asked to remove her mask and we discovered her lips and area around her nose was starting to swell. At that time she stated that her tongue felt "weird". Assessing the situation, the nurse administered an Epi-pen while I dialed 911 and gave information. Epi-pen very helpful, to the point she "wished we hadn't called the ambulance" . Once the EMTs arrived, they assessed her and after some time, had her sign a release form since she declined attention. Pt was informed that she would not be allowed to finish her shift and was asked if someone could come get her. The daughter was on her way. The nurse and I sat with her, watching to make sure she didn't have a rebound reaction which she did not in the hour + we were with her. Daughter arrived, took instruction from the nurse and took her home.
44 2021-03-25 swelling of eyelid Kidney pain, Fatigue, Swollen eye lids, Severe dry skin, Itchy skin.
44 2021-03-25 swollen tongue Patient noticed swelling of her tongue. No SOB or other symptoms. VSS.
44 2021-03-25 swollen tongue 15 minutes after second vaccine patient complained of tongue swelling, throat closing, and difficult... Read more
15 minutes after second vaccine patient complained of tongue swelling, throat closing, and difficulty breathing. She was then given epi times 1 and benadryl. Symptoms then improved. 20 minutes later symptoms returned and she was given another dose of epi. EMS then took patient to local hospital.
44 2021-03-26 taste impairment Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart ra... Read more
Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart rate, difficulty swallowing, tight feeling in chest).
44 2021-03-26 swollen tongue, lip swelling She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swel... Read more
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
44 2021-03-27 tongue itchiness, mouth tingling throat scratchy, tongue itchy, lips tingling
44 2021-03-28 mouth numbness Issue - patient had gotten shot, waited in car, then immediately after leaving grounds felt numbne... Read more
Issue - patient had gotten shot, waited in car, then immediately after leaving grounds felt numbness of the tongue, throat and roof of her mouth. EMS took vitals and patient did not wish further treatment and went home. This was her 1st shot.
44 2021-03-29 eye itchiness Pt states her throat and eyes feel itchy, Pt taken to traige 1. 126/81 HR 108, 02 97% RA. 3:30 pt... Read more
Pt states her throat and eyes feel itchy, Pt taken to traige 1. 126/81 HR 108, 02 97% RA. 3:30 pt developed blanching rash on chest and left side of neck going under chin. Pt refused Benadryl stating it makes her tired and she has an hour drive home. She received in ER when allergy to unknown antibiotic and went to sleep. pt accepted Zyrtec 15:55: pt states she feels better. Agrees to go to ED if worsens. understands to not take 2nd dose of Pfizer until discussed with PCP.
44 2021-03-29 swollen tongue About 6 hours after I got the 1st vaccine shot, my upper right arm was very sore, I had a headache, ... Read more
About 6 hours after I got the 1st vaccine shot, my upper right arm was very sore, I had a headache, I broke out in hives, and my tongue started to swell up. As soon as I started to break out in hives, I immediately took 150 mg of benadryl. I took another 250 mg over the next 10 hours. I have had several allergic reactions in the past, and know how to treat and when my doctor recommends for me to go to urgent care or the ER. It did not get any worse, but it did not start improving until the next morning. After 2 days my tongue was no longer partly swollen and all traces of hives were gone. I did report this to my primary doctor and will be talking to both my primary and my rhuematologist about it at my next appointments with both.
44 2021-03-30 deafness, ringing in ears 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 day... Read more
6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; This is a spontaneous report from a contactable nurse. A 44-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201) at the age of 44, intramuscularly, administered in the left arm on 15Feb2021 at 15:30 as a single dose for covid-19 immunization. Medical history included covid-19 (If covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); and ibuprofen (ADVIL [IBUPROFEN]) all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 at the age of 44, given intramuscularly in the left arm on 25Jan2021 at 03:30 PM for Covid-19 immunisation. On 22Feb2021, 6 days after receiving the 2nd dose, patient experienced sudden hearing loss and tinnitus in right ear and severe vertigo 8 days after (24Feb2021). Patient was prescribed high dose steroids from doctor. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient was still suffering from hearing loss and tinnitus 3 weeks later. The patient underwent lab tests and procedures which included multiple hearing tests and Magnetic resonance imaging (MRI) both on unknown date with unknown result. The outcome of the event was recovering at the time of the report.; Sender's Comments: Based on known drug profile it is unlikely that the reported sudden hearing loss, tinnitus and severe vertigo were causally related to bnt162b2. These are intercurrent medical conditions. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-03-30 double vision, eye bleeding, vision blurred, bloodshot eyes First headache, lightheadedness, nausea, then rapid onset of red eye/pink eye symptoms with bleeding... Read more
First headache, lightheadedness, nausea, then rapid onset of red eye/pink eye symptoms with bleeding starting within right eye. Severe head pressure and very blurry eyesight,. One instance of double vision. Lots of goop coming out of eyes and worsening. Some throat soreness, tightness. Eyes and vision were clear before vaccination.
44 2021-03-30 dry throat 44yo F with PMH of anaphylaxis on multiple medications who developed subjective symptoms of her thro... Read more
44yo F with PMH of anaphylaxis on multiple medications who developed subjective symptoms of her throat becoming tight, dry, and scratchy. Pt became tachypnic and tachycardia to 110s, 100% saturation. Pt was evaluated by medical staff and ems, given oral hydration and 60mg fexofenadine. Pt was monitored with symptomatic improvement after 45min. She was cleared and discharged with instruction to not recieve second pfizer dose.
44 2021-03-30 ear discomfort, ringing in ears Slight tinnitus in both ears - also feeling like ears are clogged.
44 2021-03-31 vision blurred Arm pain at first but then Got up to go to bathroom, suddenly felt nausea and then numbness on left ... Read more
Arm pain at first but then Got up to go to bathroom, suddenly felt nausea and then numbness on left side of body, vision became blurry and I passed out. Hit head when fell. Couldn?t regain consciousness for 10-20 minutes. Couldn?t move, get off floor. Husband had to come carry me back to bed. Felt tingling in arms, legs on both sides. After an hour, had water, iced arm (extreme arm pain), and felt better but stayed in bed.
44 2021-04-01 swollen tongue Swollen tongue, facial swelling, sore throat, headache>>>allergic reaction lasted 5 days; responded ... Read more
Swollen tongue, facial swelling, sore throat, headache>>>allergic reaction lasted 5 days; responded to Benedryl and Claritin. Headache continues off and on for 2 weeks.
44 2021-04-01 ringing in ears Worsening tinnitus, pulsatile tinnitus
44 2021-04-01 vision blurred Dizziness, blurred vision, dropping things for 6 days. Could not see up close and then away. motion... Read more
Dizziness, blurred vision, dropping things for 6 days. Could not see up close and then away. motion sickness
44 2021-04-02 lip swelling On 4/2/21, arm pain, body aches, bad headache, chills, fatigue, redness at injection site. At about ... Read more
On 4/2/21, arm pain, body aches, bad headache, chills, fatigue, redness at injection site. At about 7:30 pm, I started feeling bruising under my right eye. At about 9:30 pm, I had a small bump under my left eye. On 4/3/21, I woke up with facial swelling. I was swollen underneath my eyes, cheeks were swollen, and lip was swollen. Headache, slight back ache, redness at injection site and sore injection area continue. Took 2 Benadryl at 9:00 am to reduce swelling.
44 2021-04-02 vision blurred, ringing in ears Started with normal sore arm and headaches transitioned to diarrhea and fever. Tinnitus set in on Th... Read more
Started with normal sore arm and headaches transitioned to diarrhea and fever. Tinnitus set in on Thursday morning and has continued since then. Friday night I experienced a loud pop on the left side of my head - pressure released on the left year slightly followed by numbness and tingling in face along with blurred vision, dizziness and weakness in left leg. Blurred Vision lasted maybe 1-2 minutes, numbness and weakness/dizziness resolved on ride to ER so maybe 10 minutes as we live near the hospital. ER evaluated me for potential stroke. Cat scan and labs done. Nothing odd was noted. Doc decided it was parethesia of left leg and nonintractable episodic headache event. Blood pressure was elevated which is unusual for me along with a high White blood cell count- Doc said this is normal with just having received a vaccine recently. No concerns with platelets or enzymes and electrolytes. Doc does think it could be vaccine related as that is the only thing new this week. Due to earlier in the week side effects, my PCM did COVID test me just incase since the side effects were hanging around longer than the normal window of time and nasal swab PCR came back negative.
44 2021-04-04 ear discomfort, deafness Temporary hearing loss and ear discomfort. Felt like ear pressure when changing altitude quickly, b... Read more
Temporary hearing loss and ear discomfort. Felt like ear pressure when changing altitude quickly, but added with warm burning sensation. Mostly return to normal 6 hours later. Also experienced warmth and uncomfortable tight feeling in right side of neck. Neck discomfort mostly resolved 6 hours later.
44 2021-04-04 vision blurred Visible tremors in extremities, difficulty walking, blurred vision, headaches
44 2021-04-04 vision blurred First vaccine. Aches, pins and needles in both hands and feet, vomiting, headaches, blurred vision, ... Read more
First vaccine. Aches, pins and needles in both hands and feet, vomiting, headaches, blurred vision, lightheaded, feeling spaced out, exhaustion
44 2021-04-06 loss of taste Head cold (congestion and tired); Head cold (congestion and tired); Head cold (congestion and tired)... Read more
Head cold (congestion and tired); Head cold (congestion and tired); Head cold (congestion and tired); Feeling flu like; Complete loss of taste within 24 hours; Leg muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date were not reported), via an unspecified route of administration, in Left arm on 27Mar2021 at 11:00 AM (at the age of 44-years-old) at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included aripiprazole(ABILIFY), fluoxetine hydrochloride (PROZAC), Valsartan and methylphenidate hydrochloride (RITALIN). The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced head cold (congestion, tired), feeling flu like, complete loss of taste within 24 hours, leg muscle pain and joint pain from 27Mar2021 at 14:00. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Information on lot/batch number has been requested.
44 2021-04-06 dry mouth Patient reported severe dizziness, raised temperature, increased heart rate, and dry mouth. She had ... Read more
Patient reported severe dizziness, raised temperature, increased heart rate, and dry mouth. She had trouble sitting up the chair and came close to falling over several times. Pharmacist stood by the patient in case emergency attention was needed. Instructed spouse to provide water. Pharmacist provided patient with a handheld fan to cool her down. Spouse later told the pharmacist he would take the patient home. Denied epinephrine and ambulance.
44 2021-04-06 ear pain I had my second shot yesterday afternoon and after 2am the following morning, I had a pretty severe ... Read more
I had my second shot yesterday afternoon and after 2am the following morning, I had a pretty severe reaction. Chills, sweat, body aches, vomiting, but what was most concerning was I could feel intense pain in all my joints and lymph nodes. Wondering if the severity was due to my auto-immune disorder. I feel a bit better this morning but I have a wandering internal pain that seems to flare for a few seconds in different body parts: ear, foot, hip.
44 2021-04-06 mouth ulceration I started to notice mouth ulcers on the lips the morning after I got vaccinated with the first Pfize... Read more
I started to notice mouth ulcers on the lips the morning after I got vaccinated with the first Pfizer dose
44 2021-04-06 ringing in ears, taste impairment Immediately following the shot I had a metallic taste in my mouth that lasted for four days straight... Read more
Immediately following the shot I had a metallic taste in my mouth that lasted for four days straight. The morning after I had the shot I had tinnitus. The tinnitus has progressively gotten worse over the past couple weeks. I?m not sure if I should get the second vaccine. I do not want us to get worse.
44 2021-04-07 mouth numbness, mouth tingling Lightheaded, nausea, headache immediately after recieving shot. Lightheaded and nausea lasted 2 days... Read more
Lightheaded, nausea, headache immediately after recieving shot. Lightheaded and nausea lasted 2 days. Slight allergic reaction with left side of mouth with tingling and numbness. Lasting 2 days. Diarrhea started on 2nd day also.
44 2021-04-07 ringing in ears Fever; chills; fatigue; ringing ears for two days
44 2021-04-08 pain in jaw, taste impairment Within 10 minutes skin began to burn on chest, spreading to face. Over the next 5 minutes burning an... Read more
Within 10 minutes skin began to burn on chest, spreading to face. Over the next 5 minutes burning and then itchy spread to arms, back, abdomen and later to legs. Around the 20 minute mark the was a sudden chill then uncontrollably shaking . Itching and burning was intolerable covering whole body head to toe. No visible raised hives. Chest became heavy and tight accompanied by a metallic taste, pain in jaw and hips and sever headache around 45-50 min . Solumedrol, Benadryl and famotidine given in ED. Discharge home. 04/09/21- burning itching skin continues, extreme fatigue, tremor, metallic taste in back of mouth.
44 2021-04-09 lip swelling Painful Facial swelling on chin, lips, cheeks
44 2021-04-09 ringing in ears Ringing in ears, swollen glands in neck, joint pain, throbbing pain at injection site, swelling at i... Read more
Ringing in ears, swollen glands in neck, joint pain, throbbing pain at injection site, swelling at injection site, stomachache, fever, chills causing uncontrollable shaking, exhaustion, shooting pains from elbow to hand of non-injection arm, runny nose
44 2021-04-10 ear pain Sustained Ear pain on left side, slightly sore throat of left side. Injection site pain for two days
44 2021-04-10 burning mouth syndrome Got a coating on my tongue , the roof of my mouth ... Looked it up and looks like COVID tongue.. my ... Read more
Got a coating on my tongue , the roof of my mouth ... Looked it up and looks like COVID tongue.. my is very raw feeling and sore
44 2021-04-10 mouth numbness - Faster heart rate (within 15 minutes of the injection); no treatment or observation sought (didn't... Read more
- Faster heart rate (within 15 minutes of the injection); no treatment or observation sought (didn't think it was related until later reading it online) - Slight tingling in head and slight numbness is tongue and nose (approximately an hour after the injection); no treatment sought - read about similar instances online and since it was slight, I waited it out and they went away completely a few hours later. The above events occurred within the first two after the injection
44 2021-04-11 ear discomfort Day after: dizziness, chills, hot flashes, fever, fatigue 2 days post: burning and numbness of right... Read more
Day after: dizziness, chills, hot flashes, fever, fatigue 2 days post: burning and numbness of right ear, right cheek and right side of nose Day 3 post: vertigo and nausea
44 2021-04-11 mouth numbness, mouth tingling I experienced numbness/tingling of my lips and tongue about 10 min after I received the COVID vaccin... Read more
I experienced numbness/tingling of my lips and tongue about 10 min after I received the COVID vaccine, no other symptoms concerning for severe allergic reaction. This side effect lessened after about 4-5 hours, but was still present for at least 24 hours and felt lightheaded for 3-4 days. I called my primary care physician and allergist regarding this side effect for advice on whether this was related to allergic reaction and they thought it was secondary to the way the vaccine was administered. The person who administered my vaccine immediately massaged the injection site after injection stating that it was to "get the vaccine into the muscle". I was told by my physicians and the pharmacist at the facility that this was not supposed to happen (the massaging of injection site). When asked about whether or not this would affect efficacy, one of the pharmacist told me that they were unsure, but maybe would not reach full efficacy. I am still upset and left with uncertainty that I might not have the same protection at the end of my vaccines
44 2021-04-11 sensitivity to light SYMPTOMS BEGAN AROUND 10PM LATER THAT NIGHT. NECK GLANDS SWOLLEN, TONGUE HAD SMALL RED BUMPS, LIGHT ... Read more
SYMPTOMS BEGAN AROUND 10PM LATER THAT NIGHT. NECK GLANDS SWOLLEN, TONGUE HAD SMALL RED BUMPS, LIGHT SENSITIVITY, SKIN BURNT FOR A SHORT WHILE APPROX. ONE HOUR. LOOSE STOOL IN AM. 4/9-she awoke with abd pain this AM. Caller states she awoke with what felt like her usual allergy flare-up sx and wondering if related. Spoke with patient; states previous sx are gone however feels like usual allergy flare-up is happening. RN rec she contact her PCP or go to urgent care for further testing and assessment.
44 2021-04-12 mouth tingling Arm and face tingling. After we got home from appointment. I went to take a 30 min nap and my arm ti... Read more
Arm and face tingling. After we got home from appointment. I went to take a 30 min nap and my arm tingled in the upper half near the injection site (in the same way it would feel waking up from being asleep). Around 6:15pm that evening, I was taking a walk and my face began to tingle in the same way (though the "pins" felt smaller then on my arm. Tingling was all around mouth, up into sinus areas on my face. This concerned me and lasted until around 10pm that night. Arm was very sore for 4-5 days.
44 2021-04-12 vision blurred, double vision Numbness bilateral legs same day at night. Blurred and the overlapping visión few days while progre... Read more
Numbness bilateral legs same day at night. Blurred and the overlapping visión few days while progressing over the next 3 weeks, heat intolerance, left side numbness of body. Foggy/ light headedness, dizziness, vertigo and disbalance all progresss over the month the slowly started disappearing over a month after 3 dieses of high steroids and anti- inflammatory.
44 2021-04-12 vision blurred Starting few days after shot, she started having upper then lower back pain, left > right arm pain, ... Read more
Starting few days after shot, she started having upper then lower back pain, left > right arm pain, left > right leg pain, severe muscle spasms in left leg, numbness in left leg, weakness in both legs, blurry vision and balance problems. This progressively worsened over 2 weeks then started to improve, overall 75% better by 1 month out from the shot. At that time she presented for elevated blood pressure which was also new onset. Exam findings revealed mild ataxia on heel-to-toe walking, asymmetric lower extremity reflexes, and generalized muscle weakness of both upper and lower extremities. Otherwise neuro exam normal.
44 2021-04-13 loss of smell, loss of taste Received 2nd dose of COVID vaccine on 2/6/2021. On 3/29/2021 developed body aches, cough, diarrhea,... Read more
Received 2nd dose of COVID vaccine on 2/6/2021. On 3/29/2021 developed body aches, cough, diarrhea, headache, loss of taste/smell, sore throat, and nasal congestion Tested positive for COVID-19
44 2021-04-13 dry throat, lacrimation increased a 44 year old female who has completed a 15-minute observation period with the following signs and s... Read more
a 44 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: other - dry throat, coughing, vomited x 1. Endorsed that she is very nervous with the vaccine, started having dry throat and coughing with watery eyes. Then vomited x 1 with partial digested emesis. no hematemesis per patient. pt kept on coughing and anxious. Otherwise vital signs stable, physical exam unremarkable. Given cetirizine and albuterol inhaler 2 puffs. Improved post medications. Referred to allergy clinic and
44 2021-04-13 feeling of choking Within five minutes of taking first dose of vaccine I experienced adverse neurological symptoms, inc... Read more
Within five minutes of taking first dose of vaccine I experienced adverse neurological symptoms, including numbness/ tingling (paresthesia) on left side of my body from head to feet, including inside my throat, chest, jaw, and left side of face. Symptom duration lasted approximately 3 hours before gradually diminishing to mild paresthesia in injection arm. Symptoms were significant but not debilitating peaking in severity approximately one hour post dose but continuing. I felt some level of headache and mild imbalance/ vertigo.
44 2021-04-14 feeling of choking AFTER RECIEVING THE COVID 19 PFIZER VACCINE PATIENT WAITED THE REQUIRED TIME OF 15 MINUTES AND LEFT.... Read more
AFTER RECIEVING THE COVID 19 PFIZER VACCINE PATIENT WAITED THE REQUIRED TIME OF 15 MINUTES AND LEFT. ABOUT 30 MINS LATER PATIENT COMES BACK COMPLAINING OF TINGING AND ITCHING OF THROUT AND BODY. PATIENT HAS NO BREATHING ISSUES. I CHECKED HER BP AND PULSE BOTH WITHIN NORMAL RANGE. SHE SAT FOR A FEW MINUTES AND STILL HAD THE TINGING AND ITCHING SO I THEN GAVE HER AN INJECTION OF DIPHENHYDRAMINE AND OBSERVED HER FOR 30 MINS. ALL SYMPTOMS SUBSIDED AND PATIENT FELT BETTER. I ADVISED HER TO NOT DRIVE SHE CALLED HER MOTHER TO PICK HER UP. PATIENT REFUSED TO GET CHECKED BY EMS.
44 2021-04-14 ringing in ears Tinnitus: ongoing high pitched sound in left ear.
44 2021-04-15 taste impairment Metallic taste in mouth Very sore arm
44 2021-04-15 eye swelling She got the vaccine, had arm pain, minor swelling, basic reactions, headaches and took Aleve for it... Read more
She got the vaccine, had arm pain, minor swelling, basic reactions, headaches and took Aleve for it. She then starting late last night she has sharp, stabbing chest pains, as well as swollen right eye. She has not taken anything and does not have a PCP to call.
44 2021-04-15 lip blister Several cold sores. Bottom lip blistered almost completely across, swollen and painful. Top lip has ... Read more
Several cold sores. Bottom lip blistered almost completely across, swollen and painful. Top lip has small tiny, painless blisters.
44 2021-04-16 mouth numbness, mouth tingling Within 5 minutes of receiving the vaccine, I felt tingling and slight numbness or pins and needles f... Read more
Within 5 minutes of receiving the vaccine, I felt tingling and slight numbness or pins and needles feeling in my left face/cheek. Today I have the same sensation and some in my left side of my tongue and lip. The only other reaction is pain at the injection site .
44 2021-04-16 smell distorsion I smell smoke, like a cigarette type of smoke, but no one smokes in my house. This started happening... Read more
I smell smoke, like a cigarette type of smoke, but no one smokes in my house. This started happening about 4 hours after I took the 2nd dose. Two days later and I still smell it. It very persistent.
44 2021-04-17 deafness Became deaf in her right ear after receiving the 1st vaccine; This is a spontaneous report from a co... Read more
Became deaf in her right ear after receiving the 1st vaccine; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: En 6205), via an unspecified route of administration, administered in arm left on 03Mar2021 19:30 at single dose for COVID-19 immunisation. Medical history and concomitant medications were both reported as none. No known allergies. No other vaccine in four weeks, and no other medications in two weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient became deaf in her right ear after receiving the 1st vaccine on 15Mar2021 12:00 with outcome of not recovered. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the event that included steroid injections. The patient underwent lab tests and procedures in 2021 which included hearing tests: unknown results, magnetic resonance imaging (MRI): unknown results. The patient received the second dose of BNT162B2 (Lot number: Ep 7534) in the right arm on 24Mar2021.
44 2021-04-17 mouth numbness Left arm and left side of tongue went numb within minutes of shot. Had some numbing sensation near i... Read more
Left arm and left side of tongue went numb within minutes of shot. Had some numbing sensation near injection site for 3 days.
44 2021-04-17 swollen tongue, dry mouth Swollen tongue, headache, chills, difficulty swallowing, dry mouth - within 15-25 mins of injection.... Read more
Swollen tongue, headache, chills, difficulty swallowing, dry mouth - within 15-25 mins of injection. Condition peaked around 30mins and stabilized/improved. Itchy rash on forehead appeared about 90mins post-injection.
44 2021-04-18 eye pain I had a off and on temperature/fever, chills, total body fatigue, headache, nausea, sinus and eye pa... Read more
I had a off and on temperature/fever, chills, total body fatigue, headache, nausea, sinus and eye pain, and intense arm pain in vaccination arm (right) the day following the 2nd vaccination dose. On the second day my temperature regulated but I still had a headache, nausea, body fatigue. Noticed heart palpations intermediately throughout the day, while moving, lying down and sitting. On the third day still had a slight headache, slim body fatigue and noticed more consistent heart palpations. Also started my menstruation cycle on Saturday as well. Experienced more intense menstrual cramps than normal. It's the fourth day now and still feel the heart palpations more sporadically than yesterday and intense menstrual cramps. Please note that I already had a irregular heart beat prior too covid but I noticed a significant increase in the occurence of the heart palpations. Normally I only have them once a month or once very few months. This has been several times a day and on Sunday seemed to be experiencing hourly.
44 2021-04-18 mouth tingling Swollen throat, tongue and difficulty swallowing. Tingling lips and inside mouth. Today's Visit Rea... Read more
Swollen throat, tongue and difficulty swallowing. Tingling lips and inside mouth. Today's Visit Reason for Visit Allergic Reaction Diagnosis Acute allergic reaction, initial encounter Lab Tests in Progress Blue Top Tube-Hold Blood Lavender Top Tube-Hold Blood Red Top Tube-Hold Blood Done Today Discharge Home Insert PIV Medications Given diphenhydrAMINE (BENADRYL) Last given 4/18/2021 1:30 AM famotidine (PEPCID) Last given 4/18/2021 1:30 AM lactated ringers (LR) Stopped 4/18/2021 3:06 AM methylPREDNISolone sodium succinate (Solu-MEDROL) Last given
44 2021-04-19 pain in jaw stomach cramps beginning 21 hours after vaccine, intermittent, lasted for approximately 3.5 days hea... Read more
stomach cramps beginning 21 hours after vaccine, intermittent, lasted for approximately 3.5 days headache and jaw pain beginning 2 days after vaccine, still continuing dizziness beginning 2 days after vaccine, still continuing
44 2021-04-19 ringing in ears Thundering sound in left ear began middle of the night after second vaccine. Tinnitus or ringing in ... Read more
Thundering sound in left ear began middle of the night after second vaccine. Tinnitus or ringing in ear but low and humming, and has continued the past 4 days.
44 2021-04-20 eye swelling Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Int... Read more
Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation . Medical history included migraine, demyelination , post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced immediate left side (injection side) headache. on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour on 03Apr2021 11:45 with outcome of not recovered , loose stool on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events. Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53. Extreme vertigo within 1 hour, persisting now at hour 53. Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53. Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53. No follow-up attempts are needed. No further information is expected.
44 2021-04-20 ringing in ears 3 hours after getting the 1st vaccine, I noticed a loud ringing in my right ear. I then got very diz... Read more
3 hours after getting the 1st vaccine, I noticed a loud ringing in my right ear. I then got very dizzy so I laid down. I then got very nauseous. After about another 30-45 minutes later I vomited. I slept for a few hours after that and then did not feel dizzy or nauseous anymore. My left arm was very sore for 3 days. To this day, I still have a loud ringing in my right ear. .
44 2021-04-20 ringing in ears Tinnitus since shot # 2
44 2021-04-21 ear pain, pain in jaw Jaw, ear, neck pain 5 days after vaccine. Headache and eye pain 5 days after.
44 2021-04-21 eye swelling, eye itchiness Fatigue, joint pain, swollen and itchy right eye, diarrhea
44 2021-04-22 swelling around the eyes Patient c/o itching ears, scratchy throat, some swelling under her eyes. No SOB, No respiratory dist... Read more
Patient c/o itching ears, scratchy throat, some swelling under her eyes. No SOB, No respiratory distress. The patient was transported to the ER for observation.
44 2021-04-22 feeling of choking Patient received first dose of Pfizer COVID-19 vaccine on 1/21 at 1011. She presented to the ED that... Read more
Patient received first dose of Pfizer COVID-19 vaccine on 1/21 at 1011. She presented to the ED that evening around 2100 due to concerns for allergic reaction. Pt reports the reaction started around 1930 after eating and consisted of nausea, throat tingling, facial swelling and chest tightness/SOB. Oral diphenhydramine was self-administered. In the ED, she was given IM epinephrine and IV methylprednisolone with good response. Was discharged home about 2 hours later with prescription for epinephrine autoinjectors. Pt reports no new foods were consumed that day therefore, reaction likely vaccine related. Pt advised NOT to receive second dose.
44 2021-04-23 taste impairment Pt. had lightheadedness and had patches of redness on her chin , neck and cheeks, . No difficulty b... Read more
Pt. had lightheadedness and had patches of redness on her chin , neck and cheeks, . No difficulty breathing and no pruritis noted . On litter in OBs 1 she was C/O her Lt. arm feeling cold and her Lt Hand , at one point she had a metallic taste in her mouth and " prickely" feeling in her cheeks . She also was shivering when she arrived, That subsided and her face felt hot. Benadryl was offered but refused. Her first vs was 2:28 p-116, resp 20, bp, 166/105 Po2 94%. She was discharged ambulatory with her husband after her vs stabilized.
44 2021-04-24 ear itchiness her husband tested positive on 29MAR 2021 and she was direct exposed; Diarrhea; fluid in ears; teste... Read more
her husband tested positive on 29MAR 2021 and she was direct exposed; Diarrhea; fluid in ears; tested positive for Covid; tested positive for Covid; runny nose and sneezing; runny nose and sneezing; itchy ears and itchy throat; itchy ears and itchy throat; trouble breathing at night; This is a spontaneous report received from a contactable consumer (patient). A 45-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP3302) via an unspecified route of administration in left arm on 13Jan2021 at around 14:00-15:00 as single dose for COVID-19 immunization. Patient medical history included high blood pressure from 6-7 years ago and still ongoing. Concomitant medications were not reported. Patient received historical vaccination as first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Lot number: EH9899, via an unspecified route of administration in left arm on 23Dec2020 10:30 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 3Apr2021, she started having allergy symptoms like a runny nose and sneezing, itchy ears and itchy throat and had trouble breathing at night with clinical outcome of not recovered. She states that the doctor told her she had fluid in both of her ears on 5Apr2021 with outcome of event not recovered. she has diarrhea on 06Apr2021, with outcome of event not recovered. She reported that not even two months later, she has tested positive for COVID-19 on 05APR2021. She states that her husband tested positive on 29MAR2021 and she was direct exposed (exposure to SARS-COV-2) due to work she had to quarantine for 14 days, states her daughter tested positive two days after her husband, states neither of them had the vaccine. The patient did not receive any treatment for the events. The clinical outcomes of event not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-04-24 eye bleeding causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eye... Read more
causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; Nausea; repeated vomiting; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 10:15 (Batch/Lot Number: ER 8737) as single dose for COVID-19 immunization. Medical history included drug amoxillin allergy. Concomitant medication included ibuprofen, simeticone (GAS X), cimetidine (TAGAMET [CIMETIDINE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On 07Apr2021 at 23:00, the patient experienced causing burst blood vessels in face, eyes, nose and throat, nausea and repeated vomiting. The outcome of the events was recovering. The patient did not had COVID prior to vaccination and did not tested positive post vaccination. No follow-up attempts are possible. No information is expected.
44 2021-04-24 eye pain PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't star... Read more
PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't started; symmetrical lumps on the distal sides of my breasts; faint; slight injection site soreness; intense tingly whole body sensations; Sense of pressure and tingling on eyeballs; Increased sensitivity to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Mar2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Mild/moderate TBI in Oct1999 with herniated disk in lower lumbar region from auto accident (patient was a pedestrian and a car ran into her); fractured tibia/fibula from occurrence; low blood pressure which she had occasionally fainted from at blood draws (started after being active athletically during recovery from 1999 injury). Patient was not pregnant. There were no concomitant medications (no vaccine in 4 weeks and no other medication in two weeks). Patient did faint 15 minutes after receiving Pfizer Covid vaccine on 30Mar2021. Medical people at vaccination site made a vasovagal note on record. Patient reported that there were no body aches or fatigue or fever, only slight injection site soreness for a couple of days which was hard to notice through intense tingly whole body sensations that started after receiving vaccine on 30Mar2021 16:15. Still continuing to feel a week and a half later. It was very uncomfortable but not painful. Patient also experienced sense of pressure and tingling on eyeballs and increased sensitivity to touch. Menses were due one week after vaccination but 4.5 days after vaccination on 03Apr2021, nipples became very hard and sore. After a few days on nipples slightly sore still but mostly swollen breast tissue with soreness on Apr2021. Patient had not had this as PMS symptom since becoming pregnant almost 9 years ago and it never lasted 7.5 days with it still ongoing as of time of report. Her menses was late on Apr2021 and hasn't started but she was not pregnant. Patient's usual PMS symptoms have kind of started yesterday on 09Apr2021. It quickly formed bilaterally symmetrical lumps on the distal sides of her breasts which was also unusual on Apr2021. No treatment was received and events results in doctor's clinic visit. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-04-24 eye swelling Swollen lymph nodes in front and back of neck and by collarbone, puffy face/eyes and neck. Mouth/ton... Read more
Swollen lymph nodes in front and back of neck and by collarbone, puffy face/eyes and neck. Mouth/tongue feels swollen, but no trouble breathing. Itchy neck and face. Puffy hands, feet, and lower legs. Headache.
44 2021-04-24 ringing in ears, hearing loss Dizziness, muffled/hissing sound in ears, heart palpitations
44 2021-04-25 taste impairment severe hot and cold chills a few hours after the vaccine then flu like symptoms, high temperature so... Read more
severe hot and cold chills a few hours after the vaccine then flu like symptoms, high temperature sometimes reaching 104, sore body, hot and cold, burning skin, hardly able to move swollen lymph nodes under armpit on same side as vaccine (left) metallic taste in mouth day 2,3,4
44 2021-04-25 lip itchiness, lip swelling 4/22/2021 PATIENT NOTICED LIPS WERE DRY, RED, AND PEELING 4/23/2021 PATIENT LIPS STARTED ITCHING AND... Read more
4/22/2021 PATIENT NOTICED LIPS WERE DRY, RED, AND PEELING 4/23/2021 PATIENT LIPS STARTED ITCHING AND BUMPS DEVELPED IN THE CORNERS OF HER MOUTH 4/24/2021 LIPS GETTING WORSE WITH BUMPS, TICHING, AND REDDNESS. STARTED TAKING ABREVA FOR CORNER BUMPS 4/25/2021 LIPS GETTING PUFFY, SORE, TINGLY, AND MORE BUMPS NOTED 4/26/2021 LIPS VERY SWOLLEN, UPPER WORSE THAN LOWER. OUTER RIM OF LIPS VERY RED. BUMPS NOTED AS HIGH AS HALFWAY BETWEEN NOSTRILS AND UPPER LIP LOOKING BACK ON START OF PFIZER COVID VACCINE SERIES (3/30/2021) PATIENT ALSO REPORTS ECZEMA GOT WORSE ESPECIALLY ON TOP OF HANDS. HAS ITCHINESS ALL OVER BODY SINCE MID APRIL. LASTLY, AFTER DOSE 1 SHE DEVELOPED A COLD SORE 3 DAYS AFTER DOSE 1 AND STARTED GENERIC VALTREX. COLD SORE RESOLVED A FEW DAYS LATER. SHE HAS STARTED BENADRYL ON A NIGHTLY BASIS AND RESTARTED GENERIC VALTREX ON 4/26/2021. SHE ALSO HAS BEEN APPLYING LAVENDER AND PEPPERMINT LIP BALM THAT SHE MAKES HERSELF (AND HAS USED FOR A LONG TIME), CURELL LOTION, ANTI-ITCH CREAM, AND ICE PACKS. NOTHING SEEMS TO BE PROVIDING MUCH RELIEF AT THIS POINT.
44 2021-04-25 lip swelling Feeling of lump in throat and slight headache that subsided before I got back there. Lower lip on r... Read more
Feeling of lump in throat and slight headache that subsided before I got back there. Lower lip on right side was visibly swollen. Blood pressure and O2 were in normal range. had here stay an additional 10 minutes after she was evaluated. she felt good and left
44 2021-04-25 mouth tingling Pfizer-BioNTech COVID-19 Vaccine EUA The vaccine was administered around 1:25 within 10 minutes I h... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA The vaccine was administered around 1:25 within 10 minutes I had tingling in my finger. That was all & I was released. At about 1:55 I noticed tingling in my cheek & lips on the left side...numbing like done at the dentist. On the advice of a friend who is a nurse, I took Benedryl a few minutes later & drove back to the hospital to be observed. It only stayed on the left side of my face. My throat was not a concern at all. I was released again around 2:15 after consulting with the Dr on call. By 3:15 my lips were pretty much better but the cheek still had some numbing. I took another Benedryl later that evening (probably about 8 or 9) It felt heavy through out the remainder of the day & into the next day. But mid day the following day all symptoms were gone even the sore arm.
44 2021-04-25 toothache, pain in jaw, ear pain 24 hours after my second covid vaccine I came down with a very intense headache like many; it was de... Read more
24 hours after my second covid vaccine I came down with a very intense headache like many; it was deep in my eye sockets, my ears, jaw, and teeth, a radiating, pulsating type pain. By the next morning I was better. That night, April 11, I was awoken in the middle of the night with the same kind of pulsing pain in my teeth. It became progressively worse over the next two weeks to the point where I could not rest my top and bottom teeth together or eat any kind of solid food. By Monday April 19, I went to an urgent care clinic to see if there was anything wrong with my sinuses, nothing (the doctor said at the time that if it wasn't my teeth that I should see an ENT). At this point I was taking 800 milligrams of ibuprofen every 4 hours and slathering my teeth with orajel numbing gel. By 4/21 I was able to get an emergency appointment with my dentist- she did x-rays and saw nothing. She said if the pain continued for another 2 weeks she would send me to a root canal specialist. She also encouraged me to wear a mouth guard to help. By Friday, my 2 weeks after my 2 shot, I was able to get through the day without medication. Today is Monday 4/26 and while I am almost fully better, the teeth are still sore and I can only eat mushy solid foods.
44 2021-04-26 eye twitching Received the 1 dose lil bit of chest tightness after 20 mins release to leave by 4pm my right eye st... Read more
Received the 1 dose lil bit of chest tightness after 20 mins release to leave by 4pm my right eye started twitching, a Finally got home received the first dose of Pfizer yesterday morning and within hours I felt horrible got all the side effect of course and had to go to the hospital this morning. Having SOB dry cough and horrible upper back pain. Dr and I?m wheezing a lot so I got a shot of steroids and two neb treatments X-ray showed inflammation the cause was the vaccination activated my asthma and the rest side effect nd within hours I felt horrible got all the side effect and had to go to the hospital this morning. Having SOB dry cough and horrible upper back pain. Dr and I?m wheezing a lot so I got a shot of steroids and two neb treatments X-ray the cause was the vaccination activated my asthma and the rest was side effect
44 2021-04-26 ear pain, ringing in ears Persistent ringing in the ears (tinnitus) high pitch, pulsating. Ear pain.
44 2021-04-26 ear pain larger red and swollen itching injection spot; patient had larger red and swollen itching injection ... Read more
larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; tired; sore arm; nausea tired; Earache; headache; This is a spontaneous report from a contactable consumer (Patient) reported for himself. A 44-years-old female (Non-Pregnant) patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 24Feb2021 at 11:30 AM (at age of 44years) at single dose for COVID-19 immunization. Patient medical history included which was acid reflux. Patient had Known allergies to gluten, food sensitivity to dairy and tomatoes. Patient concomitant medications included esomeprazole (20mg) two times in daily, vitamin B12 (5000mcg). Patient did not receive any vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 24Feb2021 at 12:00 the patient experienced headache, nausea, earache and on 25Feb2021 second day patient had sore arm headache and tired, on 26Feb2021 (day 3) the patient had red, swollen, and itching at vaccination site also, tired, nausea. and on 27Feb2021 (day 4) the patient had larger red and swollen itching at vaccination spot nausea tired. Patient didn't take treatment for the events. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
44 2021-04-26 ear itchiness, mouth itchiness covid_test_name_post_vaccination= RT-PCR, covid_test_date= 29Jan2021, covid_test_result= Positive; I... Read more
covid_test_name_post_vaccination= RT-PCR, covid_test_date= 29Jan2021, covid_test_result= Positive; Itching soft palate area; Itching in ears; mild respiratory trouble; This is a spontaneous report received from a contactable health care professional (patient) and from a Pfizer sponsored program. A 44-year-old female patient of received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261) left arm on 22Jan2021 at 17:45 (at the age of 40-years-old) via intramuscularly at single dose on the unspecified anatomical location for COVID-19 immunization. Relevant medical history included asthma and psoriasis. The patient had known allergy to penicillin. The patient did not receive any other vaccine in four weeks. The patient was not pregnant at the time of vaccination. Concomitant medications included fluticasone propionate (FLOVENT), ethinylestradiol,/levonorgestrel (SRONYX) and cetirizine. On the same date, two hours (at 19:00) after administration of first dose the patient had Itching soft palate area, itching in ears and mild respiratory trouble. The patient received treatment with diphenhydramine 25mg. On 29Jan2021, nasal swab RT-PCR COVID test was positive for the patient. Outcome of the events Itching soft palate area, itching in ears and mild respiratory trouble was recovered while outcome of the event was unknown. The action taken in response to the event(s) for BNT162B2 was not applicable.
44 2021-04-26 lip swelling swelling to feet, body aches, chills, sinus congestion, facial/lip swelling, patient describes throa... Read more
swelling to feet, body aches, chills, sinus congestion, facial/lip swelling, patient describes throat as feeling like it is closing, cough, SOB, fatigue , mucous in stool, chest pain.
44 2021-04-26 feeling of choking Swollen lymph noses in left under arm Tingling in throat
44 2021-04-28 ear swelling I developed an itchy raised rash all over my body. First night seemed minor. Woke up next day and ... Read more
I developed an itchy raised rash all over my body. First night seemed minor. Woke up next day and my ears where both swollen and covered with rash and there was more noticeable areas on arms and wrists. Took some zyrtec and applied benadryl to control itching. By 5 pm small rash spots had spread together and gotten more raised and were now noticed everywhere, such as arm pits, fore arms, hands, breasts, trunk, legs, ears and face. Called Teledoc and was prescribed Medrol Dosepak 4 mg. I was able to take 3 the first night but it was still bad when went to sleep. Had improved by next morning. Rash still visible is worst areas but was no longer raised. Treatment seems to be working gets better each day. Only slight rash discoloration visible is worst areas.
44 2021-04-28 mouth numbness C/O tightness of airway and numbness to mouth EMS activated
44 2021-04-28 thirst Itchy skin, low grade fever, muscle pain, joint pain, extream thirst, fatigue
44 2021-04-28 vision blurred, mouth numbness I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't wal... Read more
I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't walk; my immune system attacking the nerves; The shortness of breath is very bad; My pulse is high; My blood pressure is low; I have major neurological symptoms now.; My left eye is now affected too and blurry.; keep feeling my face and now my tongue and mouth go numb; keep feeling my face and now my tongue and mouth go numb; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the second dose. A 44-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the right arm via unspecified route on 03Apr2021 (at 44-years-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot unknown expiry information not provided) in the left arm on 13Mar2021 at 12:00 (at 44-years-old) and experienced face, head and ears started tingling, shortness of breath, numbness and weakness, severe burning all over her nerves of her body, and abnormal uterine bleeding. The patient denied any known allergies and being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and the patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 03Apr2021 she received her second shot and within four hours her left leg went completely numb and she could not walk. The patient reported that she went to the emergency room three times since that time. The patient reported that she was told it was her immune system attacking her nerves. The patient reported that the shortness of breath is very bad, her pulse is high, and her blood pressure is low. The patient explained that she has major neurological symptoms now. The patient stated that she has had two magnetic resonance imaging (MRI), on computerized tomogram (CT) and two x-rays though no results were provided. The patient explained that she has appointments with neurologist and immunologist. She is unable to work since she has to be on video with people and keep feeling my face and now her tongue and mouth go numb. The patient stated that she was scared to eat food, so she does not choke. The patient mentioned that her left eye is affected too and blurry. The patient exclaimed that she cannot function, it is scarring her little kids and has affected her entire family. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the events left leg went completely numb, could not walk, immune system attacking her nerves, shortness of breath, pulse is high, blood pressure is low, neurological symptoms, unable to work/ cannot function, feeling my face and now her tongue and mouth go numb, and left eye is affected too and blurry, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) :-PFIZER (Same reporter/patient/product, similar events with first dose)
44 2021-04-29 mouth numbness On day on injection, experienced numbness on left side of lips and lower face. On day 6 (4/30/2021)... Read more
On day on injection, experienced numbness on left side of lips and lower face. On day 6 (4/30/2021), woke up with a large red rash at injection site.
44 2021-04-29 visual impairment Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient claims she did not eat or drink before coming in for the vaccine.She was given water and recovered after a few minutes after which she was helped to her car where she was taken home by her husband.
44 2021-04-30 eye bleeding, eye discomfort, eye pain It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture wi... Read more
It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture with pain; pressure emanating to left eye; Dizziness; off-balance; headache and head pressure; headache and head pressure; chest heaviness; exhaustion; nausea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 17:45 as single dose for COVID-19 immunization on an unspecified facility. Medical history included multiple sclerosis, ulcerative colitis, rheumatoid arthritis, and seasonal allergy from an unknown date. The patient took several unspecified concomitant medications taken within two weeks. The patient previously took metoclopramide (REGLAN) for nausea and experienced drug allergy. No other vaccines were taken in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 02Apr2021, the patient had MS flare, left eye blood vessel rupture with pain and pressure emanating to left eye, dizziness, off-balance, headache and head pressure, chest heaviness, exhaustion, and nausea. The patient visited the emergency room and physician's office where she was given an unspecified treatment. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
44 2021-05-03 visual impairment Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me d... Read more
Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me down with ice on the back of my neck and I felt better. All day felt weak and woozy and brain fog. Lethargic and spacey the following two days. Three days after the shot, I had a pain in my hand and a blood vessel started popping out and hurting. It was quite painful for that evening and night and after ice and rest and ibuprofen, swelling was down the next morning and it's still just a little tender to the touch.
44 2021-05-04 eye swelling, eye itchiness, eye irritation Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an A... Read more
Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an Allegra and went to the vaccination center. The Head nurse sent me to the Urgent care. During the exam I developed tightness in chest and throat started to swell. Doctor determined it was a delayed analphylactic reaction to the COVID vaccine. It was delayed due to taking the Allegra the previous day. He treated me with a benedryl shot and famotidine and prednisone in pill form. Observed for 1 hour and allowed to go home. As of April 5, 2021, still experiencing tightness in chest. Swelling in face has reduced
44 2021-05-04 ringing in ears Ringing in ears that started about 2-3 days after 2nd vaccine dose, 2 weeks at this point, seems wor... Read more
Ringing in ears that started about 2-3 days after 2nd vaccine dose, 2 weeks at this point, seems worse in L ear.; This is a spontaneous report from a contactable physician (patient). A 44-years-old non-pregnant female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318, expiration date unknown) via unspecified route of administration on arm left at a single dose on 31Jan2021 09:45 (age at the time of vaccination 44-year-old) for COVID-19 immunization. The facility type for vaccine was fire station. The patient had medical history of asthma. Patient had no known allergies. The patient received other medications within 2 weeks of vaccination reported as Beclometasone Dipropionate (QVAR), MVI, Ascorbic Acid (Vit C), Colecalciferol (D3), Melatonin, Diphenhydramine Hydrochloride (Benadryl). The historical vaccination patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246, expiration date unknown) via unspecified route of administration on arm left at a single dose on 10Jan2021 10:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 02Feb2021 (started about 2-3 days after second dose) patient experienced ringing in ears after second dose. After 2 weeks at this point seems worse in left ear. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The clinical outcome of the event as not recovered. Information on the lot/batch number is captured.
44 2021-05-07 taste impairment, dry mouth almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on ar... Read more
almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins. On 05Apr2021, the patient experienced the following events: almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that, it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.
44 2021-05-10 loss of smell, loss of taste Fatigue, soreness at injection site, loss of smell and taste. All symptoms gone within 3 days with t... Read more
Fatigue, soreness at injection site, loss of smell and taste. All symptoms gone within 3 days with the exception of taste and smell. Those are still have not returned
44 2021-05-11 taste impairment, tongue itchiness, oral mucosal blistering blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and... Read more
blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
44 2021-05-11 oral mucosal blistering, taste impairment blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received ... Read more
blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received from a contactable consumer, the patient. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 44 years-old) for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced blisters inside and outside the mouth, hives, metallic taste all on an unspecified dates. Therapeutic measures were taken as a result of hives and included the patient received a steroid shot. The outcome of the events blisters inside and outside the mouth, hives, and metallic taste was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
44 2021-05-13 deafness I lost my hearing in my right ear
44 2021-05-14 swollen tongue blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right... Read more
blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself. A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021, Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out. Her tongue also began to swell. She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive. The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).
44 2021-05-16 ringing in ears Pain at site of injection Tinnitus
44 2021-05-17 pain in jaw, toothache Right jaw and lower teeth hurt for 3 days; Right jaw and lower teeth hurt for 3 days; chills; sore a... Read more
Right jaw and lower teeth hurt for 3 days; Right jaw and lower teeth hurt for 3 days; chills; sore arm; This is a spontaneous report from a contactable Other Health Professional (Patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 44 years of age), via intramuscular administered in Arm Left on 13Jan2021 19:30 (Batch/Lot Number: EK9231) as Unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not have any other vaccine within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, has the patient been tested for COVID-19 test. The patient's concomitant medications were not reported. The patient experienced right jaw and lower teeth hurt for 3 days, chills and sore arm on 14Jan2021 03:00. The patient underwent lab tests and procedures which included smear test: negative, on 19Jun2020 Covid test. The seriousness criteria of the events were reported as non-serious by the health authority. No treatment and or medical procedure was performed for all events. The outcome of the events were right jaw and lower teeth hurt for 3 days recovered on 17Jan2021, chills and sore arm recovered on an unspecified date. Follow-up attempts are completed. No further information is expected. .
44 2021-05-18 loss of smell, loss of taste Three weeks of extreme fatigue. Exhaustion that didn't let up after sleeping or coffee or anything. ... Read more
Three weeks of extreme fatigue. Exhaustion that didn't let up after sleeping or coffee or anything. And I have what would be considered "brain fog". I'm usually a fast-brained, quick-witted individual and I feel foggy and forgetful. I also had six weeks of extreme fatigue when I had COVID in early November (and still have not recovered my sense of smell or taste). After about six weeks, my fatigue disappeared.
44 2021-05-19 ringing in ears, deafness Tinnitus & partial hearing loss in right ear; Tinnitus & partial hearing loss in right ear; This is ... Read more
Tinnitus & partial hearing loss in right ear; Tinnitus & partial hearing loss in right ear; This is a spontaneous report from a contactable consumer (the patient). A 44-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 31Mar2021 as single dose for covid-19 immunization. Medical history included supplementation therapy. The patient's concomitant medications include escitalopram oxalate (LEXAPRO), Iron supplements and Vitamin D. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 05Apr2021, the patient experience tinnitus and partial hearing loss in right ear. Started 5 days after vaccine. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered. Information about lot/batch number has been requested.
44 2021-05-23 loss of smell, loss of taste Period (Menstration) is 2 weeks late (this is very unusual for me). Did not receive 2nd dose yet due... Read more
Period (Menstration) is 2 weeks late (this is very unusual for me). Did not receive 2nd dose yet due to ongoing inflamation and increased leg nerve pain. Loss of taste and smell seems to have increased since vaccine (although started with Covid in Nov2020)
44 2021-05-23 ringing in ears, ear discomfort An hour after I received the 2nd Pfizer dose, I felt a lot of pressure in my neck which moved up to ... Read more
An hour after I received the 2nd Pfizer dose, I felt a lot of pressure in my neck which moved up to my ear canals which felt like they filled with fluid. My ear canals began to bubble and crackle like I was on an airplane with a cold. I felt pressure in my sinuses and up to my head. I took Day Quil the rest of the day to try to clear my ears & took Ny Quil that night. The pressure and bubbling & crackling in my ears was gone after that.
44 2021-05-25 feeling of choking, burning mouth syndrome Immediately felt like the way far back of my tongue was stung by something or pricked with a needle;... Read more
Immediately felt like the way far back of my tongue was stung by something or pricked with a needle; Ask for a headache on the left side only.; now my throat feels tingly; Itchy throat; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), as first dose via an unspecified route of administration, in left arm on 16Mar2021 at 11:00 AM (at the age of 44-years-old) as single dose for COVID-19 immunization. The patient's medical history included asthma. Allergies to medications, food, or other products was included Gluten and sulpha drugs. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced immediately felt like the way far back of her tongue was stung by something or pricked with a needle and now her throat felt tingly and scratchy. Asked for a headache on the left side only. The patient did not receive any treatment for the reported events. The clinical outcome of tongue was stung, throat felt tingly, throat felt scratchy and headache on the left side were unresolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
44 2021-05-25 ringing in ears Tinnitus
44 2021-05-26 mouth numbness, ear discomfort, tongue discomfort, mouth swelling, eye swelling Numbing in mouth jaw & gum, breathing wheezing problems, shortness of breath, irritations, skin & t... Read more
Numbing in mouth jaw & gum, breathing wheezing problems, shortness of breath, irritations, skin & tongue burning, messed up my monthly period, swollen eyes, swollen lymph nodes, swollen face & mouth..heart achs & discomfort.
44 2021-05-27 blindness, mouth numbness, oropharyngeal discomfort shortly after receiving the vaccine, she developed lightheadedness, frontal headache and a feeling o... Read more
shortly after receiving the vaccine, she developed lightheadedness, frontal headache and a feeling of "fuzziness." "I knew it was going to start." She describes a globus sensation. She developed nausea without vomiting. Took 40 mg of prednisone and 25 mg of diphenhydramine. EMS was contacted. She tells me that she lost vision and couldn't see the paramedics when they arrived. Discharged from ED, then returned on 3/17/21, when she began experiencing face itchiness and flushing, numbness of her mouth and lips, throat inflammation, and vision loss. Patient took Prednisone this morning with little symptom relief. Compared to yesterday, the only new symptom is throat inflammation. 4/30/21 Primary care visit: presents to the clinic for evaluation of globus sensation. Patient reports that this has been an issue ever since she got her first dose of Pfizer COVID-19 vaccine. She feels as though there is something in her throat and feels pain or discomfort, most often in the mornings and evenings for several weeks. She feels the need to "clear" her throat often. She denies any trouble eating or swallowing. She feels as though her neck and face still appear swollen compared to her baseline, since getting the vaccine. She reports occasional post nasal drip but denies significant nasal congestion and does not feel this is the typical time for her to struggle with her allergies. She has noticed frequent nose bleeds in the past 2 weeks, now daily. She states that she will sometimes bleed up to 15-20 minutes. She has been feeling more tired and "foggy" or more forgetful in the past few weeks as well and fears this is starting to affect her work performance.
44 2021-05-27 ringing in ears have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat h... Read more
have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat half of what she normally ate; have had off and on spotty bleeding but no monthly period; anaphylaxis reaction; throat to stop feeling like it was closing up; severe headache; sinus pain that felt like someone punched her in the face; all over tingling sensation 20 minutes after getting the shot; chills; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 18Apr2021 13:15 (Batch/Lot Number: ew0151) as 2nd dose, single dose (at the age of 44-years-old) for COVID-19 immunisation. Medical history was not reported. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medication within 2 weeks of vaccination. The patient has not been diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient received his first dose of BNT162B2 on the left arm on 26Mar2021 17:30 (batch/lot number: er8127) for COVID-19 immunisation and experienced extreme structural pain and severe flu like symptoms for 4 days. The patient reported that on the second shot, she had anaphylaxis reaction along with severe headache, sinus pain that felt like someone punched her in the face, and all over tingling sensation 20 minutes after getting the shot. She had to drink 3 doses of BENADRYL for her throat to stop feeling like it was closing up. She then had ringing in her ears, nausea, fever, headache, and chills for 3 days. Since then, she can only eat half of what she normally ate. She has felt nauseated for a month and have had off and on spotty bleeding but no monthly period and a lingering headache that will not go away. The patient has yet to see her doctor due to COVID restrictions. The patient recovered from chills on an unspecified date. The patient has not recovered from headache. The outcome of the remaining events was unknown. No follow-up attempts are possible. No further information expected.
44 2021-05-28 taste impairment Awful taste in mouth; feels pretty lousy; This is a spontaneous report from a contactable consumer (... Read more
Awful taste in mouth; feels pretty lousy; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9261), dose 1 via an unspecified route of administration in arm left on 28Jan2021 at 12:30 as a 1st dose, single for COVID-19 immunisation. The patient's medical history included depression. The concomitant medications included bupropion hydrochloride (WELLBUTRIN) taken for depression, from 28Jan2021 and ongoing. The patient did not had a history of immunization which would considered as suspect with the Pfizer vaccine and did not administer any vaccine on same date of the Pfizer suspect or within 4 weeks. The patient did not receive vaccine since she was a kid, she did not know any adverse event following prior vaccination. The patient reported that with Wellbutrin, it was a double whammy, she felt like crap. On 28Jan2021 at about 12:45 to 13:00, the patient experienced awful taste in mouth. The patient reported that she could taste the vaccine and it was over 24 hours and the taste did not go away. The patient ate sauerkraut and sour patch kids, the taste was so awful. She did not receive the flu shot, she struggles with medications in general. That was not the first time she tasted the medications, which was the reason why she could not handle the taste. On an unspecified date in 2021, the patient felt pretty lousy. The patient wanted the taste to go away, it was horrible and she would tough it out. There was no family medical history relevant to adverse event and the patient did not undergo relevant lab tests. The outcome of the event awful taste in mouth was not recovered and was unknown for feels pretty lousy. Follow-up attempts completed. No further information expected.
44 2021-05-28 extreme sound sensitivity, smell distorsion, sensitivity to light I received the vaccine on Friday at 12pm. Late afternoon: fatigue, joint pain, swollen lymph nodes o... Read more
I received the vaccine on Friday at 12pm. Late afternoon: fatigue, joint pain, swollen lymph nodes on left side of upper body, swollen left breast with pain and heaviness feeling that lasted for 2-3 days, Lupus butterfly rash on face, flu-like symptoms, spike in temperature to 100º, dizziness, heat radiating off body, and migraine. I took my prescribed Meloxican (for Lupus joint/muscle pain) approx 2:30pm and then my prescribed Fioricet for the migraine. Friday evening: Approximately 8pm I broke out in hives on my trunk; stomach, chest, shoulders, and back. The migraine worsened to include nausea with sensitivity to light, sound and smell. I took my prescribed Zomeg with no relief. The migraine was so severe that it kept me in bed with pain for hours that once I had some relief to be able to stand to go look in the mirror at the hives, it was approximately 1am. I put hydrocortisone cream on the areas I could reach and took Benadryl. It took over an hour to fall asleep. Saturday: I took Allegra. The hives were still prominent and itchy. Sunday: The hives were still there but most were on my shoulders and back, while some still remained on my stomach but not as prominent. The hives were still itchy. The other symptoms have subsided except the migraine, which was dull, and fatigue. Monday: The hives were not as prominent but somewhat itchy. They were some remaining on my shoulders. They other symptoms subsided with the exception of a dull migraine which I managed with Fioricet. I made the first available appointment with my primary doctor. Tuesday: I saw my primary doctor. Per my physician I still have hives on my trunk. I was instructed to continue with interventions. As of 5/19/2021, I had been treating the hives, fatigue, and migraines which occurred unexpectedly. The hives have subsided completely by Thursday, 5/20/2021.
44 2021-05-28 ringing in ears Sudden hearing loss and tinitus in left ear.
44 2021-05-31 ear discomfort, vision blurred "On 1/9 felt severe flu-like symptoms (chills, fever, nausea, dizziness, headache), and stayed in be... Read more
"On 1/9 felt severe flu-like symptoms (chills, fever, nausea, dizziness, headache), and stayed in bed until 1/10. Felt fine midday, 1/12, then sudden, intense migraine, ear/sinus pressure/pain, dizziness, blurred vision, weakness, tired. Symptoms improved but were still present the next day."
44 2021-05-31 thirst, tongue disorder, dry mouth Patient went to ED with possible vaccine related reaction. CHIEF COMPLAINT: POSSIBLE ALLERGIC REA... Read more
Patient went to ED with possible vaccine related reaction. CHIEF COMPLAINT: POSSIBLE ALLERGIC REACTION (sx p 2nd covid vax rec'd vax and was being observed developed sl dizziness and legs got weak and started shaking, en route w/ ems she felt like her tongue got thick 0.3 epi admisitered per EMS. on arrival pt is trembling but denies feeling cold, hypertensive, NSR oropharyx clear LS CTA b/l c/o feeling thirsty dry mouth after epi. obtained manual bp d/t trembling) The patient is an otherwise healthy 44-year-old female who presents to the emergency department today via EMS with concerns for an allergic reaction. The patient states she just received her 2nd Covid-19 vaccine (Pfizer) when about 15 minutes after, noticed a bilateral lower extremity weakness, dizziness, as well as dry mouth. EMS did provide IM epinephrine given at roughly 3:30 p.m.. The patient was further brought to the emergency department for further evaluation and monitoring. Patient states she has not noticed any rashes or itching, is not having any shortness of breath or trouble breathing. She states that she does have dry mouth, but is not having any sensation such as a difficulty swallowing or swelling. No headaches. No chest pain, abdominal pain, back or neck pain. No nausea vomiting dysuria or hematuria. MEDICAL DECISION MAKING The patient was seen upon arrival in the emergency department. She remained stable from a respiratory and hemodynamic standpoint. She presents status post IM epinephrine after feeling dizzy with a bilateral lower extremity weakness and shaking after the COVID-19 vaccine. On my initial evaluation, she does appear well, without any concerning propagation of an allergic response. She was monitored here in the emergency department for about 2-1/2 hours with no a change in her clinical status. She is almost 3 hours out from her IM epinephrine dose, and is feeling better. She is tolerating fluids. Does not have any posterior or pharyngeal swelling or sensations at this time, so I do feel comfortable with discharge home. Return precautions were discussed, the patient was discharged in stable condition.
44 2021-06-01 loss of taste, loss of smell can't smell or taste; can't smell or taste; nose congestion; tested for COVID-19, which came back po... Read more
can't smell or taste; can't smell or taste; nose congestion; tested for COVID-19, which came back positive; real fatigued; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) administered in the arm as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included hypertension from 2011 and ongoing; and high blood pressure. Concomitant medication included High Blood Pressure Pills (unspecified) 20 mg from 2011 for hypertension. She reported that on 05Mar2021 she felt real fatigued but did not think the vaccine could cause this. She thinks she had the symptoms of COVID-19 before getting her first dose of the vaccine. On 06Mar2021, three days after the patient was vaccinated, she tested for covid-19, which came back positive. The patient did not get any nose congestion until Sunday (07Mar2021), she had nose congestion; she had it until Tuesday and that only thing she have left is that now (unspecified date) she cannot smell or taste. She further stated that she have no other symptoms just fatigue, congestion but off course she lost my sense of taste and smell, since then and do not have anything after that, "it is very little smell". She would now like to know if it is safe to take her second dose of the vaccine which was due on 24Mar2021. She was concerned that because she had COVID-19, she may need to restart the vaccination series. The outcome of events " can't smell or taste" was not recovered; the patient recovered from nose congestion on 09Mar2021 and recovered from fatigued from unspecified date; and outcome of COVID-19 was unknown. Patient took OTC for the nasal congestion. Information regarding Lot/Batch number has been requested.
44 2021-06-01 ear pain Irregular menstruation not otherwise explained by early menopause. I?m always have a very regular cy... Read more
Irregular menstruation not otherwise explained by early menopause. I?m always have a very regular cycle and it became erratic after receiving the vaccine. With my cycle going from 27-28 days to anywhere from 10-23 days. Also very heavy clotting and menstrual pain. Have never expelled clots in such a manner other than after childbirth. I do get cold sores, usually about once sometimes twice a year. I?ve had four since the vaccine. Sharp pain in my right ear not otherwise explained by infection and not present prior to vaccines. Feels like an ear ache: comes and goes.
44 2021-06-01 extreme sound sensitivity, sensitivity to light Sore arm started about 6 hours later and lasted about 24 hours Dizziness started within half an hour... Read more
Sore arm started about 6 hours later and lasted about 24 hours Dizziness started within half an hour intermittent for 48 hours Extreme sensitivity to normal noises and lights started 20 hours after, lasted 4 hours Shooting, intermittent pain in upper left quadrant of chest, started 6 hours after, ongoing, 30 hours out also occasionally in right shoulder/chest, and left side of neck Partial PARALYSIS of left arm starting about 3 hours after, significant worsening 40 hours after and ongoing
44 2021-06-03 deafness unilateral, ringing in ears feels like there is water inside my ear; impacted my equilibrium; I can't hear from left ear; tinnit... Read more
feels like there is water inside my ear; impacted my equilibrium; I can't hear from left ear; tinnitus; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in right arm on 18May2021 11:30 (Lot number: ER8735 7/21) at single dose for COVID-19 immunization. Medical history included allergy with Vitamin E oil and Hair dyes. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In the afternoon of the day she had received the vaccine (18May2021) she got ringing (tinnitus) in ears which is unusual for her. It went away by the evening time but when she woke up the next morning (day after the vaccine, 19May2021 07:00) she noticed that she can't hear from her left ear. It almost felt like there was water inside her ear but not quite really. It's a strange sensation that she had never felt before. She also felt that it had impacted her equilibrium somewhat. No treatment received for events tinnitus and can't hear from left ear. Lab data included antibody (blood test) on 30Apr2021: negative. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of tinnitus was recovered on 18May2021, outcome of she can't hear from her left ear was not recovered, outcome of other events was unknown.
44 2021-06-03 taste impairment Bad body aches from lower back down legs; Unwell feeling all night; feverish; chills; bad taste in m... Read more
Bad body aches from lower back down legs; Unwell feeling all night; feverish; chills; bad taste in mouth; restless; Stomach turning; A red very warm blotch on my arm around the injection site; Anxiety; Feelings disappeared then came back not as harsh around 30 hours after; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 44-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN8581) as unknown, single for covid-19 immunisation. Medical history included CVC (Central venous catheter). Concomitant medications included Metoprolol succinate 25 mg, Omeprazole 40 mg, Cetirizine hydrochloride. Patient had known allergies. Patient did not receive any other vaccine within 4 weeks. Patient neither diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 post vaccination. On an unknown date, the patient experienced bad body aches from lower back down legs 12 hours later, unwell feeling all night, feverish, chills and bad taste in mouth, restless, stomach turning. Her feelings disappeared then came back not as harsh around 30 hours after. Patient went to work feeling ok thought she was back to normal but when she showered, she noticed a red very warm blotch on her arm around the injection site which slightly disappeared after 12 hours and had anxiety. The patient was recovering from the event red very warm blotch on her arm around the injection site. The outcome of all other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
44 2021-06-03 mouth itchiness, lip itchiness, tongue itchiness, dry mouth, dry throat, swollen tongue Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat... Read more
Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Tight throat and tongue some minimal; Tight throat and tongue some minimal; Swelling in tongue and throat.; Swelling in tongue and throat.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old, non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in left arm on 17Mar2021 at 08:30 (age of vaccination 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication includes vitamins C (MANUFACTURER UNKNOWN), b12 (MANUFACTURER UNKNOWN), multi vit (not coded) (MANUFACTURER UNKNOWN), omega 3 (MANUFACTURER UNKNOWN), all for an unknown indication since an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took aspirin in the past and experienced drug allergy. On 17Mar2021 at 09:15, the patient experienced dry, itchy throat, lips, mouth and tongue, tight throat and tongue and some minimal swelling in tongue and throat. No therapeutic measures were taken for the adverse event. The clinical outcome for the events dry itchy throat, lips, mouth and tongue, tight throat and tongue some minimal swelling in tongue and throat was not recovered. No follow-up attempts are needed. No further information is expected.
44 2021-06-03 swollen tongue, ear discomfort High heart rate; high blood pressure; swollen tongue; trip to the Ear for observation; This is a spo... Read more
High heart rate; high blood pressure; swollen tongue; trip to the Ear for observation; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received first dose of BNT162B2(Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 07Mar2021 09:00 AM (at the age of 44 years) as 1ST DOSE SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. Known allergies with Stevia, penicillin, and sulfa sclerosis from an unknown date and unknown if ongoing. Concomitant medication included naltrexone (NALTREXONE) 3 mg taken for an unspecified indication, start and stop date were not reported. On 07Mar2021 09:15 AM patient experienced high heart rate, high blood pressure, swollen tongue and trip to the Ear for observation. 25 mg of benedryl given orally and released an hour later. The events resulted in doctor or other healthcare professional office/clinic visit since the vaccination, patient has not been tested for covid-19. The outcome of the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
44 2021-06-05 smell distorsion, taste disorder Parosmia Peppers & onions smell & taste musky & mold Coffee smells like a waste facility Cilantro sm... Read more
Parosmia Peppers & onions smell & taste musky & mold Coffee smells like a waste facility Cilantro smells and taste like mold
44 2021-06-06 dry throat Client received her 1st dose of COVID Pfizer vaccine at 17:14. After leaving vaccine site and sittin... Read more
Client received her 1st dose of COVID Pfizer vaccine at 17:14. After leaving vaccine site and sitting in her car for 5 minutes she returned to the vaccine site at 17:44 and communicated to the Ancillary Co-Lead that she was having trouble swallowing. Ancillary Co-Lead sat client in a chair and requested EMT & Nurse assistance over the walkie-talkie at 17:45. Lead RN, Co-Lead RN, and EMT reached client at 17:47. Client stated her throat was dry and she was having mild trouble swallowing. EMT requested client to stick out her tongue. EMT, Lead RN, and Co-Lead RN observed that client's tongue appeared white and chalky. Client stated no SOB, trouble breathing, or any other symptoms. Client stated she has no allergies and has never experienced passing out or any adverse reaction to a medicine or medical procedure. Client was alert & oriented times 4. Client stated that she started to have an odd feeling in her throat when she was sitting in the observation room, but did not think anything of it and left. After getting in her car, client drank a immunity booster shot, noticed trouble swallowing and came back to the site. Client stated she was unsure if the immunity shot contained caffeine. Client stated that she has a doctor she sees regularly, has no underlying medical conditions and takes no medications. Client also stated that she had a hysterectomy 6 months prior and could be experiencing surgical menopause. Client indicated that she was nervous about getting vaccinated and felt anxious both before and after receiving the vaccine. Tech brought client a bottle of water. EMT proceeded to take client's vital signs at 17:55 as follows: BP: 146/88, HR: 75, O2: 99. The client's friend who came to the site with her also walked up at that time. Client communicated that she does not have high blood pressure. Client requested more water and ended up drinking a total of 4.5 bottles. Client stated that she had no dinner the night prior and only had a protein shake and small amount of soup today. Client stated that she was starting to feel better and that her throat was just really dry. EMT obtained 2nd set of vitals at 18:06 as follows: BP: 142/80, HR: 98, O2: 99. Client stated she was just feeling anxious about the incident, but feeling better overall. Client stated she was swallowing OK. Client stood up and stated that she felt OK. Lead RN recommended client go to urgent care if swallowing issue returned and to call 911 if she experiences any SOB or trouble breathing. Lead RN also communicated to client that she can follow up with her HCP and/or allergist for input on receiving 2nd shot of Pfizer vaccine. Client left with her friend at 18:11 and was walking with a steady gait.
44 2021-06-09 ear pain Initial reaction (2 days post): nausea, fever, chills, sore left arm, muscle aches 1month post-prese... Read more
Initial reaction (2 days post): nausea, fever, chills, sore left arm, muscle aches 1month post-present time: hip and knee pain, stabbing right ear pain, chronic fatigue
44 2021-06-10 ear pain Woke up with extreme ear pain in right ear. Waited a couple days. It got way worse with time. Went t... Read more
Woke up with extreme ear pain in right ear. Waited a couple days. It got way worse with time. Went to urgent care. NP didn?t see an infection but was confused why I had 10/10 pain. Was given rx drops that made it worse and I had to see an ENT in the following days who determined swelling and a blockage and extreme redness.
45 2020-12-31 ear swelling Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a... Read more
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
45 2020-12-31 ringing in ears Bilateral tinnitus- non stop since the day of the vaccine.
45 2021-01-01 mouth tingling, lip swelling Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt... Read more
Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt hot, lips tingling/swollen and chest red. Denies any issues with breathing.
45 2021-01-03 mouth tingling Had an episode of tounge tingling and numb throat. Lasted 30 min, resolved without any treatment.
45 2021-01-04 taste impairment Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and rin... Read more
Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and ring finger. Around 11 pm started having metallic taste and cannot get rid of it. Woke up in middle of the night having diarrhea which still having symptoms this morning.
45 2021-01-04 taste impairment Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring ... Read more
Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring finger. It went away in 20 plus minutes. Around 11 pm started having metallic taste again and woke up with diarrhea in the middle of the night. Symptoms have not subsided.
45 2021-01-04 vision blurred dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainde... Read more
dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
45 2021-01-05 lacrimation increased, lip swelling Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), ... Read more
Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly." Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.
45 2021-01-05 swelling around the eyes, dry throat Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No... Read more
Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No change in voice, no wheezing , able to drink and swallow water without difficulty. Vital signs and O2 saturation /oximetry were normal. After 30 min into observation, she c/o lightheartedness and both eyes were puffy. Vitals: BP 129/75, hr 91, O2 sat 99% at room air . Benadryl 50 mg IM given and client was taken to the Emergency room..
45 2021-01-06 mouth tingling Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, starte... Read more
Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, started approximately 10 minutes after receiving vaccine. Reaction resolved with no treatment. Patient developed Bell?s Palsy 2-3 days after vaccine. Currently being treated with high dose steroids and acyclovir.
45 2021-01-07 taste impairment After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by ... Read more
After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.
45 2021-01-07 eye swelling, bloodshot eyes Swelling and redness around the eyes and lives. Treatment benadril 50 mg po stat.
45 2021-01-07 mouth numbness, mouth tingling minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, th... Read more
minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, the roof of my mouth began to tingle and go numb as. NO difficulty swallowing or breathing, No changes in the vitals and I was given benedryl by mouth and observed for 30 minutes with no further issues and all symptoms resolved. My right arm was tingling and weak also but to date all symptoms has resolved.
45 2021-01-07 pain in jaw Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject... Read more
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Rapid Response called @1721, patient monitored.
45 2021-01-07 mouth tingling, mouth numbness tongue tingling and numb
45 2021-01-07 ringing in ears Bilateral tinnitus (non-stop); This is a spontaneous report from a contactable healthcare profession... Read more
Bilateral tinnitus (non-stop); This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 21Dec2020 at 10:15 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included chronic sinus infections in the past. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE), strength reported as 1/28, azelastine HCI nasal spray, montelukast sodium tablet. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Dec2020 at 12:00 (reported as since the vaccination), the patient experienced bilateral tinnitus (non-stop). The patient did not receive treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the bilateral tinnitus (non-stop) was not resolved. Information on Lot/Batch number has been requested.
45 2021-01-08 mouth numbness, mouth tingling, eye itchiness, ear itchiness I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot adm... Read more
I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot administration, felt itchy on limbs, then trunk and neck, then ears, eyes and into scalp. Symptoms progressed over the next 2 hours (flushed neck and then lips felt tingly and numb). At 7:30 my soft palate started to feel numb and I started to have some difficulty swallowing. Went to ER. Symptoms continued. After IV meds given swallowing difficulty continued to worsen so I was given a low dose shot of Epi. Swallowing improved (not to normal but not as severe) over the next hour but itchiness returned. It is now 8:00pm on 1/9/2021 and I continue to have itchiness, my tongue and soft palate are still numb but I am able to swallow fairly well and my entire face has decreased sensation to touch.
45 2021-01-10 eye pain, eye twitching About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after an... Read more
About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after and still today intermittent vision(focus) issues and twitching of right eye with some slight right eye pain
45 2021-01-10 eye swelling Woke up at 7am at 8:15am both of my eyes swelled almost shut instantly. Both were swollen above my ... Read more
Woke up at 7am at 8:15am both of my eyes swelled almost shut instantly. Both were swollen above my eyebrow. Whites of eyes were still white. They didn't itch or hurt. Went to Urgent care and they recommended cold compresses, Loratadine, Vaseline. About 6 hours later the swelling went down, but not completely. Woke up Sunday morning and my eyelids were dry and scaly.
45 2021-01-10 mouth numbness Patient starting experiencing full body itching and redness at approximately 20 minutes post-vaccina... Read more
Patient starting experiencing full body itching and redness at approximately 20 minutes post-vaccination. Patient reports having taken Benadryl 25 mg PO on her own approximately 1 hr before receiving the vaccine. Another Benadryl 25 mg PO x1 dose adminstered at 9:05am. BP 162/80 HR 64 O2=96% at 09:20am. Lip numbness being reported at 9:20am. Itching subsiding at 9:30am. Patient clinically stable. Patient released from clinic at 9:30am. Patient also reports itching and redness with 1st dose of Pfizer COVID-19 vaccine. Patient also reports having Bell's Palsy after receiving the 1st dose of Pfizer vaccine (with photographic evidence) that was noticed approximately 11 hours after 1st dose of vaccine administration. Patient realized she was having Bell's Palsy after she began noticing having slurred speech and facial drop. Took muscle relaxant (Robaxin) and prednisone (5 days) prescribed by her physician. Bell's Palsy resolved in approximately 6 hours.
45 2021-01-10 lip swelling Swollen lips and face hives on face
45 2021-01-10 swelling of eyelid, ear pain, mouth numbness Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monda... Read more
Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monday 1/4/21- Started feeling some slight numbness on right side of face and front of tongue, headaches continued on and off throughout the day. Tuesday 1/5/21- Woke up to get ready for work and I noticed my right eyelid was a little swollen and right side of my mouth was numb and smile was slightly crooked. Arrived at work and my right eye was not blinking properly. I went to ER room to seek treatment and was prescribed Prednisone and Valacyclovir. Wednesday 1/6/21- Started with right ear pain that radiated down to right side of neck. This is the second time I've had Bells Palsy. First time was in 1997 when I was age 22.
45 2021-01-10 swelling of eyelid, mouth numbness, taste disorder BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal ... Read more
BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal headache at night and took Tylenol 500 mg for headache relief. January 4, 2021- The slight numbness in tongue continued and my face started to feel a little different too. I had headaches on and off throughout the day and evening. January 5, 2021- Woke up to get ready for work and noticed that my right eyelid was a little swollen and the right side of my mouth looked different. I arrived at work and my right eye was not closing properly and I was having difficulty blinking. I left work an hour later and went to ER to seek treatment. I was prescribed Prednisone and Valacyclovir for a seven day course. The first time I had Bells Palsy was in 1997 when I was 22 years old.
45 2021-01-10 vision blurred, sensitivity to light, eye discomfort Started to have blurry vision with my eyeglasses on then got worst in the afternoon, which I took my... Read more
Started to have blurry vision with my eyeglasses on then got worst in the afternoon, which I took my glasses off to avoid straining my eye to focus on my computer screen and paperwork. Vision was more blurry without my glasses but could not wear my glasses which made the blurriness worst. Had pressure behind my eyes with a mild headache along with sensitivity to light. The next day 11/05/2021, had my eyes checked by the eye doctor who indicated that everything was normal, eye pressure and response to light. He did put a numbing eye drop in my eye that made the eye pressure relieve for a couple hours but when that wore off, I could feel the pressure behind my eyes. On 11/06/2021, my eye and vision were back to normal
45 2021-01-11 loss of taste, loss of smell Have a cold and headache; headache; loss smell/ taste; loss smell/ taste; This is a spontaneous repo... Read more
Have a cold and headache; headache; loss smell/ taste; loss smell/ taste; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Es1685, expiry date not reported), via an unspecified route of administration on 22Dec2020 at 09:30 AM at single dose for Covid-19 immunization. There were no medical history and no concomitant medications, no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines with 4 weeks prior to COVID vaccine nor any other medications within 2 weeks of vaccination. On 01Jan2021, the patient has a cold and headache, she was sent for Covid test 1/5 loss smell/ taste 1/3. The patient did not receive treatment for the events. The patient underwent lab test on 06Jan2021 which included nasal swab: pending result. Outcome of the events was recovered. The reporter assessed the events as non-serious. Information on Lot/Batch has been requested.
45 2021-01-11 eye strain Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility ... Read more
Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
45 2021-01-11 eye pain, dry eye Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afterno... Read more
Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afternoon around 4 or 5 got really hot and then in the evening around 9 got really cold and face started to itch. chin was bumpy and face was itching, eyes were still hurting with slight headache. I did have vivid dreams at night and slept not well. in the am my face was itchy red eyelids and under eye, patch like rash on face and itch . Ankles hurt to walk (joints hurt) and arm site was painful and hurt. was cold on and off during day and monday it was hard to wake up, v ery drosy and exhausted. Later that day the face cleared up and i could walk fine and headache was gone . I did feel a little cold monday night. Tuesday everything gone except a slight itch here and there on my face. I feel fine and arm pain is gone as well.
45 2021-01-11 lip swelling Face,neck and arms had blotches all over them and lips were swollen. Injection was at 1:15pm after ... Read more
Face,neck and arms had blotches all over them and lips were swollen. Injection was at 1:15pm after I had waited my 15 minutes I left and it happened in the car and notified the person that gave me the injection and was told to go to Emergency Room. Was told by Emergency Room that I should not have had the injection being allergic to bee stings. Was given IV with Steroid. Discharge papers said Allergic reaction to drug.
45 2021-01-11 oropharyngeal discomfort scratchy throat, trouble swallowing
45 2021-01-12 mouth numbness, mouth numbness Systemic: swelling on her throat, numbing lips; symptoms lasted 0 days
45 2021-01-12 swollen tongue after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrin... Read more
after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrine injection and 911. patient waited around for about an hour after vaccination - patient BP went up, felt weak, signs of weakness, tongue big and throat closing - patient refused epinephrine again, called on call doctor who suggested Benadryl 25mg. Facility gave patient 25mg Benadryl IM. Patient to be monitored at facility
45 2021-01-13 mouth ulceration Severe dizziness; Mouth breaking out in ulcers; extreme tiredness; headache; This is a spontaneous r... Read more
Severe dizziness; Mouth breaking out in ulcers; extreme tiredness; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 04:30 PM at single dose (vaccine location: left arm) for COVID-19 immunisation. The patient previously experienced allergies with penicillin and levofloxacin (LEVOQUIN). Concomitant medications in two weeks included cetirizine hydrochloride (ZYRTEC), colecalciferol (VIATAMIN D) and hormone replacement pellets. Patient did not have other vaccine in four weeks. Patient was not pregnant at the time of vaccination. The patient experienced severe dizziness 36 hours after vaccination, mouth breaking out in ulcers, extreme tiredness and headache on 01Jan2021. No treatment received for events. Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
45 2021-01-13 oropharyngeal discomfort c/o foreign sensation in throat immediately after COVID-19 vaccine administered. no signs of airway,... Read more
c/o foreign sensation in throat immediately after COVID-19 vaccine administered. no signs of airway, breathing or circulation complications. Diphenhydramine 25mg given with resolution of symptom & pt discharged home.
45 2021-01-13 mouth tingling Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red ra... Read more
Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red rash on bilateral forearms; Patient developed Bell's Palsy 2-3 days later; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 23Dec2020 at 14:30 at single dose in left arm for covid-19 immunization. Medical history included mitral valve prolapse from an unknown date, and allergies: Cephalosporins and nut (peanut derived). Concomitant medication included epinephrine (EPIPEN) 0.3MG/0.3ML, fluticasone propionate 50MCG/ACT nasal spray. On 23Dec2020 at 14:45, the patient experienced allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms. Reactions resolved with no treatment. The patient developed Bell's Palsy 2-3 days later in Dec2020. Currently being treated with high dose steroids and acyclovir. All events required emergency room visit and physician office visit. All events were reported as non-serious by reporter. The outcome of event Bell's Palsy was not resolved, outcome of other events was resolved on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if the patient has been tested for COVID-19 since the vaccination.
45 2021-01-13 feeling of choking, mouth tingling I received the shot at 2 o?clock. By 2:05 my tongue and the back of my throat started tingling and b... Read more
I received the shot at 2 o?clock. By 2:05 my tongue and the back of my throat started tingling and burning like it had been scolded. It was reported after 30 minutes. 25 mg of Benadryl was given PO at 2:35. I started to develop a cough and was clearing my throat but had no difficulty breathing. At 3:05 another 25mg of Benadryl po was given. I was monitored until 4:30 PM. I was sent home. By 630 the sensation had started to increase again. I took 25 mg of Benadryl PO again. By 7 PM I was not having any relief so I spoke with my physician and he advised me to take 25 mg of Benadryl PO and the first row of a steroid dose pack. By midnight the symptoms had started to reoccur. I took another 50 mg of Benadryl. I finished the medrol dose pack on Wednesday, January 13th but still have the raw sensation on my tongue.
45 2021-01-14 pain in jaw Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject... Read more
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; This is a spontaneous report form a contactable physician. A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL0142, expiry date: not reported) intramuscular, on 07Jan2021 07:30 AM on Arm Left at a single dose for COVID-19 immunization. COVID-19 vaccine was administered at a hospital. Medical history was not reported. It was unknown if patient was pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. On 08Jan2021 07:30 AM, the patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Treatment was not received for the adverse events. Outcome of the events was unknown.
45 2021-01-14 vision blurred Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administrati... Read more
Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
45 2021-01-15 taste disorder, taste impairment Headache started a couple hours after injection and lasted for days. Muscle pain, neck pain, naus... Read more
Headache started a couple hours after injection and lasted for days. Muscle pain, neck pain, nausea, fatigue, altered taste bitter,
45 2021-01-16 eye pain 2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul... Read more
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
45 2021-01-17 eye pain nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, pai... Read more
nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, painful eyes from 1/15-1/17 w/ headache severe, loss of appetite, nausea lasting from 1/15-present day.
45 2021-01-17 vision blurred 5min after vaccine became tachycardic with blurred vision and felt like she was going to pass
45 2021-01-18 eye swelling Dizziness, eye swelling, throat tightness, sense of impending doom, mild tachycardia
45 2021-01-18 mouth numbness, mouth tingling After 15 min TM started having lip and tongue numbness tingling . Then HA . Allergy to Benadryl ... Read more
After 15 min TM started having lip and tongue numbness tingling . Then HA . Allergy to Benadryl BP137/92 HR 78 O2 99%
45 2021-01-18 eye discomfort headache that would not go away, like her head would explode; pressure behind her eyes; This is a sp... Read more
headache that would not go away, like her head would explode; pressure behind her eyes; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ685), intramuscular in her right arm on 06Jan2021 at a single dose for covid-19 immunisation. Medical history and concomitant medications were reported as none. On 06Jan2021, the patient experienced headache that would not go away, like her head would explode and pressure behind her eyes. Stated that both events started 30 minutes after the shot on 06Jan2021.Therapeutic measures were taken as a result of headache that would not go away, like her head would explode and pressure behind her eyes which included ibuprofen 800 and switched it out with TYLENOL. Outcome of the events headache that would not go away, like her head would explode and pressure behind her eyes was recovered on 09Jan2021.
45 2021-01-18 thirst Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; ... Read more
Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; petichiae on site arm below injection site; sneezing; vivid dreams; swelling in legs; lower appetite; thirsty; more frequently urination with larger amounts; more frequently urination with larger amounts; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at 15:45 on arm at single dose for COVID-19 immunization. Medical history included Chronic sinusitis and had known allergies with Gluten and Sulfa. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tizanidine hydrochloride (TANIN, reported as tanins) and had known allergy. The patient experienced sleepiness, pain at site for more than 24hours less than 48hours, itching on arm below injection site, headache, petichiae on site arm below injection site, sneezing, vivid dreams, swelling in legs, lower appetite, thirsty, more frequently urination with larger amounts on 04Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.
45 2021-01-19 eye swelling Chills, lower back ache within 15 mins of 2nd dose, fever of 102, achy, chills, sweat, joint pain at... Read more
Chills, lower back ache within 15 mins of 2nd dose, fever of 102, achy, chills, sweat, joint pain at 2am (approx 14 hrs after injection), took 1000mg ibuprofen w water, sleep. Woke up w L eye swelling (have photos), appears L sinus inflamed, more ibuprofen. Effects continued into Sunday, relieved w ibuprofen, swelling of eye went down. Remained tired and achy throughout Monday 01/18 and Tuesday 01/19, woke up Wednesday 01/20 w L sinus stuffiness and "full" feeling, feels like a 1 sided sinus infection.
45 2021-01-19 mouth numbness 3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh... Read more
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
45 2021-01-19 lip swelling, eye swelling swelling of left eye on Friday 1/15/21 took Benadryl and came down by next morning. Sunday 1/17/21 ... Read more
swelling of left eye on Friday 1/15/21 took Benadryl and came down by next morning. Sunday 1/17/21 swelling of upper lip took Benadryl and it went away on its own a few hours later. Random hives all over body all weekend From 1/15/21 to 1/18/21. Generalized itchy feeling of skin.
45 2021-01-19 mouth tingling pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue are... Read more
pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue area. C/o LA hand coldness.
45 2021-01-19 visual impairment a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, thro... Read more
a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, throbbing headaches, difficulty operating a vehicle. The dizziness has now gotten bad enough that it is causing nausea.
45 2021-01-20 mouth numbness Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was cl... Read more
Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was closing. Was rushed to the hospital.
45 2021-01-20 mouth tingling Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, di... Read more
Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, diarrhea, rash, sore throat, headache
45 2021-01-20 drooling, ringing in ears, eye pain Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete b... Read more
Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete body ache, muscles, joints, everything, terrible headache. Was on couch and walked upstairs. By the time I got there, I was nearly vomiting and on the verge of losing consciousness. I laid down on the cold tiles and tried to stay conscious. I couldn't even talk. Saliva was pouring out of my mouth uncontrollably. After awhile it let up enough to scoot into the bedroom and climb into bed. Then an entire night of worsening chills, fever, aches, eye pain, sore throat, pulsating ringing in my ears. Little if any sleep. I tried to get up and sit in a chair this morning at 3am and within minutes was so nauseated and light headed I had to lay back down flat. Tried to drink some hot tea and Gatorade at 5am. Thought I heard someone walking around the house and then realized it was heartbeat pounding in my ears. This morning my feet are super sensitive, I have urinary frequency and urgency, and the pulsatile tinnitus is back. Later today had episode of sharp chest pains front to back that resolved after about five minutes. Treatment has been rest today.
45 2021-01-20 visual impairment approx 15 minutes after receiving the vaccine, client started c/o tingling in hands and arms bilater... Read more
approx 15 minutes after receiving the vaccine, client started c/o tingling in hands and arms bilaterally, as well as clammy hands and light headedness. She also said her eyes were foggy. Vital signs monitored and o2 given per mask. She c/o frontal area head pain, resolved after being on O2 for 5 minutes. 4:05pm says clamminess in hands and light headedness improved. She was release to drive home and told to report to ER if she has any more problems. client does report today of having daily headaches since she received her shot.
45 2021-01-23 ear swelling, ear pain My right arm broke out in hives a few hours following the injection, and then my left arm a few hour... Read more
My right arm broke out in hives a few hours following the injection, and then my left arm a few hours later. The next morning my right ear swelled , was red and covered in hives and very painful. It continued to swell over next few days, very painful. I was feeling drained and had gastrointestinal symptoms for days and this morning woke up with my face swollen and another rash and hives on my face. I had a little trouble breathing as well and went to an Urgent Care. The doctor believes I had an allergic reaction to the vaccine and administered a steroid injection and prescribed steroids and antihistamines.
45 2021-01-23 feeling of choking, taste impairment Immediate funny taste in back of nose, back of throat. Tingly tongue. In about 15 minutes, cheeks nu... Read more
Immediate funny taste in back of nose, back of throat. Tingly tongue. In about 15 minutes, cheeks numb and swollen feeling.
45 2021-01-24 inability to speak Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she... Read more
Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she lost her voice and she had face and neck/throat swelling
45 2021-01-24 eye swelling, inability to speak Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eye... Read more
Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eyes, face and neck swollen- felt like her throat was swelling
45 2021-01-24 mouth tingling, swelling around the eyes About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and m... Read more
About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and my face felt heavy. I looked myself in the mirror, my face, cheeks and neck became very red like beet red and warm to the touch. I returned to the vaccine site and they observed me but the symptoms worsened, my eyes started getting puffy/ my cheeks started getting purple instead of red, and they sent me to the ER. At the ER they continued to monitor me and gave me IV Benadryl and IV Pepcid and IV steroids and said I had a delayed case of hives. Once I had all the IV medication the swelling went down and the hives on my arms and my back went away, the redness in my face and neck stayed until next day and I noticed after taking a warm shower the next day the redness returned on other parts of my body. I took a Benadryl. About after 2 days it was all resolved.
45 2021-01-24 mouth tingling, swollen tongue Pt waiting in Observation had vaccine at 17:47 - 2nd dose - 18:00 c/o tingling around lips and the... Read more
Pt waiting in Observation had vaccine at 17:47 - 2nd dose - 18:00 c/o tingling around lips and then tongue swelling Had 50 mg of benadryl IM to left deltoid at 18:04 18:13 BP 108/80 HR 100 Pulse ox on RM air was 96% 18:15 HR 104 on monitor BP 110/80 18:21 Transported by Wheelchair to ED for further evaluation
45 2021-01-24 thirst I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm,... Read more
I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
45 2021-01-24 thirst About 13 hours after the vaccine she began having body aches and chills, headache and arm pain, extr... Read more
About 13 hours after the vaccine she began having body aches and chills, headache and arm pain, extreme thirst, temperature of 100.1. The next morning she had a temperature of 101.2 with improvement of the chills but ongoing headache and body aches.
45 2021-01-25 loss of smell, loss of taste started feeling like I could not smell/no smell or taste; did not have flavor/no smell or taste; Thi... Read more
started feeling like I could not smell/no smell or taste; did not have flavor/no smell or taste; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunization. The patient's patient medical history and concomitant medications were not reported. The patient reported that she received her first dose of the vaccine on Tuesday. She stated on Sunday (10Jan2021) that she started feeling like she could not smell and did not have flavor and it was getting worse on Sunday and Saturday. She does not have no fever, no headache, nothing from Covid. She stated she received a Covid test and the test was negative. She called to see if this is a side effect of the vaccine. The patient further mentioned that she has no smell or taste and wanted to know if it is related to the vaccine. She mentioned that she does not have any other COVID symptoms and she had a COVID test that was negative on an unspecified date. The outcome of the events was not recovered. The following information on the batch/lot number has been requested.
45 2021-01-25 dry mouth Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the ho... Read more
Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the hospital parking lot to wait, but decided to try and drive home. I began to feel light headed, dizzy, dry mouth, it felt hard to swallow. I knew I did not feel well so I drove myself to the fire station that was closest to me. They took my blood pressure upon arrival and it was 141/93. My normal blood pressure is around 116/63, so it was considerably high. I do not have a history of high blood pressure. The morning of the vaccination I had, had a very small cup of coffee and had eaten a piece of raisin bread. I had also taken two 250 mg generic acetaminophen tablets with 65mg caffeine prior to the vaccination. I also experienced chills and a low grade fever of 100 degrees.
45 2021-01-25 pain in jaw Rapid Response Team called to vaccination observation room. Arrived to find patient sitting in chair... Read more
Rapid Response Team called to vaccination observation room. Arrived to find patient sitting in chair, reports immediately after receiving vaccine feeling flushed and shaky, BP checked 172/95 MAP 115. Denies PMH of HTN, reports baseline BP 120s-130s/60s-70s. Denies CP/SOB or throat scratchy/swelling but does report jaw pain. Reports only allergy is to PCN, last meal was a protein shake ~1 hour prior. Symptoms did not resolve when placed in supine position, reported the feeling of ?flushed? worsening. Decision made to transfer patient to ED for further evaluation. ED work-up negative. Was observed for one additional hour in ED and discharged to home. No further symptoms documented in ED.
45 2021-01-25 mouth tingling Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out... Read more
Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out. Felt better minutes later. Reports rash to body 2 weeks after 1st injection.
45 2021-01-25 swollen tongue Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for... Read more
Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for 30 min to monitor for reaction. After 5 min, patient reported feeling dizzy, tongue feeling slightly swollen, chills, slight difficulty swallowing her own saliva. She denied difficulty breathing, racing heart. NP on site notified, who performed a focused assessment and administered 50 mg IV Benadryl IM. Patient was reassessed and monitored by NP and two RN. Patient reported instant symptom relief within 2-4 min, that her chills went away and no issues swallowing and felt "90%" better. After 15 mins patient reported she was feeling symptoms again come back. Patient was escorted to the ED with NP and RN immediately.
45 2021-01-26 mouth tingling Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of recei... Read more
Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of receiving vaccine. Transported to ER. Still has rash as of 1/27/2021 face, behind knees, and torso.
45 2021-01-26 feeling of choking Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR ... Read more
Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR 66 bpm. Given apple juice and didn't feel lightheadeness or tnling. Then expressed waves of episodes reported by the patient. Monitored for 117 minutes. PRovider called 1 hour after monitoring symptoms that were not worsening. Still felt shakey. Given option to go to ED or be transported by ambulance. Went via ambulance to ED. Did not receive any additional treatment in the ED. ED noted that it did not appear to be anaphylactic reaction.
45 2021-01-27 loss of smell, loss of taste COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patie... Read more
COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization. Medical history was none and there were no concomitant medications. The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021. All the events were reported as being medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020. Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX). The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered. The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
45 2021-01-27 dry throat Patient c/o dry throat and slight cough. No SOB nor difficulty breathing. Scratchy throat. Elevate... Read more
Patient c/o dry throat and slight cough. No SOB nor difficulty breathing. Scratchy throat. Elevated BP however patient noted that it was because she was anxious. Symptoms resolved within 30 minutes and patient left the clinic.
45 2021-01-27 taste impairment half of my legs feel uneasy; had bad taste like metal; This is a spontaneous report from a contactab... Read more
half of my legs feel uneasy; had bad taste like metal; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8482, expiration date: unknown), via an unspecified route of administration on the left arm on 14Jan2021 at 12:00 at a single dose for COVID-19 immunization. Medical history included history (Hx) of blood clots. The patient has no known allergies. The patient is not pregnant. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medication in two weeks. The patient had no COVID prior vaccination and had not tested post vaccination. On 14Jan2021 at 1315, the patient experienced half of her legs felt uneasy, no pain, just like she worked out. The patient also reported that after the vaccine, she had a bad taste, like metal. No treatment was administered for the events. The events had not resolved.
45 2021-01-27 ear pain Body aches (muscles and joints); Body aches (muscles and joints); tiredness; weakness; left arm very... Read more
Body aches (muscles and joints); Body aches (muscles and joints); tiredness; weakness; left arm very sore; left earache; back and neck pain; back and neck pain; Fever 102; Chills; Body aches (muscles and joints); This is a spontaneous report from a contactable consumer (patient herself). This 45-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL33029), via an unknown route, on 16Jan2021 (at 09:45) at single dose administered on the left arm for COVID-19 immunisation, administered at hospital. Relevant medical history included high blood pressure, asthma and COVID-19 (prior to vaccination). The patient was receiving concomitant medications (unspecified). On 17Jan2021 (at 08:00 AM), the patient developed fever 102, chills, body aches (muscles and joints), tiredness, weakness, left arm very sore, left earache, back and neck pain. It was unknown if the patient received treatments for the events. The patient was recovering from the events.
45 2021-01-27 mouth tingling Patient is a nurse and received her 2nd COVID vaccine dose 1/25/2021. She knew she was at risk for a... Read more
Patient is a nurse and received her 2nd COVID vaccine dose 1/25/2021. She knew she was at risk for anaphylaxis so she was kept under observation at the vaccine administration site. Ten minutes after receiving her shot she felt her lips starting to tingle along with lightheadedness. She did not have any other symptoms. She was given 50mg IM benadryl, and the patient was transported to the emergency department. Her symptoms resolved after receiving benadryl. After being evaluated in ER, where no further treatment was warranted, she was discharged with Pepcid, prescription for 4 days of prednisone, and EpiPen. She was given a referral to allergy clinic.
45 2021-01-27 swelling of eyelid, ear swelling 1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 ... Read more
1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 Went to urgent care for mild swelling and numbness on left side of face, scalp, ear. Also very dry flaky skin. Given desnoide cream, and instructed to take Claritin 1/13/21-1/15/21 Took Claritin, and all symptoms resolved except for dry skin 1/16/21-1/17/21 Did NOT take Claritin 1/18/21 Mild facial numbness, on left. Took Zyrtec-D, symptoms improved 1/19/21 No apparent numbness. Took Claritin 1/20/21 Possibly hint of numbness. Extremely dry skin and scalp. Took Claritin. Used desonide. Only skin around eyes slightly swollen. 1/21/21 Mild-mod numbness on left side of face. Extremely dry skin and scalp. Face feels warm. Took Claritin
45 2021-01-27 swollen tongue, lip swelling Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hive... Read more
Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hives and took a Claritin. Was at home later in the evening around 5pm and started to have lip/jaw swelling and throat tightening. Called an ambulance and they gave her EPI pen and took over treatment. Ended up getting discharged around 11-12pm last night and told to take prednisone and Benadryl. Around 5am today 1/28 had swelling in tongue and bottom lip swelling. Went back to emergency room and they did similar treatment. Is planning to follow up with her doctor and will be on her prescribed medications for a few days.
45 2021-01-28 eye itchiness Rashes face like chemical peel and red on fire, eyes itchy, red line waistline and bra line, neck an... Read more
Rashes face like chemical peel and red on fire, eyes itchy, red line waistline and bra line, neck and chest are red. Pt. had Covid in Oct. 2020, blood drawn showed no anti-bodies 3 weeks prior the vaccine.
45 2021-01-28 swollen tongue, lip swelling Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spike... Read more
Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spiked, severe headache, severe abd pain, seen at Urgent Care and sent to ER. Given meds and sent home. Next day seem at clinic and again sent to ER. . Given IV fluids, IV meds and after four hrs sent home. Experienced extreme weakness. Could barely get out of chair or walk. ED visit 1/15/2021 for acute nonintractable headache, epigastric pain, adverse effect of vaccine. Presents to the ER with epigastric abdominal pain, nausea, and headache after receiving second dose of Pfizer COVID-19 vaccination yesterday at 6 AM. Patient states symptoms started last night. Treated with IV fluids, Reglan, Benadryl, Toradol, and Floricet. Abdominal pain totally resolved and headache pain improved. Discharged to home with prescription for Reglan 10mg PRN. She does have a history of chronic migraines and already has Maxalt at home and was given a prescription for Floricet today which she is already filled.
45 2021-01-28 swollen tongue, mouth tingling Pt arrived at 1247 reported "tonsil swelling" which progressed to tongue feeling thick. Benadryl 25 ... Read more
Pt arrived at 1247 reported "tonsil swelling" which progressed to tongue feeling thick. Benadryl 25 mg IM given at 1252 without relief. Pt still reporting feeling of tongue swelling. Rash developed on neck and arms. Per protocol second dose of Benadryl 25 mg administered with slight relief at 1315. Epinephrine 0.3 ml administered at 1315 with no relief. Symptoms still persist. Second epinephrine dose administered at 1322. EMS notified and arrived at 1329 to transport pt to Northwestern Hospital.
45 2021-01-29 oropharyngeal discomfort, tongue disorder Patient reported tonsil swelling which progressed to tongue feeling thick and slight rash. Benadryl... Read more
Patient reported tonsil swelling which progressed to tongue feeling thick and slight rash. Benadryl given 25mg IM per protocol, patient thought felt slightly better. Tongue swelling reduced per patient. Patient rested, appeared comfortable. Vital signs improved. Tongue swelling appeared to be large, epi given x2, Throat still uncomfortmatble. Tongue appeared swelling. EMS activated 1:23pm. EpI 1.23mg IM repeated, rash bilateral now, patient able to swallow. Benadry .5mg IM given for a total of 50mg.
45 2021-01-31 mouth numbness, mouth tingling 1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h... Read more
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 190/100, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to normal level within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 for 12 hours before returning to my normal rate of 60.
45 2021-01-31 mouth swelling, mouth numbness Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different ... Read more
Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different and the continues of HA and numbness sensation during the day/ evening. She was unable to close her R eyelid and R side drooping. The HA increased with time after two weeks the R side of the face different mouth and R side was swollen. She then seek medical treatment at the ER where she received prednisone and valacyclovir for one week treatment.
45 2021-01-31 mouth tingling, mouth numbness 1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h... Read more
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 200/110, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to 160/92 within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 and blood pressure was elevated for 12 hours before returning to my usual results.
45 2021-01-31 mouth tingling DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT... Read more
DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.
45 2021-02-01 ear pain, hearing loss, ear discomfort Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per fami... Read more
Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per family report starting complaining about L ear pain on Friday 1/29, On Sunday 1/31, started to experience dizziness and some L ear discomfort, Had cellulitis last summer after "new earrings" in left ear and assumed this might have been it, had NP check ear on Monday at work, some fluid on R ear. Monday evening pain increased, heaviness and muffled sound increased, pain increased, started to "burn" and "itch". Tuesday AM contacted three MDs, concerns of shingles. Diagnosis later that day, vesicles in L outer ear, started on antiviral and antibiotics. Pain and dizziness at work Tuesday morning however its only Tuesday night. Pain/burning still very intense.
45 2021-02-01 oropharyngeal discomfort Patient informed vaccinator about previous allergic reaction to dose 1 that spontaneously resolved, ... Read more
Patient informed vaccinator about previous allergic reaction to dose 1 that spontaneously resolved, was instructed to stay 30 minutes for monitoring. Reports no adverse events to any vaccines in the past, including the flu vaccine. She received dose 2 Pfizer COVID vaccine at 10:57 am, started experiencing throat discomfort at 11:25 am (BP 146/65 HR 96), and was given 50mg IM Benadryl. Five minutes later, patient reported an improvement. Vital signs remained stable throughout observation. BP 126/85 HR 83 at 11:40 am and BP 120/84, HR 60 at 12 pm.
45 2021-02-01 vision blurred Light headed, blurred vision. BP/pulse: 139/92, 63; 145/82, 57. O2 sat 99%-100%. History of anxiety ... Read more
Light headed, blurred vision. BP/pulse: 139/92, 63; 145/82, 57. O2 sat 99%-100%. History of anxiety disorder. Stable, discharged to home.
45 2021-02-02 loss of taste, ringing in ears, loss of smell symptoms started Saturday, Jan 9th after my vaccine on Friday Jan 8th. Had terrible fatigue and te... Read more
symptoms started Saturday, Jan 9th after my vaccine on Friday Jan 8th. Had terrible fatigue and terrible headaches, very mild nasal congestion, chills, and a rash on my chest. On Monday, 1/11/21 I was tested for COVID and positive as I was still not feeling well and lost my taste and smell. I can?t recall if I lost taste and smell on the 10th or the 11th. Those first few days I slept most all day and the days run together a little bit. I think maybe mid week, I started with tinnitus. About Wednesday, Jan 13th, I started with what looked like chicken pox mostly on my legs and back- these were itchy and fluid filled. Symptoms were starting to improve on Thursday Jan 21st in regards to my ?pox? as I think it was that day where I did not have any new ones that developed. My fatigue and headaches started to improve that day or the Friday after as well. I still notice some fogginess or mild memory issues, tinnitus is better but not fully gone, taste and smell are returning, fatigue continues to improve, headaches are intermittent.
45 2021-02-02 eye twitching Since the vaccine I have experienced tingling of lips and face. The past few days I have started exp... Read more
Since the vaccine I have experienced tingling of lips and face. The past few days I have started experiencing more tingling/twisting sensations on left side of body and some weakness of left side of body as well as twitching of left eye.
45 2021-02-02 mouth numbness, mouth tingling numbness tingling lips, mouth, tongue Swallowing took more effort - "lump in my throat" Was given be... Read more
numbness tingling lips, mouth, tongue Swallowing took more effort - "lump in my throat" Was given benadryl, sx's started improving a couple hours later.
45 2021-02-02 mouth tingling, eye itchiness Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minute... Read more
Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minutes after receiving the vaccine; itchy eyes and puffiness in face on and off from time of vaccine to present (7 days later); vaccine and/or subsequent mild allergic reaction triggered Functional Neurological Disorder symptoms (involuntary muscle activations in legs, face and neck, dystonic posturing of feet)
45 2021-02-02 mouth tingling Paresthesias of mid-portion of upper lip and headache onset 30 mins after COVID-19 Vaccine given
45 2021-02-03 eye disorder 27th January 2021-Stuttered, right eye drooping-in the ER-patient is and employee of the staff. The ... Read more
27th January 2021-Stuttered, right eye drooping-in the ER-patient is and employee of the staff. The providers in the ER did a quick neuro check/test-27th January 2021. Outcome-she can smile, can blink and has no stutter today 4 February 2021
45 2021-02-03 visual impairment impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more... Read more
impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-02-04 ear pain My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms... Read more
My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms began 14 hours after injection. I had the normal fever, nausea, chills, body aches, also had severe ear pain in my left ear same as when I had Covid. Dizziness began 14 hours after but increasingly got worse. My blood pressure went up to 200/118 with my HR 131 with the dizziness. I have NEVER had high blood pressure!! I still have some dizziness. Not completely resolved. BP is better but still high at times. I have been monitoring it closely. I did go to the ER where my BP continued to be high.
45 2021-02-05 mouth tingling, mouth discomfort, tongue discomfort, feeling of choking 15 minutes after the injection I started getting a scratchy throat.. which lead to my throat, tongue... Read more
15 minutes after the injection I started getting a scratchy throat.. which lead to my throat, tongue, lips tingling and burning. After a couple hours my nose felt numb and tingly inside and stayed like that until the day after. The day after i had the vaccine if I try to eat it flairs the burning fizzing feeling in my mouth and lips again. Feel week and tired, headaches and body pain. Im concerned with the mouth stuff though before getting the second dose.
45 2021-02-07 dry mouth 1000-employee received vaccine 1005:employee relates a very dry mouth and possible difficulty swallo... Read more
1000-employee received vaccine 1005:employee relates a very dry mouth and possible difficulty swallowing(kind of like reaction to shellfish); 1030employee checks in to ED for further evaluation; 1100 employee discharged from ED
45 2021-02-07 lip swelling, tongue itchiness Patient developed itching of tongue and upper lip swelling after receiving the pfizer COVID-18 vacci... Read more
Patient developed itching of tongue and upper lip swelling after receiving the pfizer COVID-18 vaccine. The patient developed symptoms while in the monitoring phase after vaccination. Employee waited 30 minutes after vaccination and then spoke with POD physician explaining the symptoms. POD physician recommended taking some benadryl. The employee was planning to drive home so a 25 mg table of benadryl was given to her to take with her/take on way home. Patient did not take the medication at the POD. Patient stated the symptoms had improved.
45 2021-02-07 mouth tingling, feeling of choking Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Cl... Read more
Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Client reports taking Benadryl all evening long. Client reports 3 days later having migraines, nausea, head ache and not feeling well. Day 3 pulse dropped in the 40's which is abnormal. Denies trouble breathing. Client reports had similar symptoms of migraines but not additional symptoms.
45 2021-02-07 mouth tingling Pt c/o roof of mouth and tingling tongue. Pt c/o racing heart and sweaty palms. Pt was observed from... Read more
Pt c/o roof of mouth and tingling tongue. Pt c/o racing heart and sweaty palms. Pt was observed from 1:25pm-2pm when she stated that she was ok and wanted to go. Pt was initially offered 911 transport but declined. Pt then went to her car and felt worse. Re presented to the clinic and then 911 was initiated.
45 2021-02-08 dry mouth faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arriva... Read more
faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
45 2021-02-08 sensitivity to light Fever 102.2, chills, extreme body aches, stomach cramps, headache with light sensitivity.
45 2021-02-08 vision blurred Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues wit... Read more
Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues with dizziness. 19 days since and improving but memory and focusing occasionally an issue. Dizziness stopped on day 16. Had one of the worst migraines on about day 10.
45 2021-02-09 taste impairment metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report... Read more
metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report from a contactable health care professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization. Medical history included allergy to penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. The patient reported that minutes after the injection, she had a metallic taste in her throat, strange sensation, and then very rapid heart rate. It subsided in about two minutes. The patient did not receive any treatment for the events. The patient recovered from the events. The events were reported as non-serious.
45 2021-02-09 swelling of eyelid, vision blurred, eye itchiness 5:50p - during standby period I began to feel itching on my cheeks, scratchy throat and then my nose... Read more
5:50p - during standby period I began to feel itching on my cheeks, scratchy throat and then my nose began getting congested. 6pm - my nose was completely congested and my entire face, throat and neck was itching. 6:10p - my eyes were itching and the itching continued across my entire chest and down my entire left arm. 6:15p - upon finding nurse that administered shot advised of having reaction. Eyelids were swelling by this time, shortness of breath and vision blurring. 6:35p -While nurse was assessing my vitals code called and ER team arrived to conference room. Upon assessment by ER team, symptoms escalated with reddening of mouth and throat and multiple extremely high BP readings(highest 181/101)
45 2021-02-10 pain in jaw, eye pain Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind... Read more
Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind me eye, moderate chills, mild nausea maybe due to the pain. Symptoms started 2/10/21 at 6pm and progressively got worse to the point of being unable to sleep. Took Tylenol at 1:30am and the pain decreased and was able to sleep some, 4 hrs later symptoms returned. Took more Tylenol. 2/11/21 5:57pm still have mild sore arm, mild headache off and on and mild chills.
45 2021-02-10 mouth tingling Tingling of tongue and lips; Tingling of tongue and lips; Swelling of cheeks; face turned flush; ras... Read more
Tingling of tongue and lips; Tingling of tongue and lips; Swelling of cheeks; face turned flush; rash on neck and upper chest area; This is a spontaneous report from a contactable consumer (patient) This 45-years old no pregnant female consumer received the firs dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL3247 on 21Jan2021 04:45 at left arm at single dose for Covid-19 immunization. Medical history included:allergies to medications, food or other products and high blood pressure .The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered:Other.On 21Jan2021 17:00 the patient developed Tingling of tongue and lips, Swelling of cheeks, face turned flush, rash on neck and upper chest area.The patient was treated with Benadryl. Events was reported as non serious .Outcome of the events was recovering. No Prior to vaccination, was the patient diagnosed with COVID-19. No Since the vaccination, has the patient been tested for COVID-19.
45 2021-02-12 deafness, deafness unilateral Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profoun... Read more
Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profound deafness on audio gram.
45 2021-02-14 mouth tingling, dry mouth Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advise... Read more
Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advised to wait 30 minutes while being supervised. Reaction noted to start at 1736. Patient reported "Fire feeling" and "Tingling on my tongue." Blood pressure in right arm 190/78. Heart rate 85-90's, oxygen saturation level 98% on room air, and respirations 20 breaths per minute. Patient reported dry mouth and hot sensation. Cheeks and chest flush. Patient denied shortness of breath and swelling of the mouth and tongue. Patient reported "Could be a panic attack." Educated on importance of deep breathing. Exercise completed. Bottle of water provided. Benadryl offered and patient declined at this time. 1742: "Fire feeling" began to resolve. 1756: Blood pressure in right arm 160/80. Heart rate 81 and oxygen saturation level 97% on room air. Respirations 16 breaths per minute. Temporal temperature 98.6 degrees F. Patient reports headache in frontal region.
45 2021-02-14 mouth tingling stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like n... Read more
stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers. A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization. Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year). The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021), she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
45 2021-02-15 pain in jaw, ear pain Client woke on Thursday 02/11 at 0700 to left sided ear, jaw pain, sore throat and unable to open he... Read more
Client woke on Thursday 02/11 at 0700 to left sided ear, jaw pain, sore throat and unable to open her mouth. Also has a prior neck injury that began to have neck pain to be more prevalent going toward her back. She did not seek medical attention for these symptoms. Today client continue to have left ear discomfort and jaw is still sensitive to touch. Sore throat went away this morning and she is feeling better than before.
45 2021-02-16 oropharyngeal discomfort, mouth discomfort, mouth tingling, swollen tongue Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burnin... Read more
Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline. 1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. 1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine. 1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation. At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit. 1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.
45 2021-02-16 swollen tongue, mouth numbness, mouth tingling shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling... Read more
shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling, difficulty swallowing and speaking, nausea, numbness of lips
45 2021-02-18 inability to speak Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlyi... Read more
Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.
45 2021-02-18 eye pain, sensitivity to light Eye soreness/pain. Halos around light. Light sensitivity. Headache. Nausea. Dx: Iritis both ey... Read more
Eye soreness/pain. Halos around light. Light sensitivity. Headache. Nausea. Dx: Iritis both eyes. Dx on Friday January 8, 2021. Steroid eye drops prescribed. Infection and steroid drops are ongoing as it has not resolved yet. Needed to stay home from work due to headache/nausea. Headache and nausea is on the Covid symptom list and the hospital I work at would not allow me to work until I'd had a negative Covid test.
45 2021-02-18 swollen tongue at the time of initial assessment, patient does not have hives and is 98 to 99% on room air. She do... Read more
at the time of initial assessment, patient does not have hives and is 98 to 99% on room air. She does report a sensation of feeling like difficulty breathing or swallowing and is initially treated with Solu-Medrol and Benadryl as well as IV fluids. She reports that symptoms are improving almost immediately after meds are pushed. As result epinephrine is initially deferred for continued monitoring. However upon reassessment approximately 1 hour after reported reaction, the numbness in the hands and feet have resolved, but she is complaining that she feels as though the back of her tongue is swollen and still making it difficult to swallow though she no longer feels short of breath. As a result, we have discussed the possibility of treatment with epinephrine in order to fully resolve symptoms, and she is agreeable to proceed. ,
45 2021-02-19 lip swelling, swelling of eyelid, feeling of choking While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chew... Read more
While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chewable (12.5mg each) benadryl tablets. after about 5 min. i felt stable enough to leave. on the way home I started to feel the itching intensify and I felt very warm. I had welts forming and hives appeared all over. As I pulled into my driveway( 7 min drive from vaccination site) I felt my lips and eyelids swell, and my throat felt tingly. I took another 2 chewable benadryls. (12.5mg each). I immediately called my Doctor and explained what was going on. I also started to wheeze. I used my inhaler. He told me to use my epipen. Which I already had prepared since I knew this was anaphylaxis. I started to feel stable enough to go inside. I called my husband to come downstairs to be with me. I still wasnt feeling well and the tightness and wheezing persisted. At around 8:40, My dr. told me to use the 2nd Epipen and use my nebulaizer. If I wasn't better in 10 minutes he would call an ambulance. Thank GD the itching and hives subsided and the wheezing and tightness diminished by aroung 8:50am. My dr. comtinued to monitor me and check up on me. By 3pm I was back to myself.
45 2021-02-19 mouth tingling, mouth numbness numbness & tingling on left side of tongue VS BP 110/62 P 72
45 2021-02-22 dry mouth The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a "funny f... Read more
The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a "funny feeling in her chest, but not pain." The employee was brought into the observation room and given 25mg of PO Benadryl. Her VS were 65-18-128/79-98%. Her lung sounds were clear. At 0825 Dr was notified and he came to the clinic. At 0831 the employee states that the chest feeling was improving, her lips and mouth were feeling better. 0910: 57-18-129/75-99% The employee states that she has had an allergic reaction to Versed and Haldol
45 2021-02-22 visual impairment Nausea, vertigo, ataxia, falls, change in vision persisting currently
45 2021-02-24 thirst pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal a... Read more
pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal and ems notified and on scene with medical staff on site. Pt had LOCx2. Vitals taken. BS checked and EKG completed. IV started. pt then taken to local hospital for further eval.
45 2021-02-25 mouth tingling Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of fa... Read more
Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of face) and behind ears, lips stinging (this started first) tongue tingling, felt lightheaded or unsteady (pulse was up), and headache
45 2021-02-25 sensitivity to light Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runn... Read more
Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runny noise, lose of apatite . Extreme sweating. Extreme sweating of the under arm is still and issue. No fever now.
45 2021-02-28 eye itchiness, swelling around the eyes Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction di... Read more
Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction didn't go away until 2 hours afterwards. Puffy, itchy eyes (both eyes) with rash came and lasted about two weeks. Monday or Tuesday, I noticed a rash all over my body - red and blotchy. That went away in a day. I got chills, fever, weakness, nausea, vomiting, diarrhea and that lasted 48 hours (16th in pm-17th and got better evening of 18th). When I had the rash was all over the body, I took a Zyrtec. The weekend I was really sick I didn't take any medication. Phone visit with Doctor - January 15th - allergist - I followed up with him about the throat constriction. He just was monitoring symptoms. After the weekend that I was really sick, I told him and he ordered bloodwork.
45 2021-02-28 eye itchiness Light headed and headache and that subsided about an hour later. For the next couple of weeks, I had... Read more
Light headed and headache and that subsided about an hour later. For the next couple of weeks, I had a rash on my eyelids and bumpiness and itchiness for my upper eyelids and it eventually went away. I used antihistamine and that helped a little and then it came back.
45 2021-03-01 mouth tingling 45 yo female with h/o htn c/oed of tingling of lips 13 min after covid vaccination. pt denies rash,... Read more
45 yo female with h/o htn c/oed of tingling of lips 13 min after covid vaccination. pt denies rash, hives, fludhing , chest pain, palpitation, gi sx or dizziness pt with stable vital signs exam unremarkable : esp no angioedema and no stridor or wheezing . most likely anxiety attack wtih parathesia which resolved after 50 min observation without intervnetion other than reassurance
45 2021-03-02 eye movement disorder Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousnes... Read more
Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousness lasting <15 seconds with eyes "rolling back" and skin color change from normal for age/race to pale followed by bilateral upper extremity convulsions. Witnessed by monitoring area Registered Nurse. Hx: Seizures, last seizure secondary to codeine ingestion >1 y ago. Anxiety related to injections. Timeline: 1759- Vaccinated with Pfizer Lot # EN6199 1st dose 1805- adverse reaction occurred 1806- mental status: slow to respond, skin: pale/diaphoretic, VS: HR 51 (regular at the radial site), BP 80/palp, RR: 12, T: 36.8, Spo2 100% on RA 1807- 911 activated, placed in position of comfort. 1815- EMS arrived, EKG consistent with sinus bradycardia, HR 58, BP 150/130, RR 15, Spo2 100% on RA 1820- EMS placed patient on gurney. 1825- Departed via EMS gurney
45 2021-03-02 eye pain dizziness; achiness behind my eyes for 16 days; This is a spontaneous report from a contactable heal... Read more
dizziness; achiness behind my eyes for 16 days; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the left arm on 14Jan2021 at 12:30 PM at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK5730) on 26Dec2020 at 03:30 PM (at the age of 45 years old) at the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 16Jan2021 at 09:00 AM, the patient experienced dizziness and achiness behind her eyes for 16 days. The patient did not receive treatment for the events. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 which included Nasal Swab: Negative on 31Jan2021. The outcome of the events was not recovered.
45 2021-03-03 mouth tingling, mouth numbness Tingling and numbness in the face particularly around the mouth. Started 15 minutes after vaccinati... Read more
Tingling and numbness in the face particularly around the mouth. Started 15 minutes after vaccination and continues now 6 days later. Does not seem to have abated at all. Face feels flushed all the time.
45 2021-03-04 ear pain rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This ... Read more
rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 25Jan2021 at 15:30 (at the age of 45-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib), tachycardia, and allergy to proton pump inhibitors. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included metoprolol tartrate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 04Jan2021 at 11:00 (at the age of 45-years-old) in the left arm for COVID-19 immunization. The patient experienced body aches and fever of 102.7 on 26Jan2021, left ear pain in Jan2021, intense burning and intense dizziness on 01Feb2021, and rash and shingles on 02Feb2021. The events were reported as non-serious. The clinical course was reported as follows: The day after the vaccination, 26Jan2021, the patient had body aches intermittently (reported as: not bad) and then spiked a fever of 102.7 the evening of 26Jan2021. The pain (per family recollection: complains of left ear pain) started about 28Jan2021 or 29Jan2021, but intense burning, pain, and intense dizziness started on 01Feb2021 with diagnosis of rash and shingles on 02Feb2021. Therapeutic measures were taken as a result of all of the events, which included valacyclovir (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of body aches, fever, left ear pain, intense burning, intense dizziness, rash, and shingles was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
45 2021-03-04 tongue disorder, taste impairment Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. The... Read more
Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. Then the next day I had a headache, upset stomach, chills and a was achy.
45 2021-03-07 inability to speak thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; S... Read more
thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown.
45 2021-03-07 taste impairment groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have verti... Read more
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
45 2021-03-07 mouth numbness Headache, numb tongue and numb bottom lip and numb bottom part of mouth
45 2021-03-07 mouth numbness The patient felt fine after the vaccine at 12 noon on 03/05, she woke up on 03/06 at about 6:00 a.m... Read more
The patient felt fine after the vaccine at 12 noon on 03/05, she woke up on 03/06 at about 6:00 a.m. and noted numbness around her mouth and jaw, that felt similar to the numbness one experiences after going to the dentist. However, the patient has not gone to the dentist at all recently. This lasted most of the day and then mostly self-resolved. She still has a little bit of numbness around her lips. She never had any sensation of her throat closing up. She did not need to use an EpiPen. She is a bit concerned about getting her 2nd vaccine and if this will occur again.
45 2021-03-09 swelling of eyelid I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my che... Read more
I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my cheeks were VERY flushed. I took my temperature. Though it was 98.5, that is higher than my personal 'normal' temp. I am typically 97.3-7. Checked again on my flushed cheeks to see that my face was swollen. I ran into a neighbor, though wearing a mask, she didn't see/say anything, and I felt okay enough not to bring it up. By the end of the day, swelling in my cheeks was less noticeable so I went to bed thinking I wasn't having more than a typical vaccine reaction. I woke up the next day with swollen eyelids. I've only become concerned after googling the general side effects and saw 'swelling of the face' and/or 'swollen eyelids' listed as both "common" and "when to call a doctor". My (non)fever is up and down over the past few days though I still feel flushed with more pink in my cheeks.
45 2021-03-12 mouth tingling Patient felt tingling around mouth, lips, tongue and "gum tightening." Given 10mg Zyrtec and after 1... Read more
Patient felt tingling around mouth, lips, tongue and "gum tightening." Given 10mg Zyrtec and after 15 minutes symptoms began to subside more. Tingling is now minimal. Will discharge home.
45 2021-03-14 lip swelling SWELLING LIPS, NAUSEA AND HEADACHE. NOT FEELING WELL.
45 2021-03-15 loss of taste No taste; Migraine; Fever; This is a spontaneous report from a non-contactable consumer (patient her... Read more
No taste; Migraine; Fever; This is a spontaneous report from a non-contactable consumer (patient herself). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration on 30Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation in hospital. The patient's medical history was unknown. It was unknown whether the patient had allergies to medications, food, or other products or not. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), on 09Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation and felt tired, lethargic all weekend. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination or not. On 30Jan2021, the patient experienced no taste, fever and migraine. The patient underwent lab tests and procedures included body temperature: Fever on an unspecified date. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-03-15 lip swelling, mouth swelling, swelling of eyelid After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. ... Read more
After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. Felt burning sensation in esophagus. Experience tiredness, chill and minor diziness as well. Took Benadryl every 8 hrs and pepcid from over the counter. There is still minor swelling and continuing the benadryl after 24 hrs
45 2021-03-16 dry throat Pt developed trouble swallowing/dry throat approx 15-20 minutes after vaccination. Denies SOB or tro... Read more
Pt developed trouble swallowing/dry throat approx 15-20 minutes after vaccination. Denies SOB or trouble breathing. Benadryl 25mg PO x 1 given, pt also took 1 puff of albuterol, throat symptoms resolved, then pt developed dizziness/jitteriness. Pt monitored and symptoms resolved. Pt discharged home with family under stable condition. Respirations unlabored and even. SpO2 100% RA BP 126/61 HR 85
45 2021-03-16 ear pain I can say that my symptoms actually started on my first dose 12-17-2020, experienced chills, muscle ... Read more
I can say that my symptoms actually started on my first dose 12-17-2020, experienced chills, muscle soreness, had fever of 99.4F and thought it was menopausal symptoms. After my second dose vaccine, my lymph nodes were visibly enlarged. I experienced muscle soreness, lymph nodes were enlarged, left side, had chills, sore throat, ear ache radiated towards my neck and had a viral pink eye. I felt very tired and had muscle aches. I had a fever of 99.4F, mostly chills and joint pain to my left shoulder, left hip and left knee. I also had 3 Covid swab testes which were all negative. I saw my doctor who performed a x-ray of the chest and has put off a mammogram test till April 2021. At this time I have not recovered there is something going on with my pelvis, form my iliac crest when bending down I feel a pinched lymph node on that area of iliac crest. I get a pinch on my pelvis that is painful.
45 2021-03-16 feeling of choking Tingling back of throat and tip of nose. Dizzy on standing.
45 2021-03-17 lip swelling Patient received Pfizer Covid-19 vaccine at an off-site clinic. Patient complained of being light-he... Read more
Patient received Pfizer Covid-19 vaccine at an off-site clinic. Patient complained of being light-headed/dizzy. She appeared frightened and after a couple of minutes felt as if her lips were beginning to swell. Patient was offered and received benadryl liquid orally and felt better after 15 more minutes and left after declining any additional treatment.
45 2021-03-17 pain in jaw, swollen tongue Myalgia, NauseaVomiting, Tachycardia, MILD LIGHTHEADEDNESS, MILD CHEST TIGHTNESS, SHORTNESS OF BR... Read more
Myalgia, NauseaVomiting, Tachycardia, MILD LIGHTHEADEDNESS, MILD CHEST TIGHTNESS, SHORTNESS OF BREATH, MILD SCRATCHY/TIGHTENING OF THE THROAD, MILD SWELLING OF THE TONGUE, MODERATE FACIAL PAIN ALONG CHEEKBONES/JAWLINE/UPPER JAW, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative: Other Relevant History:
45 2021-03-17 swollen tongue, lip swelling Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vac... Read more
Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vaccine on 3/13 at 4:30pm. Immediately afterward she had sensation of lip and tongue swelling. She was given Zyrtec and monitored by the vaccination clinic for 30 minutes. She was discharged from the clinic after improvement of systems. Lip swelling presented on 3/14 at 2:00pm and she took Zyrtec. At 10pm, patient felt sensation of swelling in throat and presented to ED. EMS gave patient 50 mg IV Benadryl. Patient discharged on prednisone. Patient re-presented to ED on 3/16. Allergic symptoms subsided, but patient complained of atypical chest pain with paliptations, tremulousness. Suspect adverse reaction prednisone. She was given cardiology referral for follow up if her symptoms persisted. She remained in normal sinus rhythm with initial sinus tachycardia. Was discharged home in stable condition and counseled to return to ED for any concerns.
45 2021-03-18 vision blurred 3/19/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ... Read more
3/19/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: . BLURIED VISION Assessment : Time of assessment . 1034AM Actions taken: VS TAKEN, BP-130/89, HR-72, O2 100%, WATER OFFERED AND DRINKING, ENCOURAGED TO EAT AS SHE VOICES THAT SHE HAS NOT HAD FOOD TODAY, HAD DRIVER WITH HER. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for . minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/19/2021 10:00 AM 0.3 mL 12/11/2020 Intramuscular
45 2021-03-20 mouth tingling, lip swelling Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injecti... Read more
Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injection till 14 days after injection, sometimes subsiding with Benadryl), Feeling of right side of throat closing in (20 hours after injection, but improved with Benadryl), Red spots on upper lip together with swelling (1 day after injection till 11 days after injection, at times disappearing with Benadryl), Both lips swelling (1 to 2 weeks after injection, on and off), Headaches (most days from 2 days after injection till now, 16 days after injection), Stiffening of the back of the tongue (20 hours after injection, cured with Benadryl), Nausea (2 days after injection, every few days till 16 days after injection), Low fever (5 times, every 3 days since 3 days after injection, till 15 days after injection), Diarrhea (around every 5 days since 4 days injection), Joint pain (from 2 days after injection, continued around 6 days), Nerve pain (continuing two weeks since a few days after injection), Chills (on and off, from around 3 days after injection till 1 week after injection), Fatigue (going on 16 days since an hour after injection).
45 2021-03-21 blindness, vision blurred With in 15 minutes my fingers on my left hand started going numb. I had the shot in my Right arm. B... Read more
With in 15 minutes my fingers on my left hand started going numb. I had the shot in my Right arm. By the next morning I was numb from the neck down and my vision went in my left ye and very blurry in the right eye.
45 2021-03-21 lip itchiness, lip swelling Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in... Read more
Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in my face. Resting heart rate was as high as 140 (measured by my Apple watch) prior to seeking medical assistance. After sitting in the waiting area for 20 minutes my pulse had slowed down to 100 (my resting heart rate is typically lower-mid 60s); however, my pulse was still high and I did not feel well and had started clearing my throat with mild tightness in my throat and chest. A doctor took my blood pressure reading was 140/78, typically my blood pressure is 105/65. My throat was not visibly swollen. At about 40min the EMT hooked me up to monitor my blood pressure, oxygen, pulse. At the same time I was being hooked to the monitor, my lower lip began itching and visibly showing minor swelling as well as minor swelling and red splotches in my cheeks and forehead. My heart was initially showing PVC but returned to normal. After being monitored for about 30 minutes my adverse reactions had slowed and stabilized to be released to go home. I took antihistamines and ibuprofen.
45 2021-03-21 mouth tingling after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips st... Read more
after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips started to tingling, then my cheeks, then my tongue. My cheeks started to get red and a bit swollen, then my breathing was getting weird, my blood pressure rise. At that moment I agreed to go in the rescue.
45 2021-03-21 swelling around the eyes About 20 hours after first dose, I experienced extreme under eye puffiness. Also at injection site, ... Read more
About 20 hours after first dose, I experienced extreme under eye puffiness. Also at injection site, firm, swollen and red.
45 2021-03-21 taste disorder, smell distorsion About 3 weeks ago, I began to notice that coffee smelled odd. Since then, my sense of taste and smel... Read more
About 3 weeks ago, I began to notice that coffee smelled odd. Since then, my sense of taste and smell have increasingly worsened to the point that I am extremely nauseated. It is awful.
45 2021-03-21 visual impairment, eye pain MAY NOT BE CONSIDERED ADVERSE EVENT BUT WANTED TO REPORT IT: About 10 minutes after shot I experienc... Read more
MAY NOT BE CONSIDERED ADVERSE EVENT BUT WANTED TO REPORT IT: About 10 minutes after shot I experienced a sharp pain in my bottom right occipital lobe/base of skull. Later only about 1 min. Also experienced tingling sensation in my eyes and vision interference that lasted about 20 seconds tops. Immediately following, however, my vision appeared sharper. I also experienced sharp pain about a few hours later in bottom left occipital/base of skull that only lasted about 30 seconds. Other than that I feel great! Given the newness of the vaccine I felt it important that you know.
45 2021-03-22 ear pain, toothache First dose: mild lethargy, mild body aches. lasted for 12 hours. Second dose: Injected at 8 a.m. 4 p... Read more
First dose: mild lethargy, mild body aches. lasted for 12 hours. Second dose: Injected at 8 a.m. 4 p.m.: lethargy, headache, earache, toothache 6 p.m.: severe body aches, severe lethargy, severe chills, temperature rose by 2 degrees,cough, headache, dehydration, dizziness, earache, nausea, woke up every hour, lasted till 12 p.m. next day. 12 p.m.: temperature (2 degrees), moderate chills, moderate body aches, dizziness, severe sweating, dehydration 7 p.m.: no temperature, dehydration, dizziness, mild body aches, no chills, moderate sweating 7 a.m.: no temperature, dehydration, dizziness (mild), no body aches, lethargy (mild), no chills, mild sweating Since then still tired but improving.
45 2021-03-22 mouth tingling My resting bpm went over a 100 for about 4-5 hours. It is usually at 68-72. drinking more water help... Read more
My resting bpm went over a 100 for about 4-5 hours. It is usually at 68-72. drinking more water helped get it to the 80-90 range. When first receiving the shot I started feeling numbness in left hand. Tingling in mouth. Altogether my left side felt weird the first hour at least.
45 2021-03-22 smell distorsion, loss of taste On the day after my vaccine I was sweating all day but did not think anything of it. By the end of ... Read more
On the day after my vaccine I was sweating all day but did not think anything of it. By the end of the day I was not feeling myself, I went home and felt like I needed to rip my clothes off because I was so hot. I was sweating but freezing at the same time. I changed my clothes and went to bed. I then began freezing where I my teeth were chattering and could not get warm. I had on 3 blankets and was shaking. I fell asleep and was having hallucinations and talking to my grandparents that are deceased. I woke up not know anything but what I was told by my husband and daughter. I took my temperature and it was 104.1. I then continued to alternate between tylenol and ibuprofen for the rest of the night. I slept from 6:00 pm the night of the 12th to 10:00 am on the 13th. I still had a fever but developed a headache that nothing was helping. my fever was 101.4. I was told to go to the doctors to get checked by my job which I did, they examined me and the next day I went back for a COVID swab. I was in bed for the next 12 days and everyday I was developing various symptoms. By day 4 I had no taste and impaired smell and day 5-12 I had body aches, congestion and a cough that would not go away. I was our of work from 01/12/21-01/25/21.
45 2021-03-22 tongue discomfort, mouth discomfort, swollen tongue, oropharyngeal discomfort Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy ... Read more
Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy rash to chest, abdomen, back and bilateral arms. I was wheelchaired over to the Urgent care section of the building with a Dr following along. By the time I reached the Urgent Care room I was feeling the same strange feeling in my mouth tongue and throat that I had felt with the first vaccine. I felt as if my tongue and possibly lips may be swelling a little though I don?t think they were. It was hard to swallow but I have a mitochondrial disorder which causes trouble swallowing at times too so it may have been a little worse than what I usually feel with that. I seemed to be having trouble pronouncing words as my tongue seemed to be in the way and my voice weaker. By blood pressure was elevated as it was after the first vaccine. I was given a subcutaneous shot of epinephrine and the symptoms started to improve within approximately 15-20 minutes though I was very shaky and anxious from the epi. I was then given an IM injection of Benadryl. After possibly an hour and a half I was sent home with my husband an epi pen and a script for prednisone. I continued to have a strange feeling in my mouth and throat on and off for a couple of days but less severe and I did not use the epi pen for
45 2021-03-22 visual impairment 5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, he... Read more
5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, heart raced, shaking and sweating, hands trembled, light headed, felt both hot and cold at same time. Patient alerted pharmacist and sat down in chair. 23 minutes after vaccine patient not 100% but better, feel fuzzy in head, shaky and feel sweaty but not sweating, carpet looks weird (patient states has hallucinations from other drugs). 25 minutes after vaccine patient light headed, vision not perfect. 28 minutes after vaccine patient's body feels warmer 32 minutes after vaccine patient feels unbalanced, body warm, legs heavy. 36 minutes after vaccine patient's feet feel heavy, feel more normal, temperature difference, sweating stopped, feel more like herself. 39 minutes after vaccine patient's feet feel smidge heavy, feel like herself. 41 minutes after vaccine patient left observation.
45 2021-03-23 pain in jaw Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain M... Read more
Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain Muscle tightness in neck and shoulders Soreness at injection site
45 2021-03-24 dry mouth Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being... Read more
Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being itchy without any rash on various parts of the body" about a week after injection. Also reported no appetite and a dry mouth along with being weak and tired. Denied any dyspnea, rash, or other s/s allergic reaction or anaphylaxis. States s/s resolved after 1-1.5 weeks. Did not seek medical care. States "she thinks it may have been pre- or post- menstrual issues and/or supplements". Also states she had had rash in December 2020 of unknown cause. Reports she used "allergy cream then and was sick to her stomach" and was resolved before first dose.
45 2021-03-24 eye disorder Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine... Read more
Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.
45 2021-03-24 eye irritation, mouth discomfort At first my eyes , mouth, and throat started to burn, then I started to shake uncontrollably for sev... Read more
At first my eyes , mouth, and throat started to burn, then I started to shake uncontrollably for several hours. I went straight to the ER when it started. Every day since then I have had several shaking episodes lasting in length from 30min to 2 hours. After I get a horrible headache and feel exhausted.
45 2021-03-24 vision blurred I woke up with cold/flu like symptoms and severe vertigo on Sunday March 21 2021. I could not even ... Read more
I woke up with cold/flu like symptoms and severe vertigo on Sunday March 21 2021. I could not even walk straight the vertigo was so severe. Monday the cold symptoms were much better mostly fatigue and I still had vertigo but not as bad. To this day I still have the vertigo. When I get up or down from a laying position the room spins. If I lean my head back even when I'm standing the room spins. If I stand too long I get a fuzzy feeling. My vision is also a bit cloudy than before.
45 2021-03-25 eye swelling Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours la... Read more
Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen. I started on benedryl. 2x a day. The redness, welts and hives traveled down my face, onto my neck, then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC. I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen, bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today, March 26, it is starting to calm down.
45 2021-03-25 pain in jaw Nurse notified at approximately 2:30 Client taken to private recovery area RN also present in priva... Read more
Nurse notified at approximately 2:30 Client taken to private recovery area RN also present in private recovery area Client initially stated that it felt like she had swelling in her jaw area and neck Client reports no difficulty breathing At 2:35 After further questions the client states that a better word would be tightness. No swelling noted Client reports left sided jaw tightness and tightness and stiffness in the neck (just below her left ear) Vitals taken : BP 138/99, Pulse 106, O Sat 98 Client states that it feels like when she has TMJ Client reports feeling a flushed sensation go up her arm towards her jaw and neck after the injection At 2:40 Client reports that the pain/ tightness in her jaw has lessened and no longer feels like its building Client was previously given water Client reports no difficulty breathing and No sensation of her throat closing At 2:42 Client states that when she has issues with TMJ she normally takes Benadryl which helps One 25mg tablet of Benadryl was given with a sip of water Client is not driving and came with her husband. Her husband will drive Client reports feeling like its calming down I let her know that she didn?t have to leave immediately and could still sit At 2:49 Client reports feeling better than when she arrived in the private recovery area Vitals taken: BP 134/105, Pulse 105, O Sat 99 A few minutes later her husband arrived At 2:57 Client reports feeling well enough to leave Client was driven today by her husband Client was advised to seek further care via call 911 if symptoms worsen or difficulty breathing Client able to ambulate to the car unassisted
45 2021-03-25 swollen tongue Patient received her 1st dose of Covid-19 vaccine, Lot #ER2613, in her left deltoid on 3/25/2021 app... Read more
Patient received her 1st dose of Covid-19 vaccine, Lot #ER2613, in her left deltoid on 3/25/2021 approximately 11:53am at the Vaccination Clinic at the Medical Center. While waiting in the parking lot, patient honked her horn and alerted medics she was not feeling well. Reaction occurred at approximately 12:40pm. Patient had tongue swelling, racing heart, and lightheadedness. Medics took vital signs and administered 0.3ml Epinephrine IM. Patient was transported to Medical Center.
45 2021-03-26 eye pain, swelling of eyelid After adminstaration of vaccine, patient had sharp pain behind the eyes and patient claim to have sw... Read more
After adminstaration of vaccine, patient had sharp pain behind the eyes and patient claim to have swollen eyes lids. Paramedic came and took vitals signs and ekg. Patient symptoms subsided. She state she was fine and she was release by the nurse.
45 2021-03-27 ringing in ears Episodes of severe vertigo/dizziness beginning 3/25/2021. Tinnitus started on 3/28/2021.
45 2021-03-28 oropharyngeal discomfort Anaphylaxis type reaction with chest tightness and throat fullness. Pt had reaction first dose with ... Read more
Anaphylaxis type reaction with chest tightness and throat fullness. Pt had reaction first dose with Benadryl IM used with a lot of anxiety . Second dose very anxious gave Epi x 2 and Benadryl with pt going out via 911. Pt was awake and talking BP 175/106, P81 O2sat 98%
45 2021-03-28 taste disorder, hearing loss On approximately 1/4/21, 1 week after 1st vaccine dose, developed headache & a head cold. Went to EN... Read more
On approximately 1/4/21, 1 week after 1st vaccine dose, developed headache & a head cold. Went to ENT on 1/11, diagnosed with acute on chronic sinusitis, prescribed Augmentin & Prednisone to start 48 hours after 2nd vaccine dose. Sinusitis did not explain headache as I've never presented with headache in the past. 2nd vaccine dose 1/14/21; began Augmentin & Prednisone on 1/16 (wanted to hold off on treatment until after 2nd vaccine dose). Headache continued & began to worsen. I thought maybe due to prednisone or high blood pressure from prednisone? Visit to PCP on 1/25 due persistent headache that was not resolving (Headache was vice-like, pain moderate to severe, headache worse with exertion or bending over). 1/25 "worst headache of my life". MRI ordered & completed 1/27; MRI normal other than sinusitis. Visit to ENT on 1/28; she said sinusitis improving & prescribed Norco for headache pain. Visit to PCP on 1/30; he prescribed Gabapentin & Naproxen for headache pain. Visit to Naturopath on 2/4; recommended adding Magnesium & B Vitamin Complex. 2/5: Massage with worsening headache pain. 2/10: Chiropractor & Acupuncturist with worsening headache pain. 2/19: Visit to Urgent Care for Toradol shot & Cyclobenzaprine prescribed. 2/23: Visit with Neurology; prescribed Topamax & Prednisone. 3/5: felt strange sensations in body, wave like feeling over limbs, tension in skull, heart pounding, change of hearing, menthol sensation on skin, change of taste, worsening headache, warm feeling in chest & abdomen, lasts 1-2 minutes. 3/6: ED visit due to strange episode/sensations; Neurologist on call prescribed Fioricet & Nortriptyline. 3/9: visit to Neurology, she increased metoprolol to 50mg, injected Ajovy, prescribed more cyclobenzaprine & ordered MRI/MRV. Headache pain continued to be moderate to severe, constant & "nervy", episodes continued to occur daily. 3/12: bloodwork to check inflammation. 3/14: MRI/MRV completed. Headache worsened with MRI noise & injection of contrast. 3/16: lumbar puncture completed w/ normal pressure, awaiting CSF labs. Discontinued Topamax 3/21; thought maybe contributing to episodes. More bloodwork completed 3/24. Visit to PCP, given Nurtec sample with some relief. Otherwise, headache remains daily & persistent with little/no relief overall. Head pain is bilateral, vice-like, burning sensation @ times on skull or face, numbness & tingling both sides of face periodically. Headache worsens with activity & at night. Episodes (strange sensations) continue to occur 1-3x/day, usually when laying down, at night or in morning.
45 2021-03-28 ringing in ears Tinnitus started intermittently approximately 5 days after the vaccine. It then became constant on ... Read more
Tinnitus started intermittently approximately 5 days after the vaccine. It then became constant on 3/5/2021 (approximately 4 weeks after the 2nd dose of the vaccine). No previous history of hearing loss or hearing issues. It has not yet resolved.
45 2021-03-29 ringing in ears Buzzing in left ear that is unbearable.
45 2021-03-30 mouth swelling, eye swelling Swollen eyes, mouth, hands Labored breathing Kidney pain Elevated HR Treated with benadryl and resc... Read more
Swollen eyes, mouth, hands Labored breathing Kidney pain Elevated HR Treated with benadryl and rescue inhaler
45 2021-03-30 mouth tingling Numbness in left arm and face. Burning/raw feeling in (on) left arm. Initial reaction to shot was f... Read more
Numbness in left arm and face. Burning/raw feeling in (on) left arm. Initial reaction to shot was fine. I waited 15 minutes and had a "weird" feeling in my left arm and ring and pinky fingers. Once I started walking to my car I noticed that my cheeks were feeling different. My tongue felt larger than normal as I was driving home. For most of the day my left side from roughly my armpit down my arm and the left side of my face felt different. Not quite numb, but not normal. Spent most of the day resting in bed. The raw/burning feeling lasted until Sunday (shot was on Saturday). The injection site looks great. No swelling or itching.
45 2021-03-31 ear pain, ringing in ears Minor ear pain with tinnitus
45 2021-03-31 eye irritation Starting in the late evening of the first day and extending to the second-day chills, fatigue, and ... Read more
Starting in the late evening of the first day and extending to the second-day chills, fatigue, and fever. Today, the fourth day, my face is hot to the touch and skin is blotchy with eyes burning.
45 2021-03-31 mouth numbness, swollen tongue, mouth tingling Within 15-minutes of vaccination, the patient reported that their tongue felt like it was swelling a... Read more
Within 15-minutes of vaccination, the patient reported that their tongue felt like it was swelling and tingling. EMS evaluated the patient on-site. The patient was hypertensive (184/117). EKG demonstrated NSR, rate 71 bpm, no ST elevation. EMS administered 50mg IM Benadryl. EMS transported the patient. In the ED, the patient was hypertensive (156/90) and reported chest tightness, tongue swelling/numbness, and their heart racing. Patient has had a similar reaction to other allergens in the past. Upon examination, the patient was in no acute respiratory distress and there were no signs of angioedema. The physician administered Solu-Medrol IV, Benadryl IV, and Pepcid IV in the ED. Patient was discharged with a diagnosis of Acute Allergic Reaction s/p COVID-19 vaccine. Physician prescribed 3-day course of Pepcid 20mg PO BID and Prednisone 50mg PO QD, while also taking OTC Benadryl PO 25mg QID.
45 2021-03-31 ringing in ears, ear pain, pain in jaw within 5 min pain in ears 30 min neck and jaw pain 45 min ringing in ears next day - joint and muscl... Read more
within 5 min pain in ears 30 min neck and jaw pain 45 min ringing in ears next day - joint and muscle pain, headache, fatigue day two slurring speech, nose burning day 4- ears ringing and fatigue, dizzy
45 2021-03-31 ringing in ears First day and first night extreme Sore arm- no sleep Second day - fatigue, foggy head, nausea , mo... Read more
First day and first night extreme Sore arm- no sleep Second day - fatigue, foggy head, nausea , moodiness, extreme finger joint pain Third day (today) - Headache , ears ringing, low fever, joint pain, sensitive skin, exhaustion,
45 2021-04-01 dry mouth At approx. 5pm I started to have severe dry mouth and my heart rate was elevated. I decided to chec... Read more
At approx. 5pm I started to have severe dry mouth and my heart rate was elevated. I decided to check my BP and it was 211/110. I called my doc and she had me take Benedryl and then waited about an hour. My BP was still 200/100 so she had me go to the ER. They gave me some Ativan to help my BP and heart rate and after around 3 hours my BP was down to 155/96. It has continued to run higher than normal this week.
45 2021-04-01 mouth tingling c/o headache scale of 1-10 it is a 5-6 and tingling of lips. no diff. breathing at this time. Resp... Read more
c/o headache scale of 1-10 it is a 5-6 and tingling of lips. no diff. breathing at this time. Resp-20. 4:00pm states breathing better, but lightheadedness remains. Called husband to pick her up. 4:11pm Husband at scene, ambulance called. 4:20pm HR 108, BP 149/84, Glucose 74. Transported to Hospital via Fire Rescue. Continues to complain of light headedness.
45 2021-04-02 dry throat Have been feeling completely fine. Not been sick at all. About 5 hours after shot my throat started ... Read more
Have been feeling completely fine. Not been sick at all. About 5 hours after shot my throat started to feel scratchy and dry. Next morning feels all day like I have pharyngitis. Also tired. My lungs/chest hurts.
45 2021-04-02 ear pain Arm pain at injection site on days 1-3 Sharp shooting pain at lower left base of head along toward... Read more
Arm pain at injection site on days 1-3 Sharp shooting pain at lower left base of head along toward and in left inner ear on days 2-4
45 2021-04-02 mouth numbness, swollen tongue, mouth tingling, lip swelling 3:50pm tongue and lips were feeling swollen, numb, and tingling, body as a whole felt odd (like she ... Read more
3:50pm tongue and lips were feeling swollen, numb, and tingling, body as a whole felt odd (like she could faint), 3:52pm gave her 25mg oral liquid benadryl, 3:54pm b/p was 129/84 and pulse was 74, 3:56pm symptoms dramatically improved, but were not gone, 4:05pm slight numbness and tingling of lips and tongue, 4:22pm blushing of face and tingling of tips of fingers, 4:23pm gave another 25mg oral liquid benadryl, 4:32 gingling improved , but not gone, 4:34pm b/p 132/77 pulse 68, 4:38pm blushing almost gone, 4:39pm tingling in finger tips gone, 4:53pm no change-still slight numbness and tingling of lips and tongue, 4:55pm parents arrived and followed my recommendations and took her to the emergency room, she was treated (unknown), then released with prescriptions for benadryl 25mg and a medrol dose pak.
45 2021-04-04 taste impairment Metal taste in mouth
45 2021-04-04 mouth itchiness patient reports itching on neck and inside mouth and reports feeling like throat is scratchy, slight... Read more
patient reports itching on neck and inside mouth and reports feeling like throat is scratchy, slightly lightheaded. Epi Pen and Benadryl given.
45 2021-04-04 tongue itchiness Itchy tongue and throat. Hot flashes. Raised heart rate and blood pressure
45 2021-04-05 taste impairment metal taste in mouth for a couple of hours after vaccine. started about 30 minutes after vaccine.
45 2021-04-05 mouth tingling, lip swelling Patient had facial swelling, lip swelling, and tongue heaviness two days after recieving the second ... Read more
Patient had facial swelling, lip swelling, and tongue heaviness two days after recieving the second dose of vaccine. She took Benadryl 25 mg every six hours and this resolved in three days.
45 2021-04-05 swollen tongue, dry throat Pt started feeling itchy and dryness to the throat. Patient also felt as if her tongue was swelling.... Read more
Pt started feeling itchy and dryness to the throat. Patient also felt as if her tongue was swelling. Admin of Zyrtec 10mg ODT and Albuterol 90mcg (4puffs)). Patient stated all symptoms resolved within 3-5 minutes post medication administration. Patient was kept under observation for approximately 45 minutes.
45 2021-04-05 tongue itchiness Within 15 minutes of vaccine: lightheaded, bad headache; itchy tongue & throat; tightness in throat ... Read more
Within 15 minutes of vaccine: lightheaded, bad headache; itchy tongue & throat; tightness in throat and chest and nausea (I began Benadryl and tylenol). Lasted until about 1:30 pm and had lessened when I woke up at 3 pm. 7 hours after vaccine: chills, low fever, body aches, exhaustion, persistent headache (continued tylenol and benadryl). Lasted until 4 am.
45 2021-04-06 double vision, vision blurred About 18 hours after the vaccine, my vision became blurred and then doubled.
45 2021-04-06 pain in jaw Initial reaction: night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling fev... Read more
Initial reaction: night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling feverish w/out fever, mild chills April 2-3: moderate to severe fatigue, lethargy symptoms eased on evening of April 3 Secondary reaction: April 4, evening through today, April 7: lymph nodes in left armpit, left side of neck, left jaw sore and tender, possibly slightly swollen. Back left jaw felt slightly numb on first day. Left side of neck feels as if muscles sprained. No fever. Brief, mild tenderness at injection site on right arm.
45 2021-04-06 mouth tingling, toothache, lip swelling Was given the shot on Friday, April 2, 2021 at 4:33pm within 20mins I got mild tingling in my tongue... Read more
Was given the shot on Friday, April 2, 2021 at 4:33pm within 20mins I got mild tingling in my tongue on the left side and slight tingling in my cheek on the left side of my face--like when Novacane is wearing off. I didn't say anything since I thought it was more anxiety then the shot. It was very mild and lasted 4 hours then it moved to like a mild tooth ache by 8:45pm. The mild tooth ace would come and go for the next 3 days (April 5th last day). Woke on April 6th to a swollen top lip which went away by 12pm. No symptoms on April 7th. I didn't report this since I thought it was anxiety but I did call the next day the hospital hotline to advise about tingling then called primary care doctor on April 6th when my lip swelled.
45 2021-04-06 swollen tongue Itching on face, cheeks, scalp, moved down to hands; swelling in tongue at back of throat; heart rac... Read more
Itching on face, cheeks, scalp, moved down to hands; swelling in tongue at back of throat; heart racing; "winded"
45 2021-04-06 ringing in ears Develop Tinnitus. Saw doctor. No solution. On meds now. Hopefully it will stop over a period of tim... Read more
Develop Tinnitus. Saw doctor. No solution. On meds now. Hopefully it will stop over a period of time. Not being able to sleep due to ringing in my ears especially left side.
45 2021-04-06 ringing in ears Bruising and swelling at injection site, headaches, slight nausea on one day, and sporadic ringing i... Read more
Bruising and swelling at injection site, headaches, slight nausea on one day, and sporadic ringing in the ears.
45 2021-04-07 loss of taste, loss of smell 4/01 received vaccine at 945 am By 6pm I developed low grade fever, restlessness, difficulty breathi... Read more
4/01 received vaccine at 945 am By 6pm I developed low grade fever, restlessness, difficulty breathing. Next day 4/02 I was feeling worse. Breathing issues body aches and chills. Went home sick from work. 4/03 symptoms worse lost taste and smell. Contacted clinic, they did a covid test it was negative. Symptoms continuing to get worse. Troubles breathing, chills, extreme fatigue I can not get from room to room with out loosing my breath. Went to ER , they said they will do another covid test and that came back negative. They prescribed me steroids, cough suppressant and albuterol inhaler. Today I am still struggling to breathe can not work still. I am extremely exhausted. I feel winded just getting from room to room. Today is one week from 1st shot. Symptoms are not getting better.
45 2021-04-07 deafness unilateral Within 5 minutes I lost hearing (right eye) felt as if full of water in my canal. One of my colleagu... Read more
Within 5 minutes I lost hearing (right eye) felt as if full of water in my canal. One of my colleagues checked my ear for fluids on Thursday and prescribed me antibiotics by 1/26 it was gone. I exp nausea next day vomiting 6 times and also felt burning sensation in throat. I had no arm pain and no fatigue.
45 2021-04-07 mouth numbness I received the vaccine on April 6. At the time of receiving the vaccine I began to feel numbness in ... Read more
I received the vaccine on April 6. At the time of receiving the vaccine I began to feel numbness in the tip of the tongue, lips and central incisors, on April 7, the day after receiving the vaccine I began to feel numbness in the small fingers of both hands. Today, April 8, the numbness of the lips and the numbness and tingling still persist in all the fingers of the hands, especially the little fingers
45 2021-04-08 eye irritation On Thursday 3/18 around 5:00 I started feeling tired, went to bed early woke up Friday with my eyes ... Read more
On Thursday 3/18 around 5:00 I started feeling tired, went to bed early woke up Friday with my eyes burning, the skin around my eyes was red, creapy, and was burning and itching. It was mainly my eyes, but my face felt puffy. My torso felt hot from inside. My throat felt swollen towards the top. By Friday night it was getting worse so I took Benadryl and sat with ice packs on my eyes, and put hydrocortisone around my eyes and eyelids. I continued that til Tuesday when it finally subsided. I did take pictures of my face, and I contacted my doctor to ask about the second shot. They advised against it, so I?ve cancelled my appointment. I might try the J & J shot in a few months.
45 2021-04-08 taste disorder, taste impairment Odd taste in mouth. Not coppery but slightly metallic
45 2021-04-08 ringing in ears Tinnitus developed four days after receiving second dose of vaccine. No history of tinnitus.
45 2021-04-08 ringing in ears Nausea, ringing in ears so bad I felt like I was going to throw up or pass out. Felt like I was goi... Read more
Nausea, ringing in ears so bad I felt like I was going to throw up or pass out. Felt like I was going to get up I would fall over. Slight fever
45 2021-04-08 toothache, mouth pain, burning mouth syndrome, pain in jaw, oropharyngeal discomfort, mouth tingling I received the injection at 2pm and around 8pm my tongue and the inside of my mouth began to tingle... Read more
I received the injection at 2pm and around 8pm my tongue and the inside of my mouth began to tingle. Both my tongue and the roof of my mouth became extremely tender and sore to touch my teeth. My throat and jaw became uncomfortable, but my airway was never compromised. The soreness has lasted 3 days and has eased with the help of Benadryl each day.
45 2021-04-09 mouth numbness lip area looked a little droop; numbness around her mouth area that spread to the left cheek area; s... Read more
lip area looked a little droop; numbness around her mouth area that spread to the left cheek area; soreness/pain in the arm after the injection; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 05Mar2021 (received at 45-years-old) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid 19 vaccine at noon on 05Mar2021. She stated that 18 hours later, when she woke up the next morning on 06Mar2021, she had numbness around her mouth area that spread to the left cheek area. She said it was like going to the dentist and getting local anesthesia for a filling. Her lip area looked a little droopy, but she wasn't sure. It continued the whole day and reduced the next day (07Mar2021). She also had soreness/pain in the arm after the injection (05Mar2021) and the next morning (06Mar2021). She further stated that her doctor wasn't sure if this was a one-time issue or related to the vaccine. Outcome of Her lip area looked a little droopy was recovering, while outcome of the other events was unknown. Information about batch/lot number has been requested.
45 2021-04-09 lacrimation increased Watery eyes (3days straight), fatigue (1 week) sore throat/headaches (1 week), sore injection site (... Read more
Watery eyes (3days straight), fatigue (1 week) sore throat/headaches (1 week), sore injection site (1 week)
45 2021-04-09 lip swelling, eye swelling My eyes and lips has swollen up. I broke out with weaps/ marks on my body I had to take Benadryl su... Read more
My eyes and lips has swollen up. I broke out with weaps/ marks on my body I had to take Benadryl sue to my throat started to close
45 2021-04-10 taste impairment Sore arms Achy muscles Achy all over Stiff Joints Back Ache sharp pain in left arm where shot was ad... Read more
Sore arms Achy muscles Achy all over Stiff Joints Back Ache sharp pain in left arm where shot was administered drowsy/ sleepy Feeling Jittery Taste Buds are off (medicine taste or metallic taste in the mouth). Many of the symptoms or side affects begin to decrease after the 2nd or 3rd day.
45 2021-04-10 lip swelling woke up drenched in sweat, not sure if she had fever, has cold sore on lip, lip swollen
45 2021-04-10 eye discomfort Please see below for the worst symptoms that started on 4/9, but in chronological order here it is: ... Read more
Please see below for the worst symptoms that started on 4/9, but in chronological order here it is: 12 hours after receiving the vaccination: chills, body aches, headache and feeling of drunkenness, pressure in eyes, painful gums in mouth. On Thursday 4/8: muscle aches, chills, tiredness, pressure in head with drunkenness feeling again. On Friday 4/9 at ~ 2:30pm I got a sudden feeling of coldness and started shaking and teeth were chattering uncontrollably, my lips turned blue, this lasted for about 20 to 30 minutes. Headache and body aches continued. Measured fever of 100.5 degF. On Saturday 4/10: pressure in head intensified, feeling as if someone squeezing on head. Saturday night/early Sunday morning burning feeling in legs. sudden sweats. On Sunday 4/11 at time of writing, still feeling pressure in head, body aches, and chills.
45 2021-04-10 swollen tongue, ear discomfort, mouth pain, mouth tingling Sore throat, swollen throat, coughing, tongue feels scraped on both sides, feels like it is swollen... Read more
Sore throat, swollen throat, coughing, tongue feels scraped on both sides, feels like it is swollen, so hurts to eat or chew. Chronic constant headache, swollen glands, ears feel plugged. Bloody nose. Lips suddenly extremely chapped and raw. Hurts to swallow.
45 2021-04-10 ringing in ears Tinnitus in right ear
45 2021-04-11 ear pain, toothache On Day 1 of shot given just a few hours after shot, I started having chills, Tooth pain, burning nos... Read more
On Day 1 of shot given just a few hours after shot, I started having chills, Tooth pain, burning nostrils, burning throat. I went to sleep and later at 1 am in the morning I woke up and had an extremely painful sore throat. The next day (Day 2) began the severe chest congestion and nasal congestion. This interfered with my asthma and ability to breathe. I also had body aches, and severe nausea and headache. Each day the symptoms seemed to increase not get better. Day 3 was severe enough for me to contact my physician as I didn?t feel it should be getting worse. I also had Diarrhea on Day 3. Finally I started taking Sudafed on Day 3 which helped alleviate the congestion symptoms while taking but I could tell it wasn?t better when the medication would wear off. Day 4 the coughing was so severe my chest started to hurt and I started to have Armpit and breast pain under the arm on the side of the injection site. Day 5 I started to get a severe Ear Ache in my left ear. I cannot be up and out of bed for more than a few minutes or the nausea gets too severe. Day 6 is today and I called my Physician again. They agreed that the symptoms should not be lasting this long and had me rapid tested for Covid-19 which came back negative. I went in for an office visit and it appears I have a secondary infection in my throat (possibly caused by the drainage). They prescribed me Azithromyzcin for the infection, Cough syrup with codeine for the cough, and Zofran for the nausea. They told me to alternate Tylenol and ibuprofen for the other aches and pains and to call them Friday if symptoms do not improve. I have already missed 3 days of work and the doctor just wrote me a note for 3 days more off of work because I?m so nauseated I can?t move around.
45 2021-04-11 ear pain Left inner ear ache, fever 100.9, body aches, chills, diarrhea
45 2021-04-11 feeling of choking Patient became lightheaded and passed out temporarily. She was coherent and aware, but began to feel... Read more
Patient became lightheaded and passed out temporarily. She was coherent and aware, but began to feel tingle in throat. EMS was called and patient was taken to the hospital for observation. Per the patient, she was administered epinephrine, diphenhydramine and steroids at arrival to hospital. Upon follow-up with patient later that evening, she was home and comfortable.
45 2021-04-11 ringing in ears Soreness on the arm. Mild fever Ringing in the ear
45 2021-04-12 eye twitching Right lower eye lid twitching. Non stop for 2 weeks now.
45 2021-04-12 dry eye This vaccine caused me to have a pretty bad hashimoto flare up. Severe tiredness. Achy all over and ... Read more
This vaccine caused me to have a pretty bad hashimoto flare up. Severe tiredness. Achy all over and even tho I took eye drops as directed they were dry and Sandy feeling for a couple of days. I never stopped my meds prior to vaccine. My immunodeficiency did not require me to as it may in some other cases. Even today my left shoulder still has pain at site of injection.
45 2021-04-12 taste impairment STRONG METALLIC TASTE STARTING WITHIN 5 MINUTES. DENIES ANY OTHER SYMPTOMS
45 2021-04-12 lip swelling A couple of days after the receiving the vaccine I started having severe heart palpitations. I notic... Read more
A couple of days after the receiving the vaccine I started having severe heart palpitations. I noticed that a hemangioma on my lip was extremely swollen and black and blue looking while experiencing the palpitations. I was also dizzy. I sent pictures of mu lip to my doctor at college and he encouraged me to see my primary care doctor. Both doctors agree that they suspect I had a blood clot. I also haven't had a regular period since the vaccine. I had one brief period shortly after the vaccine, and it was unlike my periods before the vaccine. I haven't had a period in two months and I don't believe that is coincidental as I was 28 days regular before the vaccine.
45 2021-04-12 mouth tingling Right after I had tingling in arm and roof of mouth, but my face became very flushed and hot, I coul... Read more
Right after I had tingling in arm and roof of mouth, but my face became very flushed and hot, I could breath fine so didn?t report..had window down and air conditioning on to try and cool off lasted about 25 minutes, after I had neck pain and headache for a week then a week later had high blood pressure and pulse. After 8 days I finally started feeling better
45 2021-04-12 feeling of choking, mouth tingling, mouth itchiness Tingling in throat and tongue Itchiness on scalp and face and down the legs
45 2021-04-12 ringing in ears headache Ear ringing Diarrhea Chills mild isolated aches
45 2021-04-13 taste impairment I have a metatlic smell and taste since having vaccinations.
45 2021-04-13 taste impairment Metallic taste starting about 3 hours post 2nd vaccine Milder condition 24 hours after 1st dose, las... Read more
Metallic taste starting about 3 hours post 2nd vaccine Milder condition 24 hours after 1st dose, lasting several days.
45 2021-04-13 ear pain Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn... Read more
Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn't suffered from migraines in over 20 years). Went to doctor on 3/3 due to severe pain. No thoughts of what it could be. Continued headaches with no relief. Received migraine shots in hip on night of 3/11. Severe stroke on 3/13. Should not be at risk for a stroke and does not have any typical factors for being at risk. Has been in hospital and in-patient rehab since. Has a fully occluded clot in her right ICA.
45 2021-04-13 mouth numbness Rash on neck, numb upper lip; treating rash presently with hydrocortisone cream
45 2021-04-13 lip swelling, bloodshot eyes, swelling around the eyes, swelling of eyelid 3 days after shot left eyelids started itching and swelling. 4 days after left eyelids and periorbit... Read more
3 days after shot left eyelids started itching and swelling. 4 days after left eyelids and periorbital area very swollen, itchy rash on left cheek, jawline, neck, swollen painful upper lip. 5 days after left eyelids swollen shut, very red, extremely itchy rash on eyelids, left side of face, left ear, neck, jawline, swollen painful upper lip, skin gritty on upper lip. Right eyelids starting to swell. Decided to go to ER. Was given in ER: IV push meds-Solumedrol, Pepcid, Benadryl. Sent home with course of Prednisone and Atarax. I am now on day 7 from the date of the vaccine and the rash continues, still very itchy, left eyelids swollen. Left side of face, left ear, left cheek itchy.
45 2021-04-13 visual impairment Severe headaches, nausea, dizziness, overheating, tired for several days. Eyesight seems strange too... Read more
Severe headaches, nausea, dizziness, overheating, tired for several days. Eyesight seems strange too.
45 2021-04-14 swelling of eyelid I immediately had a pain in my chest that went into my stomach and I felt dizzy. My chest felt tight... Read more
I immediately had a pain in my chest that went into my stomach and I felt dizzy. My chest felt tight. I had a sun burn rash later that night the next day my eye lid swelled. That night I couldn't lift my arm. My chest pain has been on and off since then. VERY Tired! Pain all over my body. BAD headache.
45 2021-04-14 tunnel vision Numb, tingling face; difficulty breathing; increased heart rate; tunnel vision
45 2021-04-15 mouth numbness Lips and area around lips went numb about a half hour after the 2nd vaccine was administered. Numbn... Read more
Lips and area around lips went numb about a half hour after the 2nd vaccine was administered. Numbness migrated to my left cheek a couple of hours later and was gone by about noon. Elevated temperature around 5pm (99.8) the day of vaccination. Started taking Tylenol. Temperature the following day (100.9) and whole body skin sensitivity. Slight temperature returned the next day (99.8), and no additional symptoms so far after a week.
45 2021-04-15 ringing in ears Ringing in ears beginning 1.5 hours after vaccination
45 2021-04-16 eye swelling Became very itchy about 45 minutes after vaccine with small bumps around neck and scalp. Took Benadr... Read more
Became very itchy about 45 minutes after vaccine with small bumps around neck and scalp. Took Benadryl immediately. Developed swollen eyes and lips about 4 hours later, took more Benadryl. I still feel itchy today on my face one head but feel much better with no swelling or rash.
45 2021-04-16 bloodshot eyes, swollen tongue, thirst 9:20 shot 9:30 tingling in fingers on left hand 10:30 tingling, swollen tongue; tingling in chest ... Read more
9:20 shot 9:30 tingling in fingers on left hand 10:30 tingling, swollen tongue; tingling in chest and right arm 11:00 tingling in head, thirsty 17:00 arm and joints pain chemical odor in urine 3/30 next day: 0700 mild fatigue, thirsty 1300 itchy under skin 1700 upset stomach 3/31 dark circles under eyes; dry cough, hoarse voice, red eyes, sinus congestion, headache shooting from sinuses around the right to back of head 4/3-4/4 migraine, night sweats, periodic hot flashes itching under skin for a few days after shot
45 2021-04-16 sensitivity to light, pain in jaw, extreme sound sensitivity Arm sore within 2-3 hours Within 18-20 hours feel terrible. Constant headache, chills and a bit shak... Read more
Arm sore within 2-3 hours Within 18-20 hours feel terrible. Constant headache, chills and a bit shaky, no fever but goosebumps all over, all of skin is uncomfortable when touched or clothes rub too hard, jaw sore and feels uncoordinated, aches and pains come and go all over body (legs, lower back, neck, arms), nausea, send ivory to light and sound
45 2021-04-16 ringing in ears Ringing in my ears started on April 15th at night.
45 2021-04-17 lip swelling, oropharyngeal discomfort Within 10 minutes of getting the vaccination my face started feeling tight and I started feeling dis... Read more
Within 10 minutes of getting the vaccination my face started feeling tight and I started feeling discomfort in my throat. By the time the 15 minutes was up my face and lips were completely swollen and I started feeling lightheaded. I was given steroids and Benadryl through an IV and was given an EpiPen injection.
45 2021-04-18 mouth numbness My arm from shoulder to finger tips started tingling, then pins and needles, then going numb. My fac... Read more
My arm from shoulder to finger tips started tingling, then pins and needles, then going numb. My face started to feel tight like you feel with a bad sunburn. Then my face started tingling with pins and needles, my lips went numb, I started getting red splotches across my face spreading down my neck. I quickly got home and took Benadryl for the next 24 hours.
45 2021-04-18 tongue disorder Noted Reaction Type Reactions Pfizer Covid-19 Vaccine [covid-19 Vacc,mrna(pfizer)(pf)] Allergy/hyper... Read more
Noted Reaction Type Reactions Pfizer Covid-19 Vaccine [covid-19 Vacc,mrna(pfizer)(pf)] Allergy/hypersensitivity Heart racing, couldn't talk, felt need to pass out, felt weak, and not able to talk because tongue felt heavier As of 04/16/2021 still complaining of Now having palpitations, feeling weak--- this happened again on the following Sunday, again for few minutes Has chest uncomfortable but no chest pain Felt like her speech was slower
45 2021-04-18 vision blurred, dry eye Client report receiving first COVID vaccine on 04-13-2021 about 10:30 am, adverse reaction began on... Read more
Client report receiving first COVID vaccine on 04-13-2021 about 10:30 am, adverse reaction began on same day, hours later about 4:30 - 5:00 pm. Adverse reaction of blurred vision started. Client wears contacts and glasses, normally without issues. Blurred vision in both eyes, right eye feels dry. Client has not reported rubbing eyes, no drainage or redness in either eyes. Client has also reported symptoms of fatigue, headache and congestions. Took Tylenol for the headache on 04/14. No known history of allergies. Client plan to contact her PCP, regarding adverse reaction.
45 2021-04-18 vision blurred Woke up at 0500 with extreme headache and took Ibuprofen for relief, ate yogurt and cereal bar and d... Read more
Woke up at 0500 with extreme headache and took Ibuprofen for relief, ate yogurt and cereal bar and departed for work. At work headache became more vigorous and became lightheaded and nausea went back to classroom and walked into room and blacked out on floor. Blacked out for approx. 2 minutes and started to come to with blurriness in peripheral, nausea set in strong...Medics arrived on scene and took BP which was 180 over 120 (never been that high). Was taken to Hospital via ambulance, Labs taken, CT of head and chest and pain meds for headache administered. Course of time of approx. 5 hrs, doctor stated possible migraine triggered episode and was discharged. (Never had migraines before)
45 2021-04-18 visual impairment, extreme sound sensitivity, vision blurred 15 minutes after the injection I had an intense allergic/anaphylactic reaction. I was watched and t... Read more
15 minutes after the injection I had an intense allergic/anaphylactic reaction. I was watched and treated on site by EMS for 2 hours with Benadryl, oxygen and rest. We did not use epi because I was still able to breath (minus some wheezing, coughing, hoarseness and lung irritation). I felt the reaction hit when I started seeing green spots and my vitals dramatically increased (BP 181/111, HR 142 and weak). I then experienced the following symptoms: rash/hives on neck and chest, fatigue and weakness, dizzy and lightheaded and needed wheelchair for moving around, chills and shaking, blurry vision, nausea, stomach pain, headache, chest pain and increased urination. I also had elevated glucose (147). During those two hours my vitals decreased a little, but the rest of my symptoms persisted. I was not getting better and my vitals started to increase again at the two hour mark so EMS called an ambulance and transported me to hospital. I was treated with solumedrol and observed for several hours. The meds helped enough to send me home. (I did have to continue taking Benadryl at home that night and the next day because I continued to have an allergic response). I also had severe injection site pain and bruising.
45 2021-04-18 visual impairment I have had the same that most people complain about, soreness of arm, but nothing that concerned me.... Read more
I have had the same that most people complain about, soreness of arm, but nothing that concerned me. I have noticed changes to my vision and after one week, developing headaches that are not going away even with Motrin. I have also noticed after a few days after the shot a strange reaction, like if my heart jumped a beat and I had shortness of breath. It would be only one or two second episodes at a time, so I'm not too concerned, but if it continues, I will discuss this with my doctor. I had never felt that before. This is not chest pains, it's difficult to describe. It's like the heart has to "jump" a beat.. but only once or twice. It's scary, but it does not happen often and it's happening less in the past day. The headaches are not fun, but I hope they will go away after a few weeks. I don't suffer migranes or headaches on a regular basis.
45 2021-04-19 loss of taste Developed pain in arm approximately 1-1/2 to 2 hours after injection which became severe after sever... Read more
Developed pain in arm approximately 1-1/2 to 2 hours after injection which became severe after several hours. Approximately five hours after injection, developed headache, sinus pain and congestion, joint pain, muscle aches and contractions, chills, fever 103°, loss of taste, gout flare-up, and fatigue. Symptoms persisted for approximately 36 hours. Self-treated with tylenol, OTC nasal decongestant, ice (for arm pain) and lots of water and sleep.
45 2021-04-19 taste impairment, mouth numbness "Pt received vaccine at 11:57 - pt started to c/o tongue felt metallic taste and felt numb at 12:06.... Read more
"Pt received vaccine at 11:57 - pt started to c/o tongue felt metallic taste and felt numb at 12:06. Pt c/o slight sweating. Pt did not eat breakfast and states this has not happened to him before. Pt denies cp, sob, tongue swelling, trouble swallowing, dizziness. Pt requesting some water. Initial vitasl 142/76 99% RA. Hr 76. RR 20. 12:24 - pt still c/o sweating, funny taste in Mouth. Pt repeat vitasl 142/82 100% RA HR 85. RR 20. Feel pt needs further evaluation. No rash, cp, sob, trouble swallowing. Pt still diaphoretic. Note from ED: 46yoM with possible allergic reaction after Moderna vaccine. VS wnl, OP exam wnl, no signs of anaphylaxis or airway compromise. Monitored here in the ED and did well with symptom resolution. Advised on current CDC recommendations to avoid 2nd injection, as well as potential for rebound allergic reaction, with good return to ED instructions. Pt indicated understanding. No evidence of anaphylaxis or airway compromise. Discussed rebound potential; feel home observation reasonable. Instructed on antigen avoidence. "
45 2021-04-19 ear swelling My left ear is swelled shut. I have never had any type of ear problems. I was prescribed ear drops f... Read more
My left ear is swelled shut. I have never had any type of ear problems. I was prescribed ear drops for a possible bacterial infection on Friday morning however nothing is currently working. I have a follow up appointment 4/21 @ 8am.
45 2021-04-19 lip swelling Swollen lip
45 2021-04-19 pain in jaw 4/15 day of vaccine: intense headache 4/16-4/18: bouts of intense pain across face and jaw and sin... Read more
4/15 day of vaccine: intense headache 4/16-4/18: bouts of intense pain across face and jaw and sinuses...preceded and followed by tingling and numbness in face 4/19. Symptoms went away
45 2021-04-19 mouth tingling 5 min after short lips tingling moved to chin and nose. Within 25 minutes my entire face was tinglin... Read more
5 min after short lips tingling moved to chin and nose. Within 25 minutes my entire face was tingling. Within 30 minutes my thighs were numb on the top only. Similar reaction when I gave platelets. My face tingling lasted 5 hours. My thighs lasted 12 hours
45 2021-04-19 vision blurred Spike in blood pressure, dizziness, severe headache blurred vision, disorientation
45 2021-04-20 eye swelling Severe swelling of face (especially eyes), rash on chest and back, skin felt hot.
45 2021-04-20 burning mouth syndrome Over the past week and a half I have experienced lots of side effects: light headedness, fatigue, sh... Read more
Over the past week and a half I have experienced lots of side effects: light headedness, fatigue, shortness of breath, slight fever, feeling off balance, sore throat and tongue.
45 2021-04-20 lacrimation increased Dizziness, nauseous, allergy symptoms (runny nose, watery eyes, sneezing, weak) Symptoms lasted two ... Read more
Dizziness, nauseous, allergy symptoms (runny nose, watery eyes, sneezing, weak) Symptoms lasted two full days.
45 2021-04-20 ringing in ears One night of insomnia followed by persistent tinnitus
45 2021-04-21 lip swelling Swelling of Lips and little bumps on lips - after the swelling and initial itching went away - chapp... Read more
Swelling of Lips and little bumps on lips - after the swelling and initial itching went away - chapped lips
45 2021-04-21 ringing in ears Tinnitus and ringing in ears, comes and goes but more frequent at night, wakes me up out of sleep, h... Read more
Tinnitus and ringing in ears, comes and goes but more frequent at night, wakes me up out of sleep, has been happening more consistently over last week and a half
45 2021-04-22 mouth tingling Patient received first dose of Pfizer Covid vaccine 2/8 around 0810. Visitor has known shellfish al... Read more
Patient received first dose of Pfizer Covid vaccine 2/8 around 0810. Visitor has known shellfish allergy with anaphylactic response. 2/8 @ 0828 complained of having a tingling sensation in her tongue. Benadryl 25mg po given and vitals monitored. 0837 tingling sensation decreasing another 25mg po Benadryl given. 0850 symptoms resolved. 0910 reported feeling well, left auditorium 0828 HR 112 SPO2 98/RA 0830 HR 98 BP 156/88 SPO2 98/RA 0837 HR 100 BP 146/95 SPO2 99/RA 0850 HR 98 BP 156/89 SPO2 100/RA
45 2021-04-22 smell distorsion, taste impairment, loss of taste Loss of taste and metallic taste when I eat. Started a day and a half after vaccine and gets worse e... Read more
Loss of taste and metallic taste when I eat. Started a day and a half after vaccine and gets worse every day. I am 12 days after the vaccine and either I can?t taste something or it tastes metallic. Smell is off also.
45 2021-04-23 taste impairment Metallic taste in mouth at time if injection. Went away within a minute.
45 2021-04-23 sensitivity to light Migraine (severe throbbing headache, light sensitivity, nausea, vomiting) began approximately 7 days... Read more
Migraine (severe throbbing headache, light sensitivity, nausea, vomiting) began approximately 7 days after receiving my second dose and had mostly resolved by the end of that day.
45 2021-04-23 taste disorder At 1521 patient reports nausea, vitals taken. Pulse 84, Blood pressure 178/108, oxygen 100% Laid pat... Read more
At 1521 patient reports nausea, vitals taken. Pulse 84, Blood pressure 178/108, oxygen 100% Laid patient down, water given, patient drank water, ice pack given, patient reports having migraine and has history of migraines. Patient continued feeling nauseous, patient laid down on cot. At 1538 patients vitals were reassessed blood pressure 184/98, oxygen saturation 99%, pulse 64. EMS called at 1541 due to patient reporting that had a foul taste in mouth and feeling a little pressure on throat, reported no difficulties swallowing, no salivating. Throat assessed moderate swollen left tonsil with white coating. Per patient she has had swollen tonsils for 2 days. Fire department arrived at 1608 vitals reassessed blood pressure at 152/98, pulse 63, oxygen 100%, respiration?s 17, denies shortness of breath. EMS at 1614 blood pressure 162/100, respirations 18, oxygen saturation 98%, pulse 64. Patient states feeling better and refused to go to hospital. EMS advised patient to take second dose of Benadryl if she feels the pressure again and seek immediate attention.
45 2021-04-23 vision blurred I had severe veritgo with nausea and vomiting out of nowhere. I couldn't even stand up because of it... Read more
I had severe veritgo with nausea and vomiting out of nowhere. I couldn't even stand up because of it. I should have gone to the hospital but i couldn't even sit up to get the phone or see/focus to use it. I live alone.
45 2021-04-24 taste impairment Metal taste still in mouth April. Getting worse, had to seek drs advice; This is a spontaneous repor... Read more
Metal taste still in mouth April. Getting worse, had to seek drs advice; This is a spontaneous report from a contactable 45years old female consumer (patient). A 45-year-old female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot: EL8982) second dose via intramuscular, administered in left arm on 11Feb2021 11:30 AM and first dose via intramuscular, administered in left arm on 21Jan2021 10:15AM (Batch/Lot no: EL3246) as a single dose for COVID-19 immunization. Vaccination administered at living facility. The patient medical history included fibromyalgia, IBS, unknown heart issue causing hypertension. The patient concomitant medications the patient received within 2 weeks of vaccination are Omeprazole, losartan, atorvastatin, metoprolol. The patient underwent lab test and procedures which included COVID-19 tests, Prior to vaccination, was the patient diagnosed with COVID-19 was yes, Since the vaccination, has the patient been tested for COVID-19 was No. Allergies to medications, food, or other products:Sulfa based drugs . Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 patient experienced with metal taste still in mouth April. Getting worse, had to seek doctors advice. The outcome of the event was not recovered. No follow-up attempt are needed. further information is expected.
45 2021-04-24 bloodshot eyes, eye swelling, swelling of eyelid About an hour and a 1/2 after injection I was on virtual call with my sister and she asked what's wr... Read more
About an hour and a 1/2 after injection I was on virtual call with my sister and she asked what's wrong with my eye? I hadn't noticed anything. In looking in the mirror, my left eye lid was drooping, swollen and red. My right eye was a bit red and slightly swollen but not droopy. I double checked my vision but was not having any disparity. The droop, swelling and redness lasted for many hours but was gone by morning. Between getting the shot and the virtual call, I had gone to the store to pickup some replacement prescription glasses. It is possible they sprayed a cleaning agent on them (though I didn't notice them do that or smell any chemical agents, which I am sensitive to notice). I got pregnant (with donor sperm) in April 2014 with twins. Miscarried at 9 weeks. Got pregnant with (now) husband March 2015. Daughter born 7 lbs 3 oz. Did IVF this past winter/Spring. Now about 14 weeks pregnant. EDD 10/22/2021
45 2021-04-24 sensitivity to light, smell distorsion, extreme sound sensitivity Migraine that lasted for 27 hours. Migraine symptoms included severe headache with throbbing pain, n... Read more
Migraine that lasted for 27 hours. Migraine symptoms included severe headache with throbbing pain, nausea, sensitivity to light & sound & smell. Had to remain in bed for the full 27 hours.
45 2021-04-25 lip swelling, swollen tongue Pt had swelling to tongue, lower lip and hives one day after vaccine #2 given 4/22/21, symptoms star... Read more
Pt had swelling to tongue, lower lip and hives one day after vaccine #2 given 4/22/21, symptoms started 4/23/21. VAccine was received at pharmacy.
45 2021-04-25 vision blurred, tunnel vision Report dizziness, tunnel vision, nausea started on 4/25 and blurred vision of the right eye started ... Read more
Report dizziness, tunnel vision, nausea started on 4/25 and blurred vision of the right eye started today 4/26/21. Treatment: checked blood glucose which was normal. Outcome: Currently at work, Slight improvement in symptoms. Will follow-up with primary care doctor.
45 2021-04-26 eye swelling, lip swelling SWOLLEN EYES AND LIPS
45 2021-04-26 ringing in ears Persistent, constant, and loud tinnitus in bilateral ears since flu symptoms post second Pfizer vacc... Read more
Persistent, constant, and loud tinnitus in bilateral ears since flu symptoms post second Pfizer vaccination resolved
45 2021-04-26 vision blurred Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness... Read more
Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue Onset at time of vaccine administration Labeled NOT anaphylaxis
45 2021-04-27 mouth tingling, dry throat Patient reported a dry throat and tingling lips soon after administration. Patient had history of a... Read more
Patient reported a dry throat and tingling lips soon after administration. Patient had history of anaphylaxis, and stated that these symptoms did not feel the same. Patient had no difficulty breathing nor swelling of the face. Patient was monitored for worsening of symptoms. Symptoms eventually subsided and patient returned home. Patient instructed to seek medical care if symptoms returned.
45 2021-04-27 ringing in ears Tinnitus, bi lateral
45 2021-04-27 ringing in ears I have had/lived with tinnitus for a long time, but after vaccine i have had what I would describe a... Read more
I have had/lived with tinnitus for a long time, but after vaccine i have had what I would describe as a flare up. The ringing I normally hear only when all is quiet, but since the vaccine the ringing is heard at all times, even in loud spaces. I noticed amplified ringing approx one week after 2nd vaccine dose, and it hasn?t stopped since.
45 2021-04-28 eye disorder On Monday April 12th I woke in the morning not feeling myself, I noticed that i had no feelimh on th... Read more
On Monday April 12th I woke in the morning not feeling myself, I noticed that i had no feelimh on the right side of my face and no control on the left side of my face I went to the hospital because I wanted to be sure thatI was not suffering from a stroke. they ran testes. it was con firmed that i did suffer a stroke, but i was in fact suffering from Bells Palsy. Now I have never had Bells PAlsy in my life and was made aware that this could happen out of no where but hey also indicated if i had done anything out of the ordinary. In that case I was still within my five day window of receiving my 1st Pfizer vaccine.
45 2021-04-28 mouth numbness As described by the patient: As they were putting the vaccine, the area got really warm, and the ar... Read more
As described by the patient: As they were putting the vaccine, the area got really warm, and the arm began to feel inflated. Then I began to feel the liquid moving through my arm, elbow, and wrist. My wrist started hurting. I told the nurse, who told me to keep moving the arm. As time passed (15 minutes), the warm feeling flowed to my should and left side of my back. Another 15 min passed, and it moved down my left leg and knee, which started to hurt. Then got neck got warm and stiff, and I felt the warm feeling got to the left side of my brain. 15 minutes passed left side of the face got warm. And then it headed to my lips and then tongue. Lips got numb, and tongue got numb. 5 minutes pass and my tongue and
45 2021-04-28 bloodshot eyes sore throat - lasted 16 days sneezing - lasted 14 days congestion - lasted 14 days dry cough - laste... Read more
sore throat - lasted 16 days sneezing - lasted 14 days congestion - lasted 14 days dry cough - lasted 16 days red eyes with green mucus - day 3, 1 eye red, day 5, both eyes red. lasted 10 days
45 2021-04-29 eye swelling Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side o... Read more
Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side of neck... Then underneath my eye / crawl / felt strange like swelling. Then within 5-10 min my skin on left side of head crawl .... But ok within an hour. Only on left side. Also, no pain at all didn't even feel needle go in but had lump at injection site and painful when touched until Day 12.
45 2021-04-29 mouth tingling Patient experienced perioral tingling and swelling after dose #1. Experiencing tingling few minutes ... Read more
Patient experienced perioral tingling and swelling after dose #1. Experiencing tingling few minutes After administration of dose # 2 today. Benadryl 25mg PO administered. Monitored for 15 minutes. Denies any trouble swallowing, SOB, or swelling. Patient was discharged home
45 2021-04-29 vision blurred On day 5 after the vaccine, I experienced blurred vision and a crushing headache. It came on extrem... Read more
On day 5 after the vaccine, I experienced blurred vision and a crushing headache. It came on extremely quickly. I took pain medication and laid in a dark room and slept. By the next day, it was gone.
45 2021-05-04 mouth swelling, mouth tingling Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on ha... Read more
Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on hands, trunk and head: itching; itching; facial swelling/ swelling in face; hand swelling/ swelling in hands; tingling in lips; some mild difficulty swallowing; throat swelling; mild difficulty breathing; numbness; swelling in mouth; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Feb2021 15:00 (lot: EN6201) and second dose on 25Feb2021 15:00 (lot: EN6205); both via an unspecified route of administration in left arm (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included known allergies Sulfa, bee stings, shellfish and Ceclor. Concomitant medications included armodafinil; clonazepam; vortioxetine hydrobromide (TRINTELLIX), also Tooo Max and an unspecified vit. The patient experienced Bells Palsy on right side of face; throat swelling; itching; mild difficulty breathing; severe rash on hands, trunk, neck; numbness; swelling in mouth; large blister like bumps on hands, trunk and head: itching; facial swelling/ swelling in face; hand swelling/swelling in hands; tingling in lips; some mild difficulty swallowing on 02Mar2021 at 15:00. The patient considered the case as non-serious, did not result in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and non-congenital anomaly/birth defect. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received prednisone, cetirizine hydrochloride (ZYRTEC), omeprazole (PRILOSEC), methylprednisolone sodium succinate (SOLU-MEDRO) IV at ER as treatment. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-05-06 swelling around the eyes, mouth swelling Patient had syncope at work with periorbital swelling and closure of airway with swelling of the mou... Read more
Patient had syncope at work with periorbital swelling and closure of airway with swelling of the mouth. patient was given subq epi pen, solumedrol, and bendryl via EMS prior to ER arrival. 21:45pm on 05/06/2021
45 2021-05-09 ringing in ears, deafness unilateral tinnitus for 24 hours, loss of hearing for 48 hours, tinnitus for about 7 days. Received second dose... Read more
tinnitus for 24 hours, loss of hearing for 48 hours, tinnitus for about 7 days. Received second dose on 2/3/21, Lot# EL3289, tinnitus restarted at about 24 hours post-vaccine. No improvement and tinnitus continues. All symptoms only in right ear.
45 2021-05-10 mouth numbness Within an hour half of my body went numb My tongue went numb and I was in the emergency room unable ... Read more
Within an hour half of my body went numb My tongue went numb and I was in the emergency room unable to speak with what appeared to be the worst hemiplegic migraine in my life. The feeling has not returned in my left hand side of my body or my tongue. I am told the second vaccine injection will be worse. Then I was misdiagnosed with muscular sclerosis after an MRI was done and damage was found to my brain. I could not be more angry
45 2021-05-17 burning mouth syndrome Sores in mouth and tongue after 1st injection. Still have them; Sores in mouth and tongue after 1st ... Read more
Sores in mouth and tongue after 1st injection. Still have them; Sores in mouth and tongue after 1st injection. Still have them; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: El1284, Expiry date: unknown), via an unspecified route of administration, administered in left arm on 01Jan2021 at 16:45 pm (age at vaccination was 45 years) as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history included high blood pressure, diabetes and chf (congestive heart failure). The patient's allergies to medications, food, or other products included sulfa allergy. The patient received concomitant medications within 2 weeks of vaccination and the details were unknown. On 03Jan2021 at 16:00 pm, the patient experienced sores in mouth and tongue after 1st injection, still have them. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/ Administration facility. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Ek9231, Expiry date: unknown), via an unspecified route of administration, administered in left arm on 21Jan2021 (age at vaccination was unknown) as a 2ND DOSE, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The event was reported as non-serious. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.
45 2021-05-18 taste disorder, smell distorsion smell all the same (terrible) and taste weird; smell all the same (terrible) and taste weird; BNT162... Read more
smell all the same (terrible) and taste weird; smell all the same (terrible) and taste weird; BNT162B2 dose 1 and 2 received on 27Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9261), single dose, dose 1 intramuscular, administered in the left arm on 27Jan2021 at 08:15 and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6198), single dose, dose 2 via an unspecified route of administration, administered in the left arm on 27Jan2021 (at the age of 45-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) 150 mg taken for an unspecified indication, start and stop date were not reported; naltrexone 4mg taken for an unspecified indication, start and stop date were not reported; bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) taken for an unspecified indication, start and stop date were not reported and calcium levomefolate (DEPLIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took sulfa [sulfadiazine] and experienced drug hypersensitivity. On 19Mar2021 at 6:45 AM, I woke up to my husband bringing me coffee to bed. (My favorite thing). It smelled like our cat's super stinky wet cat food! I told him something was wrong with the coffee but he insisted it was fine. Since that day, cat food, coffee, steaks, dog poop, and several other things smell all the same (terrible) and taste weird. My toothpaste tastes like urine in a cat litter box (I'm using cat references because it's not the closest thing I can come up with to describe the smell/taste/sensation. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 24Feb2021 Nasal Swab. Therapeutic measures were taken as a result of smell all the same (terrible) and taste weird and included antibiotics and steroids hoping it was sinus related.The clinical outcome of smell all the same (terrible) and taste weird was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and was negative.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "smell all the same (terrible) and taste weird" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Committees and Investigators, as appropriate.
45 2021-05-19 ringing in ears Cramping of fingers; Burning hands; Itching on hand palms/itching on feet; Painful L arm; Blood pres... Read more
Cramping of fingers; Burning hands; Itching on hand palms/itching on feet; Painful L arm; Blood pressure high; Weakness in left side; Chills; Ears ringing; Flu like symptoms; Fever; This is a solicited report from a non-contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EP7533) via an unspecified route of administration on 07Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization and adalimumab (HUMIRA; solution for injection in pre-filled pen; strength: 40mg/0.4mL) subcutaneously from 2016 and ongoing at 40mg, weekly (CF, 40mg, 1 in 1 week) for moderate to severe rheumatoid arthritis and ulcerative colitis. Medical history included megaloblastic anemia, allergic to aspirin, allergic to penicillin, allergic to shellfish, allergic to tramadol, rheumatoid arthritis, ulcerative colitis, abstains alcohol, acid reflux and allergy all from unspecified dates and unspecified if ongoing. The patient had no tobacco use. Concomitant medications included methotrexate taken for an unspecified indication on unspecified dates, folic acid taken for an unspecified indication on unspecified dates, dexlansoprazole (DEXILANT) taken for an unspecified indication on unspecified dates, dexlansoprazole (DEXILANT) taken for acid reflux on unspecified dates, montelukast sodium (SINGULAIR) taken for an unspecified indication on unspecified dates, cetirizine hydrochloride (CETIRIZINE) taken for allergy on unspecified dates, fluticasone propionate (FLONASE) taken for an unspecified indication on unspecified dates and salbutamol (ALBUTEROL) taken for an unspecified indication on unspecified dates. On 07Apr2021 the patient experienced chills, ears ringing, flu like symptoms and fever; on 22Apr2021 the patient experienced weakness in left side, painful L (left) arm and blood pressure high; on 25Apr2021 the patient experienced burning hands and Itching on hand palms/itching on feet and on an unspecified date the patient experienced cramping of fingers. The events were all assessed as non-serious. The action taken in response to the events for adalimumab was dose not changed. The clinical outcomes of the events chills, ears ringing, flu like symptoms and fever were recovered/resolved on 07Apr2021; weakness in left side, painful L arm, blood pressure high, burning hands and Itching on hand palms/itching on feet were recovered/resolved on an unspecified date and cramping of fingers was not recovered/not resolved. The reporter's causality for the events chills, weakness in left side, Itching on hand palms/itching on feet, burning hands, ears ringing, flu like symptoms, fever, painful L arm, blood pressure high and cramping of fingers with adalimumab was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information provided, a causal association between suspect drug and the reported events cannot be completely excluded considering a temporal relationship. Case will be reassess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
45 2021-05-21 ear discomfort, deafness unilateral, ear pain, ringing in ears Fever 100.8 x 30 hours chills headache in nape of neck. unsteady arm soreness weak no sleep little a... Read more
Fever 100.8 x 30 hours chills headache in nape of neck. unsteady arm soreness weak no sleep little appetite felt very very bad after 2nd dose on April 27. Awoke sweating profusely bed damp pajamas damn at 6:30 on Thursday, April 29 to loud ringing buzzing whining in both ears. Pressure in ears soreness in ears deep where ears meet brain. Feels as if ears will burst if I lean over. Headache in forehead. Fever 99.0 -99.4. Ear pressure aching ringing has continued since. At times, left ear feels like a void like I can?t hear. Right ear like it hears too well too loud. Music songs sound different. Like not blended. Like missing a part. When 2 many sounds happening, I can?t distinguish detail. It?s all blurred. An ambulance went by. I couldn?t hear with my left ear. Seatbelt beeping in car is faint and does not bother me now.
45 2021-05-24 ear pain, mouth numbness Within an hour, extreme headache, left side of entire body ;limp/numb, tongue and face numb-- nexty ... Read more
Within an hour, extreme headache, left side of entire body ;limp/numb, tongue and face numb-- nexty day, entire body numb, except extreme pain and stinging wrists, hands, feet, mouth, ear to ear (trigeminal) extreme pain, difficulty wakling cannot use body strength came back and left again today 5/25 started course of methlyprednisone which will make me have weakened immune system fear getting covid now as I have to be around people I have not contracted covid. Docs at a aloss. said I was having signs of MS I do not have MS MS medically, and legally requires LP MRI is no longer gold standard for MS I went to school for things A transfection and expression event took place in my arm without my permssion after I was fear mongered to get this being told I would die if I did not I fear death now I have loss of function in arms and hands, I cannot do homework, it is difficult to ype, my hands feel like I am being stung by bees I just moved here because I was the main witness in a jury trial Upset is not the word I would use to describe
45 2021-05-24 sensitivity to light horrible body pain all the way to my finger nails (not ache) sensitivity to light, extreme exhaustio... Read more
horrible body pain all the way to my finger nails (not ache) sensitivity to light, extreme exhaustion. Headache.
45 2021-05-25 inability to speak Two days after the 2nd Pfizer vaccine, Sunday May23rd, I woke up with a slight sore throat. I didn?... Read more
Two days after the 2nd Pfizer vaccine, Sunday May23rd, I woke up with a slight sore throat. I didn?t make much of it because I thought it was maybe my sinuses dripping more than usual. However, when I woke up Monday, the sore throat was evident and very bothering some. Throughout the day I experienced cold/flu symptoms like tiredness & coughing. I couldn?t function normal so I had to take DayQuil. At night in order to go to sleep I had to take NyQuil. Tuesday morning I woke up feeling worse, my nose was very congested, the sore throat persisted and my voice was changing. Very tired. I still did not have a fever, muscle aches nor chills. Although I did have a congested nose, I did not lose the sense of smell & taste. Today, Wednesday I lost my voice so I?m writing this. I haven?t had a cold in 2 years nor o have been exposed to people or places to catch COVID 19 so I?m almost positive these are side effects and symptoms from the Pfizer second vaccine. These symptoms needs to be brought out to the light. It is very unfair to feel like one is alone on this one. Fortunately, thanks to blogs I was able to read other bloggers who are experiencing the same symptoms, especially the SORE THROAT.
45 2021-05-25 deafness unilateral, mouth pain Day 1: hearing loss in left ear, face felt sunburned, pain at surgical site (had oral surgery 4/15/2... Read more
Day 1: hearing loss in left ear, face felt sunburned, pain at surgical site (had oral surgery 4/15/21), fatigue, headache Day 2: fatigue, headache Day 3: fatigue, headache Days 4-6: headache
45 2021-05-25 taste impairment After receiving second COVID vaccine, pt reported to provider in waiting area that her heart was rac... Read more
After receiving second COVID vaccine, pt reported to provider in waiting area that her heart was racing and she had a metallic taste in her mouth. Initial VS 158/96, HR 58; RR 20; O2-98% on RA; after initial VS check pt reports that her heart racing isn't happening anymore. She does report a history of PVCs, and reports taking Metoprolol. After her 30 minute wait time post vaccination, pt denies any abnormal symptoms, and VS are 130/96; manual HR 54; RR 18; pulse ox 97% on RA. Pt allowed via provider to go home at this time, with post care instructions provided by provider in room at this time
45 2021-05-25 taste impairment Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Late m... Read more
Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps; Fever; chills; nausea; headache; muscle heaviness; metal taste in mouth; sinus swelling; sneezing; extreme fatigue; This is a spontaneous report received from contactable consumers (one of them is the patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737) via an unspecified route of administration, administered in right arm on 22Apr2021 13:00 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure and allergy to sulfa drug. Patient was not pregnant. The patient's concomitant medications were not reported. On 23Apr2021 11:45, patient experienced fever, chills, nausea, headache, muscle heaviness, metal taste in mouth, sinus swelling, sneezing and extreme fatigue. On 03May2021 03:00, patient had late menstrual period by 2 weeks and extreme heavy period (thin, clotty) with lots of cramps on an unspecified date when it did came. The patient did not receive treatment for the events reported. Outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
45 2021-05-26 blindness Headache, vision loss, stiff neck. Caused Aseptic Chemical Meningitis
45 2021-05-26 lacrimation increased She is just not feeling well; flare up of her environmental allergies (sneezing, itchy, watery eyes.... Read more
She is just not feeling well; flare up of her environmental allergies (sneezing, itchy, watery eyes.); Sneezing; coughing; congestion; itchy; watery eyes; headache; fatigue/She sleeps 10 hours every night and she does not feel rested; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EN5318) via an unspecified route of administration in left arm on 02Feb2021 (at the age of 45-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history included seasonal allergy, allergic conjunctivitis, environmental allergies. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced very intense flare with sneezing, coughing, congestion, itchy, watery eyes. Patient reported that she remembers she took it that evening. she got it through her job and she was able to go after work and immediately she felt fatigue on 02Feb2021. She was sleeping that whole night and that has continued she has had the same level of fatigue since then. She sleeps 10 hours every night and she does not feel rested. She had headache that started the next morning wednesday on 03Feb2021. It's like headache, head pressure and she know that's expected and she would say it's been the same level of intensity until about saturday or sunday slowly getting less but it's still there. She had a question of duration and is this normal symptoms and how long they last and the agent said she doesn't have the information for the first dose. She has seasonal allergies, environmental allergies and she had a break for a couple weeks and did not have any kind of flare, they were under control with medications then thursday. She started having a very intense flare sneezing, coughing, congestion, itchy, watery eyes, things she would normally take meds for, the meds are not working. She takes over the counter or prescribed meds she has still been taking them but she is flared up more than usual these past few days. She names of medications, she can check know the Allegra. It was reported that patient spoken 2 different people but she was calling reporting some of side effects that were listed but then she have had some questions about duration of some of them after the first dose. She have had other symptoms that were not listed on the list and she was wondering if there were connections to the vaccine. She was just not feeling well, she did called her doctor but saw the number on the fact sheet and she wanted to called pfizer as well. Patient took medications such as flonase for her nose and the lot number is AB1350A expiration May2022, Allerfex for her eyes lot number is 0FR0350 and expiration Jan2022. The new eye drop she has been on for 2 weeks is Ellistat, the eye drop lot number F0904 and expiration Sep2021. The outcome of the events headache was recovering, fatigue was not recovered and other events was unknown. Follow-up attempts are completed. No further information is expected.
45 2021-05-26 swollen tongue, taste impairment Swollen tongue and metallic taste; Swollen tongue and metallic taste; This is a spontaneous report f... Read more
Swollen tongue and metallic taste; Swollen tongue and metallic taste; This is a spontaneous report from a contactable HCP (patient). A 45-year-old female (no pregnant) patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 18May2021 at 09:45 (Lot Number: 59267100001) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included seasonal allergies-asthma. Known allergies is sulfas. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). The patient experienced swollen tongue and metallic taste on 18May2021 at 10:45. The adverse event result in doctor or other HCP office/clinic visit. The steroids had been received as treatment for the adverse events. The outcome of events was recovered on an unspecified date. No attempts are possible. No further information is expected.
45 2021-05-27 ear pain, thirst FIRTS: TIREDNESS, ARM PAIN, ONE WEEK LATER: FEVER, MUSCLE ACHE, HEADACHE, EAR ACHE, THIRST
45 2021-05-27 pain in jaw, mouth pain, toothache Sore arm the night of the vaccine. Progressed to sore arm, neck and left side of body throughout th... Read more
Sore arm the night of the vaccine. Progressed to sore arm, neck and left side of body throughout the night. Sunday afternoon I could feel a lymph node in the left side of my neck had swollen. Sunday night I started feeling sensitivity in my left jaw and teeth which progressed to my entire mouth the next day (Monday). Tuesday the sensitivity was only in the right side of my mouth. The right side of my mouth, especially my teeth hurt and is extremely sensitive when I drink and eat anything.
45 2021-05-28 taste impairment weird taste in my mouth like metal; This is a spontaneous report from a contactable other hcp (patie... Read more
weird taste in my mouth like metal; This is a spontaneous report from a contactable other hcp (patient herself). A 45-year-old-female patient (non-pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EM9810, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 03Feb2021 15:45 (at the age of 45-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included food allergy (Soup), allergy to arthropod sting (wasps), drug hypersensitivity (medication). Concomitant medications were not reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Feb2021 06:00 PM the patient experienced, having a weird taste in my mouth like metal. The outcome of the event was reported as unknown. Follow-up attempts are completed. No further information is expected.
45 2021-05-28 pain in jaw Bell?s palsy. Started with pain in jaw and paralyzed right side of face a few days after pain began
45 2021-05-28 ringing in ears headache; tiredness; ringing in my ear; Muscle ache; This is a spontaneous report from a non-contact... Read more
headache; tiredness; ringing in my ear; Muscle ache; This is a spontaneous report from a non-contactable consumer reported for herself. A 45-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration at left arm on 29-Jan-2021 14:30 as a 1st dose single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient had not diagnosed with COVID-19 prior to vaccination and since vaccination. On 30Jan2021 the patient experienced Muscle ache, headache, tiredness, ringing in my ear. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-05-29 mouth tingling, lip swelling approximately 5:05pm started to become itchy, hives on face, neck, chest, breast and arms. lips felt... Read more
approximately 5:05pm started to become itchy, hives on face, neck, chest, breast and arms. lips felt tingly and started to swell, became pale and found a nurse in the waiting area. I was taken to the ER and seen by ER Doctor, IV solumedrol and IV famotidine were administered. Placed on heart monitor and blood pressure. Was monitored in ER for 5 hours before being released with rx for Prednisone and advised to continue my current course of allergy mediations - famotodine, singulair. hyrdoxozine and zyrtec, epipen if needed. Friday morning I had a secondary reaction, became itchy all over, hives returned on face, neck, arms, chest and lip swelling. I took benadryl and was seen by doctor at the clinic, as my normal allergist was out of the office. I was given a half dose of epinephrine and was okayed to return to my desk in the Surgery Center with instructions to contact office if symptoms did not improve or if they started to worsen. I spoke with nurse around 1pm, symptoms had not improved and I was asked to come back to the allergy department. I was given an additional half dose of epi in the office. I was sent home with a half dose of epi in case needed. Was advised that if did not improve would need to return to the ER.
45 2021-06-01 mouth numbness This is a 45-year-old female who presents to the emergency department after having a reaction to the... Read more
This is a 45-year-old female who presents to the emergency department after having a reaction to the COVID-19 vaccine. She reports that she received her first dose about 3 hours ago. Following the injection she had almost immediate chest tightness and perioral numbness. Symptoms have been constant for the last few hours. She took a dose of Benadryl which provided some temporary relief of her symptoms. She denies shortness of breath. No coughing. She has a history of prior anaphylactic reactions to antibiotics.
45 2021-06-01 mouth tingling Neurological: tingling in arms, legs, face, tongue. Effects still persist and have not subsided (12 ... Read more
Neurological: tingling in arms, legs, face, tongue. Effects still persist and have not subsided (12 days later so far) General: Low grade fever 100.1 within 24 hours lasting no more than 4 hours, mild joint pain
45 2021-06-02 ringing in ears Tinnitus
45 2021-06-03 visual impairment PT STARTED EXPERIENCING INTENSE HEADACHES ON THE MORNING OF 5/21/2021. THE HEADACHES CONTINUED ON AN... Read more
PT STARTED EXPERIENCING INTENSE HEADACHES ON THE MORNING OF 5/21/2021. THE HEADACHES CONTINUED ON AND OFF FOR SEVERAL DAYS UNTIL ON 5/24/2021 AT 3 PM, SHE HAD A DEBILITATING HEADACHE WITH DIZZINESS THAT COULD NOT BE RELIEVED. THEN ON THE AFTERNOON OF 5/25/2021, SHE STARTED EXPERIENCING VISUAL CHANGES WITH BLACK SPOTS IN HER VISION. SHE WAS ABLE TO SEE HER DOCTOR ON 5/27/2021 AT 10 AM. HE SENT HER FOR A CT SCAN OF HER HEAD WHICH WAS FOLLOWED BY A MRI OF HER BRAIN. THE MRI AND CT SCAN REVEALED THAT SHE HAD A LEFT FRONTAL ISCHEMIC STROKE. SHE WAS ADMITTED TO THE HOSPITAL ON 5/27 AND DISCHARGED HOME ON THE AFTERNOON OF 5/28. SHE HAD A CT ANGIOGRAM OF THE BRAIN, AN ECHO OF THE HEART, ULTRASOUND OF THE CAROTIDS AND A HYPERCOAGULATION BLOOD PANEL. ALL OF WHICH WERE NORMAL AND SHOWED NO EVIDENCE OF WHERE THE BLOOD CLOTS CAME FROM THAT CAUSED HER STROKE. SHE CONTINUES TO HAVE HEADACHES WITH DIZZINESS, FATIGUE, AND NOW BAD ANXIETY.
45 2021-06-06 ringing in ears Ongoing migraine headaches that are not relieved. Loss of peripheral vision in left eye. Constant ea... Read more
Ongoing migraine headaches that are not relieved. Loss of peripheral vision in left eye. Constant ear ringing. Blood clot in right arm. Ongoing dizziness and vertigo. Possible intracranial hypertension. I am being tested next week. These symptoms have been ongoing and have not been relieved. I was given Eliquis for the blood clot, which I no longer take. I take Trokendi 100 mg daily which is being increased for the migraine. I am also suffering with chronic fatigue.
45 2021-06-06 visual impairment, thirst, sensitivity to light, vision blurred, eye disorder +- 30 minutes after the shot I felt very woozy and my vision became impaired. Since then I have ongo... Read more
+- 30 minutes after the shot I felt very woozy and my vision became impaired. Since then I have ongoing intermittent numbness/tingling/itching/inflamation in face/head/arms/mid-spine, a drooping right eye, headaches/pressure, blurry/impaired vision, light sensitive eyes (feels like theres sand in them) and dizzy spells. At Urgent Care the doctor diagnosed me with "Facial Paresthesia and adverse effects of vaccine." He sent me to the ER where blood clots/stroke was ruled out. They referred me to a neurologist for next week Friday. I also had a few days of excessive thirst, unusually heavy menstrual cycle and a week of a pain above my right elbow. My symptoms have persisted for 11 days and counting.
45 2021-06-08 pain in jaw grogginess; no appetite; sore jaw; extreme headaches; flu like symptoms; dizziness; achy body; pain ... Read more
grogginess; no appetite; sore jaw; extreme headaches; flu like symptoms; dizziness; achy body; pain in arm near injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left unknown on 09Mar2021 08:00 (Batch/Lot Number: EN6205) as a Single dose for covid-19 immunization. The patient past Medical history included asthma and breast cancer in remission 11yrs out. The patient's concomitant medications were not reported. The patient had Allergic to Codiene. 8hrs after the administration of vaccine the patient experienced flu like symptoms, dizziness, achy body, pain in arm near injection site on 09Mar2021 at 4:00pm, after the 17hrs the patient reported extreme headaches and 24hrs after reported grogginess, tension headache, dizziness, no appetite and sore jaw on 10Mar2021 at 01:00. The patient did not take any other vaccine within 4 weeks. The patient was not tested for Covid-19 prior to vaccination. The outcome of the events were recovering. No follow-up attempts are possible; No further information is expected.
45 2021-06-08 mouth tingling neurological side effects; Paresthesia, the tingling in the legs and in arms and the tongue, both le... Read more
neurological side effects; Paresthesia, the tingling in the legs and in arms and the tongue, both leg, both arms and the tongue; Paresthesia, the tingling in the legs and in arms and the tongue, both leg, both arms and the tongue; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), dose 2 via intramuscular route, administered in left arm on 21May2021 15:30 as SINGLE DOSE for covid-19 immunisation. The patient had no medical history and concomitant medications. Patient previously received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0172 and Expiration date: unknown), dose 1 via intramuscular route, administered in left arm on 30Apr2021 15:30 as single dose for covid-19 immunisation. Patient has not received any other vaccine 4 weeks prior to COVID-19 vaccine. In May2021 (within 24 hours after second shot), the patient reported that she was going to ER (today as reported) to see neurologist because she experienced neurological side effects, paresthesia, the tingling in the legs and in arms and the tongue, both legs, both arms and the tongue. The patient underwent lab tests and procedures which included blood work with unknown results on an unknown date. Outcome of events was unknown.
45 2021-06-08 vision blurred 1/11/21 It started 10 hours after vaccine with chills fever, headache and it lasted for 3 days and ... Read more
1/11/21 It started 10 hours after vaccine with chills fever, headache and it lasted for 3 days and still felt fatigue and drained and started getting headache non stop and blurry vision medication was not working and my doctor kept prescribing different medication and sent me . to a neurologist. I got an MR, MRA , MRV and CT and noticed my spinal lumbar fluid increase. I was unable to drive due to blurry vision
45 2021-06-09 mouth tingling I had severe chills body aches and nausea for about a day and a half and I felt really lethargic. S... Read more
I had severe chills body aches and nausea for about a day and a half and I felt really lethargic. Symptoms started to dissolve on day 2. Day 3, I started feeling numbness and tingling in both arms and my tongue. I had a little chest discomfort and felt like I was about to have a heart attack. I went to an Express Care for treatment because I felt like I could not make it to the Emergency Room.
45 2021-06-09 ringing in ears Acute vertigo transient but now new chronic unilateral tinnitus
45 2021-06-09 vision blurred I sat for 15mins after getting my shot , I had blurred vision after about 10 minuteses and I felt ok... Read more
I sat for 15mins after getting my shot , I had blurred vision after about 10 minuteses and I felt ok but I was a little lightheaded. I assumed it may have been because I hadn't eaten. I got in the car and headed home we did do some shopping prior to heading home. .At that time my heart started racing I had tremors that felt like electrical pulses going through my arm we turned around and went back to CVS because the nearest hospital was too far we were just up the road from the CVS. I looked at the clock around 3:35pm and questioned whether I had waited long enough before leaving the vaccine site I was worried about anaphylactic shock at that time. I was feeling so bad when we arrived that I didn't know if I could walk the feeling shot from my arm to my abdomen and continued down my legs into my. I was advised to put my legs up I had to make myself breathe or I would have stopped breathing. It lasted for about 15 minutes and I was able to drink water after about 5 minutes . A nurse on duty sat with me and they told me to check with my doctor before getting the 2nd dose. Around 11pm that night, it started again I went to the ER at Hospital and they did an EKG and blood work to check for an allergic reaction and monitored me for about 4 hours and I was told everything was fine.
45 2021-06-10 eye disorder I guess it was like bell's palsy and I had it happened to me three times, two times in one day and t... Read more
I guess it was like bell's palsy and I had it happened to me three times, two times in one day and then one time like a couple days later; Mouth twisting; Eye closing; This is a spontaneous report from a contactable consumer or other non hcp reported herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 14:15 (Batch/Lot Number: EW0185) as a Single dose for covid-19 immunization. The patient past Medical history included asthma. The concomitant medication was reported as no. the patients historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW0167) as a Single dose for covid-19 immunization. The patient was not administered another vaccine within 4weeks prior. On 26May2021, after the second dose of her vaccine the patient experienced side effect of the mouth twisting, eye closing and she couldn't like, she guesses it was like bell's palsy and she had it happened to her three times at 5:30 in the morning and then again at 8:45 when she went to work and then she had to go to the emergency on the Wednesday and then again on the 28th in the morning at about 6 O'clock in one day and then one time like a couple days later. The patient confirmed went to emergency, stated, "she called the advice nurse and they said nothing was going on like when they did there, but she had her, when she was at work, she had people who seen it happening to her. So that was a good thing because as it met, she doesn't think that people would believe that it happened to her and she didn't want to take the shot just because of the side effects. But due to her job policy that we had to take it, so that's why she took it to keep her job. Consumer stated, "No, they didn't do anything for me.". The outcome is Recovered on an Unspecified date in 2021.
45 2021-06-10 eye bleeding May not be related, reporting just in case. Bp and pulse went up around 11:00pm on 6/6/21. Normal 11... Read more
May not be related, reporting just in case. Bp and pulse went up around 11:00pm on 6/6/21. Normal 115/75 and pulse 75 at rest. Went to 140/90 and 100. Felt heart palpitations. Went to bed hoping it would go away. Woke up feeling unwell again and still high. Also, developed a large subconjunctival hemorrhage in my right eye. BP and heart rate normalized a few hours later. Went to doc and normal EKG and BP/pulse. Went to eye doc and confirmed vessel burst. No loss of vision (was 20/20). Told would self resolve in 2-3 weeks. However, on 6/10/21 at around 10:00pm my husband got one in his left eye. He had heart palpitations prior too. He's never had one in his entire life. Because of this, I thought it best to report it just in case it was not a strange coincidence but related to the vaccine or COVID. Will follow up with COVID testing to rule that out. He also will be submitting his experience on Vaers.
46 2021-01-04 loss of smell tested positive COVID; tested positive COVID; nasal congestion; loss of smell; This is a spontaneous... Read more
tested positive COVID; tested positive COVID; nasal congestion; loss of smell; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Expiration Date Mar2021), via an unspecified route of administration in her right deltoid on 19Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease from 2007/ diagnosed at 33 years old. There were no other concomitant drugs. The doctor who received the COVID vaccine stated that she must had been exposed to the virus prior to receiving the vaccine because she became symptomatic 48 hours after getting the vaccine. She noted that on Pfizer website recommended that a person not get the vaccine until 6 weeks after active infection but she of course did not know she had been exposed and when her second dose was due, she would not be 6 weeks after active infections. The vaccine was received on 19Dec2020 and she tested positive on 22Dec2020. The only symptoms she had experienced after testing positive are nasal congestion and loss of smell and they started on 21Dec2020 in the morning. She had had no worsening of her Crohn's disease. The only testing she had had done was the PCR testing for COVID. No treatments for the symptoms at this point. The outcome of the events tested positive COVID was not recovered, while for other events was unknown.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination therapy and the event onset.
46 2021-01-04 eye swelling At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an... Read more
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
46 2021-01-04 mouth numbness, mouth tingling nausea, numbness & tingling of mouth/tongue
46 2021-01-04 lip swelling Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ... Read more
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
46 2021-01-04 ringing in ears ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient... Read more
ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of bnt162b2 (Batch/lot number: EH9899), via an unspecified route of administration (reported as one injection to left arm) on 16Dec2020 at a single dose for COVID-19 vaccination. Medical history included allergy. Concomitant medication included prednisolone acetate (PREDNISOLONE ACETATE, Manufacturer: Pacific Pharma. NDC: 60758119-05, Lot: E88990, Exp. date: Feb2023) 1%, four eyedrops a day until she is out, 7 days at most or a week for allergy. The nurse called as a patient about the Pfizer COVID-19 vaccine, which she received on 16Dec and had a headache - only a slight headache, the day after and ringing in her ears that has not gone away. She says it was her first injection of the vaccine. The patient says she was given the vaccine through her work, and says she had a headache that evening and then a slight headache the next day. She says that the ringing in the ear, she noticed the next day in the morning. She says it is hard to tell if the ringing is just one ear or not, the ringing is staying about the same, and is more in her right ear. She says she has not had treatment for either the headache or the ringing in her ears, and the headache improved on its own. She had no new medications and didn't receive any other vaccines when she got this one. She says that she went to the eye doctor in the past week and he started her on eye drops, she has never been on prednisone for allergies, and for her eyes he gave her prednisone drops and allergy drops. She says she started that medication on the evening she got it, Monday 21Dec. She would like to know if there could be some type of allergy, she doesn't know if she should take the second dose of the vaccine. She says she doesn't know if there is something she should do for the ringing in her ears, like a common treatment or anything, or if others have been reporting this. She says she saw on the website that one side effect said ringing in ears, but she isn't sure if the website was either of those provided by call handler for further information. The outcome of the events slight headache was resolving while ringing in the ears had not resolved.
46 2021-01-04 vision blurred Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; Thi... Read more
Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
46 2021-01-05 taste impairment now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneou... Read more
now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneous report from a contactable other healthcare professional (hcp). A 46-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiry date not reported), via an unspecified route of administration on 30Dec020 16:45 at a single dose in the left arm as Covid vaccine. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient previously took iodine and experienced allergies. The patient was not in other vaccine in four weeks. The patient had no prior COVID vaccination and was not tested for COVID post vaccination. The patient experienced metallic taste almost immediately (30Dec2020 16:45) and now 2 hours (18:45) later patient have a rash on the belly. No treatments received in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The events metallic taste and rash on the belly was not recovered.
46 2021-01-05 taste impairment About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever a... Read more
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
46 2021-01-05 eye itchiness, dry throat c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to even... Read more
c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to event. 0900 - bp 126/70, hr 107, rr 20, sats 100 0905 - bp 122/67, hr 90, rr, 18, sats 100 0910 - bp 113/66, hr 81, rr 20, sats 100 - lightedness no longer present, she c/o of being cold, 0915 - dry throat that water helped. denied throat itching, states breathing wnl. 0915 - bp 120/80, hr 88, rr 20, sats 100 Pt reports that she feels better. She is off work today, but she will stay in the rt office with staff for 30 minutes before going home.
46 2021-01-05 lacrimation increased, eye pain muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; he... Read more
muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus. Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
46 2021-01-05 mouth itchiness UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. ... Read more
UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. 0957 PT STATES NOW ITCHING TO PALATE; FEELS "SWOLLEN"; NO NOTED OBSTRUCTION TO AIRWAY NOTED; EMS CALLED; 1015 PT DECLINED TRANSPORT TO ER VIA EMS; REMAINS STABLE; SAT 98%; DENIES DIFFICULTY BREATHING. 1035- BENADRYL 25MG PO ONCE ORDERED BY DR, AND GIVEN BY RN. VSS; P-74; R-16; SAT-99%; BP-133/79; TEMP-98.6;PT ABULATED TO OFFICE; HUSBAND TO DRIVE PT HOME LATER TODAY.
46 2021-01-05 smell distorsion Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not ... Read more
Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
46 2021-01-05 swollen tongue the patient experienced tongue swelling 9 hours after injection; This is a spontaneous report from a... Read more
the patient experienced tongue swelling 9 hours after injection; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Arm Left from 28Dec2020 12:45 to 28Dec2020 12:45 as single dose for COVID-19 immunization. Medical history included allergy to Latex and depression. Concomitant medication included duloxetine hydrochloride (CYMBALTA). The patient previously took Percocet and experienced allergies. On 28Dec2020 at 09:45 PM, the patient experienced tongue swelling 9 hours after injection. The patient stated had this similar feeling or reaction after taking Percocet when she had her first child. The patient took Benadryl 25mg as treatment to the event. The outcome of the event was recovered. Information about lot/batch number has been requested.
46 2021-01-06 mouth numbness jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around he... Read more
jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-01-06 lip swelling, swelling of eyelid 01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wris... Read more
01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wrist swelling today 1/07/2020 sinus tachycardia 140-150.
46 2021-01-06 pain in jaw I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on... Read more
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
46 2021-01-06 vision blurred Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body a... Read more
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.
46 2021-01-07 eye pain Injection site pain. Muscle pain. Joint pain. Chills. Headache. Eyes pain
46 2021-01-07 lip itchiness, lip swelling Patient called from clinic about 1 hr after receiving Covid vaccine. She had visible lip swelling an... Read more
Patient called from clinic about 1 hr after receiving Covid vaccine. She had visible lip swelling and lip itchiness that was worsening. She had no SOB, no C/P, no dizziness, no generalized itching or rash. She has history of allergic reaction to unknown substance leading to ED visit. I advised she go to ED for eval, a friend accompanied her, she did not feel ambulance was necessary.I called report to the ED Addendum on 1/1/2021: When I called, she said that one week later she had a similar reaction of lip swelling to another area of lips.
46 2021-01-10 loss of taste, loss of smell Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain... Read more
Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain. Patient now knows she was exposed before receiving vaccine.
46 2021-01-10 dry mouth About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik... Read more
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
46 2021-01-10 eye swelling 01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vacci... Read more
01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vaccine 01/09 body aches, headache couldn?t move neck due to stiffness; 01/10 left arm soreness, armpit pulsation, fever range 102 F,; 01/11 vomiting. seasonal allergy eye drops for right eye swelling (went away), Benadryl 50 mg.; ibuprofen and Tylenol around the clock starting 01/09 to present day, 01/11/2021
46 2021-01-11 dry mouth Body aches, chills, feverish feeling, mild shortness of breath, dry mouth
46 2021-01-11 ear pain 1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t... Read more
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
46 2021-01-11 mouth ulceration, swollen tongue Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headach... Read more
Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headache that worsened to a severe migraine throughout the day. Also that afternoon, developed sores/ulcers inside of mouth. Next day developed worsening sores in mouth and then my tongue began to swell and then noted sores on my tongue as well. This improved with Benadryl over the next 36 hrs.
46 2021-01-11 mouth tingling, oropharyngeal discomfort rash and itching around neck and upper chest, tongue feeling funny and tickle in my throat
46 2021-01-11 mouth tingling Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is... Read more
Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is really cold; Caller is continuously coughing during the call.; Fever; Headache; joint and muscle achiness all over; joint and muscle achiness all over; Tiredness; joint and muscle achiness all over, it started in her right arm where she received the injection; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscularly in right arm on 05Jan2021 around 1315-1320 at single dose for covid-19 prophylaxis in hospital and vaccine was not administered at Military Facility. Medical history included ongoing asthma diagnosed as a child, leaky valve closed up in her heart from 2020 to an unknown date. Family medical history included her mother had Covid over around May2020 and the mother was positive for quite sometime and had to take 3-4 tests, her son had tested positive for Covid and the patient had been around him a little bit. Prior Vaccinations (within 4 weeks) were none and adverse events following prior vaccinations were none. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BRIO INHALER) at 200/25 once a day by inhalation, nebulizer by inhalation every 4 hours as needed, salbutamol sulfate (PROAIR) at 2 puffs every 4 hours when needed, montelukast at 10mg every evening by mouth, all ongoing for asthma. The patient received the Covid-19 vaccine yesterday 05Jan2021 and reported that on 05Jan2021 she has had tiredness, headache, joint and muscle achiness all over. On 06Jan2021, she had fever and chills. She said that she was really cold. She also had a little tingling under her lip and chin area, but it is resolved. She stated that this was this morning 06Jan2021. She said that she did not have the physician details to provide at this time. She said that she had only seen this doctor once on a virtual appointment. She said that tiredness started around 1830-1900 05Jan2021. Headache started 05Jan2021 around when she got off of work at 1500. For event fever, she took her temperature 3 different times, it was at 101.2, then she had a temperature of 102. She last checked it about a half an hour ago on 06Jan2020. For event joint and muscle achiness all over, it was noticed the achiness around 9-10 pm 05Jan2021, she said that it started in her right arm where she received the injection, then moved down to her legs and her back. She stated that it was worse and when she went outside. For chills it started this morning on 06Jan2020 when she was still in bed before she got up at about 0500. She said that she called out of work. This was her first dose of the vaccine. Her next dose is supposed to be on 26Jan2021. The patient was continuously coughing during the call on 06Jan2020. The fever, joint and muscle achiness all over were worsened. The adverse events did not require a visit to emergency room or physician office. The outcome of tiredness, headache, fever, chill, joint and muscle achiness all over, it started in her right arm where she received the injection, were not resolved, outcome of the tingling under her lip and chin area were resolved on 06Jan2021, outcome of she was really cold and cough were unknown.
46 2021-01-12 deafness unilateral, ringing in ears Woke up on 26th and couldn't hear anything out of left ear - like I was deaf in that ear - Buzzing a... Read more
Woke up on 26th and couldn't hear anything out of left ear - like I was deaf in that ear - Buzzing and constant titch in it. Went to ER and they first thought I had wax in it - couldn't hear after they flushed it with warm water. Didn't change anything . Did a brain MRI - and that was negative. Did some bloodwork - and it all came back okay. After all that - 6 hrs there: Prednisone - 60 mg a day for 10 days. After 24 hours of taking that my hearing was back - there was huge improvement. I Still have very loud ringing in my ear. Constant buzz in my ear. Had a hearing test to test and it looks pretty good. Going back in three months for hearing test.
46 2021-01-12 ear pain Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for ... Read more
Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for 3 days. Fatigue day after for 5 days all other sxs started day 5 and still continue
46 2021-01-12 pain in jaw, hearing loss Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tin... Read more
Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tingling around area of right ear and hearing changes on right side. Numbness in arms/fingers. Symptoms presented about 6 days after 1st vaccine , worsened. Persisted for about 5 days.
46 2021-01-12 swelling of eyelid 01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slight... Read more
01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slightly nauseated. Instructed by employee health to take Benadryl STAT and report to ED for worsening symptoms. 01/13/2021 Pt reports symptoms are no longer present and has no complaints.
46 2021-01-12 swollen tongue, mouth tingling After waiting in the waiting area for about 20 minutes following the vaccination, I left to return t... Read more
After waiting in the waiting area for about 20 minutes following the vaccination, I left to return to my car and go home. While walking through the hospital, I started to feel weird - almost light headed and fuzzy. By the time I got to the hospital entrance, my tongue had started to tingle and swell (I don't know that it ACTUALLY swelled, but that's how it felt) and I was concerned about losing the ability to breath. I started going back to the vaccination site, but the feeling started to subside. After about another 15 minutes, the feeling was gone. I did NOT report this to the vaccination site and instead just proceeded home.
46 2021-01-12 ringing in ears Developed tinnitus the day I got first Pfizer COVID vaccine. Never had any known tinnitus nor hearin... Read more
Developed tinnitus the day I got first Pfizer COVID vaccine. Never had any known tinnitus nor hearing concerns nor hearing problems prior. Tinnitus is bilateral has been constant and continues now day 9 post vaccine. Did a hearing test that is showing mild sensorineural hearing loss in the high frequencies
46 2021-01-12 ringing in ears Systemic: dizziness, tinnitus, blood pressure 220/112
46 2021-01-12 vision blurred The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also ha... Read more
The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also had a muscle pain in the arm and I felt tired during the day and in the evening. My pulse rate continues to be high. My pulse rate was 100 on the second day and for number of days it is around 95. Today it was 95 most of the day. I have not been regularly checking my pulse rate before, but based on what I found in some information in my medical record, it is most likely around 75. I notice the higher pulse rate through pulsation in the chest and temples. I have a hard time concentrating on work and reading things on the screen.
46 2021-01-13 mouth tingling, ear discomfort Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or poppin... Read more
Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or popping on an airplane; Severe arm pain; This is a spontaneous report from a contactable consumer reporting for self. This 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 06Jan2021 at 13:20 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. Concomitant medications included ascorbic acid (VITAMIN C) and ibuprofen. The patient got the flu shot every year for immunisation, and got arm pain with the flu shot. No prior vaccinations within 4 weeks. The patient received Pfizer COVID-19 Vaccine on 06Jan2021, at 13:20. By 15:30-15:45, the right side of her face was numb. Had tingling in her lips. Stated the experience was similar to the feeling of receiving procaine hydrochloride (NOVOCAIN) or similar to the feeling when procaine hydrochloride begins to wear off. Her ear was plugged like she was on an airplane. Sated feels like she has water in her ear or like her ear is popping on an airplane. The whole right side of her face was doing something funny. Her lips began to tingle first, then face went numb, then her ear clogged. She talked to an ER physician who advised her to take a diphenhydramine hydrochloride (BENADRYL). ER physician stated these side effects are being seen. No further details provided. Clarified did not require ER Visit, just talked to an Emergency Physician and explained symptoms. She took diphenhydramine hydrochloride at home and the numbness and tingling went away after a couple hours. Her ear is still plugged today. Everything was echoing in her head and it was driving her crazy. Stated she also experienced severe arm pain happened evening of 06Jan2021. Arm pain in only in injection arm. Outcome of right side of her face was numb and tingling in her lips was recovered, outcome of ear feels plugged was not recovered, outcome of other event was unknown.
46 2021-01-13 smell distorsion, taste impairment sensed/tasted metallic; sensed/tasted metallic; This is a spontaneous report from a contactable cons... Read more
sensed/tasted metallic; sensed/tasted metallic; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot EK9231) solution for injection in the left arm on 05Jan2021 at 16:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included hypertensive. Concomitant medications included metoprolol; ascorbic acid/herbal nos/levoglutamide/lysine/magnesium/manganese/retinol/riboflavin/selenium/tocopherol/zinc (AIRBORNE); and an unspecified diuretic. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 at 16:30, the patient experienced sensed/tasted metallic. The patient stated, "Immediately after the vaccine was injected, I sensed/tasted metallic. It has been four days since the injection and I still have the metallic taste." No treatment was provided for the event sensed/tasted metallic. The outcome of the event sensed/tasted metallic was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
46 2021-01-13 vision blurred Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101,... Read more
Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101, fatigue, facial swelling (eyes and nose), blurred vision Symptoms lasted for 48 hours and did not respond to IBU, Toradol, or Tylenol. Headache was the worst that I have ever experienced- missed 2 days of work Symptoms resolved in the morning on 01/14/2020
46 2021-01-14 dry mouth, thirst, taste impairment Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird meta... Read more
Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird metal taste; very thirsty at times; throat seemed swollen; Still feeling tired and weak; Still feeling tired and weak; running nose and draining in the back of my throat; running nose and draining in the back of my throat; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received first dose of BNT162B2 (Lot# EK9231), via an unspecified route of administration, in left arm, on 07Jan2021 14:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Medical history included migraines, depression and allergy: latex. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced flu symptoms, fever, chills, achy body, dry mouth with weird metal taste, very thirsty at times, throat seemed swollen, all symptoms started Thursday, the evening of getting the vaccine and lasting until Saturday morning. Still feeling tired and weak. Now have running nose and draining in the back of my throat. The start date of all the events was 07Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
46 2021-01-14 dry mouth Lightheaded, dizzy, nausea, dry mouth, shortness of breath
46 2021-01-14 ear pain arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold ... Read more
arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at 13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water. They kept her for 30 minutes on observation. She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00. She took Motrin 600mg and it helped out. The outcome of the events was recovered. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.
46 2021-01-14 mouth tingling A few minutes after receiving the vaccine patient developed tingling in her extremities and stated t... Read more
A few minutes after receiving the vaccine patient developed tingling in her extremities and stated that her lips felt funny.
46 2021-01-14 mouth tingling A few minutes after receiving the vaccine patient developed tingling in all four extremities and st... Read more
A few minutes after receiving the vaccine patient developed tingling in all four extremities and stated that her lips felt weird
46 2021-01-14 tongue discomfort I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by ... Read more
I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by a truck. Later that evening my temp went to 102F, after that I was sleeping 10 hours a day, no appetite, nausea, vomiting, diarrhea, 9lbs in 9 days, back was killing me, alternated hot and cold compress. One morning I woke up and my tongue was like a rock, I was so dehydrated. Fever for 5 days, took Tylenol and it would just break it down to 100F. Went to COVID and flu on the 12/29 got positive for COVID on 12/31/20. Yesterday I felt hot and flushed and was sweating profusely, other than that no other symptoms. ( I received the second dose on 01/13/21)
46 2021-01-15 lip swelling, mouth tingling, swollen tongue Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swo... Read more
Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swollen, developed minor tightness in throat and feeling tongue swollen along with tremors and lightheadedness. BP 140/102, HR low 100s. Took Benadryl 50mg with bottle of water. Symptoms resolved over next 30 minutes. Developed numbness in left 4th and 5th digit which resolved at approximately 1 hour. About 1 1/2 hours after injection some abdominal cramping and 1 episode of diarrhea. BP and HR back to normal at about 1 hour after event.
46 2021-01-17 loss of smell, loss of taste 1/6/21 Cough, loss of taste and smell, congestion, runny nose, HA, fatigue, wheesing
46 2021-01-17 mouth numbness This time I predosed per allergersit recommendation with 25 mg benadryl, 300 mg pepcid, zyrtec 10 mg... Read more
This time I predosed per allergersit recommendation with 25 mg benadryl, 300 mg pepcid, zyrtec 10 mg and acetominopehn 500 mg 2 hours prior to vaccine. 15 min in I got wheezing, thorat tightness and tongue numbness. EMTs again called and again sats ok, BP ok and HR in 90s. Wheezing better with 4 inhalations of Albuterol HFA. They wouldn't give me any meds without sending me to ER, so I left and went home and took 50 mg Benadryl and another 2 sprays of albuterol at 4 hours post vaccine and did well.
46 2021-01-17 mouth numbness I developed acute wheezing, thorat tightening and tongue nubness. I got 50 mg Benadryl and 4 puffs ... Read more
I developed acute wheezing, thorat tightening and tongue nubness. I got 50 mg Benadryl and 4 puffs ALbuterol and monitored by EMTS for 30 mins more. I had sl elevated BP 148/86 and pulse ox at 97% and HR 95. Symptoms improved 20 min after Benadryl so I was released hom as I had my own epi pen and was a doctor so could self monitor.
46 2021-01-17 lip itchiness, mouth tingling, lip swelling Pt presented to ED with allergic reaction after receiving Pfizer Covid vaccine itching, swelling in ... Read more
Pt presented to ED with allergic reaction after receiving Pfizer Covid vaccine itching, swelling in right upper lips, slight tingle Patient received the Pfizer vaccine and developed right upper lips swelling plus pruritus within a span of approximately 45 minutes. After presenting to the ED, she was found to be hemodynamically stable with no further complaint in regards to pain, fever, nausea/vomiting, rash or other systemic responses. Airway appeared to be intact. Patient had a tryptase lab drawn (4ug/l which was within normal limits). Patient had a distant history of hives although the med/agency was unknown. No other signs of allergic reaction. Speaking in a clear voice. Maintaining good oxygen saturation. less likely anaphylaxis. Given 50 mg of Benadryl in triage. Pt Observed for 3 hours after the vaccine for progression of the swelling. Patient continued to do well and was sent home with follow up occupation health regarding recommendations regarding the second dose in 3 weeks. Given the limited nature of exam findings, mild form of vaccine reaction could not be ruled out. However, the cause of her symptoms could also be due to other factors including food (no detailed history on this).
46 2021-01-18 taste impairment, mouth numbness, mouth tingling 1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sen... Read more
1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sensation of tightness in chest and throat but no dyspnea, able to talk, no change in MS. Evaluated by PA - Code Green called. VS stable, transferred to ICU> In ICU labs completed, monitoring continued - all stable. Ate sandwich without difficulty or N/V. discharged to home 1/13: Had continued sensation of numbness and tingling in tongue that night and metallic taste in mouth with fatigue and headache. Aprox 11am 1/13 developed racing heart , increased numbness and tingling in tongue and metallic taste in mouth. Called 911 - transferred to different hospital. Evaluation including EKG completed without finding. Symptoms gradually resolved - discharged how with instruction to f/u with PCP. 1/14 - Home/stable, mild change in sensation in mouth and tongue persist otherwise tolerating all activity, working from home without difficulty.
46 2021-01-18 lip swelling Patient received vaccine around 1pm and during the 15 minute observation period she became nonrespon... Read more
Patient received vaccine around 1pm and during the 15 minute observation period she became nonresponsive. She did not fall, but slumped in her chair and would not answer questions. Glazed look. Removal of mask showed swollen lips and neck and an epi-pen was administered at 1:14 and 911 called immediately. During the next 5 minutes the patient began to answer questions. EMTs arrived 1:25 and by then the patient was speaking, and did not want to go to the emergency room. EMTs loaded her onto the stretcher and transported her at 1:35.
46 2021-01-18 mouth tingling I waited the 15 minutes. I walked to my car and drove to work. Got very busy with work, coughed here... Read more
I waited the 15 minutes. I walked to my car and drove to work. Got very busy with work, coughed here and there. Noticed my tongue felt swollen and tried to swallow some water and had difficulty, realized I was having a little anaphalxsis reaction. It started approximately it 12pm, maybe earlier, I was busy.
46 2021-01-19 ear discomfort, mouth itchiness A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. ... Read more
A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. Right ear was flushed red. No symtoms in left ear. No tongue swelling. Symptoms eventually resolved after approximately 1 hour.
46 2021-01-19 ear discomfort Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 min... Read more
Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
46 2021-01-19 pain in jaw, ear pain Tmax (max temperature) 102; chills; muscle aches; headache; sharp shooting jaw pain; shooting into e... Read more
Tmax (max temperature) 102; chills; muscle aches; headache; sharp shooting jaw pain; shooting into ears; This is a spontaneous report from a contactable nurse who reported for herself. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK 9231) second dose, via an unspecified route of administration on 07Jan2021 10:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have prior vaccination. Patient did not test COVID post vaccination. Patient had no known allergies. Historical vaccine included first dose of bnt162b2 (lot number EC 0140) on 21Dec2020 11:45 AM at single dose on right arm for COVID-19 immunisation. Patient experienced side effects included Tmax (max temperature) 102, chills, muscle aches, headache, sharp shooting jaw pain, shooting into ears, all on 07Jan2021 20:00 with outcome not resolved. It was unknown if patient received treatment for the events or not.
46 2021-01-20 mouth numbness numbness and mild pins and needles in my right thumb, index and middle finger, Right side of mouth a... Read more
numbness and mild pins and needles in my right thumb, index and middle finger, Right side of mouth and right cheek, and Headache. all except fro headache Resolved by 0630. Numbness lower lip and chin started at 0831 1/21/21, headache persists. No muscular deviation.
46 2021-01-21 ear pain On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side ... Read more
On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side wit ear and base of neck was tender and painful to touch. Client has been taking tylenol, lemon candy lozenges, hot packs, and herbal tea. These have provided short periods of relief.
46 2021-01-21 sensitivity to light Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fe... Read more
Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fever starting around 24 hours after vaccine dose, subsiding with medication after about 8 hours. Diarrhea and blanching red rash at chest, shoulders and back starting 48 hours after vaccine dose.
46 2021-01-22 dry mouth, thirst Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right ... Read more
Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right leg shooting pain
46 2021-01-23 loss of taste, taste impairment Metal taste (immediate - within 5mins post injection and lasted approx 5days) Fever of 101; myalgia;... Read more
Metal taste (immediate - within 5mins post injection and lasted approx 5days) Fever of 101; myalgia; chills; nausea; loss of taste; malaise (almost exactly 12-hrs post injection and stopped 24-hrs post injection (almost to the exact timing from inj)). Please note: Lot number could be: ER4176 or EU4176 (unable to clearly ready handwriting on the card)
46 2021-01-24 eye irritation, eye pain I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes we... Read more
I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes were hurting and burning really bad.
46 2021-01-24 mouth numbness Had soreness in the arm for two days. On the 26th, evening, I went to take drink of water and some o... Read more
Had soreness in the arm for two days. On the 26th, evening, I went to take drink of water and some of spilled down my face and I thought I just had a fat lip. 27th, I went to work and went to lunch at noon, I went to eat food and I noticed that my mouth -right side was numb. I thought something might be wrong and someone told me that my right side of my face looked slack. Saw on Dec 28, Dr. - had already scheduled an appt for follow up for diabetes - and I told her about my symptoms and she looked at my face and had me smile and crinkle my face. She sent me to my doctor downstairs (she had the nurse call downstairs and told them I needed to be seen that day). I went downstairs and I saw my doctor and my doctor scheduled an MRI on 28th at 7 PM and also ordered for me to take Prednisone and Valtrex. MRI result came back fine. I responded well to both of these meds - I started to get muscle control back into my face. It shot my sugar numbers up but solved the other problem in about 15 days I could shut my eyes without delay and I feel like I have muscle control in my face. January 22, I got the second dose and so far I don't notice anything different.
46 2021-01-24 eye discomfort fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he... Read more
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
46 2021-01-24 mouth tingling, visual impairment Individual started to feel her heart begin to race. she said she felt a little light-headed and her... Read more
Individual started to feel her heart begin to race. she said she felt a little light-headed and her vision was "off". She had a headache coming to the clinic which she had taken excedrine for prior to arriving. We took her blood pressure about 10 minutes after vaccination and it was 150/88 HR 130. We moved her into a private room to monitor and attempt to relax her. continued BP monitoring every 5-10 minutes- 148/92 147, 160/90 155. She stated that her left lip felt tingly so at that time we decided to call 911.
46 2021-01-24 swelling of eyelid Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank... Read more
Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank and left breast. Severe swelling and joint pain at left knee and hives down left leg calf. Significant rash and swelling of both eyelids and allover body soreness.
46 2021-01-25 taste impairment Sore Throat immediately tasted alcohol and immediately started with a dry cough and sour throat, be... Read more
Sore Throat immediately tasted alcohol and immediately started with a dry cough and sour throat, before the shot she had no sore throat or Cough
46 2021-01-25 ear pain, eye pain, pain in jaw, toothache Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i... Read more
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
46 2021-01-25 mouth tingling Patient reported her tongue felt tingly 5 minutes following the first dose. She reported this findi... Read more
Patient reported her tongue felt tingly 5 minutes following the first dose. She reported this finding at today's visit. She said she just took a Benadryl when she got home following her first dose. I did question if she has had anaphylaxis in the past to any meds, etc, and she said no, but reported having allergic symptoms with an antibiotic. No other allergic history to vaccines, meds, etc. Patient wanted to continue with second dose of vaccine today. Vaccinated at 1615. Patient reported tongue tingling at 1640. 25mg PO Benadryl given at 1640. Patient left the clinic at 1700 stating that she felt ok to leave. She had Benadryl at home and knew who to call if symptoms worsened. Writer called the patient back on 1/26/2021 at 1100. Patient stated that at 1900 last night (1/25/2021) she had to go to the Emergency room and received 2 doses of Epinephrine. She then had to stay the night to be observed. Patient stated that she was being discharged today.
46 2021-01-26 mouth numbness, mouth tingling the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; ... Read more
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
46 2021-01-26 swelling of eyelid right side under her eye was swollen; right side of face was swollen; This is a spontaneous report f... Read more
right side under her eye was swollen; right side of face was swollen; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient reported she had the first shot on yesterday (12Jan2021); it was given by a nurse at the hospital where she works. Last night, she noticed on the same side that she got shot, her right side under her eye was swollen and the right side of her face was swollen too. She wanted to know what to do and wanted to know if they were side effects. No therapeutics measures were done in response to the events. At the time of last observation, events' outcome was not recovered. Information about Lot/Batch number is requested.
46 2021-01-26 ringing in ears Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing i... Read more
Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing in ears began about 1 hour after vaccine given. Fever greater than 102 / chills began about 2 hours after vaccine given. Severe body aches, nausea, and extreme fatigue, extreme weakness, dizziness, and chest pain when taking a deep breath began within 4 hours after vaccine.
46 2021-01-26 tunnel vision tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizzine... Read more
tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizziness; This is a spontaneous report from a contactable nurse reporting for herself. A 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number Ek9231, via an unspecified route of administration in left arm on 28Dec2020 at 11:45, at 46 years of age, at single dose for COVID-19 immunization. The patient was not pregnant when she was vaccinated and received the vaccine in Hospital. She didn't receive any other vaccine in the previous 4 weeks. Medical history included Meniere's disease with sudden hearing loss in left ear from an unknown date, gastrooesophageal reflux disease from an unknown date and allergy to penicillin and sulfa drugs. Concomitant medication included famotidine (PEPCID), paracetamol (TYLENOL), ergocalciferol (VITAMIN D) supplements and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, 2 minutes after vaccine injection, the patient experienced tunnel vision, assessed as medically significant, her heart rate went to 138 and she experienced dizziness. The same happened again "at the 8 min mark": heart rate at 110 and dizziness. The events resolved on their own. Dizziness and elevated heart rate happened again later that evening. At the time of the report the reported events had resolved without any treatment.; Sender's Comments: Based on the compatible time association, the events tunnel vision, heart rate increased and dizziness are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-01-27 eye strain, bloodshot eyes About an hour and a half after the injection, I felt nausea, a headache, tiredness, and a genal feel... Read more
About an hour and a half after the injection, I felt nausea, a headache, tiredness, and a genal feeling of not feeling well. I ate some food and drank some ginger tea and it helped a little but after another hour I felt terrible with the same symptoms. They lasted for three days where I needed to go to bed by 6:00 PM or as soon as I could each night. On Sunday, January 24, 2021, 12 days after receiving the vaccine my eyes turned red and tired. I took my Claritin that I take if my allergies bother me and did some eye drops but it did not go away. I have had read eyes for five days now, it's more of a strained eye look and no other symptoms such as discharge, just a red eye on the whites of my eye. I do not know if this is related to the vaccine, but my allergies meds are not working, eyedrops are not working, and I had a COVID Lab test Monday 1/25/21 it was negative and a COVID Rapid test today 1/28/21 and it was negative.
46 2021-01-27 burning mouth syndrome High Fever bones hurt sores under tongue and inside throat Weak
46 2021-01-28 ear pain Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated... Read more
Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated to minor dizziness within 15 minute wait; Pain in shoulder to neck; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date unknown), via an unspecified route of administration (left arm) on 13Jan2021 at 10:45 at a single dose for COVID-19 immunization. Medical history included Polycystic Ovarian Syndrome (PCOS), allergies, excessing calcification of veins and arteries, high blood pressure (BP), and known allergies to trees, grass and weeds. Concomitant medications included metformin (METFORMIN), rosuvastatin (ROSUVASTATIN), levothyroxine (LEVOTHYROXINE), and liothyronine (LIOTHYRONINE). The patient had no other vaccine in four weeks. On 13Jan2021, the patient experienced pain traveled up shoulder to ear, strong dizziness that dissipated to minor dizziness within 15-minute wait and pain in shoulder to neck has lessened 48 hours later, but still present. The patient had no COVID prior vaccination and had no COVID test post-vaccination. No treatment administered for the events. The events were resolving at the time of the report.
46 2021-01-28 visual impairment I only experienced mild arm pain after the injection. Five days later, I was walking down a hallway ... Read more
I only experienced mild arm pain after the injection. Five days later, I was walking down a hallway at the hospital (I am a physician) when all of a sudden I experienced vertigo (I was not dizzy, but I felt my vision shift to the left). I fell down, landing against 2 crash carts that were in the hallway. I did not lose consciousness. I had persistent dizziness and nausea for at least 10 days afterwards.
46 2021-01-29 pain in jaw, dry mouth, eye twitching 4 hours after the administration of her COVID-19 vaccine, she developed the onset of twitching of he... Read more
4 hours after the administration of her COVID-19 vaccine, she developed the onset of twitching of her left eyelid, some left-sided jaw pain, a cotton mouth sensation, and migratory left-sided facial paresthesias described as a tingling sensation that could involve the eyelid, nostril, scalp, cheek, or forehead. These sensory symptoms feels somewhat like a Christmas tree with lights going on and off in different spots but always restricted to the left side of her face. In addition she experience a mild headache but without associated scotoma, nausea, vomiting, or vertigo. Upon looking in the mirror she thought that perhaps there is some slight facial asymmetry on the left side. In addition she reports feeling that her neck is weak on the left side and that she has to support her head in order to keep it from flopping further to the left. The symptoms have been also associated with some pain in the left arm which has since improved as well as discomfort and achy sensation involving her left leg extending from the hip laterally down to the level of the knee. She was evaluated the next day by a neurologist. Her neurological examination demonstrates some subjective decrease in sensation involving the left V1 and V2 distribution but is otherwise normal. Difficult to know to what extent the prior Botox injections could be contributing to her worsening left-sided neck weakness. We are aware that the vaccine does induce a inflammatory cytokine response and it is conceivable that this is contributing to some of her symptoms. MRI was obtained to exclude any underlying CNS pathology that could be conceivably exacerbated in the setting of an inflammatory micro environment induced by the vaccine. There was no clear evidence of a new CNS lesion based upon the examination.
46 2021-01-30 eye itchiness The evening after 2nd dose I developed itching and 3 hives over my left eye. I took Benadryl 25 m... Read more
The evening after 2nd dose I developed itching and 3 hives over my left eye. I took Benadryl 25 mg at 6 pm and again at about 2 am as itching intense and disrupting sleep (as did chills and myalgia.)
46 2021-01-31 lip swelling mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary nod... Read more
mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary node enlargement and mild localized redness at the left delt injection site. Pt received lip fillers slightly over one year ago. She does not remember which brand of name of filler.
46 2021-02-02 permanent deafness, ringing in ears sensory neuro bilateral hearing loss worse on one side; tinnitus; This is a spontaneous report from ... Read more
sensory neuro bilateral hearing loss worse on one side; tinnitus; This is a spontaneous report from a contactable physician (patient). A 46-years-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular into right arm on 05Jan2021 at 0.3 mL, single for covid-19 immunization. Time the vaccination was reported as 10:00-10:30. Medical history included food and environmental allergies. The patient had a history of autoimmune antibodies to thyroid but with normal thyroid numbers. No medication was needed, but autoimmune antibodies was found in the past. She had a propensity for autoimmune disease, it was just not active. She was diagnosed the first time she found auto antibodies 12 years before 19Jan2021 (2009) and checks her thyroid yearly and they had been normal. She still had antibodies, but thyroid hormone levels are normal without intervention. The patient's concomitant medications included Vitamin C and Vitamin D. Historical vaccine included Pneumovax 30 days before getting the COVID vaccine (06Dec2020, 46-years-old). Her pneumonia titers were low. Historical vaccine also included flu shot, she felt sick but like everyone else, she did not consider that abnormal. She thought most people felt kind of down and it did not have long term effects. It did not require any doctor visits. She did not have a rash or anaphylaxis. The patient was a physician and well versed in terms of symptoms. By evening of 05Jan2021, she developed tinnitus, which she had never had and has been there ever since. She was on day 13 post vaccine and still having bilaterally, every day and it never went away. She had a physician visit on 12Jan2021 and hearing test performed that day. They did find sensory neuro bilateral hearing loss worse on one side, her test confirmed bilateral hearing loss at 11:00 on 12Jan2021. It was mild so far in the high frequency ranges. So, they gave option to start 14 day course of high dose steroids with steroid injections into the ear, because in some cases of acute hearing loss, it can curb or reduce it. She decided to do that. Now she was going to be on steroids. She would be temporarily immunosuppressed. She did not know if that will affect the vaccine. She had not decided if she will get second shot. It is due next week, but she was a little nervous. She was considering delaying the booster a couple months out to see if more information develops. She provided her weight as between 175 to 180lb. Right now, the hearing loss was mild and it won't be that bad, but normally, it was permanent, which would be disabling hearing loss. She was going 20Jan2021, for the steroid injection in the ear canal. That would be the first injection. She was taking oral steroids now. They would see if this limits the progression. The events outcome was not recovered.; Sender's Comments: The possible causality between the reported tinnitus/sensory neuro bilateral hearing loss and the administration of COVID-19 vaccine, BNT162B2, cannot be fully denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
46 2021-02-02 lip swelling About 3 hours after the shot my lower lip started to swell. It lasted about 24 hours.
46 2021-02-03 eye pain Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site te... Read more
Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site tenderness, sinus pressure, sore throat, eye pain (R), burning sensation and tingling. Seen at ED on 1/12/21.
46 2021-02-03 mouth numbness Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report fr... Read more
Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse. A 46-year-old nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose in the Left arm on 15Jan2021 at 11:30 am for COVID-19 immunization.Medical history included allergy to latex. The patient's concomitant medications were not reported. On 15Jan2021 at 12:00 am the patient experienced lip and mouth numbness, hoarseness, chest pressure and lightheadedness. Since the vaccination, the patient has not been tested for COVID. No treatment was received. The outcome of the events was unknown. Information on the lot/batch number has been requested.
46 2021-02-03 lacrimation increased, taste impairment, eye itchiness Metallic taste, eyes watering, feeling jittery, eyes itching, needs to take deep breathe
46 2021-02-04 eye itchiness, eye swelling Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att... Read more
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
46 2021-02-06 eye pain, bloodshot eyes On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itch... Read more
On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itchy. N 2/3/2021 I developed swollen and sensitive lymph nodes in front of left ear. On the evening of 2/4/2021 rash to forehead now red and sensitive and looking more blister like. Left eye blood shot and eyelid and left face swelling. Shooting pains into head on left side. 2/5/2021 made same day appointment with pap. Shingles diagnosed and started on Valacyclovir. Appointment with Ophthalmologist scheduled for 2/8/2021. Went to ER on 2/6/2021 for left eye pain. No change in treatment. Still to follow-up with eye doctor on 2/8/2021. Not able to work due to pain and nature of worK (around pregnant women and babies<1month old).
46 2021-02-07 oropharyngeal discomfort When driving home , I felt like my right side of my neck was swelling but it wasn?t and then it felt... Read more
When driving home , I felt like my right side of my neck was swelling but it wasn?t and then it felt like my right side of my throat was sweet and then my asthma kicked in , I used my inhaler and I few hours all my symptoms went away.
46 2021-02-07 swollen tongue Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and ch... Read more
Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and chest within 10 minutes of shot. Feeling of nausea after 25 minutes Selling of tongue with a fuzzy feeling 35 minutes after test.
46 2021-02-08 ear swelling 7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to th... Read more
7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to the ER and had high bp 153/101 and tachy arrhythmia, such as trigeminy and bigeminy and heart rated in the 130?s. My ear also swelled and got hot and red on the same side as the shot. I was monitored for about three hours and then released after bp went down to 130?s/ 90?s and palps decreased.
46 2021-02-08 burning mouth syndrome, taste impairment See page 1. (Box 9).
46 2021-02-08 lip swelling Upper and Lower Lip Swelling, swollen lymph node left axillary. Resolved after 36 hours Used Benadr... Read more
Upper and Lower Lip Swelling, swollen lymph node left axillary. Resolved after 36 hours Used Benadryl 25mg every 8 hours I have had lip filler approximately 14 months prior
46 2021-02-08 swollen tongue, mouth tingling, taste impairment Tip of tongue feels slightly enlarged; Salty taste in mouth; Tingle sensation on tip tongue; This is... Read more
Tip of tongue feels slightly enlarged; Salty taste in mouth; Tingle sensation on tip tongue; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3302), via an unspecified route of administration on 22Jan2021 08:00 at single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications included amlodipine and ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 12:00, the patient experienced salty taste in mouth for over 2days. Tingle sensation on tip tongue. Tip of tongue feels slightly enlarged. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered.
46 2021-02-08 swollen tongue One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and w... Read more
One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
46 2021-02-08 vision blurred 0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg s... Read more
0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg spasms, she took 12.5mg of Benadryl, 1030- BP slightly elevated, dizziness, numbness in face and arms, flushing- took 25 mg Benadryl per house MD. had her lye down and within 2 hrs most of symptoms resolved. at 1530 continued to c/o facial numbness. sent home with co-worker so she didn't need to drive.
46 2021-02-09 eye pain Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain ove... Read more
Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain over left eye; Nausea; No appetite; This is a spontaneous report from a contactable consumer reported for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, brand=Pfizer, lot number=EL3247) via unspecified route of administration at age of 46 years old on 21Jan2021 05:00 PM at single dose at left arm, for COVID-19 immunization. The patient medical history included patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other concomitant medications the patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT 25mg), atorvastatin statin. It was reported patient experienced chills and night sweats started 2 days later. Pain over left eye, nausea, no appetite, can sleep at night. All the adverse events started on 23Jan2021 04:00 PM. It was reported case type non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Since the vaccination, the patient had been tested for COVID-19 on 27Jan2021: Nasal Swab (PCR): Negative. There was no treatment received for the adverse event. Outcome of events at the time of last observation was recovering.
46 2021-02-09 mouth numbness Ten minutes after receiving the vaccine, patient reported to MD in Observation area that she was exp... Read more
Ten minutes after receiving the vaccine, patient reported to MD in Observation area that she was experiencing a headache, tongue and right arm numbness. After MD assessed patient (and patient relayed this was the same reaction she had with the first vaccine), MD kept her in the observation area for 30 minutes as the symptoms subsided. Patient was released when all symptoms were gone.
46 2021-02-09 swelling of eyelid, eye pain Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, ... Read more
Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, mainly my neck, stomach and back Day 10 Left eye is swollen and pain on eyelid and behind eye lid
46 2021-02-10 loss of smell, loss of taste The day before the vaccination (12/14/20) I was exposed to COVID. I even filed an incident report at... Read more
The day before the vaccination (12/14/20) I was exposed to COVID. I even filed an incident report at work but they told me to receive the vaccine the next day (12/15/2020). I asked for a test before the vaccine and I was refused. The day after the vaccine (12/16/2020) I started with muscle ached and soreness. Talked to employee health who told me it was expected from the vaccine. I asked to be tested again and they told me no need to, it was from the vaccine. On the 3rd day after the vaccine, I stated with elevated temperature (99.9F and 100.1F) and also fatigue and not feeling well. Communicated with Employee health and once again, was refused the test. On the 4th day I started with cold symptoms and a cough - reported to employee health and once again, no test. All this time I have been working with patients at the hospital, I was not away from my duties. On day 7 I lost my sense of taste and smell and finally on day 8th t(12/23) they tested me after I insisted a lot. My result came back positive. I still had fever for another 3 days after the positive result and the sense of smell/taste and the fatigue were present for another 2 or 3 weeks.
46 2021-02-10 lip swelling Had #2 Pfizer 1/13 8am. At 12 noon noticed tingling and swelling/fullness in upper lip which persist... Read more
Had #2 Pfizer 1/13 8am. At 12 noon noticed tingling and swelling/fullness in upper lip which persists. Slight lightheadeness with exertion, "bad HA," slight ST. During call patient looked in mirror and noted fullness in upper lip with new "cold sore" and lightly flushed forehead w/ flat, non-pruritic, red rash. Denies SOB, wheezing, swelling of tongue or throat. Denies dyphagia, eye swelling. Instructed patient to see provider at clinic now (she is in clinic now) and be evaluated.
46 2021-02-11 mouth tingling 1st COVID vaccine received 2/12/2021; experienced flushing, dyspnea, and tongue tingling within an h... Read more
1st COVID vaccine received 2/12/2021; experienced flushing, dyspnea, and tongue tingling within an hour after receiving dose. Was seen at care center and symptoms resolved; see care center encounter from 2/12/21.
46 2021-02-11 mouth tingling Flushed, tingling in mouth
46 2021-02-14 visual impairment, eye swelling Rash to sore rash to upper chest , and bloating and diarrhea, swollen eyes where vision was like loo... Read more
Rash to sore rash to upper chest , and bloating and diarrhea, swollen eyes where vision was like looking through a glass of water.
46 2021-02-15 mouth numbness Bell?s palsy. Numbness in front part of tongue started the afternoon of 2/12/2021. Morning of 2/13... Read more
Bell?s palsy. Numbness in front part of tongue started the afternoon of 2/12/2021. Morning of 2/13/2021 half of face was unresponsive and droopy. Talked to my doctor on call and she recommended I be seen at urgent care immediately for evaluation. Was seen at Urgent Care on 2/13/2021 and it was determined I had Bell?s palsy as a side effect of the COVID-19 vaccine. They still recommended to get my second vaccine as scheduled on 2/17/2021.
46 2021-02-16 mouth tingling Within an hour of receiving 2nd dose of Pfizer Covid Vaccine, presented to emergency department repo... Read more
Within an hour of receiving 2nd dose of Pfizer Covid Vaccine, presented to emergency department reporting paresthesia in lips and in feet.
46 2021-02-16 swollen tongue, lip swelling This happened the first shot also but I thought it was just me being anxious. Immediately following... Read more
This happened the first shot also but I thought it was just me being anxious. Immediately following my roof of my mouth felt big. Then my tongue and lips felt the tiniest bit swollen. I could breath fine. Then my face (especially my left side) was a bit numb. The same thing happened to my friend but we couldn?t find anything online about our symptoms. I ended up telling the nurse at the front and they told me to take Benadryl and call 911 if scared. They made sure I wasn?t going to be home alone. I felt better within a 1/2 hour of taking the meds. My throat feels a little sore right now along with my arm.
46 2021-02-16 taste disorder, dry mouth After first shot I had difficulty swallowing along with blister like sores on my tongue. I took Bena... Read more
After first shot I had difficulty swallowing along with blister like sores on my tongue. I took Benadryl allergy when I got home, but it didn't help. I ended up going to urgent care the next day because I wasn't feeling any better. The doctor felt it was more so a immune response then an allergic reaction. So for my second shot my doctor prescribed 50mg of Prednisone 7 hours before and 1 hour before the injection. Also Benadryl 50mg 1 hour before the injection. The second shot I did not have the tongue and throat issues, just dry mouth and horrible taste in mouth right after vaccine.
46 2021-02-16 toothache Fillings in my teeth on the left side of mouth began to hurt after shot. Pain continued for over 2 h... Read more
Fillings in my teeth on the left side of mouth began to hurt after shot. Pain continued for over 2 hours post shot and while completing this form.
46 2021-02-17 dry mouth Woke up on Tuesday 2/16/21 feeling normal, by 8:30 am symptoms of dry mouth, scratchy throat, achy ... Read more
Woke up on Tuesday 2/16/21 feeling normal, by 8:30 am symptoms of dry mouth, scratchy throat, achy all over, neck tightness and pain (more on left side), runny nose, minimal drainage. Left work around 9:30 am, received rapid COVID test which was negative. Symptoms continued at the same level through this morning 2/18/21 around 6 am at the start of my day.
46 2021-02-17 taste impairment tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingl... Read more
tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; raised blood pressure; metallic taste; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number 0041297301), via an unspecified route of administration in left arm on 15Jan2021, at 17:00 as first single dose for covid-19 immunisation. Medical history included obesity, opiate allergy and artichokes allergy from an unknown date. Concomitant medication included unspecified probiotic, levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), linum usitatissimum seed oil (FLAXSEED OIL NATURE MADE). The patient experienced the following non-serious events: metallic taste on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; raised blood pressure on 15Jan2021, at 17:30 with outcome of recovered in Jan2021. Details were as follows: following vaccination the patient reported a metallic taste in her mouth, then a tingling sensation in her jaw which extended to her nose and it felt numb with difficulty swallowing, and she also had raised blood pressure. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
46 2021-02-17 lip swelling Lips felt big to client ×5-10 min, also was wearing 2 masks,throat felt ok, history face swelling w... Read more
Lips felt big to client ×5-10 min, also was wearing 2 masks,throat felt ok, history face swelling with ibuprophen,
46 2021-02-17 sensitivity to light, extreme sound sensitivity Migraine headache lasting 12 hours, sensitive to light and sound, dizziness, nausea
46 2021-02-18 dry mouth, swollen tongue, feeling of choking, mouth tingling, lip swelling CHIEF COMPLAINT: TONGUE SWELLING (patient had her second COVID vaccine today, later developed tingl... Read more
CHIEF COMPLAINT: TONGUE SWELLING (patient had her second COVID vaccine today, later developed tingling in her mouth and tongue/lip swelling and dry mouth. Denies difficulty swallowing) Assessment/Plan: DIAGNOSIS at time of disposition: 1. Allergic reaction, initial encounter Symptoms: Patient had second dose of COVID 19 vaccine today at 1230 p.m. She states at around 530 - 6 p.m. she started coughing and felt like that was a hair caught in the back of her throat, states throat is tingling and looked in the mirror and states her tongue is swollen. Feels that her heart rate is abnormal, but states it could relate to anxiety. COVID vaccine clearance needed if future booster needed. Informed patient to follow up with PCP if needed after ED visit. HISTORY OF PRESENT ILLNESS: The patient got her 2nd dose of COVID vaccine today at noon. At 5 she started feeling a bit of a tickle and scratchiness of her throat and her mouth felt very dry. She was concerned about allergic reaction. No shortness of breath chest pain rash itching hives or any other concerns. She has not taken any Benadryl. The patient is in no distress. Symptoms been going on for 3 hours. This could be a very mild allergic reaction. Therefore I am giving her 50 mg of oral Benadryl. Given the symptoms been going on for 3 hours and I do not see any angioedema I am comfortable letting her go home at this point in time. I do not think steroids would be beneficial. She will return here if worsening and I instructed her to use Benadryl 50 mg every 4-6 hours if needed. BLOOD PRESSURE SCREENING: Based on last blood pressure taken in the ED of 171/98, HTN (>/=140/90), recommend follow up with PCP within 1 month.
46 2021-02-18 mouth tingling Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. ... Read more
Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. Approximately 50 min after mouth felt fuzzy/tingly, face felt tingling; had a lightening pain go across body.
46 2021-02-18 swollen tongue Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo... Read more
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
46 2021-02-19 bloodshot eyes, eye strain, vision blurred Eyes blurry, left eye only, red eyes, strained
46 2021-02-19 visual impairment 24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 ... Read more
24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 days after vaccine), woke up with vertigo, visual changes, severe nausea, diagnosed with cerebrovascular accident
46 2021-02-22 eye swelling, lip swelling Heaviness in chest. Swelling on face , eyes and lips
46 2021-02-23 mouth numbness on the 3rd of feb, my left lips went numb, called 911 and by 11 was diagnosed with bells palsey. Du... Read more
on the 3rd of feb, my left lips went numb, called 911 and by 11 was diagnosed with bells palsey. Due to the fact I have no chronic conditions, live a pretty healthy life, I was told by EMS and various ID doctors it was most likely from the vaccine. Today is day 21 and I still have no movement in face
46 2021-02-23 mouth tingling, feeling of choking Patient complained of tingling of lips & tongue, tingling of throat w/ cough, tight breathing. Clea... Read more
Patient complained of tingling of lips & tongue, tingling of throat w/ cough, tight breathing. Cleared by EMS after supportive care.
46 2021-02-24 mouth numbness Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptom... Read more
Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptoms of difficulty breathing, tight throat and tight and numb lips at 16:34 today and alerted staff. At 16:35 epinephrine was given for suspected anaphylactic reaction. Vitals at 16:35 before administration of epinephrine were pulse ox 100% and pulse 67. Vitals at 16:37 were pulse ox 100%, pulse 170, and BP 162/102. First response called at 16:35. Patient felt immediate improvement in symptoms with epinephrine administration. First response team took patient to ED for further evaluation at roughly 16:40 by wheelchair.
46 2021-02-25 taste impairment Metallic taste in mouth... slightly itchy throat which went away but the metal taste did not
46 2021-02-25 mouth numbness Numbness in tongue and hands
46 2021-02-25 mouth discomfort, lip swelling, swollen tongue Swollen lips, tongue and mild burning sensation in the lips and tongue.
46 2021-03-01 eye twitching The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal s... Read more
The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal syncope immediately upon withdrawing needle from muscle and occurred immediately after vaccine administration. The nurse lowered the patient slowly to the groundf and put the pt's feet up. The pt has had prior episodes of vasovagal syncope in the past. Her pulse was noted to be in the 70s. Small eyelid and lip twitching noted. Pt had no injury as a result of the syncopal episode. Patient transported to the Emergency Room for evaluation at 4:09 pm. Blood pressure upon arrival in the EC was 143/74, pulse 57, Resp 14, pulse ox 99%. Patient able to open eyes to command and nod yes or no. Blood Glucose was 74 and ECG was unremarkable. Discharged to home at 1822.
46 2021-03-02 eye pain, sensitivity to light body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight ... Read more
body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight throbbing in head/throbbing in head became much worse by midday; very tired; body chills and hot sweats on and off; body chills and hot sweats on and off; still lethargic and achy but improving; slept all day, and all night; eye pain which was triggered by light and eye movements; eye pain which was triggered by light and eye movements; This is a spontaneous report received from a contactable nurse (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 11:15, at single dose, for COVID-19 immunization, at an urgent care center. There was no medical history. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included probiotics. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 08Jan2021 11:15, for COVID-19 immunization. On 30Jan2021 at 07:00, the patient experienced body aches and slight throbbing in head which became worse by midday; was very tired; returned to bed within 30 minutes and slept all day, and all night; had eye pain which was triggered by light and eye movements; body chills and hot sweats of and off. The patient reported that although she never had a fever according to her non contact forehead thermometer, she had body chills and hot sweats on and off. 48 hours later, she was still lethargic and achy but improving. Treatment for the events included ibuprofen 600 mg every 4-5 hours which helped but did not completely relieve the discomforts. The patient was recovering from the events.
46 2021-03-02 swelling of eyelid On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head... Read more
On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head. The headache was intense. I could not open my left eye. I had facial paralysis on the right side of my face. I had slurring of speech. When I walked I was dizzy. I fell asleep all day long, and woke up each time completely disoriented.
46 2021-03-03 burning mouth syndrome Tongue soreness and anxiety, resolved without medication intervention
46 2021-03-03 mouth tingling, mouth numbness Tip of tongue and upper and lower lip fell numb and tingly. Alleviated with Benadryl 50mg orally.
46 2021-03-03 mouth tingling Patient received her first dose of the Pfizer vaccine today. She had developed chest tightness and ... Read more
Patient received her first dose of the Pfizer vaccine today. She had developed chest tightness and wheezing yesterday, she has a history of asthma. The chest tightness and wheezing increased after her vaccine. She also noted tingling to her lips and dizziness. She had no shortness of breath, cough, palpitations or chest pain. No angioedema, rash or pruritis. She was in no acute distress. She was talking in complete sentences and drinking water without any issues. Her lungs were clear through out with no bronchospasm, her heart rate was regular. BP 160/100, HR 66, RR 22, O2 99% on room air. I spoke with the RN at ICC who accepted patient to be seen at the ICC for further evaluation and monitoring. Patient declined ambulance transfer and felt comfortable enough to drive her self to the ICC. She was monitored at the vaccine clinic for 35 minutes after receiving her vaccine and left in stable condition. Her sister was notified.
46 2021-03-04 mouth tingling, swollen lips Lips and tongue felt tingly and raw
46 2021-03-04 mouth tingling Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) s... Read more
Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) she began to feel " a tingly sensation in my tongue" and felt warm. She also had localized redness and swelling at the site of injection (Right deltoid). She denied any symptoms of chest pain, SOB, palpitations, difficulty swallowing, drooling, nausea/vomiting, dizziness or light-headed or near syncope. Patient was observed by provider for a course of one hour. We recommended to be taken by EMS to ER for further observation, she refused. Patient drove herself and was not able to take Benadryl. Initial vital signs taken 10:54am 177/114; HR 92; O2 98% RA; RR 18 -sitting position Second vitals 11:35am 134/96; HR 79; O2 100% RA ; RR 16- sitting position Patient was observed for an hour and decided to drive home. Recommend hydration and call 911 if needed.
46 2021-03-05 eye pain, vision blurred Headache, blurry vision, heart palpitations, feeling off, eyes sore, eyes hurt,
46 2021-03-05 swollen tongue, eye itchiness After waiting the 15 minute observation period, I left. While driving home my eyes started itching a... Read more
After waiting the 15 minute observation period, I left. While driving home my eyes started itching and my face felt strange. When I got home I looked in the mirror ni didn?t see a rash or any swelling in my face but then felt my tongue was swollen. I took a Benadryl and called the on call doctor from primary care physicians office and was directed to go to the ER since it was a potentially life threatening reaction.
46 2021-03-06 taste impairment, lip swelling reaction began with a Metalic taste in mouth within 10 minthen haziness, lip and throat swelling, t... Read more
reaction began with a Metalic taste in mouth within 10 minthen haziness, lip and throat swelling, tachycardia and high blood pressure I was given benadryl and when symptoms did not improve was taken to ER and given Decadron at 4:42pm then Famotidine and Sodium Chloride 0.9%
46 2021-03-07 oropharyngeal discomfort Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM... Read more
Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM given.
46 2021-03-07 swollen tongue, tongue itchiness Mild tongue swelling and tongue itching. No treatment given, signs dissipated in 1-2 hours. Received... Read more
Mild tongue swelling and tongue itching. No treatment given, signs dissipated in 1-2 hours. Received shot at 10:39 am showed signs at 10:42am
46 2021-03-08 mouth itchiness 2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light hea... Read more
2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light headed, tingly hands and face. On 3/6/21, woke up with swelling, hot, red, itchy swelling at injection site. On 3/8/21, patches of rash that would come and go, face, mouth, and throat itchy. Hand and arms tingly and felt like I was going to pass out. Later that day, had my 1st migraine in my life. 3/9/21-Today, hands, arms, face, mouth, and throat itchy. Finger tips went numb and ring finger on left hand showed signs of bruising (I didnt hurt it that I know of). By the time I got to urgent care, finger no longer bruised color. Light headed, felt like going to pass out again.
46 2021-03-08 swollen tongue 20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized ting... Read more
20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized tingling in her hands and feet and felt like her tongue was a bit swollen. Stated she felt "funny". Also stated that she had a similar reaction after her first dose but states this reaction was more severe.
46 2021-03-08 ringing in ears ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER... Read more
ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER EARS. HUSBAND WENT TO GET HELP AND PT FELL OUT OF HER CHAIR WITH LOSS OF CONSIOUSNESS. PT RECOVERED IMMEDIATELY WITHOUT CONFUSION,. VITALS BP: 102/71 HR: 81. PMH STROKE 2008 WITH RESIDUAL L WEAKNESS. MEDS: ASPIRIN, ZYRTEC, FLONATE. NO PREVIOUS VACCINE REACTIONS OR ANAPHYLAXIS. EMS CALLED TO TRANSPORT TO ER. VASOVAGAL LIKELY.
46 2021-03-09 deafness unilateral Complete left ear hearing loss two weeks after vaccine #1
46 2021-03-09 lip swelling, swollen tongue, dry mouth The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything... Read more
The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything went back to normal. Monday around 3:00 or 3:30, face was hot and had hives. She went to the ER. Was told she had a mild rash, and gave Benadryl and ordered EpiPen for emergency. Left ER to pick up prescription but tongue began to swell, went back to ER, gave you Cortisone 50 mg and Pepcid Benadryl IV for 7 days. Yesterday, had another face reaction, had hives very mild only in the morning. Today at 8:00a.m., had redness in face. Around 3:00pm, lips and tongue were swollen and has extremely dry mouth. Today, she is on her way to the ER because her tongue has swollen again.
46 2021-03-09 mouth tingling 1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient ... Read more
1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient anxious. 1030: Red, raised rash noted to begin on forehead, cheeks, and upper chest. Shaking (slightly) noted in hands. Patient states "feeling cold." BP 162/94, P 108, O2 99% RA. Patient A&Ox3 sitting in chair. 1040: Patient complaint of "lips feeling 'tingly'". Quickly progressed to full facial tingling. Denies dyspnea or chest pain. Still states she " feels dizzy." 911 called. BP 142/88, P 95, O2 99% RA. 1045: Turned over to paramedics. Patient A&Ox3. Rash still present but no worse. Denies dyspnea or chest pain. Still shaky, slight diaphoresis. Husband & son with patient. Patients belongings given to husband. Taken by EMS offsite.
46 2021-03-09 swollen tongue Pt reported tongue swelling 92% 02 RA, throat itches, given Zyrtec 10mg, PO @1400. pt given Benadry... Read more
Pt reported tongue swelling 92% 02 RA, throat itches, given Zyrtec 10mg, PO @1400. pt given Benadryl 50mg IM, 14:12 02 93% RA, placed o2 2L via nasal canula, 14:21 Pt reports feeling better. BP 128/71, HR 67 02 99% RA. Pt dc home stable. Pt has a partner with her to drive.
46 2021-03-13 ear discomfort Fever, chills, body aches, headaches, nasal congestion, runny nose, ear pressure.
46 2021-03-14 mouth numbness, lip swelling Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips sw... Read more
Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips swelling and numbness. Epi pen given. Patient rash and hives continued. patient shaky and nervous. patient denied difficulty breathing. BP elevated. O2 sats stable. IV placed in right AC , IV Benadryl 50mg given IV push. Paramedics on site. Patient transported to ED.
46 2021-03-14 oropharyngeal discomfort, mouth tingling I stayed for 15 minutes and when I was driving home my face started to swell. I had tingling in my... Read more
I stayed for 15 minutes and when I was driving home my face started to swell. I had tingling in my teeth and lips. My throat felt full and I was coughing slightly. Within an hour and 10 minutes after the injection, I started to feel back to normal.
46 2021-03-14 visual impairment 3/11 to 313 - Flu like symptons...no fever. Chills, aches and severe fatique 3/14 to present day - V... Read more
3/11 to 313 - Flu like symptons...no fever. Chills, aches and severe fatique 3/14 to present day - Vertigo - non stop dizziness, foggie vision
46 2021-03-15 mouth tingling 25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave ... Read more
25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave me two Benadryl?s and 4 Pepcid Waited for a hour in a half Symptoms subsided. Around 9 pm I had horrible pain under my arm pit and top of my breast. And fast heartbeat I took two Tylenol and the pain subsided but I am also getting pain in my two lymph nodes on the left side all the time
46 2021-03-15 swollen tongue First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat cl... Read more
First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
46 2021-03-16 ear pain 03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very... Read more
03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very sore but also felt kinda fatigued and sweating on and off. 03/12/21 woke up at 7:00 a.m with my throat red and tonsils red and lymph node on right side of neck was a-little swollen. Ear hurt on right side. I sounded muffled sounding when talked. I called in sick to work took some Tylenol and went back to bed. I slept all day till 8 p.m got up and ate something and went back to bed. 03/13/21. Throat still sore and red but a little better took Tylenol. Ear hurt on right side as well. 03/14/21 Throat a little better but still felt sore took Tylenol felt energetic all morning and about 5:30 or so felt fatigued. 03/15/21 ear still sore some throat better than before went to work. Had a temp Of 99.1 03/16/21 Sweating on and off today
46 2021-03-16 mouth tingling Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizzines... Read more
Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizziness and confusion, slow words. Uncoordinated hands and legs
46 2021-03-16 thirst, eye swelling I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of t... Read more
I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of the night. In the morning I had above symptoms, painful lymph nodes in neck and groin, and elevated body temp of 100. But the most significant reaction was swelling and BRUISING around the eyes. Left side definitely worse than the right. I haven't heard of this, so I thought I'd reach out to you.
46 2021-03-17 swollen tongue Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with sh... Read more
Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with shellfish allergy. Face and neck area were flushed. Benadryl 50mg IM given in right arm. Pulse at 80 BPM throughout the event, alert and oriented, normal breathing. Benadryl took effect within 5 minutes with person stating she could feel her throat loosening up, and tongue feeling smaller. Requested no epinephrine unless really needed. Does carry and EpiPen with her. Observed for one hour after event pulse 78 BPM at discharged. Advised to take Benadryl every 4 hours as needed and to come to ED with any return of worsening symptoms. Escorted to car where family member will drive her home.
46 2021-03-18 taste impairment Metallic taste in mouth that does not go away.
46 2021-03-18 ear pain On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days la... Read more
On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days later, however, sometime early morning on March 12, (I was in and out of sleep because of it), I had pain swallowing my saliva on my left side (also the side of my vaccine in my arm). It was hard to pinpoint but the pain came from somewhere at the back of my throat and my ear. If I had to guess what time it was, it probably was around 1-2am that the pain began. March 12, I went to see my primary care doctor. He checked my ears & didn't see any concern. He saw a little redness at the back of my throat but couldn't definitively say what I had. He thought it was a virus but didn?t discount a reaction to the vaccine (although he said it was unlikely since reactions usually happen within 3 days). He ran no tests and didn't prescribe anything. March 13, I was feeling worse. I suddenly had a fever (101 was the highest it ever got), swollen lymph nodes, a white tongue. I went to the local ER at 9am who said I might have oral thrush but he didn?t sound convinced because my tongue wasn't as white o thick as thrush would present (he said for example that typically when you have thrush, you could scrap it off and it would bleed). He diagnosed me with Thrush and Lymphadenopathy. He prescribed anti-fungus medication Clotrimazole 10 mg Troche, five times a day. On Sunday, March 14, my throat pain got worse (it was constant pain v.s. pain only swallowing) so I called the on-call doc who told me to get tested for Strep. The next day, on March 15, I could swallow easier so my doctor didn't think it was necessary. My lymph nodes were still swollen, I had a bit of a fever, and it was still a bit hard to swallow but I was recovering. I had some lingering ear pain. By March 15 I was much better. Today, March 19, I still have a sensation on my left ear/throat area after swallowing but I am much better. Please note that while the ER doctor thought it was fungal and my primary care doctor thought it was viral, neither were sure/thought it was the vaccine. ** Also please note, this is the second time I am completing this because the system booted me off after 20 min the first time and it was erased. It takes times to complete. Just a thought for future reference, it might be helpful to allow for more time.**
46 2021-03-19 mouth tingling This was the second dose. No immediate reactions after injection. Approximately 6 hours later, inter... Read more
This was the second dose. No immediate reactions after injection. Approximately 6 hours later, internal itching began throughout my entire body. I also had a slight tingling of the tongue and lips. Benadryl did not ease the itching or mouth tingling. The internal itching by the next day and increased doses of Benadryl still did not help. Intense itching by day 3 as well as fever of 99.5. Saw an online doc who prescribed Hydroxyzine for itching. It is now day 9 after the second vaccine. Itching internally has worsened. Still have tongue and lip tingling as well. I saw another online doc to tell them symptoms have continued and have worsened a bit and that I have been 24 hours without the Hydroxyzine. The prescription ran out the day prior. Doctor prescribed more Hydroxyzine. This time around the Hydroxyzine does not seem to be as effective. While it helps a bit with me sleeping, the itching is still quite severe. The severe internal itching has been going on for 9 days and has affected my quality of life. The itching is nonstop and is happening in all parts of my body. No other antihistamine is effective and is able to be taken during the day except the Hydroxyzine which causes grogginess and has become less effective.
46 2021-03-20 tongue itchiness 1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vacc... Read more
1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vaccine!!Lasted 15 -25min!! 2nd shot- itchy tongue, throat swelling, flemy throat, horse voice,tongue swelling!All happened very quickly, went away within 1-2 hrs! Was very sleepy afterwards and had bad headache!!
46 2021-03-21 hearing loss, deafness, ear discomfort Hearing loss. Feels like pressure in ears. Like they need to pop. Noticed I can?t hear as well when ... Read more
Hearing loss. Feels like pressure in ears. Like they need to pop. Noticed I can?t hear as well when in the car listening to radio.
46 2021-03-21 tongue disorder 10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine receiv... Read more
10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine received @9:55a in Left Deltoid. BP 100/50, HR 76 and regular. Pt reports this BP being ?a little low for her?. Pt ate breakfast and then had a snack before coming to clinic. She has a distant history of ?getting very sick with the flu vaccine?. Within a few hours of the dose 15 years ago or so, she developed a fever of 103 and had flu symptoms of aching everywhere. The next year they gave her a pediatric dose and she had a similar response and has not had another flu shot since then. She has received allergy shots for more than 10 years and takes OTC allergy meds daily. She took her Zyrtec this am. She spoke with her allergist and received the recommendation to get the Covid vaccine. Her next allergy shots are due next week. She reports feeling fine before and during the injection and then the light-headedness started 5-6 minutes after sitting in the obs area. Site director and pharmacist aware of events. 10:22a Pt drinking water and reports ?feeling strange with swallowing and jaw feels tight?. Pharmacist to pt side and decision made to give 12.5mg of liquid Benadryl. Pt states, ?I wonder how much of this is me being anxious?. 8 oz water consumed and tolerated well. Pt reports ?tongue feels thick? with drinking Benadryl 10:24 pt reports legs feel less weak. 10:29 HR 76, BP 110/70. Husband arrived. Pt reports still feeling the same level of dizzy and throat feeling ?less tight?. 10:38 No change is s/s. Consult with pharmacist-advised giving additional 12.5 mg oral Benadryl. 10:41 Benadryl given and tolerated well. ?I don?t feel great?. Finished second 8 oz bottle of water and third given. Pt reports still feeling the same level of dizzy but has some increased thickness in throat. Improves with drinking cold water. 10:46 Pt reports although throat feels better with water, that her airway still ?feels smaller?. When describing her throat and airway, ?it?s not 100% normal, but better?. 10:50 HR 64, BP 104/64. Pt reports ?dizziness unchanged throughout, legs still feel weak, jaw and tongue feel back to normal, but back of throat still feels tight, but cold water helps but when swallowing, it still feels harder to do?. Reviewed case with pharmacist and site director, recommendation to take pt to ER for further obs. Pt agrees to go. 10:59 Pt transferred safely to wheelchair and escorted to ER. ER RN given report after pt checked in with husband beside her. Recommended to pt that she notify her PCP and Allergist of today?s event and recommended they get a recommendation for receiving the second dose.
46 2021-03-22 eye movement disorder Bell's palsy symptoms. Droopy eye (right) and tingling in the ears.
46 2021-03-22 swelling around the eyes, eye swelling Progressive over 3 days: Throat irritation, throat burning, difficulty breathing, puffy/swollen eye.
46 2021-03-23 bloodshot eyes, eye pain, lacrimation increased, eye discomfort Injection site soreness; fatigue; severe headache; feeling pressure behind my eyes/eye trouble; both... Read more
Injection site soreness; fatigue; severe headache; feeling pressure behind my eyes/eye trouble; both eyes are bright red; both eyes are bright red, watering, and aching; both eyes are bright red, watering, and aching; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 17Feb2021 at 23:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number unknown) on 07Jan2021 at 14:00 (at the age of 46-years-old) in the left arm for COVID-19 immunisation. The patient reported that on 18Feb2021 she experienced injection site soreness, fatigue, severe headache and now (as of 21Feb2021) eye trouble. She had been feeling pressure behind her eyes and now (at of 21Feb2021) both eyes were bright red, watering, and aching. She didn't know if she would need to have her eyes treated. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The clinical outcomes of feeling pressure behind her eyes/eye trouble, injection site soreness, fatigue, severe headache, both eyes are bright red, watering and aching were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
46 2021-03-23 mouth itchiness, mouth tingling Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight... Read more
Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight. My heart rate felt like it had jumped and my heart was pounding. I started to feel like it was very hot and I was getting somewhat nauseated and feeling like I might pass out. I checked my smart watch and my heart rate had jumped to over 120. The lady who administered the shot got the EMT on site and they took me for observation. They took my blood pressure and it was 157/114 (which is far beyond the norm for me). They took an EKG on site which they said was not alarming in any way. They checked my blood sugar and it was normal. My oxygen level stayed within a normal range. I had some mild feeling of itching/tingling in my mouth and felt like I had a lump in my throat like a marble. My BP and HR came down some after about 15 minutes but was still high. They called an ambulance and had me go to an ER for further observation since the feeling in my mouth and throat was not resolving and my BP was not coming down to a better range after about 30 minutes. By the time I got to the ER and they monitored me, my BP was still 154/70 and my HR was still in the 80s while at rest. They kept me in observation for long enough for the doctor to feel that I was not in any immediate danger so they discharged me with instructions to return to the ER if things got worse.
46 2021-03-23 oropharyngeal discomfort About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throa... Read more
About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throat, and a headache that felt like my head was going to explode. My face felt flushed, tingly and stiff like a mask. When I stepped out of the car, I felt wobbly and weak. I started feeling nauseous, exhausted and just "out of it". I took an ibuprofen and an acetaminophen. The symptoms slowly decreased over the evening and my air was never fully cut off so I didn't go to the Emergency Room. Today (the day after vaccination), the symptoms were much less severe but I felt more lightheadedness, like I'm on a boat, however, that is something that has been an issue for me over the past several months so it might not be vaccine-related. My arm hurts quite a bit today but not debilitatingly so. I also feel alternately chilled and feverish. Although the highest my temperature measured was 98.9 F, my temperature is typically in the 97's so it was definitely elevated.
46 2021-03-23 taste disorder Medicine taste on tongue that has been ongoing for the past 11 hours thus far
46 2021-03-23 ringing in ears 9 days after the first vaccine, my ears started ringing so loudly. About a week later, it calmed do... Read more
9 days after the first vaccine, my ears started ringing so loudly. About a week later, it calmed down and I did get the second vaccine. 9 days after that, my ears started ringing again, this time the volume much higher. It has been 3 weeks today and it is still ringing so loudly. It is interrupting sleep, causing anxiety and making day to day activities difficult. It is ringing all the time and is unrelenting.
46 2021-03-24 dry mouth, oropharyngeal discomfort, taste impairment, eye strain I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon a... Read more
I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon after, I started getting a mild headache toward the front of my head which intensified towards my temple area. My eyes felt strained ( the back of my eyes ). The feeling was similar to a migraine/sinus pressure. I started getting cold and then my extremities were freezing. I got chills and was shivering ( it was cold in the building, but I wasn?t that cold upon entering ). This was all in the first 15 minutes. I was told to stay for 30 minutes in the waiting area because of my allergy to erythromycin, just as a precaution. Around 20 minutes my mouth became very dry. I also had a metallic taste in my mouth. It became hard for me to swallow and I had to think to swallow because it wasn?t happening naturally. At that time I alerted someone and asked if these reactions were normal. I was given a 25mg Benadryl and had people continuously check on me. It took some time before I was able to not feel the choking closed feeling from swallowing. Once I was able to swallow it felt as if I had something lodged in the back of my throat. Similar to the feeling of phlegm. I kept having to clear my throat because that phlegm feeling wouldn?t ?wash down?. I felt light headed, but not dizzy. More of a foggy feeling. Once they felt it was safe for me to leave I came home and rested. The headache lessened, I was still cold, but not chilled. Into the evening I was very tired and foggy in thinking.
46 2021-03-24 mouth discomfort congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu... Read more
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
46 2021-03-24 mouth itchiness, mouth tingling, swollen tongue Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thicknes... Read more
Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thickness, itchy mouth, and rapid heartrate within 10 minutes, redness, burning, swelling, and itchy skin on face within 15 minutes. Epi-pen given within 14 minutes, and transport to hospital, wheezing in bases of lungs noted by ER physician and diphenhydramine, famotidine, and solumedrol given. Swelling of tongue took 1.5 hours to reduce to half. Overnight stay at hospital, due to severity and duration of symptoms.
46 2021-03-25 taste impairment Metal taste lightheaded and nausea
46 2021-03-25 oropharyngeal discomfort, swollen tongue Tongue swelling and posterior throat discomfort GIven 25 mg PO Benadryl with resolution
46 2021-03-25 swollen tongue, taste impairment Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusi... Read more
Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusion, tingling, swelling lymph nodes, body ache, headache.
46 2021-03-25 ringing in ears Tinnitus
46 2021-03-26 eye swelling On the morning after the second vaccine I woke with swelling of my left eye,face, neck and under arm... Read more
On the morning after the second vaccine I woke with swelling of my left eye,face, neck and under arm/breast area on the left side .By the afternoon all swelling was gone except under the arm. It is uncomfortable to put my arm close to my body and to lay on that side today. It is still sore and swollen today.
46 2021-03-26 mouth tingling tongue tingling, observed an extra 30 minutes, denied Benadryl
46 2021-03-27 mouth discomfort For about a week after the shot, I felt like my mouth was filled with cat fur. Not cotton mouth, not... Read more
For about a week after the shot, I felt like my mouth was filled with cat fur. Not cotton mouth, not thrush, but specifically cat fur. It would disappate if I drank a lot of water, but would come back in a few hours. Lasted about a week.
46 2021-03-27 mouth tingling Immediate tingling sensation on left side of face, mainly around the mouth area. As days continue, ... Read more
Immediate tingling sensation on left side of face, mainly around the mouth area. As days continue, still tingling sensation around the mouth, and fatigue. The fatigue never went away.
46 2021-03-28 ear itchiness SEVERE RASH - ARMS AND CHEST, ITCHY EARS AND PUBIC AREA
46 2021-03-29 mouth numbness, mouth tingling numbness/ tingling in tongue after 5 minutes of vaccination. v/s 157/98, patient did not take blood ... Read more
numbness/ tingling in tongue after 5 minutes of vaccination. v/s 157/98, patient did not take blood pressure medication this morning.patient refused transport. s/s resolved after 2 minutes.
46 2021-03-30 loss of taste, loss of smell arthritis; I lost my smell and my taste; I lost my smell and my taste; My stomach was very, very bad... Read more
arthritis; I lost my smell and my taste; I lost my smell and my taste; My stomach was very, very bad like diarrhea; pain like in my back, in my upper back like really bad/her lower back, like she was having a baby, it was opening in her lower back; I could not sleep that day; I felt very, very tired/I felt like I was sick; I have nausea all that; I got was like huge pain on my arm; I began to have rash all over like my left arm and my body; felt like I was sick; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) on 03Mar2021 at single dose for COVID-19 immunization. Medical history included atopic dermatitis. Concomitant medication was none. Patient used took the first dose of BNT162B2 (lot number: EL9266) on 11Feb2021 at single dose for COVID-19 immunization. patient got her second vaccine last Wednesday (03Mar2021) she was like she just have secondary effect like for one week not only it's super late and what surprised her the most it that she lost her smell and her taste, so she thought like she got the COVID, that was on the 4th day (06Mar2021) but she did 2 test, she didn't know one want to keep a track, like how they went like the first day (03Mar2021) she got the vaccine the only thing that she got was like huge pain on her arm that she did not have in her first dosage, she thought it was fine and then next day that was Thursday (04Mar2021), no she felt like she was going to die because the pain like in her back, in her upper back like really bad, she could not sleep that day, she felt like her lower back, like she was having a baby, it was opening in her lower back. She felt very, very tired like she have nausea all that, like all day long, she didn't eat anything because the nausea began in like through the night she could not sleep that night. she said one of like the things that one mention it's going to happen so affects that, then the next day that was Friday (05Mar2021) her stomach was very, very bad like diarrhea or whatever but she felt little better felt tired and then Saturday in the morning (06Mar2021), she lost the smell and the taste so that was when she thought that she really have gotten the COVID, because secondary effect it does mention that one lost smell and taste so she went to do a test and she began to have rash all over like her left arm and her body and then she did the test to the one like quickly and the other one took 2 day and both were negative then on Sunday (07Mar2021) the smell and the taste came back but she still felt pretty tired, feel a lot of rash in her left arm and in her shoulder of right part and she felt like she was sick or maybe yesterday she began to feel better but really tired, really like that one are sick, but this happen not only in today it happen like all this week, this today she began to feel better but she was like that was not because of the vaccine because she thought she got the COVID. It was also reported the first effect (event) was 12 hours lately, 03Mar2021. She thought she had arthritis she went to did her see the doctor and also the doctor like said probably 89% sure that patient don't have arthritis but she was going to do also another because she did rheumatoid test or whatever but also she put her on antibodies or whatever test, that day 2 day ago on Wednesday (10Mar2021) and then she will received those 2 test in last 2 weeks but the first one is like blood test you know. Treatment included the lady that vaccinated her told her took lots of water and Tylenol so she took Tylenol, she took 2 pills of. Outcome of very tired was not recovered. lost her smell and her taste was recovered on 07Mar2021. Outcome of arthritis was unknown, and outcome of other events was recovering.
46 2021-03-30 loss of smell Loss of smell
46 2021-03-30 eye swelling Within 10 min, mild headache. Around 2 hrs, eyes slightly swollen, dizzy. Next morning, noticed 2 it... Read more
Within 10 min, mild headache. Around 2 hrs, eyes slightly swollen, dizzy. Next morning, noticed 2 itchy hives 1.5" from injection site.
46 2021-03-30 pain in jaw Pain in left side of the jaw. Painful to talk, chew. Feels like I'm drooling.
46 2021-03-30 mouth tingling, loss of taste, taste impairment, mouth numbness, swollen tongue, taste disorder tingling and numbness at the tip of my tongue, headache, and food taste sweet or spicy such as banan... Read more
tingling and numbness at the tip of my tongue, headache, and food taste sweet or spicy such as bananas and ice cream taste very sugary and fries taste peppery and some foods don't have any taste. 20 minutes after vaccine my tongue felt swollen and under my chin felt swollen. Swelling was mild and went away after an hour or 2.
46 2021-03-30 mouth tingling tingling around moth & tips of tonque. symptoms resolved.
46 2021-03-30 swollen tongue, lip swelling, mouth tingling About 7 minutes after receiving my vaccine, my tongue started tingling. It felt slightly swollen. ... Read more
About 7 minutes after receiving my vaccine, my tongue started tingling. It felt slightly swollen. About 20 minutes after the vaccination, my lips started tingling and felt slightly swollen as well. This tingling was severe for about 4-5 hours and was gone within about 12 hours. The next day I had headache and fatigue as anticipated, but the tingling was gone.
46 2021-03-30 tunnel vision Within 3-5 minutes after my injection, my heart rate increased and my blood pressure increased. I b... Read more
Within 3-5 minutes after my injection, my heart rate increased and my blood pressure increased. I became very dizzy and my hands were tingling. I felt like I had tunnel vision, couldn't catch my breath. The nurse monitored my heart rate and then notified the rapid response team. While monitoring my blood pressure, they made the call to get ENT's to get me to the ER. I was in the ER for 5 hours for monitoring, iv fluids and testing.
46 2021-03-31 ear discomfort, ringing in ears day 2 post vaccine ear fullness started and continues, day 7 post vaccine tinnitus in both ears alo... Read more
day 2 post vaccine ear fullness started and continues, day 7 post vaccine tinnitus in both ears along with facial tingling on right side and around eye. the tinnitus is still 11 days post vaccine along with ear fullness.
46 2021-03-31 tongue disorder Tongue felt heavy after shot was administered at approximately 12:52pm. Headache followed along with... Read more
Tongue felt heavy after shot was administered at approximately 12:52pm. Headache followed along with nausea. When I got home I felt hives on my forehead and had chills as well. Later on that night my asthma started to act up with wheezing. The next day I experienced my throat swelling/ closing at which point my husband drove me to the Emergency Center. The doctor gave me Benadryl and a steroid (orally). I was monitored and subsequently released. The doctor prescribed Banophen(Benadryl) and prednisone for the next five days.
46 2021-04-01 ear itchiness, mouth swelling, lip swelling, lacrimation increased Excessive yawning and watering eyes started immediately, but otherwise fine. 30 mins after vaccine ... Read more
Excessive yawning and watering eyes started immediately, but otherwise fine. 30 mins after vaccine started with ?tickle in throat? and coughing. Within minutes wheezing and immediately left for urgent care. Wheezing was increasingly pronounced and couldn?t breathe. Itchy ears and throat, swelling of mouth/lips and felt throat closing. Husband pulled over to administer epi shot (used inhaler multiple times prior with no relief) At urgent care received steroids and benedryl through IV and oxygen. Rushed immediately to hospital by ambulance where I received additional meds and albuterol breathing treatment
46 2021-04-01 swelling of eyelid, lip swelling, swollen tongue Swollen lips, tongue and gums an hour after the 1st dose, then swollen left eye lid and rashes on le... Read more
Swollen lips, tongue and gums an hour after the 1st dose, then swollen left eye lid and rashes on legs 4 hours after vaccination, Benadryl every 4 hours Swelling slowly subsided in 24 hours, rashes disappeared after 2 days
46 2021-04-02 oropharyngeal discomfort Swelling in throat; Feeling of tightness/closing of throat. I was able to swallow liquid but had dif... Read more
Swelling in throat; Feeling of tightness/closing of throat. I was able to swallow liquid but had difficulty when attempted to swallow solid food. No difficulty breathing. No other symptom presented. Throat discomfort lasted 2-3 hours.
46 2021-04-02 visual impairment, eye discomfort About between 30-60 minutes after the vaccination, I began feeling mild pressure in my left eye, and... Read more
About between 30-60 minutes after the vaccination, I began feeling mild pressure in my left eye, and it felt as if my eyes weren?t properly ?matching up? in my glasses, like the prescription in one eye wasn?t correct. It wasn?t bad enough for me to stop driving home, but it was definitely noticeable and odd. I will keep an eye on it and phone my physician if it worsens.
46 2021-04-03 ear pain Frequent Urination (every 20 minutes) and severe pain in right ear cartilage Twin sister and daugh... Read more
Frequent Urination (every 20 minutes) and severe pain in right ear cartilage Twin sister and daughter experienced the same issues.
46 2021-04-04 lip swelling severe itching, wheezing, coughing, severe chills, severe nausea, vomiting, not able to really eat, ... Read more
severe itching, wheezing, coughing, severe chills, severe nausea, vomiting, not able to really eat, hives, rashes, small bumps frpm scalp through entire body. fash and lips swollen
46 2021-04-04 feeling of choking Patient reorted tingling sensation from shoulder down arm and up side of head, on right side. Same s... Read more
Patient reorted tingling sensation from shoulder down arm and up side of head, on right side. Same side that vaccine was given, right deltoid. Began 7 minutes after vaccination while patient was in the observation area. MD on site and assessed patient. Plan is to monitor for 30 minutes. After 10 more minutes, patient reported tingling in her throat. MD ordered Cetirizine 10mg (Zyrtec) once now. Given to patient at 1255 pm. Vaers info gathered from pateint. 30 min of observation done. Patient feeling well, no swelling nor shortness of breath. MD assess her and discharged her home.
46 2021-04-05 ringing in ears Tinnitus/loud ringing in both ears. Buzzing sound during the day and night 24/7
46 2021-04-06 lip swelling patient presented to the emergency dept with lip swelling and throat fullness after receiving the va... Read more
patient presented to the emergency dept with lip swelling and throat fullness after receiving the vaccine. symptoms occurred about 15min after receiving the vaccine. IM diphenhydramine given and symptoms resolved within 15min.
46 2021-04-06 tongue itchiness, oropharyngeal discomfort Pt received vaccine and was waiting in observation area. After 20 min., pt reported to observation n... Read more
Pt received vaccine and was waiting in observation area. After 20 min., pt reported to observation nurse that her tongue and throat were itchy and she had "an unusual feeling in her throat." Pt denied SOB, WOB, was able to speak normally and answer questions appropriately. Pt was escort by observation nurse and on-site EMT to quiet AE observation area. VS and spo2 were recorded, all were WNL (SP02 98 on room air). Pt states she had a similar reaction to shellfish 2 years ago, which resolved on its own w/out treatment. After 30 min of observation, VS were rechecked and were again WNL (SPO2 99 on room air). Pt stated she no longer had symptoms and felt well and ready to leave. Pt was advised to seek emergency care if sx return or worsen. Pt stated understanding and agreed w/ plan.
46 2021-04-06 visual impairment towards end of monitoring time post vaccine, c/o feeling shaky, having visual disturbances, nausea, ... Read more
towards end of monitoring time post vaccine, c/o feeling shaky, having visual disturbances, nausea, and headache. brought back to obs 1722, 1724 bp 134/78 hr 71 rr 18 sao2 99% on ra. patient laying on stretcher, feeling relief of headache, flushing, and lightheadedness, but headache remains, though improved. 1730 bp 120/81 hr 73 rr 18 sao2 99% on ra, s/s improved, head pressure relieving, and visual disturbances improved. patient sitting up on side of bed at 1745 bp 124/75 hr 75 rr 20 sao2 99% on ra, denies increased s/s with standing. agrees stable to be escorted to personal vehicle, no further issues
46 2021-04-07 eye pain Patient complains of hallucinations a few times throughout the day on the day after receiving vaccin... Read more
Patient complains of hallucinations a few times throughout the day on the day after receiving vaccine. On the evening she received the vaccine, she experienced arm and shoulder pain and severe headache/pain above the eyes.
46 2021-04-07 lacrimation increased Headache - feels like my brain is swollen and ready to blow up, stiff neck, collar bone pain, hands... Read more
Headache - feels like my brain is swollen and ready to blow up, stiff neck, collar bone pain, hands and veins feel swollen, feet feel swollen, feel hot inside, sweaty at night, cold when I uncover, cold with no socks, dizzy, threw up, stomach feels gassy and swollen, back hurts, painful to inhale, out of breath, weak, tired, can't sleep, dry phlemy cough, watery nose, watery sticky eyes....my brain feels like it's gonna blow up.... did I say MY BRAIN FEELS LIKE IT'S GONNA BLOW UP!!!!!!
46 2021-04-07 oropharyngeal discomfort developed scratchy throat and hives post vaccine, medicated with Benadryl 50mg and observed for an h... Read more
developed scratchy throat and hives post vaccine, medicated with Benadryl 50mg and observed for an hour
46 2021-04-07 mouth tingling, swollen tongue atient felt subjective swelling and parasthesias in her tongue within first 30 minutes and eventuall... Read more
atient felt subjective swelling and parasthesias in her tongue within first 30 minutes and eventually sensation of swelling in her throat within 60 minutes. There were no other secondary systemic/organs affected apart from mild transient hypertension. Given the strong concern for subjective airway compromise, I directed the administration of epi which the patient said she felt her throat relax after adminstration. 911 was called and patient was transported to ED.
46 2021-04-07 swollen tongue post vaccine observation session, patient complained of throat tightness/trouble swallowing and voic... Read more
post vaccine observation session, patient complained of throat tightness/trouble swallowing and voice became raspy. patient has multiple reported allergies and carries epipen. Received 2 doses of epi IM and one dose Benadryl prior to arrival in EC, for throat and tongue swelling again. At triage, sleepy, on transfer to floor became unresponsive and noted to be seizing (received 3 doses ativan) with no resolution, subsequently intubated for airway protection and transferred to ICU.
46 2021-04-08 taste impairment, smell distorsion Metallic taste and smell on EVERYTHING since ive received second dose on 02/25/2021
46 2021-04-08 mouth numbness, mouth tingling, loss of taste After first shot I had tingling on the back of my tongue. It went away later that day. The second sh... Read more
After first shot I had tingling on the back of my tongue. It went away later that day. The second shot I had tingling later that day and had a headache but it went away the next day. April 2 woke up with tingling on my tongue and then I couldn't taste anything plus a bad headache. Around 4 pm I went to ER because my lip started to pull to the side and I still didn't have any taste and my tongue was tingling more. My lips started to feel numb along with the side of my face. I went to ER and was sent to hospital for a MRI by ambulance.I was told I have Bells Palsy and was giving steroids to take for 5 days and to see my dr.
46 2021-04-08 mouth tingling Pt c/o difficulty swallowing, tongue tingling, and feeling "fuzzy overall" 25 min post vaccination. ... Read more
Pt c/o difficulty swallowing, tongue tingling, and feeling "fuzzy overall" 25 min post vaccination. EMS called. Transferred to local hospital.
46 2021-04-08 mouth tingling -itchy all over - started on soles of feet but is now all over - hands, tummy, back. Degree of itch... Read more
-itchy all over - started on soles of feet but is now all over - hands, tummy, back. Degree of itchiness is bothersome, yet not intolerable. -tingling of lips and tongue - no swelling of lips or tongue noticed -flushing at chest, neck, and face (flushed in color and skin is warm to the touch) Planning to take some benadryl soon to attempt to curb itching. Had taken Tylenol at 6pm and then again at 10pm (4/8). 4/9 took daily prevacid and atorvastatin as usual in the morning.
46 2021-04-09 smell distorsion, taste disorder Dizzy, Pain in joints, smell changed, taste, headache, pain in eyebrow, hallucinations, flushed
46 2021-04-12 eye pain headache, pain behind left eye, nausea, Dizziness, fever, chills, migrane, back rash and rash on pal... Read more
headache, pain behind left eye, nausea, Dizziness, fever, chills, migrane, back rash and rash on palms.
46 2021-04-12 bloodshot eyes Initial stomach discomfort beginning minutes after injection. 2-3 days of digestive issues most seve... Read more
Initial stomach discomfort beginning minutes after injection. 2-3 days of digestive issues most severely blood in stool that cleared up after a few days. Beginning around 4/3/21 began to have a sore between two toes along with redness and swelling and other redness in hands/wrists and around one eye. Doctor prescribed Antibiotic and antihistamine via tele-med video visit.
46 2021-04-12 swollen tongue skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla... Read more
skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-04-12 thirst Started to feel badly (headache, slight fever, typical side effects) around 10-11pm Thursday... Was ... Read more
Started to feel badly (headache, slight fever, typical side effects) around 10-11pm Thursday... Was very thirsty so got out of bed to go the bathroom and get more water around 3am. On the way back, fainted. Not sure how long was out, but came to and was able to get up and back to bed after lying on the floor for ~10 minutes. The rest of Friday, just felt feverish, headachy and fatigued.
46 2021-04-12 ringing in ears ringing in both ears sonstantly since I received a second dose. I saw Dr. about 3 weeks after the s... Read more
ringing in both ears sonstantly since I received a second dose. I saw Dr. about 3 weeks after the shot and there was no water in my ears. She diagnoised it as a side effect of the vaccine and had no other informaiton on how long it would last or if it would go away given the newness of the vaccines. Unknow if it will result in disability or permanent damage. I hope not so i am not checkign that box below. But that could change.
46 2021-04-13 eye swelling Left eye swelling
46 2021-04-13 tongue itchiness, lip itchiness, lip swelling, mouth discomfort, swollen tongue, tongue discomfort Started with itching, swelling and burning of lips the day of.took benadryl then all day the 13th. ... Read more
Started with itching, swelling and burning of lips the day of.took benadryl then all day the 13th. That evening I started feeling it in my tongue and throat I did benadryl and epi went to emergency room and was given steroid
46 2021-04-14 mouth ulceration, burning mouth syndrome White patchy and cracked tongue, sore inside lips and side of tongue, small mouth ulcers, rash under... Read more
White patchy and cracked tongue, sore inside lips and side of tongue, small mouth ulcers, rash under arms, sore in back of mouth, discolored on roof of mouth with red sore.
46 2021-04-14 pain in jaw Left sided jaw soreness 3/10 then 2/10, no radiating pain No itching, swelling, SOB, tachycardia, di... Read more
Left sided jaw soreness 3/10 then 2/10, no radiating pain No itching, swelling, SOB, tachycardia, diaphoresis, dizziness. h/p PCN allergy resulting in throat and mouth swelling Vitals @1424 HR 97, BP 174/105, O2 97, @1427 HR 93, BP 161/98, O2 97, @1434 HR 93, BP 152/99, O2 97, @1440 sitting HR 92, 157/88, O2 97, standing @ 1446 HR 97, BP 159/86, O2 99 Pt discharged to home, self, at 1447
46 2021-04-14 swollen tongue, mouth tingling, mouth numbness, tongue itchiness Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face... Read more
Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face? chin area. Within 39 minutes, left side of face was numb with tingling sensation and lips were fully numb and tingly. Tongue felt swollen and itchy, as well. Symptoms lasted several hours. It is now more than a week later and there is still slight numbness in lips and on left side of face. No visible changes have been noticed, just the sensation of numbness as of given Novocain at the dentist.
46 2021-04-14 tongue discomfort, mouth ulceration, burning mouth syndrome White, cracked, painful tongue, small white mouth ulcers on inside of lip, red painful side of tongu... Read more
White, cracked, painful tongue, small white mouth ulcers on inside of lip, red painful side of tongue, discolor on roof of mouth, rash/hives around both armpits
46 2021-04-14 tongue itchiness, mouth itchiness itching of tongue and mouth, dizzy
46 2021-04-15 mouth numbness Face felt flush, irritated by mask. But after mask was removed my face continued to appear red and f... Read more
Face felt flush, irritated by mask. But after mask was removed my face continued to appear red and feel hot to the touch (no fever). (Both sides). Swelling of face became more evident (mostly cheeks) over the next two hours.Flush areas of face also felt numb/tingly. Mouth also felt numb-teeth felt like after dentist anestheic injection. began about 10:50, peaked around 1pm maybe. By 4 felt mostly normal. Face stayed flush looking after no longer felt hot or numb. Just fatigue after. Also some swelling/numbness at site of injection. But more mild.
46 2021-04-15 mouth numbness FACE AND TONUGE NUMBNESS 15 MINUTES AFTER ADMINISTRATION, WAS ADMINISTERED 50 MG OF BENADRYL, PROCEE... Read more
FACE AND TONUGE NUMBNESS 15 MINUTES AFTER ADMINISTRATION, WAS ADMINISTERED 50 MG OF BENADRYL, PROCEEDED TO HOSPTIAL JUST IN CASE, COUGH AND HEADACHE THE FOLLOWING DAY
46 2021-04-15 swelling of eyelid Large patches of a red rash only on left side of face with significant swelling in left eye. Slight... Read more
Large patches of a red rash only on left side of face with significant swelling in left eye. Slight itching, no pain. Swelling of left eye lid much worse 36 hours later.
46 2021-04-15 vision blurred Slightly blurry vision in 15 minutes. Then at the 31 minute mark, my throat started swelling and my ... Read more
Slightly blurry vision in 15 minutes. Then at the 31 minute mark, my throat started swelling and my chest was tight, so it was hard to catch my breath. My whole face and ears turned red and i was itchy on my arms. 2 doses of Benadryl made the allergic reaction ease. I was tired for the next two weeks, and then started having heart palpitations regularly. Went to ER was diagnosed with Tachycardia, Hyperkalemia, Hypomagnesemia, and Hypocalcemiaand. Corrected with intravenous drugs and overnight stay in the hospital. Slowing feeling some better, but struggling with inflammation and being exhausted. Felt 100% great before getting this vaccine. Advised by doctors not to get second shot and did not get it.
46 2021-04-16 lip swelling, mouth numbness, mouth discomfort, feeling of choking, mouth tingling About 15-16 minutes after the shot I got elevetad heart rate, tingling and numbness in tongue and mo... Read more
About 15-16 minutes after the shot I got elevetad heart rate, tingling and numbness in tongue and mouth palate. I had left the facility so decided to walk outside. Hart pulse got better in about 30 minutes, but the tongue tingling stayed. About 1 hour after the shot, the tingling got more intense and spread on my face around my mouth and chicks. I felt intense burning above my lips, looked in the Mirror and saw that my upper lip was swallen and red. Went back to the vaccination site, and talked to a paramedic. She said to take Benadryl. It is now 1 week after the shot. Tingling and numbness are getting worse in my mouth and tongue. A doctor prescribed me coticosteroids. He said I should take then to prevent anafilactic shock from the vaccine. I still have the tingling. When tingling and numbness in tongue and throat starts increasing, I have a feeling that my throat is closing and it is difficult I breathe.
46 2021-04-16 ringing in ears Sleeplessness, headache, whole body muscle pain, pain in right temple, fever, tinnitus.
46 2021-04-17 lip swelling Lowe grade fever, chills, hot flashes, then lack of energy, nausea, diarrhea, skin reaction spots, l... Read more
Lowe grade fever, chills, hot flashes, then lack of energy, nausea, diarrhea, skin reaction spots, lips swelling, wheezing
46 2021-04-18 taste impairment sever arm pain (injection arm), severe dizziness, sever tiredness, moderate body ache, mild nausea,... Read more
sever arm pain (injection arm), severe dizziness, sever tiredness, moderate body ache, mild nausea, metallic taste in mouth. All starting about 2.5 hours after injection and starting to vane after 48 hours clearing up 72 hours.
46 2021-04-18 taste impairment Dizzy left arm numb, metallic taste, had to keep swallowing? Swollen glands under chin on neck
46 2021-04-18 eye swelling FEVER RASH SHINGLES ON RIGHT BACK, HIP AND GROIN AREA FATIGUE SWOLLEN EYES
46 2021-04-18 mouth tingling, swollen tongue TONGUE AND THROAT SWELLING AND TINGLING OF THE TONGUE
46 2021-04-19 tongue disorder Day of headache (Sun), that night sore arm, and next day some sleepiness, but that doesn't concern m... Read more
Day of headache (Sun), that night sore arm, and next day some sleepiness, but that doesn't concern me. What does it Thurs (~Day5) afternoon, it felt like my tongue was getting "thick" and pressing my back teeth, then I noticed that the lymph node on the left side of my throat began to really swell. It got really enlarged by Friday evening (~ Day 6) to the point that I wondered if I had tonsillitis - no pus/not strep. But being only on the left side (same as shot) and not both, I figured that it could be a reaction. Called my after-hours doctor on Sat who confirmed that this did sound very much like a reaction (not much to be found online) and nothing to be too concerned about unless it didn't resolve in a few days. Swelling went down significantly by Sat. a.m. and was back to normal by Sun (Day 8).
46 2021-04-20 loss of taste Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately an... Read more
Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately and hotness around site for three days, heaviness in chest all the way through to back, shortness of breath
46 2021-04-20 bloodshot eyes 1100.- Vaccine given, 1115- pt. felt dizzy - difficult to breathe 1118- nausea- RN with patient -... Read more
1100.- Vaccine given, 1115- pt. felt dizzy - difficult to breathe 1118- nausea- RN with patient - 1120- B/P 198/115- HR 82- O2 Sat 99%- MD notified - 1126- B/P 187/112 - HR 80 - O2 sat 100%- M.D. with patient - eyes red- no itchy throat- no swollen throat - no swollen legs, arms, or hands- 1130- patient taken to ER via gurney, accompanied by staff
46 2021-04-21 loss of taste, loss of smell VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/12/21,pfizer,Lot#EL3248 2nd dose:02/02/21 Pfizer,Lot# EN5318 Diagnosed covid positive:04/19/21 Exposure:Home exposure Symptoms:Cough,loss of smell/taste,Diarrhea,sore throat,runny nose,body aches,fatigue,feeling foggy,fever(subjective)
46 2021-04-21 lip swelling, taste impairment, mouth numbness, vision blurred I received my first dose of the Pfzer vaccine on 4/14/2021 I was asked to wait in a waiting area fo... Read more
I received my first dose of the Pfzer vaccine on 4/14/2021 I was asked to wait in a waiting area for 15 minutes to be monitored. Within 5 minutes of receiving the vaccine. I had a strong metal taste in my mouth and felt like my lips were swelling. I alerted the medical staff team and they brought me back into a room to be monitored. My mouth was numb. (felt as if I was given numbing shots at a dental facility) A nurse gave me a zyrtec and pepsid. They monitored my for 30 minutes. Numbness still was strong and present but I showed no signs of respiratory distress and they allowed me to go home. I was told a staff would be calling on me to check on me later that day. (this never occurred) About 30 minutes later on my way home, the numbness I was experiencing in my mouth now was in my Right Arm starting at my elbow and was spreading upward toward my shoulder, neck and right side of my face. I called the clinic back and was advised to go immediately to the ER. I went to Hospital in. I was checked out by a physician, given a neurological assessment, given 5 steroid pills and also given a eye exam. The numbness was intensifying and I felt extreme pressure accompanied by blurred vision in my right eye. My Blood pressure was also extremely elevated. I was left in a exam room for 4 1/2 hours. I had no signs of sensation returning to the numb areas. ER Doctor consulted with the Neurologist and then advised me to follow up with my primary care for potential Neurologist referral for a MRI. He stated that the medical staff was slammed and that I could not have a MRI at that time. He felt that I wasn't critical and that a MRI could be scheduled at a later time. I followed up with my Primary Care Physician. She did blood work, another eye exam and referred me to see a Neurologist, Ophthalmologist and allergist. I have made the necessary appointments and am awaiting further testing for ongoing issues. (MRI, VEP, & EMG) Numbness lasted two days, followed by tingling for another day. I continue to struggle with blurred vision in my right eye, severe headaches and pain in my shoulder and neck area.
46 2021-04-21 oral mucosal blistering, lip blister five blood blisters in mouth (two large blisters under tongue, one large blister on inside lower lip... Read more
five blood blisters in mouth (two large blisters under tongue, one large blister on inside lower lip, two small blisters on inside left cheek)
46 2021-04-21 mouth tingling, feeling of choking, mouth swelling mild intermittent tingling throughout body lasting for more than 24 hours after vaccine. More consi... Read more
mild intermittent tingling throughout body lasting for more than 24 hours after vaccine. More consistent tingling in mouth/throat began approximately 7 hours after injection and continued for 3 hours. Throat began to close up and I took a Benadryl which stopped the tingling in my throat and I was able to breathe better. I repeated a second dose of Benadryl before bed that night to ensure that the event did not repeat itself. Tingling and swelling in throat and mouth never returned , Mild intermittent tingling in rest of body continued throughout day two post injection but it tolerable and did not require medication. Fever (101), body aches, chills and muscle pain began 12 hours after injection and persisted for approximately 18 hours.
46 2021-04-21 swollen tongue, mouth numbness, mouth swelling, eye swelling Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue l... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue left side, jaw left side, forhead left side novacaine like feeeling-Medium, Additional Details: left side under tongue numb, left jaw numb, forhead numb decreased with administration of benadryl butr did not go away 1.5 hors post shot. pt states feels like when she gets novacaine at dentist..tingly as well\r\n
46 2021-04-21 swollen tongue 7 minutes after receiving my 1st dose of Pfizer, I felt slight swelling in the back of my throat beh... Read more
7 minutes after receiving my 1st dose of Pfizer, I felt slight swelling in the back of my throat behind my punching bag. I waited a couple minutes thinking I was having a mental reaction, but then I couldn?t swallow. I notified a nurse and was given Benadryl. A few minutes later the swelling went away and I could swallow again. I was breathing just fine during all of this. Then the swelling moved to the left side of the back of my throat and my tongue on the left began to swell. I was given Epi and sent to the emergency room for observation. I continued to have weird swelling coming and going on my left side of the throat for 90 minutes. I continued to breath just fine through all of this. Was given Benadryl, solu medrol and Pepsi?s by IV injection. Sent home with 5 days of prednisone.
46 2021-04-22 eye swelling Swollen right eye
46 2021-04-22 smell distorsion Headaches, joint pain, muscle pain, vomiting, nausea, change in smell - everything smells very bitte... Read more
Headaches, joint pain, muscle pain, vomiting, nausea, change in smell - everything smells very bitter/burnt rubber., extreme fatigue
46 2021-04-22 swollen tongue Within 5 minutes after receiving injection in the arm, I felt a heat wave coming over my body (start... Read more
Within 5 minutes after receiving injection in the arm, I felt a heat wave coming over my body (started in my legs) & instant headache and sore arm. After the 15 minute duration, I left the building and sat in my car for about 30 minutes having the coldest setting of the A/C blowing in my face. I also felt my tongue swell up and felt a bit dizzy. Spoke to my family, informed them about my status. When I felt well enough to leave (within 45), I went home. Symptoms did not come back. Arm remained sore for three days.
46 2021-04-22 swollen tongue Reported tongue swelling.
46 2021-04-22 ringing in ears Loud ringing in both ears nonstop since first covid vaccine.
46 2021-04-23 dry throat Chest pressure, dry throat. Evaluated by EMS-Cleared
46 2021-04-23 lip swelling Diarrhea, swollen of lips and face , stomach pain. Second day now
46 2021-04-24 ear itchiness, lip swelling, mouth tingling, swollen tongue aches keep coming and going, on and off; massive headache; weird pulling feeling on both of her legs... Read more
aches keep coming and going, on and off; massive headache; weird pulling feeling on both of her legs/like a light switch; burning sensation in her nose; lips swelled up; weird feeling on the edges of her tongue; she felt off; tongue swelled up; blisters on the tip of her tongue; hasn't been feeling right; face was itchy/ skin was itchy; inner ears were itchy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 31Mar2021 at 09:30 (46-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing MTHFR (genetic thing called MTHFR. She has trouble digesting synthetic vitamins and folic acid), IVF, COVID-19 virus in Mar2020. Patient had no known or documented allergies. Concomitant medications included monascus purpureus (RED YEAST RICE) and multivitamin (unspecified). The patient previously received famotidine from an unspecified date to 2021 (stopped several weeks before). Patient reported after receiving the COVID-19 vaccine her tongue swelled up and she hasn't been feeling right since she got the vaccine. When asking caller to clarify what she meant when she reported "not feeling right" she reports she didn't feel right immediately after getting the COVID-19 vaccine. On day 1 of getting the COVID 19 vaccine, 31Mar2021, her face was itchy but her face wasn't red, she had no rash or hives; her inner ears were itchy and her skin was itchy. She got the COVID-19 vaccine at 9:30 and an hour or two later her tongue swelled up. She took diphenhydramine hydrochloride (BENADRYL). She also had blisters on the tip of her tongue. The next day, 01Apr2021, the swelling had subsided but she still had a weird feeling on the edges of her tongue. It felt weird. Her tongue was not red or swollen at that time. On 01Apr2021 she felt off. Then on day 3, 02Apr2021 she had a burning sensation in her nose and her lips swelled up. On Saturday, 03Apr2021 she went to(visit to physician office) because she had a weird pulling feeling on both of her legs. The pulling feeling on her legs was like a light switch. The feeling was going on all day 03Apr2021. Then the next day, Sunday 04Apr2021, the pulling sensation on her legs was gone but she did wake up with a massive headache. She had the headache since 04Apr2021 morning. She's been having these symptoms since she received the COVID-19 vaccine and she can't attribute the symptoms to anything else. She's also had aches throughout this whole process and the aches keep coming and going, on and off. She still feels a weird thing on her tongue but she can't see anything on her tongue. She'd be in a better place except for her headache. She never had a fever. She was expecting to have flu like symptoms after getting the COVID-19 vaccine. She didn't have any of those symptoms. When probing medical history and concomitant medications she reports she's been to an allergist and she has no documented allergies. Her doctors are aware of the symptoms she's been having since she received the COVID-19 vaccine. There is something, she does know she has a genetic thing called MTHFR. She has trouble digesting synthetic vitamins and folic acid. She knows she has this genetic thing because she went through IVF to have her children and the MTHFR came up on one of the blood panels. She can't break down certain vitamins so she has to avoid anything that has folic acid in it and she can't take vitamins with folic acid in it. She reports she took no medications on the same day that she received her COVID-19 vaccine. She reports she used to take Famotidine but stopped taking it several weeks ago. She did go to the physician's office because she got really nervous when she had the pulling sensation on her legs. The physician's office had no explanation and nothing to really report. The physician's office told her to contact the CDC. She is asking if she's had an allergic reaction and should she even consider getting the second COVID-19 vaccine. Therapeutic measures were taken as a result of the events and included diphenhydramine hydrochloride. The outcome of massive headache was not recovered; tongue swelled up was recovered on 01Apr2021; weird pulling feeling on both of her legs/like a light switch was recovered on 04Apr2021; outcome of other events was recovering. Information on the lot/batch number has been requested.
46 2021-04-24 eye swelling, eye itchiness, bloodshot eyes 3/31/2021 - First dose of Covid 19 Pfizer vaccine 4/14/2021 - Revenesse Versa - under both eyes - in... Read more
3/31/2021 - First dose of Covid 19 Pfizer vaccine 4/14/2021 - Revenesse Versa - under both eyes - injectable filler 4/24/2021 - I have very bad allergies to pollen/trees/grass and was outside all day doing yardwork...eyes started to bother me very badly -itchy, red, and both swelled up under both my eyes (injection site) 4/25/2021- symptoms continue. swelling not subsided. have been taking Benadryl since 10am. Its now 4:30PM. no doctors are available to report this to since its a Sunday 4/26/2021 - after doing research ive decided to cancel my second dose of Pfizer vacinne which is scheduled for 5pm 4/26/2021. the risk is too high in my mind and im already 80percent immune.
46 2021-04-24 ringing in ears ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatu... Read more
ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatus; same pain only it is far worse; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration, administered in he left arm on 22Mar2021 17:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included paracetamol (TYLENOL) for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 01Mar2021 (Lot Number: En6205) in the left arm for COVID-19 immunisation (reported in Pfizer case # 2021314445). The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported, that on 22Mar2021 at 05:30 PM, "Immediately after injection the first dose time I had a weird pain in the left side of my head. Today, I received my second dose and I had the same pain only it is far worse. It was within 10 minutes of injection. Within 30 minutes there is a ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatus". No treatment for the events was provided. Outcome of the events, ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatus and same pain only it is far worse was unknown.
46 2021-04-25 mouth tingling Pt called back 2-3 hours after leaving from vaccine to report that her lips were tingling and her ch... Read more
Pt called back 2-3 hours after leaving from vaccine to report that her lips were tingling and her chin was tingling, and she had some flushing. She stated that she had been monitoring her vitals and that she had no trouble breathing or swelling. Pt stated that she took a Benadryl to treat it. I told pt that if she was having any difficulty breathing she should call 911 or go to the hospital immediately. She stated that she thought she was past the anaphylactic reaction point, and she did not want to go to the doctor. I informed her that if she begins to have any trouble breathing to call 911 as soon as possible.
46 2021-04-26 mouth numbness After I received my first dose the area around my lips felt numb for a few minutes and then that fee... Read more
After I received my first dose the area around my lips felt numb for a few minutes and then that feeling started going away and the feeling disappeared by the end of the first day. I also had on and off aching feelings from the injection spot. I also had disappearing headaches that rotated with the aching on my arm at the injection spot. The Getwell Network directed me to include this issue here.
46 2021-04-26 mouth ulceration Around 4 hours after the vaccine, I got minor head pressure and a little nausea. Around 12 hours aft... Read more
Around 4 hours after the vaccine, I got minor head pressure and a little nausea. Around 12 hours after the vaccine, I woke up with head pain that escalated very quickly. It was some of the worst pain I have ever had next to childbirth. My entire head, temples, forehead, and back of neck had excruciating pain and felt like the skin was on fire. It wasn?t hot to touch but to me it felt like my skin was burning only from my neck up. I had a fever of 101. I used ice packs directly to my head and neck and Tylenol. Neither took the pain away. This all lasted 15 hours. The fever broke and the pain went away. The next morning, about 40 hours after the vaccine, my entire neck and spine wore sore and I was achy. This lasted the whole day. I have had periods through the next couple days where I have brief moments of feeling hot. I also developed 2 small bruises (one on each leg), but neither are painful. Today I have had mouth sores/irritation but by evening that went away.
46 2021-04-26 ringing in ears, ear discomfort 1st dose: 3/4/2021: a few days after ringing in both ears 2nd dose: 4/1/2021: a few days after ringi... Read more
1st dose: 3/4/2021: a few days after ringing in both ears 2nd dose: 4/1/2021: a few days after ringing got much louder and is still present today. Ringing in right ear more pronounced as well as occasional popping noise and the feeling of both ears being clogged or needing to be pressurized. Second dose was Lot# EW0150
46 2021-04-26 ringing in ears, ear pain I woke up with ringing in my ears the next morning 4/23. It has been constant and has not gone away... Read more
I woke up with ringing in my ears the next morning 4/23. It has been constant and has not gone away. I also have ear pain that has started from the constant ringing. My ears have been ringing for 5 days now. I am starting to get very concerned as I have not had this problem before. I am wondering when the ear ringing is going to go away, and why my body has responded this way to my first dose of Covid vaccine. I had an appointment with my Primary Care Dr. today who is referring me to an ENT now. I wish I could make the ear ringing go away and am concerned as to why the vaccine would give me this side effect.
46 2021-04-27 eye pain, ringing in ears Excrutiating headache Nausea Repeated vomiting - over the course of 2 days, about 30 times Stiff nec... Read more
Excrutiating headache Nausea Repeated vomiting - over the course of 2 days, about 30 times Stiff neck Stabbing eye pain Humming/ringing/muffled sounds in my ears
46 2021-04-27 eye pain Fever of 101.0, severe chills, severe body aches (joint and muscle pains including pain in wrists, h... Read more
Fever of 101.0, severe chills, severe body aches (joint and muscle pains including pain in wrists, hands, neck, arms, shoulders, back and legs), severe headache, for 48+ hours, loss of appetite and even pain behind my eyes. Administered Advil and Tylenol on a rotation schedule every 4 hours (taking the medications 1 hour a part from each other) to no avail for more than the first 24 hours. Arm pain from injection site lasted 4-5 days. It took more than 48 hours for the fever to break and for severe muscle and joint pains to calm down. Felt fatigued and weak for another 2 days following.
46 2021-04-27 lip swelling Received dose2 at 3:38pm. Lip swelling at 3:53pm. pt given Benadryl 25mg. MD evaluate the patient as... Read more
Received dose2 at 3:38pm. Lip swelling at 3:53pm. pt given Benadryl 25mg. MD evaluate the patient as per nursing staff the lip swelling was already improved. Vitals 177/110 mmHg rechecked again after 15 minutes came down to 130/102 mmHg. During MD exam there was no tongue swelling no lip swelling. Advised patient to monitor symptoms at home and to call 911 if she develops any worsening above symptoms. Work note given to the patient and advised to follow-up with her primary doctor in 2 to 3 days. 1650-Friend here to drive her. Friend also educated on S&S of severe reaction and when to call 911. Per MD ok to DC home. BP164/82, P76+, R18, O2 sat 100% RA 1700- DC with friend in stable cond.
46 2021-04-28 extreme sound sensitivity Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensi... Read more
Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
46 2021-04-28 visual impairment some itchiness and swelling to her left eyelid and the area immediately around it. She also felt a ... Read more
some itchiness and swelling to her left eyelid and the area immediately around it. She also felt a little numbness in this patch of skin around the area. these all resolved with cetirizine. She reports a reduction in left visual acuity today (4/29/21) since the vaccine that did not go away and resulted in her needing to get a new prescription for glasses. there urgent care note from 01/31/2021 remarks "no vision changes"
46 2021-04-29 deafness unilateral Sudden idiopathic hearing loss, right ear
46 2021-04-29 oropharyngeal discomfort CHEST PRESSURE, THROAT PRESSURE, NAUSEA, DIZZINESS. HX OF GENTAMYACIN AND HAS SIMILAR REACTION.VSS. ... Read more
CHEST PRESSURE, THROAT PRESSURE, NAUSEA, DIZZINESS. HX OF GENTAMYACIN AND HAS SIMILAR REACTION.VSS. CODE GREEN CALLED, PT RECD BENADRYL 50 MG AND ZOFRAN 8MG. REFUSED TRANSPORT
46 2021-04-29 pain in jaw My whole upper left arm hurts, and the pain worsens when I move it. I also feel weak in my left arm.... Read more
My whole upper left arm hurts, and the pain worsens when I move it. I also feel weak in my left arm. The right side of my lower jaw hurts, and it worsens with movement. I took Tylenol, but it did not alleviate the pain.
46 2021-04-29 vision blurred, swollen tongue, smell distorsion, lacrimation increased, taste impairment I had advised the staff, like I was previously advised, of the mild reaction last time. They had th... Read more
I had advised the staff, like I was previously advised, of the mild reaction last time. They had the shot administered by a Dr there and the personnel were alerted to keep an eye on me. Shot was administered and they kept me at the seat with the doctor for several minutes before placing me in the waiting room. Metallic type taste and smell occurred in less than 5 minutes of the shot. Slight swelling of the tongue and throat. Caused the need to repeatedly clear my throat and more coughing than the first time. Could not catch my breath easily and felt labored. Was light heads, eyes watering and a little ?foggy.? Used my inhaler but that did not seem to help. Used my emergency inhaler a 2nd time about 2 minutes later. Was advised my face and chest were very red and a party sat with me for a bit. Took about 10 minutes before the breathing/coughing finally seemed to be resolving. The party checking on me stayed in the room and rolled a chair with wheels near incase she need to take me to the ER just down the hallway. She also had an epee pen and advised me she had it with her just in case. My tongue and roof (Ridges) of the mouth was noticeably swollen to me after just an hour. After about an hour and half there, the allergic reactions seemed to stabilize and the staff and I both felt we were out of the woods but I was not ok to leave yet. Coughing subsided drastically and color became normal again. Kept there for a little bit longer? I was at the hospital until 5:20pm-ish. Was advised to go home and take another antihistamine, drink a lot of water and rest. They also advised to report adverse reactions stating I had another mild allergic reaction to the 2nd shot. Came home and took another zyrtec and went to bed because I was so tired. Woke up to my arm being extremely sore but the area of the shot was not raised this time but was warm and painful to the touch. Felt very achy, headache, and exhausted the next day like I had the flu. Slept the majority of the next day. Smell and taste resolved within a few hours but the roof of the mouth is still rigid but metallic taste and soreness is gone. I can tell the tongue is no longer swollen. It?s no longer bulging to the side of my teeth and I no longer seem to have a little lisp. This is now April 30, 2021 at 8:15am.
46 2021-04-30 lip swelling Patient reported top lip swelling 25 minutes after injection accompanied by a sudden rush of numbnes... Read more
Patient reported top lip swelling 25 minutes after injection accompanied by a sudden rush of numbness/tingling up the left side of her neck to the left side of her jaw and cheek. SHe is still experiencing this symptom 48 hours post immunization but has improved.
46 2021-05-02 toothache as soon as I got the vaccine I felt a small shooting pain on my right leg. the first 2 days I felt ... Read more
as soon as I got the vaccine I felt a small shooting pain on my right leg. the first 2 days I felt nothing out of the ordinary. Chills, sleepy. as days progressed I started to feel something that was more that chills, uncomfortable teeth feeling, some shooting tingling in feet and fingers, then on it started to feel uncomfortable to specially at night and early morning. Doctor said it was paresthesia and that a nurse said she had seen other paitients with similar symptoms. April 6 and 7 I had a fever all day long. Still have chills all over but it feels more than that, it's more like a paresthesia kind of thing. Very uncomfortable and I have been so worried. I have a 6 year old daughter so not getting 2nd shot.
46 2021-05-10 ear discomfort I have had problems with my ears since my second vaccine. My ears have felt chronically clogged and... Read more
I have had problems with my ears since my second vaccine. My ears have felt chronically clogged and I've been experiencing mild loss of hearing in one or both ears consistently since the vaccine. This has continued through today and I'll be heading to the doctors today for treatment.
46 2021-05-10 lip swelling had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills;... Read more
had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
46 2021-05-14 ear discomfort, ringing in ears states she cant sleep; cant concentrate; tinnitus, ringing of ears; Ear fullness; Tingling in right ... Read more
states she cant sleep; cant concentrate; tinnitus, ringing of ears; Ear fullness; Tingling in right side of face, around eye and cheeks and everything; This is a spontaneous report from /Medical Information received from a contactable nurse reporting for herself A 46 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206) on 21Mar2021 at single dose via an unspecified route of administration on right deltoid for COVID-19 immunization. Relevant medical history included ongoing autoimmune disease from 2016 (diagnosed about 5 years ago). Concomitant medications were not reported. On 21Mar2021 the patient experienced Tingling in right side of face, around eye and cheeks and everything, started little bit the day of vaccination and then just kept going and got gradually a little bit worse. The events was considered as medically significant. On 23Mar2021 the patient started complaining ear fullness, started to get full like feeling in ear, like plugged under water kind of thing described as ongoing as improved slightly but it comes and goes (as such). The event was considered medically significant. On 27Mar2021 the patient also started experiencing tinnitus, clogged/plugged ears and ringing in the ears. The event was considered medically significant. This was not going away, she also mentioned can' t sleep and can' t concentrate. Patient also informed that she is part of a huge online Support group (1500-2000) for people who have developed tinnitus after covid vaccination with either of Pfizer, Moderna or Jansen and Jansen Covid vaccine. Patient declined to provide information on the persons other people who were experiencing the same symptoms, hopefully, those persons call Pfizer on their own. She also informed that was not be getting her second dose (as such). The patient recovered from 'Tingling in right side of face, around eye and cheeks and everything' on an unspecified date in Mar2021, was recovering from ear fullness, while have not yet recovered from tinnitus, ringing of ears. At the time of the reporting outcome of other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event "tingling in right side of face" with BNT162b2 can not be fully excluded. The association between the events "ear fullness" and "tinnitus" with BNT162b2 can not be fully excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-05-17 eye disorder Left eye started going crossed/turning towards nose on first day of side effects. Next day, both eye... Read more
Left eye started going crossed/turning towards nose on first day of side effects. Next day, both eyes would cross/turn into nose at different times through out the day. Called Neurologist, office stated to go to ER at Hospital to have an MRI. Was admitted to hospital. Ran multiple tests, CT and MRI. NO new lesions on MRI from MS. Doctor stated possible Myasthenia Gravis (MG). Appointment with Dr at Institute. Doctor did not agree with this was MG. Suggested botox injections into eye muscle. No relief from eyes crossed after 3 weeks. Dr stated possible Myasthenia Gravis after first stating he doesn't believe it to be that. Started Pyridostigmine to combat MG on 5/7 at half dose. No relief. after 1 week. Dr increased to full dose 5/14. No relief as of 5/18
46 2021-05-18 inability to speak anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations... Read more
anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed. No further information expected.
46 2021-05-19 ringing in ears I had my second dose of Pfizer vaccine on April 12, 2021. Approximately April 14, 2021 I began exper... Read more
I had my second dose of Pfizer vaccine on April 12, 2021. Approximately April 14, 2021 I began experiencing ringing in my ears that in constant since that time.
46 2021-05-25 eye swelling numbness and tingling on right side of face and in right arm and shoulder.; numbness and tingling on... Read more
numbness and tingling on right side of face and in right arm and shoulder.; numbness and tingling on right side of face and in right arm and shoulder.; tingling on right side of face and in right arm and shoulder.; swollen right eye; nausea; severe headache; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH6198; DOSE NUMBER: 1) via an unspecified route of administration on her left arm on 06Mar2021, as single dose for Covid-19 vaccination (at the age of 46 years). Medical history and concomitant medications were not reported. No other vaccines were administered within four weeks. The patient has allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 20:00 (reported as 6 days post-vaccination), the patient developed nausea, swollen right eye and severe headache that had persisted for several days then. On 15Mar2021 (reported as day 3), the patient developed numbness and tingling on right side of face and in right arm and shoulder. The patient underwent Computed Tomogram (CT) scan and Magnetic Resonance Imaging (MRI) (dates and results not reported). The patient received treatment for the events (treatment details not reported). She was taken to emergency room due to the events. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.
46 2021-05-26 vision blurred Blurred Vision
46 2021-05-27 eye irritation, eye swelling Burning eyes. Left eye worse than the right. Left face and eye swelling. Rash on face, neck. Random ... Read more
Burning eyes. Left eye worse than the right. Left face and eye swelling. Rash on face, neck. Random spots of rash on body
46 2021-05-27 swollen tongue Pt c/o "tongue feeling thick" while sitting in observation area after receiving the Covid vaccine. N... Read more
Pt c/o "tongue feeling thick" while sitting in observation area after receiving the Covid vaccine. No shortness of breath, chest pain or trouble breathing. No drooling or trouble swallowing.
46 2021-05-28 ringing in ears, eye itchiness, eye irritation I had COVID-19 (diagnosed on 1/7/2021) and the main symptom I had was a total loss of sense of smell... Read more
I had COVID-19 (diagnosed on 1/7/2021) and the main symptom I had was a total loss of sense of smell. I got the Pfizer vaccine on 3/9 and 3/30/2021 because it was available to me. I started having symptoms of irritated eyes (at the bridge of my nose), tinnitus, sensitive teeth (upper and lower) when eating or drinking and even when not eating or drinking, itchiness around my jaw line and upper arms after the second dose of the vaccine. I thought it was seasonal allergy-related, so I took Allegra for a couple of weeks, and then asked my PCP about a Kenalog shot on 4/15/21 for seasonal allergies. After the Kenalog shot, my symptoms heightened (itchy upper arms and eyes) mostly in the morning upon waking. I started taking Benadryl, and took the lowest dose 3 times per day from 4/17 to 5/20. I went to an acupuncturist on 4/28, 5/8 and 5/22 with some herbal tea formula prescribed. I went to an allergist on 5/27/21
46 2021-05-28 vision blurred Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Within 40 minutes o... Read more
Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Vision blurred; Body grew heavy feeling; Cclumsiness of movement; This is a spontaneous report received from a contactable Other Health Care Professional. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number; EL9262 and Expiration Date was not reported) via an unspeci-fied route of administration in Arm Left on 21Jan2021 15:00, as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, diverticulum, asthma all from an unknown date and unknown if ongoing. Concomitant medication(s) included liothyronine sodium (CYTO-MEL); levothyroxine sodium (SYNTHROID); ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN LO) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers, vision blurred, body grew heavy feeling, clumsiness of movement. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.
46 2021-05-31 taste impairment, swollen lips Metallic taste in mouth shortly after getting shot, and a raw spot feeling inside upper lip on right... Read more
Metallic taste in mouth shortly after getting shot, and a raw spot feeling inside upper lip on right side.
46 2021-06-01 ringing in ears, visual impairment, tunnel vision, extreme sound sensitivity Same day as vaccine, felt adrenaline rush, heightened level of energy the rest of the afternoon and ... Read more
Same day as vaccine, felt adrenaline rush, heightened level of energy the rest of the afternoon and evening. Two days following vaccine, I experienced some muscle coordination issues, dropping things, neurologically felt out of balance and slightly intoxicated. Explained to friends and family that I felt weird and not right in the head. Tiredness followed through next week, followed by extreme sensitivity to loud or high pitched noise. Started having multiple "brain zaps" or "brain fades" where I temporarily felt a rush of brief black, tunnel vision space, followed by panic attack ... left ear ringing at immediate onset. 10 days post vaccine, I had 6 hour episode of intense ringing in left ear. It subsided some and I slept well, very tired the next day. Scheduled appointments with my neurologist and ENT. Episodes resulted in tiredness/fatigue.
46 2021-06-03 gaze palsy Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: <5 min post dose patient noted feeling short of breath, numbness, dizzy, sweaty, shaky and then lost consiousness. I was able to catch her head so she didnt hit a hard surface. Patient was unresponsive for 10 seconds. She started to seize and her eyes rolled to the back of her head. After she regained consciousness she was moved into the pharmacy and laid down. Pt was given a cool towel and water.1st BP (112/70 & HR74), 2nd BP 15min later (110/70 & HR 84). After 45 min pt left with family member
46 2021-06-04 pain in jaw Numbness feeling on left side of body; sharp pain in jaw; This is a spontaneous report from a contac... Read more
Numbness feeling on left side of body; sharp pain in jaw; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: En8201), dose 1 via an unspecified route of administration, administered on Arm Left on 25Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, on 25Feb2021, The patient experienced numbness feeling on left side of body, sharp pain in jaw. No treatment was received for the events. The outcome of events was "recovered".
46 2021-06-07 ringing in ears Tinnitus Began one day after receiving the first shot and condition remains 3 weeks later
46 2021-06-08 thirst, ringing in ears fever; she is not able to hold herself up to walk; ringing in her ears/buzzing in her ears; pain in ... Read more
fever; she is not able to hold herself up to walk; ringing in her ears/buzzing in her ears; pain in her lower back has become stronger/pain in the lower back worsened; severe headache; she can't even stand; she can't walk; little bit of pain in her lower back; very tired; really thirsty; my lips felt like I had become dehydrated; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and Lot Number: EW0191) via an unspecified route of administration in arm right on 27May2021 15:00 (at the age of 46-year-old), as a single dose for COVID-19 immunization. Patient medical history included fever. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration in left arm on 06May2021 (at the age of 46-year-old) as a single dose for COVID-19 immunization. It was reported as patient stated that she received the second dose of the Pfizer Covid-19 vaccine on 27May2021 at 15:00. The next day she went to work but two hours later she had a severe headache, fever and some pain in her lower back. The next day she was fine but since yesterday the pain in the lower back worsened. Today she woke up with such pain that she can't walk, she can't even stand, she feel like she have a fever and a ringing in my ears. The day after the vaccine, she felt very thirsty, her lips felt like she had become dehydrated. She is also very tired. On 01Jun2021 it was reported as the pain in her lower back has become stronger, on 02Jun2021 it was reported as she is not able to hold herself up to walk today. She is feeling feverish and has ringing in her ears and buzzing in her ears. She also stated that the next day after receiving the vaccine she was really thirsty and feels like she's dehydrated. She took Ibuprofen. Her right arm didn't ache but she had the other symptoms. She had to get the COVID 19 vaccine because she works with a lot of people. She had to get the vaccine for work. She reports she has no other medical conditions and she only takes Ibuprofen if she has discomfort. She works as she normally does. These symptoms she had with the second dose are normal symptoms. She was told to treat her symptoms in her house. She has the symptoms listed above and pain in her lower back on the left side but now she can't support herself to walk. On the day after she received the COVID 19 vaccine she was thirsty and she felt tired and she feels buzzing in her ears. Outcome of events headache, Fever, really thirsty, Dehydration, Difficulty in standing, Unable to walk was unknown and not recovered for other events. Follow-up attempts are possible; Additional information is been requested.
46 2021-06-09 mouth tingling Patient started started having tongue was tingling and started to move down her throat. Continued to... Read more
Patient started started having tongue was tingling and started to move down her throat. Continued to monitor patient, patient later stated she could feell her throat closing but was not having trouble breathing, patient also started to fan herself. Ambulance was then called and patient help in ambulance while still conscious.
46 2021-06-09 thirst upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Sw... Read more
upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Swollen throat; Left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) as single dose via an unspecified route of administration on left arm on 11Mar2021 at 18:30 (at the age of 46-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that none other medications received by the patient within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not been diagnosed with COVID-19. On 11Mar2021 at 20:30, the patient experienced hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain and also reported left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin. The patient says no fever and it was a week after 1st dose and symptoms still existed and she felt like she was overdosed. The patient visited Doctor or other healthcare professional office/clinic and she reported the same to physician and waiting for response. Therapeutic measures taken was unknown. The clinical outcome of events hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain, left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin were not recovered. No follow-up attempts are needed. No further information is expected.
47 2021-01-05 eye pain Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous re... Read more
Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 02Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included COVID on an unspecified date. The patient's concomitant medications were not reported. The patient stated, "fever, fatigue, uncontrolled headache, eye pain, chill, joint pain. nausea. Get more worst and worst". The patient received treatment. The outcome of the events was not recovered.
47 2021-01-05 lip swelling Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain... Read more
Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain, no palpitations, no tongue swelling, no rash, no redness, no nausea, vomiting or lightheadedness, no diaphoresis, no Hives improved in 1 hour and with Benadryl
47 2021-01-06 vision blurred Mild throat swell, nausea, blurred vision
47 2021-01-07 dry throat Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside m... Read more
Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat. Then I began to have difficulty swallowing my saliva. And then the lump inside my throat started to feel larger and larger. By this time Dr had already injected me with Epipen and the pharmacist injected me with Solumedrol and I still felt as if I was having difficulty breathing and then I was taken to ER and I really can't remember too much after that. I was very groggy and then I was discharged from ED about 9:30 pm.
47 2021-01-07 mouth tingling, mouth tingling 12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling li... Read more
12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling like throat was swelling. Patient was taken to ED via wheelchair. Monitoring and BP @7:40 135/83 HR 72 Resp. 18. Under oBS at hospital, not admitted. *Initial dose reported symptoms of feeling sick with dose 1 but not to extent of second dose
47 2021-01-07 mouth tingling dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h... Read more
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
47 2021-01-07 swollen tongue tongue swelling; This is a spontaneous report from a contactable nurse. This 47-years-old female nur... Read more
tongue swelling; This is a spontaneous report from a contactable nurse. This 47-years-old female nurse reported that she received BNT162B2 (lot EL0140) 1st dose intramuscular at Left Deltoid on 28Dec2020 9:38 for COVID-19 vaccination. Medical history was none. Concomitant drug was not provided. The patient reported in the evening on 28Dec2020, she noticed her tongue swelling. She started to notice her tongue swelling shortly after dinner, probably around 6:30-7 in the evening. She was a little bit on pins and needles regarding this reaction. It happened quite a few hours later after receiving the vaccine. She was thinking should she go to urgent care or emergency room or not. Her tongue was still swollen but it seemed like over the week, the swelling had gotten better. However, the swelling came back. So really overall, the swelling hasn't gotten much better. She hasn't been drooling due to the swelling. She hasn't had issues with eating, drinking, swallowing or breathing. She just had ridges around her tongue. Her tongue felt a little bit heavy. The question she had was how long was this going to take before the swelling went away and was it safe her to take the booster shot (second vaccine)? The swelling was still persisting. The outcome of the event was not resolved.
47 2021-01-07 tongue discomfort, swollen tongue Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontan... Read more
Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown. Information on the lot/batch number has been requested.
47 2021-01-07 tongue itchiness Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over b... Read more
Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over body itching with no rash and mouth swelling, eye swelling. No SOB, or difficulty swallowing.
47 2021-01-08 swollen tongue, dry mouth, thirst Dryness in mouth immediately as vaccine was being administered. Within 2-3 minutes mouth, tongue and... Read more
Dryness in mouth immediately as vaccine was being administered. Within 2-3 minutes mouth, tongue and throat started to swell. 50 mg of Benadryl was given. Started to feel better but 45 minutes later swelling started back up. Dryness in mouth still there and water couldn?t quench my thirst. Escorted to Emergency department. Epinephrine shot given 40mg of prednisone, 20 mg of Pepcid and 10 mg of Zyrtec given. Given another 20mg of prednisone, 10 mg of Pepcid and 10 mg of Zyrtec 1.5 hours later. Release after 4.5 hours. Given 3 days of medicine previously given. Swelling started back up 6 hours later so I took 50 mg of Benadryl. Swelling continued every 6-8 hours. Mouth was still really dry but as long as I drank 100 oz of water a day I was ok. Tuesday I had a small fever and very achy. Went to doctor and he prescribed 20 mg of prednisone twice daily tapering off for 11 days, 10 mg of Pepcid and Zyrtec twice daily for 11 more days. Finished my medicine Saturday January 2nd. I have been feeling better but still have swelling occasionally.
47 2021-01-08 taste disorder About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did... Read more
About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very "fuzzy". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very"plastic" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.
47 2021-01-10 taste impairment Metallic taste in mouth for 5 to six minutes after injection. Body aches 4 hours later, able to s... Read more
Metallic taste in mouth for 5 to six minutes after injection. Body aches 4 hours later, able to sleep after 2 Aleve.
47 2021-01-10 mouth numbness, tongue itchiness ? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to... Read more
? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
47 2021-01-10 oropharyngeal discomfort Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of... Read more
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
47 2021-01-10 mouth tingling Within 1 minute after the injection I felt tachycardia and the tightness in my neck and an abnormal ... Read more
Within 1 minute after the injection I felt tachycardia and the tightness in my neck and an abnormal sensation in the back of my tongue. This lasted for about 20-25 minutes and then mostly resolved. I was monitored by the paramedics. I had normal vitals at the time of evaluation which was soon after notifying staff. After the 1st injection I had a similar episode, but I thought it was anxiety related.
47 2021-01-10 swollen tongue 3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went ... Read more
3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went home and had rash to stomach, thighs, tachycardia, pulse about 130, hypotensive, swelling to tongue, eyes. Called provider when she got home and took Benadryl. Provider advised Pepcid, Benadryl, steroids x6 days. She is feeling ok now.
47 2021-01-10 taste disorder At 4:43pm while in observation refers to itching in throat and bad taste in the mouth. Dr is notifie... Read more
At 4:43pm while in observation refers to itching in throat and bad taste in the mouth. Dr is notified who shows up immediately and evaluates, BP150/80mmhg Pulse 72/minute, Breaths 18/minute, afebrile, Communicative and alert in time place and space, not complications, is placed oxygen by nasal cannula at 3lt/min at 5:05pm by medical order be administered Benadryl 50mg IM in right deltoid under aseptic techniques and kept under observation, at 5:45pm goes out walking and in stable condition by medical order to her home in company co-workers, oriented at notifying any other event, verbalize understanding
47 2021-01-11 inability to speak Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of... Read more
Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of voice. Day after vaccination, Severe body pain - back, shoulders, hips, abdomen with Muscle aches, Headache, Mild Discomfort in chest and ribs when breathing, and General feeling of being unwell
47 2021-01-11 swelling of eyelid tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her a... Read more
tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
47 2021-01-11 swollen tongue, toothache tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole f... Read more
tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
47 2021-01-11 taste disorder At 4:43pm while in observation refers to itching in throat and bad taste in the mouth, Dr. is notifi... Read more
At 4:43pm while in observation refers to itching in throat and bad taste in the mouth, Dr. is notified who shows up immediately and evaluates, BP 150/50mmhg, Pulse 71/minute, Breaths 18/minute, afebrile, Communicate and alert in time, place and space, not complications, is placed oxygen by nasal cannula at 3lt/min, at 5:05pm by medical order be administered Benadryl 50mg IM in right deltoid under aseptic techniques and kept under observation, at 5:45pm goes out walking and in stable condition by medical order to her home in company co-workers, oriented at notifying any other event, verbalize understanding.
47 2021-01-11 ringing in ears Headache; fatigue and feeling run down; developed a clicking sensation in her right ear/ persistent ... Read more
Headache; fatigue and feeling run down; developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization, also reported as "for work." The patient has no medical history and there were no concomitant medications. The patient received the first dose of the COVID 19 vaccine on 22Dec2020. She was scheduled to receive the second on 12Jan2021, Tuesday. Since receiving the vaccine, the night of receiving it, she developed a clicking sensation in her right ear. It hasn't gone away. It was kind of like "when you have water in your ear." It is not popping like on an airplane. She can trigger it if she hums or makes her vocal cords vibrate. She can make it happen. It is not painful. She notices it a lot at night. It might be a eustachian tube thing. At first, she was wondering if it could be coincidental. She hasn't experience it before though. It could be related to a sinus thing. But she hasn't realized a sinus issue. She thought, by now it would have gone away. No one has looked in her ear though. She works in healthcare. She doesn't have a prescribing doctor. She got the vaccine at work. She noticed the clicking in the middle of night so she can't say an exact time of onset. She thought it might have been improving, but she thinks she is just getting used to it. She is less aware of it now. The patient asked if she should be seen by her HCP or have her ears checked out. She asked if the clicking sound that developed in her ear after getting the first dose of the vaccine was normal? It is persistent like "if you have water in your ear." It happens mostly at night but is happening right now. The patient further reported having the expected side effects of headache, fatigue and feeling run down since an unknown date. The patient has not recovered from the event "developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now." Outcome of the events "headache" and "fatigue and feeling run down" was unknown. Information on the lot/batch number has been requested.
47 2021-01-12 taste impairment Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart ra... Read more
Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart rate 100. 8:32 b\p 130/80 Heart rate 100 discomfort in neck back and headache. Reported she had a headache with the first dose. 8:50 states she is better and ready to go home. b\p 128/88 heart rate 90 Advised to seek medical help if symptoms worsen.
47 2021-01-12 lip swelling approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down... Read more
approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down to my hands and right side of my chest. Lips felt swollen but not visible to the eye. My right lower extremity had the same feeling as describe what happened to my right arm. I went to the ED of the hospital where I worked. This my second dose and I had the same experience with the first dose but on my left side.
47 2021-01-13 feeling of choking, feeling of choking Voiced tingling to throat/tightness in face. Discoloration noted to face/neck/chest. Red in color.... Read more
Voiced tingling to throat/tightness in face. Discoloration noted to face/neck/chest. Red in color. Voices s/s of reaction to previous dose (swollen tongue). Initial compliant begin @ 1248, entered observation @ 1242. Benadryl 25mg was given @ 1249. S/S, relieved around 1305. Voices no other s/s of distress. Cold compress also applied to help alleviate s/s. Denies SOB or trouble breathing. Voices allergies to Aspirin, Morphine, Phenergan, Erythromycin. Left observation @ 1310.
47 2021-01-13 ringing in ears, extreme sound sensitivity Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in lef... Read more
Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in left ear, severe sound sensitivity, headache, then myalgia, fatigue, brain fog and disorientation, low grade fever of 99.6. Was sent home from work. Had COVID-19 testing and was negative. Worked from home the next day and still had myalgia and then had gastric issues of nausea and diarrhea, low grade fever.
47 2021-01-14 dry throat Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then i... Read more
Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-01-14 lip swelling Pt reports lip swelling starting roughly 18 hours post vaccine.
47 2021-01-14 mouth tingling, mouth numbness 24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No S... Read more
24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No SOB, no swelling. 4 days later lips tingling. 7-9 days later random numbness and tingling of tongue, r. cheek, lips....comes and goes. No rescue medication used. No follow up pursued by patient.
47 2021-01-14 mouth tingling, mouth numbness approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to t... Read more
approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to take deep breath. Severe difficulty swallowing. Difficulty getting words out, then slurring of words/poor pronouncing of words. Foggy head. Poor balance.
47 2021-01-14 smell distorsion Change is related to sense of smell. Sweet aromas are not the same, the perception of sweeter aroma... Read more
Change is related to sense of smell. Sweet aromas are not the same, the perception of sweeter aromas is altered.; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) solution for injection, via an unspecified route of administration on left arm on 28Dec2020 12:30 at a single dose for COVID-19 immunization. The patient medical history included allergy to echinacea. The patient was not pregnant. Concomitant medications included vitamin b complex and glucosamine. The patient reported that a change was related to sense of smell. Sweet aromas were not the same, the perception of sweeter aromas was altered on 31Dec2020. No treatment was received. The patient underwent nasal swab and tested negative on 06Jan2021. Outcome of the event was not recovered. No follow-up activities are needed. No further information is expected.
47 2021-01-16 lip swelling, swelling of eyelid I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on m... Read more
I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on my back, swelling of my eyelids, and lips.
47 2021-01-17 lip itchiness, lip swelling, vision blurred I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my... Read more
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
47 2021-01-18 loss of smell, loss of taste Symptomatic with covid 12/22-started with just sinus congestion and fatigue. Progressed to fever, ch... Read more
Symptomatic with covid 12/22-started with just sinus congestion and fatigue. Progressed to fever, chills and body aches 12/25, coughing shortness of breath 12/26,loss of taste and smell 12/27
47 2021-01-18 taste impairment Metallic taste in mouth within minutes of injections, throat felt swollen at 40 minutes but both res... Read more
Metallic taste in mouth within minutes of injections, throat felt swollen at 40 minutes but both resolved without intervention. Diarrhea within 24 hours of shot. Runny nose that started 24 hours later and lasted for 24 hours.
47 2021-01-18 ear swelling Lymph node on the side of the injection, behind ear at base of head swelled about 1.5 hours after in... Read more
Lymph node on the side of the injection, behind ear at base of head swelled about 1.5 hours after injection swelled. within a few hours unable to turn head without pain. From base of head to back was so sore and for 24 hours hard to turn head..
47 2021-01-18 eye pain, bloodshot eyes Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mi... Read more
Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mid cheek and full face mild puffiness. Difficulty swallowing only for 5 min then sore throat since then. Nausea starting about 2 hours after. Left arm swelling and a lot of pain for a couple hours in the middle of the night and still very sore but better. Woke up with both eyes bloodshot. Feeling like my scalp was hot and tight for about a half hour but that went away.
47 2021-01-18 eye pain fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, we... Read more
fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, weakness, bone pain, abdominal cramps, loose stool--that had mucous and blood in it. Also had a small amount of vaginal bleeding/spotting not associated with her period. Multiple days of these symptoms.
47 2021-01-19 eye pain Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cra... Read more
Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cramping; Fatigue; Some sweating in the middle of the night; some pain behind her eyes; Shoulder area is sore; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 09Jan2021 11:00 in left arm at single dose for COVID-19 immunization. Patient take medications for mood and sleep with were very low doses. But she didn't have any medical problem. She took 10 mg of fluoxetine hydrochloride (PROZAC), 150 mg of bupropion hydrochloride (WELLBUTRIN) and 10 mg of doxepin for sleep. Yesterday after the vaccination towards the end of the day (09Jan2021 approximately 11 o' clock am), she developed a stomach ache about 5 pm and it went on throughout the night and she normally didn't have issues with her stomach. Maybe it was because she was hungry because she went ice skating with her son where they wore mask in the afternoon yesterday and she was feeling perfectly fine. But when she came home, she noticed her stomach started hurting at 5 pm and she wondered maybe it is because she was hungry. And after she ate it was still bothering her and then it got progressively worst in the middle of the night where it would wake her up periodically. But she was so fatigue that she was able to sleep still. But she noticed in the middle of the night that her stomach would wake her up because it was aching and cramping in the middle of the night. And then she also had some sweating in the middle of the night as well as some pain behind her eyes. And today (10Jan2021) she had some fatigue which she noticed was not usual, she had mild headache which she saw was a common side effect. And then in the morning (10Jan2021) some fatigue and weakness like when she walked to the bathroom it was hard for her to walk. And when she went to use the bathroom she had some loose stools which was not common for her unless at all she was sick or have eaten something that makes her stomach really sick which was very unusual for her. Her stomach was still hurting her, if she walked it will start getting cramped so she was sitting down. The only thing she toon this morning was 2 acetaminophen medicine tablets because she was having pain behind her eyes when she woke up. She was just going to say she had influenza type A and type B on several occasions. And these symptoms are similar to when she had type B influenza, which was not as difficult as type A. So this is, they seemed to be like a mild version of type B influenza which she had terrible stomach issues, diarrhea and fatigue and pain behind the eyes from type B influenza. She had not any sickness because she work from home and she had limited field contact. So, she hadn't had illness from past year now. Because she worked from home. She provided mental health counselling remotely. So, she didn't think it could be attributed from anything else. The left on arm which was up toward like shoulder area and it was sore but it was tolerable in Jan2021. Outcome of stomach ache/stomach cramping was not recovered, and outcome of other events were unknown.
47 2021-01-19 lacrimation increased fever, sweats, body aches, headache, watery eyes fever sweats started at 3:30 am. Body aches 5:00am ... Read more
fever, sweats, body aches, headache, watery eyes fever sweats started at 3:30 am. Body aches 5:00am along with headache and constant watery eyes. Difficulty taking deep breaths due to muscle soreness in back and ribs
47 2021-01-19 mouth tingling Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt h... Read more
Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt her legs shaking and tingling on her top lip. She came back to the vaccine clinic and asked to be monitored. Vital signs taken 138/90, HR 109 POX 100 RA. Continued to have tingling upper lip and brought to ED for further observation. Warm hand off to ED RN
47 2021-01-19 mouth tingling Tingle in tongue Fullness in throat
47 2021-01-19 taste disorder, smell distorsion, taste impairment Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my... Read more
Injection site slight red and swollen for a day; Injection site slight red and swollen for a day; my taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten.; everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten.; taste was bitter; This is a spontaneous report from a contactable Nurse (patient). This 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), on 07Jan2021 at 10:00 AM in right arm at single dose for COVID-19 immunisation. Age at vaccination was 47-years-old. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 17Dec2020 at 02:00 PM in left arm (age of vaccination was 46-years-old). Medical history included hypothyroidism. Known allergies included metoclopramide (REGLAN) and tramadol hydrochloride (ULTRAM). Concomitant medications were unknown. The patient was vaccinated at hospital. No other vaccine was received in four weeks. The second injection was given in the AM. By the afternoon on 07Jan2021 at 04:00 PM noted that her taste was bitter. Then for the next 30 hours everything smelled and tasted like spoiled or rotting meat. Even water tasted rotten. No fever or chills. Injection site slight red and swollen for a day, no joint pain, no body pain. Outcome was recovering. No treatment was received for the events.
47 2021-01-20 dry mouth 10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and f... Read more
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous, and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
47 2021-01-20 mouth numbness Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 1... Read more
Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 102 fever, severe body aches, chills, stomach ache, and diarrhea. Took acetaminophen 1000 mg at 2 am. Stomach issues subsided 7 am, 20 hours after vaccine. Fever over 101, chills, body ache, and headache remained for 3 days. All symptoms have subsided except right side of face still tingling and numb.
47 2021-01-20 mouth tingling, mouth numbness Pt received Pfizer vaccine at 9:15 in left deltoid. At 9:30 pt complained of throat feeling itchy, a... Read more
Pt received Pfizer vaccine at 9:15 in left deltoid. At 9:30 pt complained of throat feeling itchy, and tongue feeling larger than usual and numb. Provider informed, provider assessment revealed no rash, no redness, no visible swelling of tongue, and patient reported an itch on right arm. Vitals 9:35 BP 126/70, HR 88, oxygen saturation 99% on RA, and respirations of 20/min. Vitals retaken at 9:40 BP 117/70, HR 75, oxygen saturation 98% on RA, and 20 breaths/min. Vitals retaken at 9:50 BP 115/71, HR 74, oxygen saturation 98% on RA< and 18 breaths/min. At 9:53 patient stated her throat is no longer itchy, and tongue no longer feels large.
47 2021-01-22 oropharyngeal discomfort, mouth discomfort Patient reports thickness on roof of mouth and back of throat. NP notified and 25mg Benadryl PO give... Read more
Patient reports thickness on roof of mouth and back of throat. NP notified and 25mg Benadryl PO given with good effect
47 2021-01-22 pain in jaw, ear swelling, ear pain Headache, muscle soreness within 30 minutes of leaving the site. Then within 2 hours body fatigue, n... Read more
Headache, muscle soreness within 30 minutes of leaving the site. Then within 2 hours body fatigue, neck pain, jaw pain and ear pain with swelling. Dr visit by Wed afternoon and meds to fight ear pain and swelling.
47 2021-01-24 eye swelling, eye disorder, eye itchiness, bloodshot eyes right eye shut/she couldn't open the right eye, it was glued shut completely; right eye red/ right E... Read more
right eye shut/she couldn't open the right eye, it was glued shut completely; right eye red/ right Eye being Red; mucus from throat, clear mucus; Right eye weeping; Right eye pink; She was super congested/she couldn't breathe through the nose; barely being able to sleep; Right eye itching/Left eye itching; red and swollen eyes/right eye swollen; itchy throat/itching of the throat/scratching in the throat; runny nose, clear mucous (post nasal drip); This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Left arm, via an unspecified route of administration on 07Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Sinus infection, Kidney stones, pink eye when she was a kid. The patient's concomitant medications were not reported. She reports the following side effects: itchy, red and swollen eyes, itchy throat, runny nose, clear mucous (post nasal drip). The patient experienced Right eye itching, red and swollen eyes/right eye swollen, Right eye pink on 08Jan2021 with outcome recovering, right eye shut on 09Jan2021 with outcome of received on 09Jan2021, itching throat, mucus from throat, clear mucus, Right eye weeping on 08Jan2021 with outcome of recovered/resolved with sequel on 11Jan2021, Left eye itching on 08Jan2021 with outcome of recovered on 09Jan2021, runny nose, clear mucous (post nasal drip) on 08Jan2021 with outcome of recovered on 11Jan2021, right eye red/ right Eye being Red on 09Jan2021 with outcome of recovered on 09Jan2021. The patient got her First shot on Thursday morning at 7:30AM, then on Friday night 08Jan2021 at 7 in the evening her right eye was itching and weeping, it felt like something was in the eye but there wasn't. The right eye was swelling as well on Friday. On Friday the itching of the throat started. She is also having scratchiness in the throat. Her eye is scratchy also. When she woke up Saturday 09Jan2021 she couldn't open the right eye, it was glued shut completely and red. When she was a kid, in the past she has had pink eye, and there was green stuff coming out the eye but this was not like previously. She had to pull the eye lids apart, maybe this is viral. With her throat, she has had sinus infection in the past before in which she couldn't breath out of the nose, but with this she is experiencing Mucus that is clear and thin from the throat. Her left eye itching started Friday night, but it was only slight itchiness and by Saturday the left eye was normal. She is purely doing this report to help, in case other people have this happen. Early today, she did use a Neti pot and it did help a little, she has had horrible sinus infections in the past but this is not it. In the past, once you get a sinus infection you are prone to getting them, thankfully she has not had one in a few years, she would get thick crap in the sinuses, in this case her eye was draining going into her nose, therefore making her have a runny nose, and she also had scratching in the throat. She is breathing clearly through the nose. Itching in the right eye was ongoing but less intense. Right Eye Swollen: She was looking at mirror hates looking at herself but the eyelid was back to normal, however the white part of eye is still swollen. Right eye being Shut: It is open now, that was a one day occurrence. Itching in the throat: She noticed that today at noon around 1 is when she last had it, it is 5% still there where she feels something. Mucus from Throat: She used the Neti pot a couple hours ago, at about 1:30 PM. Since then she has had some drainage but it is 95% better. Her Right Eye ball is still pink looking like as if she was hung over. The Left eyeball is white. Right Eye Weeping: She left work because her right eye was weeping so much, going into her nose, and she is running at work, she has glasses, goggles, face shield, and so she cant wipe the liquid. She came home and iced her eye which helped. Right Eye Pink: On Saturday the right eye was red. Right now it is pink, like an eye lash is in the eye. The right Eye being Red was only for Saturday, like sclerosis, it was red and swollen. The left eye was swollen, but it is better now from this morning. She was super congested on Friday (08Jan2021), barely being able to sleep, she couldn't breathe through the nose. Weird, she barely slept but it wasn't a sinus infection. She couldn't sleep because of nose running and the eye running then Saturday into Sunday she was able to sleep with eye running. The runny nose got better with the neti pot. She is schedule for the 2nd dose on 28Jan2021. The outcome of other events was unknown. Information on the lot/ batch number has been requested.
47 2021-01-24 lacrimation increased, swelling around the eyes, swelling of eyelid, bloodshot eyes Swollen face, eye lids , area below eyes and redness in eyes Water eyes, congested nose, slight head... Read more
Swollen face, eye lids , area below eyes and redness in eyes Water eyes, congested nose, slight headache
47 2021-01-24 light flashes or floaters in the eye Mild headache progressing to intense throbbing headache with flashes of white light, lasting for sev... Read more
Mild headache progressing to intense throbbing headache with flashes of white light, lasting for several hours, severe myalgias, high fever, episodes of delirium, right shoulder and right neck burning pain, chills, sweating, intense fatigue, rash on arms/stomach/back/thighs
47 2021-01-25 lip swelling, swelling around the eyes mild puffiness under eyes and on lip, mild sore throat, beginning about an hour after the shot and c... Read more
mild puffiness under eyes and on lip, mild sore throat, beginning about an hour after the shot and continuing to this writing
47 2021-01-25 bloodshot eyes, eye pain My left eye turned red. I went to the doctor on 12/21, 12/23 it was not better. I woke up in tears b... Read more
My left eye turned red. I went to the doctor on 12/21, 12/23 it was not better. I woke up in tears because it was so painful. I went to the doctor again, they said it looked like inflammation of the iris. On 12/26 is saw an eye doctor that said it was episquaritis. I had a follow up appointment on 01/11 with the eye doctor he found out I have nodular degeneration. I had a follow up on 01/25 and was referred to a cornea specialists. This all started post vaccine. I have not history of eye problems.
47 2021-01-27 ear pain, deafness, ringing in ears Hearing loss in left ear. Not complete but high pitch sounds. Ear has been ringing since onset. Came... Read more
Hearing loss in left ear. Not complete but high pitch sounds. Ear has been ringing since onset. Came on abruptly while sleeping at 5 am. There was pain initially. I am not sure if it is related as this did not occur until 1 week after I had the vaccine. However, I thought it was worth mentioning as the vaccine is so new.
47 2021-01-27 ringing in ears, ear pain Swollen lymph nodes in left armpit and left neck. Ringing and pain in ears. Ear pain started 2 hours... Read more
Swollen lymph nodes in left armpit and left neck. Ringing and pain in ears. Ear pain started 2 hours after vaccine. Swollen and painful armpit node started 1 day after vaccine.
47 2021-01-28 eye strain, visual impairment, vision blurred Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision;... Read more
Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; has pain in her rib cage close to the arm pit occurring mostly at night; hot at night; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). This 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left upper arm on 11Jan2021 at 11:00 at single dose for COVID-19 immunisation. Relevant medical history included knee pain. There were no concomitant medications. On 11Jan2021, the patient experienced "blurry vision; darkening in the eyes; I felt like something in my eye like heaviness" and in Jan2021 she experienced pain in her rib cage close to the arm pit occurring mostly at night and hot at night. The patient stated "I wanted to tell you that after the shot I was for 15 minutes sitting on a chair and I didn't feel anything and then I left and went for a walk and when I was walking by the gift shop at hospital, I noticed I just got blurry vision like when I looked at the stock, it kind of looked darkening in the eyes and blurry". She stated also "You know exact time I wouldn't tell but for the day like it happened first time near the store and later in the day when I was working, I felt like something in my eye you know like heaviness I don't know if that's blurriness but then runs away so like later yesterday I am fine and today I am okay". The patient also specified that blurry vision started 20 minutes after the vaccine and lasted 10-20 seconds and later during the day when she was reading. The patient also reported she was hot at night and has pain in her rib cage close to the arm pit occurring mostly at night. The patient did not receive corrective treatments; she just blinked and then she went and sit down, it never came back again. At the time of the report, the outcome of the events was unknown. The information on the lot/batch number has been requested.
47 2021-01-28 ear discomfort ears have been burning; she checked her temperature and it is lower than normal, her temperature is ... Read more
ears have been burning; she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit; feels like her ears are hot; low iron; it feels like someone is pouring ice on her back/ she finds herself so cold; chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) intramuscular on 30Dec2020 at, single for COVID. The patient had no medical history. There were no concomitant medications. The patient said that calling she was having a side effect that is not on the list of side effect. She does not know if it was from the chills but her ears have been burning ever since had the shot. She feels like her ears were hot. Can the vaccine cause this to happen? She clarified she was not having chills, it doesn't feel like chills, she said on the second day after the vaccine she had chills but right now it felt like someone was pouring ice on her back and she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit. Her ears have been burning. Her first dose was given 30Dec2020. That was another reason she was calling should she get the second dose if she was feeling this way. She said her ears began burning sometime last week and it has not stopped. Sometimes it will go away and come back but she find herself so cold she has to get under the covers and it takes forever to warm up. Today she put a hat and a scarf around her ears to warm up in doors. She has low iron. She doesn't know with her having low iron all her life and she has never experienced this before. Outcome of the event ears have been burning was not recovered while unknown for the other events.
47 2021-01-28 oropharyngeal discomfort, feeling of choking Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccinat... Read more
Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccination in her left arm. Within the 15-minute observation. She started developing a dry cough. She subsequently felt shaky, short of breath and felt a tingling in her throat. She states it feels funny when she swallows. She has noted tingling in her fingertips with associated discoloration. She has not noted any redness or swelling at the injection site. She has not developed a rash on her skin. She does have a history of COPD and uses inhalers and nebulizers. She has not tried an inhaler for the cough. She has had multiple medication allergies in the past including reactions to the Pneumovax and MMR. She denies chest pain. She has no abdominal pain. No nausea or vomiting. No leg pain. The patient presents to the emergency department after developing a cough, throat discomfort, shortness of breath and paresthesias following COVID-19 vaccination at 4 PM. She has no evidence of swelling of the lips, tongue or oropharynx on exam. She has no stridor or wheezing on exam. Her pulse oximetry readings are in the high 90s on room air. She received Benadryl, prednisone and a nebulizers treatment. She was observed in the emergency department for 2 hours and had improvement in symptoms. She was discharged in stable condition.
47 2021-01-28 taste disorder, smell distorsion Fever as high as 103, muscle aches, joint pain, nausea, change in smell and taste, headache, chills
47 2021-01-30 eye swelling, mouth numbness, lip swelling On Sunday morning I woke up with a mildly swollen right eye. I took Benadryl, but later developed h... Read more
On Sunday morning I woke up with a mildly swollen right eye. I took Benadryl, but later developed hives on my back, shoulder, and torso. Continued to take Benadryl that night. The next morning, Monday I woke up with continued hives on my torso, back, additionally on my bikini line area, and lower back area. I called my doctor's emergency line, to which I was instructed to continue with Benadryl, if it became worse, seek immediate medical attention. Tuesday morning I woke up with both arms covered in hives from shoulder of wrists, some on my neck and lower chin, swollen upper lip which also felt numb. I sought medical attention from primary care physician, Tuesday morning, by the time I arrived, the hives were also on my legs.
47 2021-01-31 pain in jaw Chest pain. Upper back pain, jaw pain, pain in opposite arm
47 2021-02-01 mouth swelling, mouth tingling, swollen tongue, taste disorder Almost immediately after the shot I could feel it/taste it in my mouth. I had some swelling/tingling... Read more
Almost immediately after the shot I could feel it/taste it in my mouth. I had some swelling/tingling of the tongue mouth. They had me wait the additional 15 mins. Did the pulse/ox. I was normal. Advised to take antihistamine, which I did when I got home. Felt better that day. On Friday, Jan. 29 I noticed a rash on my torso - stomach, back from bra line down to buttocks. I texted a pic to my friend who is a pediatrician. She said it looked pityriasis rosea. It doesn't itch. I also began having tingling on my tongue again. As of today, 2/2, I still have the rash and some tingling on the tongue. I've been taking a generic claritan in the morning and a benadryl in the afternoon and before bed. I also received a notice at work on Friday and a phone call from the county on Saturday that I may have been exposed to covid on Jan. 26. I have had none of the symptoms typical of covid. Just the rash and the tongue tingling. I called the number today. They advised I complete this form. I am getting a covid test tonight.
47 2021-02-01 mouth tingling Received shot at approximately 2pm and was in observation chairs. Around 205pm I took a dose of tyl... Read more
Received shot at approximately 2pm and was in observation chairs. Around 205pm I took a dose of tylenol to attempt to prevent fever. I immediately noticed that the medication felt stuck in my esophagus and it was hard to swallow them down. Being a nurse I began to monitor more closely my breathing. I was able to take air into my lungs easily. Next I noticed that my nose became very stuffy and was difficulty to breath through but my airway continued to seem ok and I was breathing without difficulty through my nose. By about 210pm I had noticed that my face felt strange. As another few minutes progress my entire face felt numb like when your dental lidocaine is wearing off. It was a very disturbing feeling. I never had difficulty breathing but the throat and nasal swelling lasted about 1 1/2 hours. The facial numbness lasted at least 4 hours and my nose and tongue still feel a little strange even at this moment. I stayed in the observation area for about 35 minutes just to make sure I was not going to lose my airway before leaving. I am a nurse and I didn't want to get sent to the ER for hours just to be given benadryl since my airway was ok so I didn't report it at the time of incident. I had preloaded with zyrtec, pepcid and ibuprofen the morning prior to injection to try and avoid reaction or side effects that others were reporting. I think if I had not had antihistamine in my system I would have had anaphylaxis for sure. I went straight home and took more antihistamine. Contacted my doctor so she knew of the symptoms. She told me to continue the antihistamines for a few days and to go to the ER if severe issue happened. This was a VERY VERY scary incident. For a little history: after my first vaccine I noticed itching on my chest but couldn't see any rash. About day 3-4 a rash appeared. I was unsure if this was vaccine related since it took 3 days to appear. It was cleared after a few days of steroid cream.
47 2021-02-01 visual impairment 1225- Patient reported nausea, visual spots, and fatigue after receiving second dose of vaccine to t... Read more
1225- Patient reported nausea, visual spots, and fatigue after receiving second dose of vaccine to the Nurse. She also reported that she had the same symptoms after receiving the first Pfizer vaccine. Vitals were taking and patient was monitored. Patient later starting vomiting in clinic. EMS was called and patient left via ambulance. Methodist ED contacted prior to the patient arriving.
47 2021-02-02 pain in jaw, ear pain right side neck pain, pain behind right ear and jaw with constant headache and heaviness in right e... Read more
right side neck pain, pain behind right ear and jaw with constant headache and heaviness in right eye. Symptoms started suddenly 5 days after vaccination without any trauma or change in my daily routine and are still present at this time. Pain relieved by Nsaids for about 4 hours then symptoms return.
47 2021-02-02 vision blurred Employee complained of itchyness, blurry vision, feeling dizzy 10 minutes after vaccine was injecte... Read more
Employee complained of itchyness, blurry vision, feeling dizzy 10 minutes after vaccine was injected, and then complained she feels burning sensation in her throat. Denies difficlty of breathing, headache. Transported to ED and treated with Benadryl. Took Benadryl for 3 days. Headaches lasted about 1wk and took ibuprofen. Employee reported she had hives for 3 days after her 1st dose. Took Benadryl. This wasn't previously reported to us.
47 2021-02-02 visual impairment, vision blurred I was disoriented & confused the day after I got my last vaccine shot. I didn?t know how to even se... Read more
I was disoriented & confused the day after I got my last vaccine shot. I didn?t know how to even send a text message. I?ve had a headache since I got the last vaccine, dizzy, blurred or abstracted vision.
47 2021-02-03 eye strain Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heav... Read more
Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heavy" and hard to keep eyes open. Also reported feeling like heart was "racing"
47 2021-02-03 eye discomfort Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ... Read more
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
47 2021-02-03 light flashes or floaters in the eye Itchy, lightheaded, high blood pressure, seeing stars, diarrhea
47 2021-02-03 swollen tongue Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressu... Read more
Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
47 2021-02-03 vision blurred Immediately upon having the injection administered, my heart rate sped up. I sat down within the wai... Read more
Immediately upon having the injection administered, my heart rate sped up. I sat down within the waiting area for monitoring thinking that if I sat down for a bit, that it would maybe pass . Within about 7 minutes of that, I began to feel the back, left side of my throat go numb. I began to get very dizzy after that and I alerted one the pharmacy Nurses, that was on duty. She asked for me to open My mouth so that she could see if my throat was swelling & said that she didn?t see anything and I was told by her that it may just be anxiety that I was experiencing and she asked me to take a few sips of water and to try and relax a bit. She resumed helping others, while I continued to sit there. It was then when I experienced a heavy onset of chest tightness and the inability to breathe. The left side of my face and jaw went numb & that?s when I really knew something was wrong. I was taken outside for some fresh air and realize that I was so nauseous, more dizzy, very weak upon standing and I told the same nurse and another young lady that was assisting me that I felt like I was going to pass out and to please call EMS for me . At that time, I lost temporary feeling in all 4 limbs and I began to experience heart palpitations . I was having some trouble swallowing and I was laid down and. My blood pressure was taken. Blood Pressure was 235/130 and it was taken several times until emts arrived. It was then 200/120 and 180/112 by the time help arrived. Overall I experienced burning sensation in chest and abdomen, facial weakness and numbness left side fever loose stools weakness, shortness of brEath and chest tightness blurred vision felt like I?m out of touch with reality Malaise restless and the loss in feeling in my Limbs are slowly returning body And muscle and joint aches and pains and wheezing bouts
47 2021-02-04 tunnel vision 2nd dose: Pt c/o "numbness down my arm and it feels cold down to my hand" left arm, "intermittent ... Read more
2nd dose: Pt c/o "numbness down my arm and it feels cold down to my hand" left arm, "intermittent numbness". Tingling felt like crawling ants on arm. "more numb in my last two fingers", "discomfort in nape of neck, lightheadedness, and tunnel vision". Patient given 8oz of fluids, PO. BP: 180/105. No medications administered. Transported to ED. Recovered night of 1/16/21.
47 2021-02-06 swollen tongue, mouth numbness, mouth tingling 2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w... Read more
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
47 2021-02-06 ringing in ears 1st Vaccine: soreness in upper arm 2nd Vaccine: Chills, fever, body aches, muscle aches, nausea, ... Read more
1st Vaccine: soreness in upper arm 2nd Vaccine: Chills, fever, body aches, muscle aches, nausea, dizziness, lethargic, hissing noise from my right ear
47 2021-02-07 loss of taste Loss of taste; This is a spontaneous report from a contactable pharmacist (patient). A 47-year-old f... Read more
Loss of taste; This is a spontaneous report from a contactable pharmacist (patient). A 47-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 21Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were none. No known allergies. There is no other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. The patient previously took the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 31Dec2020 14:30 at a single dose for covid-19 immunization. The patient experienced Loss of taste on 22Jan2021. There is no treatment received for event loss of taste and no covid test post vaccination. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
47 2021-02-07 inability to speak #1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surf... Read more
#1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surface of the skin, then it was black and blue. From start to finish from the redness to the bruising was about 3 days. #2 Sore throat, followed by hoarseness and then ultimately loosing my voice, body aches, headache, fever and chills with the fever lasting 4 days and ranging from 99.5 to 106.1. Also have had a runny nose, followed by congestion with a course and constant productive cough. I still have all the symptoms listed above today 02/08/2021 except the fever, chills and body aches.
47 2021-02-07 dry mouth Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushe... Read more
Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushed feelings. Patient stated she did not eat breakfast and has not been drinking water. Patient also states she has a history of panic attacks, anxiety, IBS, Cevo. Patient did have c/o a slight headache however, felt it was due to lack of water intact today. Patient sat for remaining 30 minute observation with nurse and provider on duty and was given water. At the end of the 30 minutes patient had decreased symptoms and stated her husband drove her. Provider gave ok for patient to take a prescribed Lorazepam when arriving home today. Patient discharged home after 30 minute observation period was complete with husband.
47 2021-02-07 visual impairment Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (cli... Read more
Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (clinic) extended by per RN. VS assessed frequently. EMS called due to patients condition not improved but worsening and transported to ER. Patient noted similar reaction with first vaccine. Patient had COVID in September.
47 2021-02-08 double vision, visual impairment Visual problems, diplopia, concerns for left 4th cranial nerve paralysis
47 2021-02-09 loss of taste Chills started by 2 pm on 2/9/21; extreme chills and shaking by 4 pm. Body aches , low fever, joint ... Read more
Chills started by 2 pm on 2/9/21; extreme chills and shaking by 4 pm. Body aches , low fever, joint pain, and fatigue came after. By 7 pm, I had all of these symptoms, plus nausea and no taste. Today (2/10/21) by 4 pm, the chills and low grade fever were gone but still have body aches, joint pain, and fatigue.
47 2021-02-09 taste impairment, smell distorsion Immediate dysosmia and dysgeusia; Immediate dysosmia and dysgeusia; This is a spontaneous report fro... Read more
Immediate dysosmia and dysgeusia; Immediate dysosmia and dysgeusia; This is a spontaneous report from a contactable other health professional (patient herself). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: 31Mar2021), via intramuscular route of administration in the left arm on 28Dec2020 17:00 at a single dose for covid-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced immediate dysosmia and dysgeusia on 28Dec2020 17:30. The events were reported as non-serious and no treatment was received for the events. The outcome of the events was unknown. The patient had not been tested for COVID-19 since the vaccination.
47 2021-02-09 taste disorder, loss of smell, loss of taste Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the tas... Read more
Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events. Information on the lot/batch number has been requested.
47 2021-02-10 lip swelling Angioedema the following morning [ my lips were swollen +3] . No treatment sought .
47 2021-02-10 vision blurred My blood pressure which has been stable became elevated. I experienced severe headache for a full da... Read more
My blood pressure which has been stable became elevated. I experienced severe headache for a full day, a little blurred vision, bp 160s / 100s. My bp remained elevated for several days, is normal today at last check. I saw my primary care provider yesterday and we are monitoring things for a week to see if this passes. If not further testing or medication adjustments may be needed.
47 2021-02-15 eye swelling With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose ... Read more
With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose I had severe fatigue, joint pain, my wrist and my armpit was budging, I noticed swelling my clavicle on my left side, chills, and dizzy. I had to miss work for 2 days. I had to lay bed in for 2 days. By 3rd it was much improved but I still feel weak. About 4 days after receiving the vaccine I was back to feeling my self. On 2/14-15/2021, my face was itching, I scratched it, and there is a small abrasion. My face started to swell, around 2AM this morning I had to go to the ER because my eyes were getting small, the swelling was getting worse. I also had bumps that looked like hives on my face, there was some fluid coming out of my face. I went to early this morning, The ER doctor said she thinks it is not infected she thinks it is inflamed. I did not mention that I had recently received the COVID vaccine and did not realize that it may be linked to the vaccine until later in the day. She prescribed Hydrocortisone 0.5 % cream and Mupirocin 2% cream. Since I have been home the ER the swelling has worsened. My face is painful, it feels like an orange peel when you touch.
47 2021-02-16 hearing loss, ear pain I have dizziness, diminished hearing, headaches, vertigo and ear pain.
47 2021-02-16 swollen tongue, oropharyngeal discomfort roughly 30 minutes after injection, you started to notice difficulty swallowing, tongue swelling. ... Read more
roughly 30 minutes after injection, you started to notice difficulty swallowing, tongue swelling. took benadryl which improved tongue symptoms, but throat still felt different x 3 hrs. back normal 10-12hr after injection.
47 2021-02-17 swollen lips My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, g... Read more
My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, gums, and inside lips); sores in nostril; sores on nose and lips; sores on nose and lips; Face swelled significantly on my left side; pink eye; severe headache; sinus pain; jaw main and numbness in my molars; severe shooting nerve pain in my front teeth; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 18:45 at a single dose for covid-19 immunization. Medical history included breast cancer survivor as of 11Sep2019. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), clonazepam, anastrozole (ARIMIDEX), vitamin D3, calcium, vitamins NOS (MULTIVITAMIN), "It Works" and "Fat Fighter". The patient previously took fentanyl but had allergies. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph node in her neck swelled to the point it stuck out like a robin egg. It was mentioned that it was more swelled there as well and super sensitive to touch. These reactions occurred only on left side of her face, sores in mouth (roof, gums, and inside lips) and sores in nostril. She had sores on nose and lips. The patient mentioned that her face swelled significantly on her left side. She had pink eye, severe headache, sinus pain, jaw main and numbness in her molars, severe shooting nerve pain in her front teeth. The events were considered as non-serious and adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. The events required treatment for the adverse events that included Keflex, Bactroban, prednisone, Valtrex, and lidocaine viscous-aluminum &magnesium hydrAM. The outcome of the events was recovering.
47 2021-02-17 thirst Left axillary lymph node swollen . Sleep paralysis. Tired. Dizzy, hungry thirsty.
47 2021-02-18 swollen lips, mouth itchiness, mouth tingling The roof of my mouth began it itch the next couple of day my mouth broke out into small red bumps on... Read more
The roof of my mouth began it itch the next couple of day my mouth broke out into small red bumps on the roof of my mouth and them on the tip of my tongue, on the inside of my top and bottom lip as well. The itching in my mouth started almost immediately but i disregarded it. When the bumps began I began to get concerned hoping it would clear up in a day or so. It has not. I used some meds i had at home for trash but it is not helping much. Everything I eat if it contains salt it burns as well as sodas. My lips are tingling and jumping
47 2021-02-18 ear pain Symptoms: Headache, Nausea, Fever, Aches, Chills, Ear pain, Swollen glands, Fatigue
47 2021-02-18 eye discomfort 12 pm felt woozy and mild headache and blood pressure spiked 4 pm nauseous and woozy something not ... Read more
12 pm felt woozy and mild headache and blood pressure spiked 4 pm nauseous and woozy something not right headache got worse 6pm arm started to hurt, headache got worse and so did nausea 10 pm whole body started to ache and chills with major headache and throwing up 4am next day 17th pain through whole body and headache so bad I was dizzy throw in up still 17th hard to walk from total body pain and headache 18th and 19 terrible headache pressure on whole head and neck can?t move neck. Eye pressures
47 2021-02-18 mouth discomfort After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 4... Read more
After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 48 hours of the second injection on 1/8/2021, I had angioedema facial swelling on the lids of my eyes bilaterally, facial burning- lips, nose, and right side of face, as well as the upper chest rash. Tried cool compresses, ibuprofen and rest however did not go away. Went to employee health, threw away all my make up incase, prednisone taper and antihistamine QD, eat clean, lots of water. The swelling went away after a few days of cool compresses and when on 10 mg of the prednisone taper, it came back. Went to PCP this time and gave me dexamethasone injection, prednisone taper, antihistamine BID and continue all other o
47 2021-02-18 mouth tingling Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15... Read more
Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15 hours later on Saturday morning. Highest fever 101.2. Symptoms lasted approximately 13 hours. Sunday morning woke feeling fine. On Monday morning I felt a tingle on my lip. By mid-day there were vesicles and by evening an apparent cold sore forming on right upper lip. Large cold sore still present 5 days later.
47 2021-02-20 swollen tongue throat and tongue swelled, but not enough to cause breathing problem, just enough to make it hard to... Read more
throat and tongue swelled, but not enough to cause breathing problem, just enough to make it hard to talk. Resolved after a week. Developed red, bumpy, itchy rash on back of both hands and lower arms. Ended up scratching to point of bleeding. Rash resolved after 2 weeks and benadryl. Felt irritable for a full week. NEVER felt fluish, just the swollen throat and rash on back of hands and lower arms and irritableness.
47 2021-02-21 loss of smell Loss of smell, high temperature of 104 degrees.
47 2021-02-21 swollen tongue, mouth numbness, taste impairment About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, stron... Read more
About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated. Received 50mg of Benadryl.
47 2021-02-24 visual impairment Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past menin... Read more
Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past meningitis event. Insomnia, vision changes, agitation. Prednisone is helpful in making pain bearable. Gabapentin started today. Labs pending.
47 2021-02-25 burning mouth syndrome Shot #1 12/18, Shot #2 1/15. 2 white lesion appeared on tongue on 1/25. No associated loss of taste,... Read more
Shot #1 12/18, Shot #2 1/15. 2 white lesion appeared on tongue on 1/25. No associated loss of taste, smell, ulceration, pain, fever. Remained unchanged. Perhaps increased tongue sensitivity. 2/17 photos evaluated by Derm colleagues, concern for COVID tongue, recommended ENT evaluation. 2/18 dentist full oral exam, concern for lichen planus, recommended ENT evaluation. 2/19 evaluated by ENT, concern for lichenoid reaction d/t vaccine. Oral topical steroids started (dexamethasone swish and swallow). Today is day 7 of 9 day course. Appreciable near resolution of lesions. Resolving tongue hypersensitivity.
47 2021-02-28 dry mouth, tongue itchiness, tongue discomfort, mouth itchiness, lip itchiness Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, foll... Read more
Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, followed by burning and itching on both sides of tongue. Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth. Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy. It was not anaphylaxis because my breathing was okay. We drove home, and I took two Benedryl (50 mg) upon arriving home. Within 2 hours all symptoms subsided with the exception of a nasty headache. Today, I am fine, but just have a sore arm at the site.
47 2021-02-28 mouth numbness, mouth tingling Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling trav... Read more
Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling traveled down to legs bilat. Approx 15min after that, tingling traveled into face around cheeks and lips bilaterally. Patient noted numbness around face and lips. Pulse 70, Resp 14, no BP taken due to equipment failure. Recommended patient seek further medical observation by ER or Urgent Care, patient verbalized understanding.
47 2021-03-02 lip swelling Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a cont... Read more
Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 31Jan2021 at 08:43 (at the age of 47-years-old) at single dose for COVID-19 vaccination. Medical history included seafood allergy (also happens when she gets seafood from, company name, it makes her lips puffy). Concomitant medications were not reported. The patient stated everything was fine except for some injection site soreness on 31Jan2021 that lasted about two hours then completely resolved. On 01Feb2021, the patient stated this morning her upper lip is a little swollen (puffy). The puffiness as if a 2 year were to head butt you and it left your lip puffy. The patient stated last night for dinner she ate ham which was a different brand than usual and was wondering if it may have had some preservatives in it that could have caused the lip swelling and did not have any lip swelling before she went to bed at 10 pm last night. The outcome of the event lip swelling was unknown. The outcome of the event injection site soreness was recovered on 31Jan2021 after 2 hours. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
47 2021-03-02 bloodshot eyes, eye swelling redness in face an neck/chest. Mildly swollen/red eyes. Developed within 15 minutes. Improved with... Read more
redness in face an neck/chest. Mildly swollen/red eyes. Developed within 15 minutes. Improved with 50mg benadryl. Stayed an additional 30 minutes after benadryl and symptoms continued to improve.
47 2021-03-04 mouth numbness The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I ... Read more
The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I thought it could be in my head. Throughout the evening after my shot I felt a bit of contracting of leg muscles and neck/shoulder muscles on the left side of my body. The left side of my face felt noticeably warmer than the right. This was all very mild, but just noticeable. In the middle of the night, I woke up with extreme night sweats but only on the left side of my body. The next morning (today) the left side of my face is still warmer but it feels droopy and bloated and slightly "Numbish". My left eyelid feels heavy. My left cheeks feel swollen and puffy and my left gums and lips feel slightly numb. I also have a very mild headache only on the left side. This is disturbing, while it is not debilitating or painful, it is strange and makes me think I should not get the next shot. Even as I type this, my left hand feels very fatigued. I don't know who to call or talk to about this. I do not have a health care provider.
47 2021-03-05 swollen tongue, thirst, tongue itchiness Heart rate increase approx. 4 minutes after injection. Tongue became swollen and itchy on the side s... Read more
Heart rate increase approx. 4 minutes after injection. Tongue became swollen and itchy on the side s of the tongue about 18 minutes after injection, with a difficulty in ability to swallow. Extreme thirst for about 1.5 hours following the injection. No difficulty breathing, no throat swelling.
47 2021-03-06 swollen tongue, mouth tingling Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst ... Read more
Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst point about 36 hours after injection: Swelling in throat, tongue, face, lymph nodes, generalized swelling (all the way to fingers and toes). Tingling in lips, tongue, face, scalp, left leg and left arm Shaking hands and racing heart, intermittently 48 hours later Entire left hemisphere of body want numb for about three hours. I freaked out and cried. *I had the vaccine in my left bicep, and I have a pinched nerve in that shoulder, which is teemed to activate. The nerve has never caused numbness beyond my left arm before, however, Last round of trembling about 48 hours after injection 72 hours later: Left tonsil and throat and armpit lymph nodes still swollen, but markedly less. Moderate numbness in left cheek and left side of throat, but less.
47 2021-03-06 vision blurred Nausea, blurry vision. BP 142/104 (pulse 82).
47 2021-03-07 hearing loss Facial numbness, tingling in the nose, right ear hearing affected. Consulted with doctor's office ov... Read more
Facial numbness, tingling in the nose, right ear hearing affected. Consulted with doctor's office over the phone daily on 03/03, 03/04, 03/05.
47 2021-03-09 eye itchiness, swelling of eyelid, bloodshot eyes Severe Rash, Itchy Red Swollen Eyes
47 2021-03-09 mouth numbness Within 5 minutes of receiving my vaccine, I suddenly felt the back of my mouth, throat, and back of ... Read more
Within 5 minutes of receiving my vaccine, I suddenly felt the back of my mouth, throat, and back of my tongue feel numb. I also felt a slight nausea. The sensation lasted for about a minute. I told the staff at the hospital that was observing me. It started to subside gradually, but twice while I was still being observed the sensation came back, but not as strong and not for as long as it did the first time. I had no other symptoms. I want to add that I was not anxious about receiving the vaccine and nothing like this has ever happened to me before, but it was quite alarming at the time. I was observed for an hour in total after the shot. I was offered to go to the ER if I wanted to but I declined. It is now about 3 hours since the shot and I feel ok now just slightly tired.
47 2021-03-10 swollen tongue Tightness of throat and swelling of left side of tongue
47 2021-03-11 deafness unilateral, permanent deafness Sudden sensorineural hearing loss that developed over the course of 3 days. Severe to profound heari... Read more
Sudden sensorineural hearing loss that developed over the course of 3 days. Severe to profound hearing loss in left ear. Responded well to intratympanic dexamethasone and oral steroids. Hearing fully recovered within 2 weeks.
47 2021-03-11 lip swelling, mouth numbness Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, ... Read more
Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, tightness in chest and throat, numb mouth and throat and chest, blood pressure very high, difficulty breathing, fever, PVCs (detected by EKG from EMS); benadryl 62.5mg then EMS arrived and gave IV steroid 125mg; EMS transported to ED where another 25mg Benadryl was administered and Pepcid 20mg; symptoms improved enough to discharge patient
47 2021-03-14 ear pain After my second vaccine, I developed severe right earache. It was inflamed and by the night my left ... Read more
After my second vaccine, I developed severe right earache. It was inflamed and by the night my left wrist had a rash that looked like shingles. I told my doctor about my symptoms and he suspected cellulitis. My doctor gave me ear drops and placed me on antibiotics. So my rash was still present and by the next day I experienced headaches and nausea and felt out of place. I called into work since I did not feel good. On Thursday 01-14-2021, I went back to work but now the same rash I developed on my left wrist was in my right ear. My ENT doctor did lab work and a culture test to check for herpes or shingles, both of these exams were negative and these symptoms lasted one week then they resolved.
47 2021-03-15 eye swelling "my side effects from the Covid-19 shot on 03/06/21. I had fatigue, nausea, stuffiness with sinus pr... Read more
"my side effects from the Covid-19 shot on 03/06/21. I had fatigue, nausea, stuffiness with sinus pressure, headache, and swelling of the eyes/face. These symptoms began a few hours after the shot and subsided by Tuesday. I used over the counter medication to treat the symptoms. It was not severe enough for me to feel the need to seek additional medical care. If it had worsened, I would have gone to the doctor"--copied from pt email
47 2021-03-16 eye pain Moderate headache, pain behind eyes, pain at base of neck, tired, joint pain
47 2021-03-16 mouth numbness Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower... Read more
Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower lip, tingling in hands and feet, consistent headache, fatigue, memory problems, and filling out of my body are all still occurring five days later.
47 2021-03-16 vision blurred, hearing loss This is a follow up report starting from day after that first report was made -Report # 244159 - Sta... Read more
This is a follow up report starting from day after that first report was made -Report # 244159 - Starting with the 17th of January - I was still having facial numbness/tingling/pressure in my head/feeling like head was going to swell; arms were so heavy - couldn't lift my arms - like a heavy pressure on my chest; breathing was a problem; Swelling in my head caused eye issues. 18th - tingling started on back of neck; affecting my hearing and eyes (swelling in head); a lot of cognitive challenges. 1-20-2021 - heart racing; itchy all over; blood pressure spikes. Heart can feel like it's too fast and then going too slow. 1-21-2021 - legs burning from waist to hip; chest pain; heart racing; struggling to breath. 1/22 - chest pain and discomfort - pain shooting through arms; didn't sleep well. Arms wanted to pull into my chest. Stomach cramping on 1/23 - stabbing pain in wrists and hands; left side on heart pain. Pain was like having a beating. Left knee pain - January 24 - up all night with shooting pain in arm; fine motor pain skills shot - can't do what I need to do. January 25 - Elevated heart rate; elevated blood pressure. 1/26 - vision challenges; fuzzy. Heart racing; feet swollen; face feels puffy doesn't look puffy - pressure/tingly feeling in left cheek. Ongoing and Changing symptoms every day/week - with no let up. 3/11/ - buckling of legs started. Big thing now is my legs are buckling (happening from the hips) - when I try to get up or walk. I haven't fallen yet but I know it's coming. 3/12/2021 - heavy weight back in the arms. I still don't have the fine motor skills. I still can't drive and don't have control over my body and reflexes enough. Still having Pressure in chest and the face and head swelling - is unbearable and affecting my vision. I will see a neurologist next month. Dr is not sure what to do. Jan 12 - first ER visit. I have specific notes/log on all of my symptoms each day. If anyone wants to call - please call on Mondays or Wednesdays only( or Saturday or Sunday.) Also, Menstrual cycle is wonky. I had a normal period before the vaccine - 12/28-12/31/2020 - but didn't have one in January and I had one in February 10th - but just one day; 3/11/2021 - I had my next one and it was four days long and fourth day was very heavy then all the rest of the days.
47 2021-03-18 dry mouth Extreme dry mouth noticed around 7:30 pm the evening I received the vaccination. This lasted about 1... Read more
Extreme dry mouth noticed around 7:30 pm the evening I received the vaccination. This lasted about 16 hours. Insomnia the first night after receiving the vaccination.
47 2021-03-18 extreme sound sensitivity, sensitivity to light Massive headache resulting in nausea, light sensitivity, runny nose, sound sensitivity
47 2021-03-18 lip itchiness, lip swelling, swollen tongue Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadry... Read more
Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadryl. Seemed ok after 45 post shot was allowed to leave drove home. Then about 1 hr post shot tight chest , itchy lips, puffy feeling lips, drive to urgent care, oxygen sat was 92 coughing swollen tongue gave myself epi, taken by ambulance to ER. Given more epi, Pepcid, steroids, Benadryl and Ativan. Was stable and discharged after 4 hrs. Next day very tired, throat sore lymph nodes swollen. Day 2 worse fever exhausted, sore muscles and joint pain. Increased Pepcid to 2 a day and 3 antihistamine a day. Day three increased steroids to 40 mg a day. Day 2 of increased steroids. Lymph nodes down , still exhausted, nausea, sore.
47 2021-03-19 vision blurred I am really concern because since yesterday I had blurred vision that is getting worse now, feels li... Read more
I am really concern because since yesterday I had blurred vision that is getting worse now, feels like on and off I am looking through eyelashes. I would like to know if this one will be temporary or if I should call a Doctor. I am also a Dialysis nurse at medical facility. Please let me know.
47 2021-03-20 smell distorsion, swollen tongue Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and to... Read more
Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and tongue have been swollen. I cannot be around certain smells because my tongue and throat start to swell.
47 2021-03-21 ear swelling, ear pain, sensitivity to light 1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body ac... Read more
1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body aches, extreme exhaustion, swollen throbbing ears, fever, nausea, and stomach ache went to bed woke up a 9 pm 102.5 fever barely able to function. Took Vicks 44 tried to sleep completely miserable. Took Tylenol to try to get fever down. Still so miserable I couldn't swollen because my ear pain was bad. My friend drove me to the nearest minor med. I couldnt tolerate any light, barely walk, dizzy and hurting all over. My lymph nodes started swelling up all over my body. I am still in pain and hurting , exhausted 5 days later. I have kept a constant headache, still exhausted, and can rest with pain meds.
47 2021-03-21 pain in jaw Patient states she is having soreness to her injection site and soreness up her arm, neck and into h... Read more
Patient states she is having soreness to her injection site and soreness up her arm, neck and into her left jaw.
47 2021-03-21 vision blurred, visual impairment Blurred vision, "seeing spots" throughout the day after the vaccination
47 2021-03-22 ear discomfort Horrible headache. Bad muscle pain stiffness, pain in throat. Burning in throat and ears, severe an... Read more
Horrible headache. Bad muscle pain stiffness, pain in throat. Burning in throat and ears, severe anxiety
47 2021-03-23 inability to speak, swollen tongue About 40 minutes after inject, had stomach upset, went to gas station across the street, then starti... Read more
About 40 minutes after inject, had stomach upset, went to gas station across the street, then starting having a tickle in my throat, then coughing, then wheezing, intense headache and sore throat pain like it felt like I swallowed pieces of glass then more wheezing and hard to breathe and losing my voice. Arrived at ER about 1 hour or so after injection time about 12:35 maybe?, they started IV of steroid, benedryl and pepcid rather quickly I don't remember a lot , was very out of it. But the medicine worked and swelling went down on tongue and throat and my voice came back. They prescribed steroids, benedryl, pepcid and zofran because I was and still very nauseous. Taking advil for headache. I think i was home by 4 or 4:30. Still feeling awful today.
47 2021-03-23 swollen lips Started developing a sore in the corner of my lip Friday night/Saturday morning (vaccination was on ... Read more
Started developing a sore in the corner of my lip Friday night/Saturday morning (vaccination was on Thursday morning). The little sores continued to emerge along my lower lip and continued to come out on the top lip. It?s almost following in a line across the middle of my upper and lower lip. The little sores hurt seem swollen and are red. They are all now forming little scabs and appears to be shingles.
47 2021-03-23 ear swelling After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe ... Read more
After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe 30seconds and immediately after that I had feeling of sinking as if l am going to die for 30 seconds and I was alright after.
47 2021-03-23 ringing in ears Chills nausea fatigue headache tinnitis soreness for 10 days
47 2021-03-24 taste impairment Stomach upset; Mid back hurting; Metallic taste mouth; Nausea; This is a spontaneous report from a c... Read more
Stomach upset; Mid back hurting; Metallic taste mouth; Nausea; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in arm left on 09Mar2021 at 07:58 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing gastrooesophageal reflux disease (GERD) and ongoing allergies from an unknown date. Concomitant medications included lansoprazole (PREVACID) taken for gastrooesophageal reflux disease, start and stop date were not reported. The patient got her first dose of the vaccine yesterday (09Mar2021) and immediately when she was given the injection, she had a metallic taste in her mouth. This lasted 10-15 minutes. She added, she has allergies and she told them that when getting the vaccine. She was told to sit for 30 minutes. She actually sat for 45 minutes instead, but that went away. She later clarified she was referring to the metallic taste that went away. She also had nausea throughout the day. Last night, she took medicine for acid reflux because she has GERD and had stomach upset from the nausea. She clarified she took PEPCID. Then after that, she noticed her mid back was hurting. She is not sure if this is considered a muscle ache, did not really feel like a muscle ache, but it was like a burning type of pain. This was in her mid-back area. It would like to start on one side and rotate to the other and go back and forth. She sent an email to the doctor. She is the one who suggested she get the vaccine because at first, she was not going to get it. The doctor talked her into it. Metallic taste in mouth she did not have after leaving the area. It was a different taste. She was unable to clarify outcome. It was just something she noticed. Nausea: Commented she also take lansoprazole (PREVACID) every day. Last night, she took PEPCID. From what she can tell this morning she has not had nausea. However, she has not gone through the full day yet so would say it's still ongoing, but better. PEPCID (Lot: MHF063, Exp: Mar2021) at 20mg tablet, as needed, for stomach upset. She commented she does not know if she will take the second dose. Stomach upset seriousness criteria was confirmed as medically significant. It has gone away, but medically significant because she did not feel it until after the shot. Mid back hurting seriousness criteria was confirmed as medically significant as it is significant to her even though she is not currently getting treated for it. She still feels the ache. Yesterday, it was like a burning ache. Today it is just an ache on her right side, but still mid back. She does not know if it is a muscle ache. The outcome of the events was stomach upset was recovered on 10Mar2021, Mid back hurting and nausea was recovering, while of metallic taste mouth was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of stomach upset and back hurting due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-03-24 mouth ulceration Developed mouth ulcers on left incide cheek and left side of tongue; Dentist thinks shingles; This i... Read more
Developed mouth ulcers on left incide cheek and left side of tongue; Dentist thinks shingles; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302), via an unspecified route of administration on arm right on 19Feb2021 00:15 at single dose for COVID-19 immunisation in hospital. The patient medical history was not reported. Concomitant medications included piper methysticum (KAVA); vitamin D [vitamin D NOS]; cetirizine hydrochloride (ZYRTEC) and ashwaganda. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed mouth ulcers on left inside cheek and left side of tongue on 22Feb2021 15:00. Dentist thinks shingles. Ulcers increased in pain and amount over the three weeks since the first vaccine. The events result in doctor or other healthcare professional office/clinic visit. The patient received treatment with unspecified antiviral medication. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. Later the patient received her second dose of BNT162B2 (Lot number: En6208) on 11Mar2021, on right arm. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown.
47 2021-03-24 feeling of choking, mouth numbness, mouth tingling first developed tingling in both hands, then developed numbness and tingling in lips, then palate, t... Read more
first developed tingling in both hands, then developed numbness and tingling in lips, then palate, then throat. She was given water, and while she could swallow, the water felt thick and her swallow felt off/weird. she was given IV benadryl and taken to the ER. There she was given steroids and H2 blockers. She felt her symptoms resolve about 20 minutes later.
47 2021-03-24 swollen tongue Tongue swelling with sores, burning sensation
47 2021-03-24 visual impairment I woke up this morning with a headache so bad that I can barely see out of my eyes. It feels like my... Read more
I woke up this morning with a headache so bad that I can barely see out of my eyes. It feels like my eyes are going to pop out of their sockets, the headache is that bad.
47 2021-03-25 ear discomfort vertigo like symptoms, dizziness rt ear
47 2021-03-25 ear pain 20 minutes after receiving the vaccine, I had a severe headache with pain in ears, itching and swell... Read more
20 minutes after receiving the vaccine, I had a severe headache with pain in ears, itching and swelling in my throat and increased heart rate. I took 10 mg of liquid cetirizine hcl oral solution which I carry with me. I waited an additional 25 minutes at the facility and the itching and swelling and heart rate diminished. I took 800 mg ibuprofen and 1000 mg Tylenol to treat the severe headache. About 30 minutes after that, my headache was much better. I went home and slept for 3 hours and felt almost normal thereafter.
47 2021-03-25 sensitivity to light 15 minutes after receiving her vaccination, she developed lightheaded and photophobia. She was take... Read more
15 minutes after receiving her vaccination, she developed lightheaded and photophobia. She was taken to a private section of the arena for monitoring. She had mild tachycardia with heart rate of 105 bpm. With subsequent monitoring, her HR normalized. After 20 minutes of monitoring, her symptoms fully resolved.
47 2021-03-26 taste impairment Metallic taste in mouth a few minutes after the first dose. About 3.5 hours later it?s still there... Read more
Metallic taste in mouth a few minutes after the first dose. About 3.5 hours later it?s still there less than the original taste, not as strong, but still preset at 7pm
47 2021-03-26 ringing in ears, ear discomfort humming in both ears and ear pressure/stuffiness. feels as though my ears are clogged
47 2021-03-27 taste impairment, smell distorsion Tingling in face, face numb, metal smell, metal taste in back of throat
47 2021-03-28 ear pain, lip swelling, ringing in ears, ear discomfort Minutes after injection, I developed pressure and pain in my ears followed by ringing. I was observe... Read more
Minutes after injection, I developed pressure and pain in my ears followed by ringing. I was observed for 30 minutes due to my prior anaphylactic reaction to a wasp sting. 40 minutes after injection, 10 minutes after leaving the pharmacy, I developed a welt-sized hive on my left foot. It was gone by the time I returned home. I then had hives on my left forearm. They went away with out treatment. At thas point, I had itching and swelling of the thumb on my left hand. That was somewhat painful. That was also the location of my wasp sting in July 2020. That also disappeared without any treatment from my of oinment or benadryl. I then found hives on my waist and stomach while lastly experiencing swelling on my lip. Again, this was all methodical almost over the course of 5-6 hours after injection. One hive would go away to have hives appear in another location. At 9pm that evening, I experienced sudden lower back pain on the right side and had difficulty walking due to the pain resulting from weight being placed on that side. My research suggested it was sciatica. I have no history of sciatica other than some discomfort during my pregnancies, the last of which was nine years ago. I treated this with 8oomg of ibuprofen and went to bed. Several hours later, I was awoken by the right leg shaking in my sleep. It was like a significant tremor. It stopped within a few minutes of me waking up. I was able to go back to sleep. However, I continued to experience sciatic pain on Sunday, March 28th and a bit today, March 29th. It has dissipated significantly and I am not functional. There was no repetition of the leg tremor after the initial and sole incident. I continued to have sporadic hives on my upper body on Sunday, March 28th. There are none present today, March 29th.
47 2021-03-29 blindness On 3/18/2021 at 7:00 pm I lost my vision in my right eye I went to the ER where they did blood tes... Read more
On 3/18/2021 at 7:00 pm I lost my vision in my right eye I went to the ER where they did blood test and Ct scan to my head and they send me to a different Medical Center because they don't have vision specialists. In the Medical Center they examine my vision and they recommended me to go to see Dr. at his office in the morning. Next day I went to the Dr. , he examined my eye and he told me there is a blood in my back eye and he recommend to see another Dr. I went immediately to the other Dr . and she diagnosed retinal vein occlusion and she gave me a shot in my eye
47 2021-03-30 lip swelling Full blown allergic reaction to vaccine within minutes of administration/redness all over her body, ... Read more
Full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 11Mar2021 (at the age of 47 years old) at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Clinic/Veterans Administration facility. Medical history included connective tissue disorder, high cholesterol, and chronic hip/labrum issues, all from an unknown date and unknown if ongoing. Patient was not pregnant. There was no COVID prior vaccination and not COVID tested post vaccination. The patient's concomitant medications were not reported. The patient previously received flu vaccine for immunization and experienced known allergies: flu vaccine. The patient experienced full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction on 11Mar2021. It was reported that the patient was taken to the ER by EMS for observation, treated and released, all on 11Mar2021. She took Benadryl at the vaccination site and was given prednisone treatment at the hospital. The outcome of the event was recovering. Information on the batch/lot number has been requested.
47 2021-03-30 mouth swelling Oral swelling , itching ,right side facial drooping. Taken to ER by staff in wheelchair
47 2021-03-30 ringing in ears Ringing in ears that started within the 15 minute wait time post injection. It waxes and wanes but i... Read more
Ringing in ears that started within the 15 minute wait time post injection. It waxes and wanes but it is still always present. Both ears. Hearing not noticeably impaired.
47 2021-03-30 vision blurred Fatigue, headache, fever, chills and blur vision left eye.
47 2021-03-31 loss of taste The night after the vaccine, Pt was very tired and achey and also had a strange taste in her mouth. ... Read more
The night after the vaccine, Pt was very tired and achey and also had a strange taste in her mouth. By 4/1 She loss her sense of taste and still experiences pain in her bones throughout her body.
47 2021-03-31 loss of smell, loss of taste Loss taste and smell 2 days post Covid injection.
47 2021-03-31 mouth numbness, mouth tingling PATIENT REPORTED TINGLING SENSETION ON TIP OF THE TONGEU AND ARM , , NO PROBLEM BREATHING. PT BP WA... Read more
PATIENT REPORTED TINGLING SENSETION ON TIP OF THE TONGEU AND ARM , , NO PROBLEM BREATHING. PT BP WAS CHECKED 3 TIMES, NORMAL, TONGUE NUMBNING GOT WORSE AFTER 15 MIN , WE GAVE 50 MG BENADRYL, BP STILL OK AFTER 20 MINUTES PT REPORTED NUMBNESS GONE REFUSED 911 HAD NO PROBLEM BREATHING , PT ADVISED TO CALL MD TOO
47 2021-03-31 mouth tingling, mouth numbness 5 minutes after receiving the vaccine my mouth started to feel numb and tingly, then my whole face f... Read more
5 minutes after receiving the vaccine my mouth started to feel numb and tingly, then my whole face felt numb and then I felt it rush through my body. They told me it was histamine being released in my body and that it was normal. The kept me only for the full 15 minutes. I had a dissolvable Zyrtec on me, so I took one 10ml. After about 45 minutes to 1 hr my face felt normal again. Until that time my face felt as if it was puffy and had a numb feeling.
47 2021-04-01 taste impairment, mouth tingling Nausea, sort of breath, tingling around lips with odd taste. Patient was given oxygen and Benadryl ... Read more
Nausea, sort of breath, tingling around lips with odd taste. Patient was given oxygen and Benadryl PO and reported complete resolution of symptoms at 9:25am.
47 2021-04-01 mouth numbness, swollen tongue, mouth tingling 03/11/2021-4:40pm-Pt called-rec'vd Pfizer vac at 1:15pm, in observation area L arm felt heavy, didn'... Read more
03/11/2021-4:40pm-Pt called-rec'vd Pfizer vac at 1:15pm, in observation area L arm felt heavy, didn't tell anyone, left the clinic, 3 pm, tingling up L arm, collarbone sore, 4pm mouth tingling, tongue numb/swollen, states same reaction w/ shellfish yrs ago, no shellfish since. Pt took fish oil, B12, Magnesium /Calcium citrate supplements for first time this am, instruc Pt to call 911 immediately, Pt called a clinic instead, has epi pen at home, decided to take Benedryl. 5:30pm tongue less swollen, Pt to consult with PCP re 2nd dose. 3/19/21- tongue remained swollen thru day 5/6. PCP told Pt reaction not vaccine related, ok'd to get 2nd dose. Pt plans to consult with son's allergist, will report back to PHN.
47 2021-04-01 lip swelling, swollen tongue Started 1 minute after vaccination. Started with nausea and chest pain and tingling in vaccinated ar... Read more
Started 1 minute after vaccination. Started with nausea and chest pain and tingling in vaccinated arm down to hands/fingers. Swelling at injection site. Then started to feel hot/sweaty. Swelling occurred in bilateral arms and fingers and weakness in the legs. No breathing issues but then reported swelling of lips and tongue. Gave 50mg Benadryl. Called EMS with consent
47 2021-04-01 mouth tingling Dizziness, Headache, Tingling in the mouth 112/70
47 2021-04-01 swollen tongue My tongue was swollen, my heart was racing. I thought I felt other things going on, but my mind was ... Read more
My tongue was swollen, my heart was racing. I thought I felt other things going on, but my mind was all over the place once my heart started racing.
47 2021-04-01 vision blurred Patient received the covid-19 vaccine, about 5 minutes after the patient starting having blurred vis... Read more
Patient received the covid-19 vaccine, about 5 minutes after the patient starting having blurred vision, at this point the pharmacy staff was alerted and the emergency kit was taken to the patient. The patient then started flushing and began swelling. Patient's vitals were normal but she continued to swell showing significant signs of allergic reaction. Patient was transported by ambulance to Hospital ER
47 2021-04-03 mouth numbness Moderate numbing of right side of face and tongue
47 2021-04-03 smell distorsion Phantosmia (very, very strong cigarette smell), constant until day 5, then intermittent , still have... Read more
Phantosmia (very, very strong cigarette smell), constant until day 5, then intermittent , still have symptoms every day but not constant, also had mild headache and fatigue day after, also developed "covid arm" one week after vaccine 4/3/2021. Redness, itching, swelling, discomfort at site of injection
47 2021-04-04 mouth tingling Patient had reaction to pfizer dose 1 where they experienced a funny taste, prickly tongue. Her tong... Read more
Patient had reaction to pfizer dose 1 where they experienced a funny taste, prickly tongue. Her tongue felt like she had eaten a lot of spicy food. All of this occurred at 9:45am, 7 minutes into her 15 minute wait. Benadryl was given by a Nurse at 9:47am. Patient observed for 30 minutes after benadryl was administered. She was then picked up by her husband. Patient was instructed to go to the ED if she experienced further symptoms. Also instructed to consult her PCP before scheduling her second dose appointment. Blood pressure was 139/95 (9:55am), then 144/89 (10:10am)
47 2021-04-05 ear discomfort I got sick as if I had the flu, or COVID itself ... raw/sore throat, stuffy head, stuffy nose, plugg... Read more
I got sick as if I had the flu, or COVID itself ... raw/sore throat, stuffy head, stuffy nose, plugged up ears, sneezing, coughing (still have cough as of 04/06/2021), chills, fever, and body ache.
47 2021-04-05 mouth numbness Patient describe "numbness of tongue". No respiratory distress observed. Patient vital signs assess... Read more
Patient describe "numbness of tongue". No respiratory distress observed. Patient vital signs assessed and found to be within normal limits. Patient reassessed and found to be within normal limits. She reported numbness went away. 11:10am: BP 131/82, HR 89 bpm, SpO2 99%, RR 14. 11:25am: BP: 121/76, HR 72bpm, SpO2 99%, RR 14.
47 2021-04-05 mouth tingling, feeling of choking, mouth numbness Tingling/numbing in the throat and tongue 4 hours post injection. Took 25mg Benadryl and symptoms di... Read more
Tingling/numbing in the throat and tongue 4 hours post injection. Took 25mg Benadryl and symptoms dissipated within 30 minutes. Symptoms reappeared in 4 hours. Took 25mg Benadryl and symptoms dissipated. Slept through the night, woke the next morning to milder, but similar symptoms (tingling/number throat and tongue). Contacted general practitioner and she advised not to take the second dose.
47 2021-04-05 thirst Tired, thirsty. Flushing/sweating - BP119/68 (pulse 65).
47 2021-04-06 blindness, deafness Slight loss of hearing, vision completely whited out, blood pressure dropped to 60/40. I felt very ... Read more
Slight loss of hearing, vision completely whited out, blood pressure dropped to 60/40. I felt very sleepy. This started about 2 or 3 minutes after the vaccine was injected. Medics started me on oxygen and elevated my feet. Attempted to start an IV (not successful because I have hard to find veins), checked blood sugar (normal) and did EKG (normal). After about 15 minutes my blood pressure returned to normal and I felt fine except for a headache. They wanted to send me to the hospital but I refused. My primary care physician advises me to not take the second dose of this vaccine.
47 2021-04-06 ear swelling, eye swelling, lip swelling 24hrs after - tired and minimal tenderness where shot was administered. 4 days after - woke at 1am ... Read more
24hrs after - tired and minimal tenderness where shot was administered. 4 days after - woke at 1am with itchy scalp, swollen ears and hives mostly upper body. Called Dr. and sent pictures and was told to take Benadryl. 5th day - woke to swollen eyes, upper lip and full body hives. Went to ER and was given IV, Benadryl and steroid and continued to take Benadryl and Prednisone for 5 day. Day 3 of Prednisone, hives had subsided.
47 2021-04-06 mouth numbness Felt fine during monitoring period. Went to auto and started feeling palpitation and then lips felt... Read more
Felt fine during monitoring period. Went to auto and started feeling palpitation and then lips felt numb. Returned to building, sat for a few minutes and felt better. Never had shortness of breath or any respiratory symptoms. PSO@100% b/p 138/88 resp 18
47 2021-04-06 lip swelling SEVERE HIVES HEAD FACE BODY HANDS ARMS, SWOLLEN LIPS TAKE TO EMERGENCY ROOM IV WAS GIVEN STEROIDS BE... Read more
SEVERE HIVES HEAD FACE BODY HANDS ARMS, SWOLLEN LIPS TAKE TO EMERGENCY ROOM IV WAS GIVEN STEROIDS BENEDRYL AND PEPCID
47 2021-04-06 bloodshot eyes, swelling around the eyes, swelling of eyelid One week after receiving vaccination patient woke up with swollen red eyes/puffy. No pain or itching... Read more
One week after receiving vaccination patient woke up with swollen red eyes/puffy. No pain or itching. No other subsequent swelling at time of assessment over the phone. No other explanation to symptoms besides vaccine per patient. Patient referred to doctor for follow up and instructed to call 911 if a medical emergency.
47 2021-04-07 mouth tingling tingling to roof of mouth and tongue
47 2021-04-07 ringing in ears Several mins after vaccine, patient began to feel weak. felt like she was going to pass out. has hx ... Read more
Several mins after vaccine, patient began to feel weak. felt like she was going to pass out. has hx of tinnitus, ringing in left ear intensified after injection. was diaphoretic and clammy. sat in med obs, drank some water, and felt better. 1630 bp 120/80 hr 82 rr 18 sats 95% on ra. 1647 bp 117/78 hr 82 rr 18 sats 96%. s/s resolving. 1700 escorted to vehicle with no issues.
47 2021-04-08 mouth swelling, mouth tingling, swollen tongue Tingling and minor swelling of tongue, mouth & throat
47 2021-04-08 swollen tongue Rash, Hives, Itching, Tongue swelling lasted 4 days - took high doses of benedryl; shoudld have gone... Read more
Rash, Hives, Itching, Tongue swelling lasted 4 days - took high doses of benedryl; shoudld have gone to urgent care.
47 2021-04-08 ringing in ears Instant, horrible Tinnitus. Very red, thick, vein-like mark in appreance, but not a vein, down fore... Read more
Instant, horrible Tinnitus. Very red, thick, vein-like mark in appreance, but not a vein, down forearm down from injection site. Hot to touch.
47 2021-04-09 ear pain About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up a... Read more
About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up as well as my hands. Then My right ankle swelled up. My face and hands had hives on them. My throat felt better, I thought but about 1/2 hr. Later I started wheezing and my right ankle and leg were swollen so, I went to the urgacare. They saw me but told me that I should've gone to the ER. I have a history of anaphylaxis. They gave me steriods and Benadryl via shots and sent me home with the same. I woke the next morning with a sore arm, a horrible headache and my face broke out into hives and was swollen again. Today is the 4th day after and my face still feels a little swollen, I have a headache and now an earache in my left ear. Today I also felt nauseous and couldn't eat.
47 2021-04-09 mouth numbness, taste disorder, feeling of choking Immediate taste and tickly/tingly feeling in back of throat that left tongue and back of throat feel... Read more
Immediate taste and tickly/tingly feeling in back of throat that left tongue and back of throat feeling a little numb. This all lasted a couple of days. Face and neck were itchy for a couple days. Face became red and splotchy 7 hours later but only lasted 30 min. Felt generally off for a couple days (tired, achy, nauseous, pain at injection site). Itchy rash and pain at injection site started 1 week later and lasted 3-4 days.
47 2021-04-10 taste impairment Patient reported difficulty swallowing and metallic taste in mouth within 15 minutes of vaccination.... Read more
Patient reported difficulty swallowing and metallic taste in mouth within 15 minutes of vaccination. BP 175/120. Patient was transported to ER by EMS.
47 2021-04-11 taste impairment, vision blurred I was starting my period (light spotting) and it just stopped after the first dose. That was Mar 9, ... Read more
I was starting my period (light spotting) and it just stopped after the first dose. That was Mar 9, 2021. I have not gotten my period since. According to the doctors as well as my menstruation cycles prior there were no signs or peri menopause or menopause. Additional symptoms: After the first dose: (lasted for 3 weeks) Extreme fatigue. (Sleeping 20 hours a day) Swollen joints. (Radiating pain from the occipital ridge downward through out the spine & the right knee). Constant pain in my neck, shoulders, hips. Brain fog. Blurry vision/vision changes and things looked like they were vibrating/jumping Numbness in my face Tasted metal in my mouth Nausea Diarrhea Loss of appetite Depression After the second dose (lasted 10 days) Entire left arm was in pain Swollen and stiff from left arm, base of my occipital ridge/top of spinal column , neck shoulders, all the muscles between my shoulder blades the day after. Starting on day 3, all the areas up and down my spinal column felt swollen, stiff and in pain. Dissipated after 10 days. I lost mobility in my hip joints. Swollen right knee ( I am still experiencing these 2 symptoms, 4/12/21). Fatigue Brain fog. Diarrhea. Nausea Loss of appetite
47 2021-04-11 ringing in ears Loud ringing in both ears
47 2021-04-11 vision blurred Patient received her second Pfizer Covid vaccine 4/12/2021 at 3:24 pm as noted in medical record. A... Read more
Patient received her second Pfizer Covid vaccine 4/12/2021 at 3:24 pm as noted in medical record. At approx. 3: 25 PM pt c/o dizziness, headache, severe nausea and blurred vision. She had beads of perspiration on forehead, and a cool cloth was applied to back of neck. Water was also given. B/P was 210/140 Left arm. Pt states she takes B/P medication but did not take it today. She states she last ate at 11 AM. Pt states she did not have any SOB or difficult breathing. Respirations slightly shallow. She states she did not have any untoward response to first vaccine. She also denies any numbness or tingling of lips, difficulty breathing or thickness of tongue, itching or double vision. She states she did have blurred vision initially but denies any at present. At 3:40 PM transported Pt to Emergency Department via wheelchair for further observation and care. Pt verbalized agreement and notified her spouse via cell phone.
47 2021-04-12 mouth numbness Wednesday Night I started feeling slightly dizzy with a seeming loss of equilibrium. When I woke T... Read more
Wednesday Night I started feeling slightly dizzy with a seeming loss of equilibrium. When I woke Thursday morning I felt a slight numbness and tingling in the left side of my face. My left ear felt "full" After my second dose on Saturday, April 3, at 8:35 a.m., Starting Wednesday, April 7 around 7:00 p.m., I experienced a slightly more serious facial tingling and numbness, including tongue on the left side. This feeling was continuous for several days and is currently coming and going. Tingling and numbness continues and my ear still feels full today, April 13
47 2021-04-12 swelling of eyelid Woke next morning with swollen eyelids, pink skin, itchy/tingling sensation on left side of face, pa... Read more
Woke next morning with swollen eyelids, pink skin, itchy/tingling sensation on left side of face, pain left arm/ache, pinching sensation in left side/middle of neck, fatigue. Eye swelling gone by end of day after taking shot. Have had continued lowered blood pressure, low pulse pressure, increased blood pooling in hands and feet, left leg pain (no swelling) behind the calf and upper inner thigh, left arm numbness that comes and goes particularly at inside wrist and top of shoulder front near armpit since the shot.
47 2021-04-12 swollen tongue It wouldn't let me add this, but it was my first Pfizer shot. I started feeling dizzy within the fir... Read more
It wouldn't let me add this, but it was my first Pfizer shot. I started feeling dizzy within the first 30 minutes, and didn't think much of it. Went home and just under 3 hours later, started to feel strange. I felt almost drunk, like my brain was fuzzy. Even more dizzy. Then my tongue swelled. I then had palpitations and felt my heart jump. The palpitations came and went a few times through the night. I couldn't sleep and experienced some slurring. I then took aspirin and tried to drink a lot of water. I felt scared so asked my parents to call every hour to make sure i was alive. I didn't think to call 911 because I felt so out of it. I had a mild headache that went from my forehead to the back, but it felt more strange than anytthing. The next morning my tongue had several bites all along the edges and top of the edges. I then got hives on my face, on Sunday, April 11. I took benadryl and put cortizone cream on. I took benadryl again on 4/12. I'm still dizzy and slightly short of breath. i have an appointment with an immunologist for thursday.
47 2021-04-12 ringing in ears Ringing in my left ear and a hallow sound... this has been happening on short intervals over the pas... Read more
Ringing in my left ear and a hallow sound... this has been happening on short intervals over the past 2 days
47 2021-04-13 swollen tongue hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa... Read more
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
47 2021-04-13 swollen tongue Dizzy; lightheaded; warm tingly arm; tongue swelling; fast heart rate; This is a spontaneous report ... Read more
Dizzy; lightheaded; warm tingly arm; tongue swelling; fast heart rate; This is a spontaneous report from a contactable Other HCP.A 47-years-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot noEL3247, Expiration date: unknown), via an unspecified route of administration anatomical location Right arm on 28Jan2021 12:30PM at single dose for COVID-19 immunization. Patient medical history included Hypothyroid, depression,add, Known allergies: Diflucan. Concomitant medication included Levothyroxine, Valacyclovir, Bupropion, Pepcid. On 28Jan2021 at 12:30 PM patient experienced Dizzy, lightheaded, warm tingly arm, tongue swelling, fast heart rate.resulted in: [Emergency room/department or urgent care] patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient was not diagnosed with COVID-19; Since and prior to the vaccination. The outcome of the events was Recovering
47 2021-04-13 swollen tongue Cheast pain , swelling of tongue, airways constricting , low blood pressure, emphiderphine .3mg ... Read more
Cheast pain , swelling of tongue, airways constricting , low blood pressure, emphiderphine .3mg administered, x 2 , ambulance called & transported to hospital
47 2021-04-13 tongue disorder 1135 RNs responded to vehicle 2 to c/o dizziness, numbness in hands, swelling nasal passages. Pt ale... Read more
1135 RNs responded to vehicle 2 to c/o dizziness, numbness in hands, swelling nasal passages. Pt alert, oriented, denies SOB. Benadryl 25mg PO ADMINISTERED PER 50 Driver moved car to front of lot. Pt reported further dizziness, headache, tongue becoming thick. 1145 RN contacted Dr. instructions to give another 25mg Benadryl PO
47 2021-04-14 ringing in ears, deafness unilateral Woke up w/ no hearing in my RT Ear for 1 1/2. Then ringing of the RT Ear. Only for a few minutes.
47 2021-04-15 eye movement disorder Started with tingling of fingers within 15 minutes of vaccination. Another 15 minutes patient develo... Read more
Started with tingling of fingers within 15 minutes of vaccination. Another 15 minutes patient developed tightness in throat and whole arm began to tingle. Patient seemed okay and then at 11:26 AM patient felt sick and felt like throwing up and dizzy then patient rolled eyes back into head. She was pale and clammy. Epinephrine was then given at 11:28 AM. Upon administration of epinephrine patient woke up and took a deep breath. She was then picked up by ambulance. Patient was oriented x 3. Vitals were stable (Oxygen 98 %. Heart rate was 68, BP 100/68).
47 2021-04-15 toothache Day 1 Nausea Dehydrated Headache Fatigue Felt heavy, freeze/stabbing pitch fork headache all day D... Read more
Day 1 Nausea Dehydrated Headache Fatigue Felt heavy, freeze/stabbing pitch fork headache all day Day 2 Headache Fatigue Arm pit itch Teeth pain and clinching (neurological uncontrollable) vertigo/dizzy Stiff neck sore muscles and joints Day 3 Fatigue Headache Day 4 Fatigue Ankles got really swollen Out of breath on just a walk Headache Shooting Pain in legs and feet Pain at past mohs surgery site Day 6 Agitated Nauseous Dizzy Headache Bells palsy like symptoms right side of my face
47 2021-04-15 visual impairment pt states vision dark and dizzy, feeling racing HR, and feeling warm all over, staff lowered pt to f... Read more
pt states vision dark and dizzy, feeling racing HR, and feeling warm all over, staff lowered pt to floor pt assisted self to stretcher laying down and taken to OBS. pt given water feeling better once laying down, VS as noted pt evaluated and feeling better pt concerned due to 12 yr old daughter outside in car by herself pt requesting to leave as soon as she can due to feeling better and her daughter in car, pt sitting up and then dangling at side of bed then standing and denies feeling dizzy or other symptoms as previously stated. discharged from OBS area ambulated to car without diffiuclty at 1011. VS 0959 bp 122/84 hr 66 rr 18 o2 100, 1004 sitting bp 131/83 hr 72 rr 18 o2 100 1007 dangling bp123/84 hr 70 rr 18 o2 100 1010 standing bp 110/89 hr 71 rr 18 o2 100
47 2021-04-16 ear pain Fever, fatigue, body aches/chills,-headache lasting 48 hours. Extreme dizziness, nausea, headache, ... Read more
Fever, fatigue, body aches/chills,-headache lasting 48 hours. Extreme dizziness, nausea, headache, fatigue, vertigo symptoms, (pain in right ear), loss of balance- lasting 10 days and continuing
47 2021-04-16 lip swelling, swollen tongue 3 minutes after injection, mild tongue and lip swelling, running nose, itchy throat, red splotches a... Read more
3 minutes after injection, mild tongue and lip swelling, running nose, itchy throat, red splotches and hives on chest and arms, mental confusion, and sudden extreme fatigue
47 2021-04-17 mouth numbness Numbing feeling on lower left side of face, lips, chin, and inside of mouth
47 2021-04-17 mouth tingling, swollen tongue April 17th 10:28 Took Vaccine 10:45 Reaction started with tightening of my throat and drank some wat... Read more
April 17th 10:28 Took Vaccine 10:45 Reaction started with tightening of my throat and drank some water 11:00 ish gums started swelling and lips tingling My hands and tongue started swelling and my face was warm 11:15 ish-took 25 mg Benadryl via shot 12:27-arrived at ER for monitoring 2:22-took Pepsid and steroid ( dexamethasone) orally 4:00-50 mg of Benadryl orally 10:00 pm- 25 mg Benadryl and Pepsid tablet April 18th Symptoms: ? Face flushed and stretched ? Face and neck itchy / small hives ? Mentally scattered ? Auras Headache 4:00 am - 50 mg of Benadryl oral 10:00 am - 25 mg of Benadryl oral 10:00 Pepsid 11:00 Tylenol 4:00 Tylenol 6:00 Benadryl 7:25 Imetrex
47 2021-04-17 vision blurred Blurry near and far vision. This was still occurring when I received my second dose on 03/31/2021 a... Read more
Blurry near and far vision. This was still occurring when I received my second dose on 03/31/2021 at same location. (Lot EP 6955) I continue to have issues with blurry vision. I did not have this issue prior to the vaccination.
47 2021-04-18 ear pain I have an ear ache, nasal sensitivity, eye pain, slight headache all on the left side of head, shot ... Read more
I have an ear ache, nasal sensitivity, eye pain, slight headache all on the left side of head, shot was in left arm.
47 2021-04-18 eye swelling, lip swelling Adverse effect from 1st dose of Pfizer vaccine for COVID: - swelling of head with hives, - swellin... Read more
Adverse effect from 1st dose of Pfizer vaccine for COVID: - swelling of head with hives, - swelling of face, lips, eyes - swelling of feet, - shortness of breath, chest tightness - extreme itching and rashes across all over body.
47 2021-04-18 swelling around the eyes, eye pain Swollen eyes. mostly right eye. painful to blink. Dr prescribed steroid eye drops to treat. fo... Read more
Swollen eyes. mostly right eye. painful to blink. Dr prescribed steroid eye drops to treat. follow up appt in 2 days.
47 2021-04-19 oral mucosal blistering Rash (burning and itching) then blisters on nose, around mouth, left cheek. Two days later same rash... Read more
Rash (burning and itching) then blisters on nose, around mouth, left cheek. Two days later same rash then blisters on right ear. Symptoms began one week after vaccine. First dose. Still experiencing burning and redness on ear but nose and mouth and cheek have cleared up.
47 2021-04-19 swollen tongue tongue swelling
47 2021-04-19 ringing in ears Tinnitus, rash and blister on right arm
47 2021-04-20 mouth swelling, swollen tongue, eye swelling Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-M... Read more
Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: pt reported slight swelling in throat but no trouble breathing, paramedics came and checked vitals and cleared, pt was monitored for an hour and given benadryl, symtoms went away and pt left
47 2021-04-20 pain in jaw, ear pain Neck pain/ spasm left sided - severe pain that lasted 1 week - moderate pain that lasted 2-3 additi... Read more
Neck pain/ spasm left sided - severe pain that lasted 1 week - moderate pain that lasted 2-3 additional weeks... mild issue still Left-sided - Ear / Jaw and face pain started about 20 mins after vaccine and lasted 3-4 days
47 2021-04-20 mouth tingling pt stated her mouth tingly, VS taken and WNL. Pt self administered epi pen. Rapid Response team call... Read more
pt stated her mouth tingly, VS taken and WNL. Pt self administered epi pen. Rapid Response team called. O2@2L given to patient to help calm her down. RRT transferred pt to ER for further treatment.
47 2021-04-20 sensitivity to light Tremendous pain, stabbing muscle pains, fever, chills, exhaustion, vertigo, sensitivity to light
47 2021-04-20 swollen tongue Patient Per Patient Email: "I see on the paperwork that we should contact you with any reactions ... Read more
Patient Per Patient Email: "I see on the paperwork that we should contact you with any reactions I did have some minor allergic reactions: ? My tongue swelled up ? My throat swelled up ? My throat felt / still feels sore ? The site of the injection is sore and swollen After my 30 minute wait in the vaccination center, I sat with my husband outside by the ER, just to be on the safe side. I have had severe anaphylaxis several times in my life, so I could recognize what was happening. Sometimes it starts with the tongue and throat swelling and gets worse / life-threatening later, other times it dissipates. Today it gradually dissipated (the tongue and throat swelling), and now is almost back to the usual state. My throat and arm are both still sore, but the allergic reaction has calmed down. I do have an epi-pen and I do have Benadryl (pill form). I plan to take the Benadryl soon, but thought I should perhaps email prior (it will likely put me to sleep)."
47 2021-04-21 ear discomfort "pt felt warm hot at the right side of the neck and ear and a lot of pressure in front of the head. ... Read more
"pt felt warm hot at the right side of the neck and ear and a lot of pressure in front of the head. also, pt's throat felt tight."
47 2021-04-21 mouth swelling Anaphylaxis symptoms: tingling, dizziness, mouth and throat swelling and chest tightness warmth. I ... Read more
Anaphylaxis symptoms: tingling, dizziness, mouth and throat swelling and chest tightness warmth. I administered my Epipen in the car and my father drove me to the ER where I received:Benedryl, Pepcid, soul-medrol, and sodium chloride.
47 2021-04-21 mouth tingling 17 hours post vaccine had chills, profuse sweating, headache, nausea, lethargy, lack of appetite. ... Read more
17 hours post vaccine had chills, profuse sweating, headache, nausea, lethargy, lack of appetite. 44 hours post vax - felt better and decided to take a shower. Felt faint in the shower. Returned to bed and went into a full body cramp. My arms, hands, legs, feet all went into a severe cramp. My husband was unable to extend my arms or get my fingers to unfurl. I was in extreme pain. My lips started tingling and my word started slurring. My husband called 911. I was diagnosed with dehydration and low potassium. My potassium was 2.6 I received 3 bags or fluids. Pain meds. A potassium drip and oral potassium at the emergency room.
47 2021-04-21 vision blurred High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st ... Read more
High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st night, 4 hours 2nd night, 4 hours 3rd night), Very low mood and wishes I would die on 4/15 morning as pain/discomfort was so great. Severe Chills (shaking, needed 3 blanket) from late afternoon to early morning hours during the 1st 72 hr post injection, Severe night sweats 1st 3 nights - body was soaking wet and soaked through pajamas, Joint and muscle pain in arms, legs, face/jaw starting the 1st night after injection and continuing for 4 days after injection, Swollen, painful lymph nodes in under arm/neck - continues to this day (started night 1 and now 9 days after injection), Occasional dizziness when standing and sitting starting 4 days after injection and continuing for 48 hours, Blurred vision, people looks like they were swaying starting day 5 through day 6, Very Heavy vaginal bleeding started on day 7 (4/20), got worse on day 8 (4/21), and the same on day 9 (4/22): soaking through pad every 2-3 hours on day 8 and day 9. bleeding continues at time of this report. NOT like a period, or timing of my period. My period is not due to start until 4/25 and I have been regular my entire life - 36 years! Cough and left arm pain started on day 8 (4/21) - I went to ER after calling my OBGYN and talking with the nurse. NEVER had a fever, NEVER had cramps.
47 2021-04-22 loss of smell, loss of taste There was no place to enter the date of the two above vaccines. The 1st 1 was on 2-22-2021, the 2nd ... Read more
There was no place to enter the date of the two above vaccines. The 1st 1 was on 2-22-2021, the 2nd dose was on 3-13-2021. On April 17th, I started to have Covid-19 symptoms: runny nose, headache, exhaustion. On the 2nd day, body aches, congestion, headaches, exhaustion. On the third day, all symptoms continue and I lost my sense of smell and taste. No fever ever. On the 4th and 5th day, a runny nose has stopped. all other symptoms continue.
47 2021-04-22 ear itchiness, mouth numbness Patient received 2nd dose of Pfizer Covid-19 vaccine and during post vaccination waiting period she ... Read more
Patient received 2nd dose of Pfizer Covid-19 vaccine and during post vaccination waiting period she reported feeling numbness on her lips, gums and left cheek. She reports taken a children's dose of Benadryl at around 10:55. Patient is able to talk and is breathing normally but has a small rash on her cheek. Patient indicates that she has an extensive list of allergies to medications and foods. Patient is not taking medications currently . Her BP is 169/113 p is 91. At 11:06 Patient had developed a rash on her face, ears ad her chin as well as a large area on her chest. EMT on site- evaluated Patient and administered Epi pen (lot DFM355 exp 11/21) on the left thigh at 11:10am. 911 was called and EMS transported Patient to the hospital. Patient's husband is by her side.
47 2021-04-22 lip swelling Patient developed formication; followed by dyspnea, sensation of swelling of lips/throat, and nausea... Read more
Patient developed formication; followed by dyspnea, sensation of swelling of lips/throat, and nausea.
47 2021-04-23 blindness, mouth numbness, deafness tia in right eye, on Friday morning on 4/16/ 21, between the hours of 8 am and 9:30 am, I went from ... Read more
tia in right eye, on Friday morning on 4/16/ 21, between the hours of 8 am and 9:30 am, I went from feeling fine and sleeping to waking up not being able to hear in both ears, not being able to see anything out of my right eye, my left arm was completely number all the way up to my shoulder and neck, the right side of my tongue was numb and my blood sugar was over 611. Initially they thought it was just a reaction to my high sugar levels, since the mri's showed I did not have evidence of a stroke. It wasn't until I saw a retina specialist the following Tuesday that she confirmed that yes I did have a stroke in my eye. I have not recovered my vision fully in my eye or the sensation in my tongue. I didn't connect it to the vaccination until I spoke with a friend whose sister also got pfizer 5 days before me and suffered a stroke 3 days before me, and two days after we spoke they announced Johnson& Johnson pause due to clots in women. The retina specialist says we will have to wait and see if the damage heals on it's own in the meantime I need to see her on a monthly basis.
47 2021-04-24 ear pain Shingles outbreak on upper left lip and face, extreme ear and facial nerve pain, burning and tinglin... Read more
Shingles outbreak on upper left lip and face, extreme ear and facial nerve pain, burning and tingling, migraine for 4 days, and severe fatigue for 7 days
47 2021-04-25 eye strain Shortness of breath, couldn?t walk (legs felt like in cement), lightheaded, and hard to keep eyes op... Read more
Shortness of breath, couldn?t walk (legs felt like in cement), lightheaded, and hard to keep eyes open.
47 2021-04-25 taste impairment Itching, red swollen chest (hot to touch), hives on neck to chest area, metal taste in mouth.
47 2021-04-25 mouth itchiness, lip itchiness Woke up Sunday with a fever, chills and sore throat, but figured allergies. Sunday night I noticed m... Read more
Woke up Sunday with a fever, chills and sore throat, but figured allergies. Sunday night I noticed my lips and around my mouth was getting itchy. I took some Benadryl and when I woke up this morning, my bottom lip is swollen and my whole lower face is itchy.
47 2021-04-25 ringing in ears, ear swelling Worsening of tinnitus, keeps me up at night, ears have been swollen after vaccine, unable to comfort... Read more
Worsening of tinnitus, keeps me up at night, ears have been swollen after vaccine, unable to comfortable wear hearing aids since vaccine. Have an appointment with hearing doctor on the 28APR2021 to try to get relief. Do not feel I will be able to complete the vaccine series due to this reaction.
47 2021-04-26 lacrimation increased, eye pain Left eye pain/lacrimation 3 days after vaccination; left eye pain/lacrimation; This is a spontaneous... Read more
Left eye pain/lacrimation 3 days after vaccination; left eye pain/lacrimation; This is a spontaneous report from a contactable physician (patient). A 47-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Mar2021 at 15:00 (at the age of 47-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included rosacea. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not take any concomitant medications. The patient had no allergies to medications, food, or other products. On 26Mar2021 at 06:00 the patient experienced left eye pain and lacrimation. The patient did not receive any treatment for the events. The outcome of left eye pain and lacrimation was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
47 2021-04-26 mouth ulceration diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/... Read more
diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation. Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering. Information about lot/batch number has been requested.
47 2021-04-26 mouth tingling, tongue itchiness PT was administered their 2nd dose of Pfizer, and started experiencing symptoms about 15 minutes lat... Read more
PT was administered their 2nd dose of Pfizer, and started experiencing symptoms about 15 minutes later. Stated that they have history of anxiety, and was having a tightness in their throat. Also was feeling a tingling and itching on their tongue. PT was administered PO antihistamine 50mg. PT cleared the site after waiting additional time under their own power.
47 2021-04-27 taste impairment 4/22- within minutes I felt dizziness and unsteady but was sporadic. As the day continued, became mo... Read more
4/22- within minutes I felt dizziness and unsteady but was sporadic. As the day continued, became more fatigued. 4/23 - Continued with previous symptoms and added headache, more fatigue, nausea, and chemical taste will all food/drink 4/24 - Continued with above symptoms and added: muscle aches, joint stiffness, extreme nausea and vomiting and weakness, severe fatigue. Went to ER for evaluation. (see below) Received IV fluids and Zofran In the 3 days since the ER visit, I am still unable to eat any solid food and can only drink after taking Zofran
47 2021-04-27 lip swelling swelling lips- itching body- rash-headache-body ache
47 2021-04-27 lip swelling Patient received 1st dose covid vaccine; during observation period experienced slight red rash acros... Read more
Patient received 1st dose covid vaccine; during observation period experienced slight red rash across chest, very slight facial swelling around lips, and facial flushing; patient stated this was usual reaction to vaccines; 50 mg benadryl given along with cool water; symptoms started to subside, patient felt ok, blood pressure was within normal range; patient was released after all symptoms gone (approx. 40 minutes total observation time) with recommendations if symptoms reappear to either go to ED or call PCP.
47 2021-04-27 oropharyngeal discomfort 10:42: Patient complained of scratchy throat and mild anxiety and claims to have history of anaphyla... Read more
10:42: Patient complained of scratchy throat and mild anxiety and claims to have history of anaphylaxis with penicillin and Aleve allergy. Patient's initial blood pressure at 148/91, 98% O2 sat, 74 HR, RR 16. Patient requested and was given 25 mg/1 tab of benadryl PO. Patient with no labored breathing or respiratory distress and no swelling at vaccine left upper arm injection site. 10:57: Vitals retaken. BP 136/84, hr 70, 96% RR 18. At this time, patient decided to go AMA. Risks and benefits explained. AMA form signed by patient. Pt in stable condition with steady GAIT and able to exit facility with no issues.
47 2021-04-27 swollen tongue 4/28/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ... Read more
4/28/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate. Assessment : Time of assessment 1336. Alert and oriented, and anxious. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Water given, VS at 1336- BP- 148/92. P-136, O2- 100%, recheck at 1346- BP- 128/90, P- 90, O2- 100%, patient reports anxiety Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/28/2021 1:12 PM 0.3 mL 2/25/2020 Intramuscular
47 2021-04-27 swollen tongue developed swollen tongue and throat and red, itchy, bumpy rash on back of hands several days after v... Read more
developed swollen tongue and throat and red, itchy, bumpy rash on back of hands several days after vaccine. Went into dermatologist six weeks later to have skin looked at after rash and derm cut off a lesion from back of hand and found malignant melanoma - amelonotic melanoma. additional skin was removed one month later.
47 2021-04-27 swollen tongue Patient stated they felt difficulty breathing shortly after injection but left observation area afte... Read more
Patient stated they felt difficulty breathing shortly after injection but left observation area after 15 minutes without saying anything to staff. Patient got into their car and drove several blocks away but decided to return to observation area. Patient then complained of a swollen tongue. Vital signs stable. Physician ordered Zyrtec, 10 mg given at 9:20am. Symptoms resolved and patient was discharged with physician approval.
47 2021-04-27 ringing in ears Slight ringing in ears began after first vaccination. After the second vaccination, the ringing in ... Read more
Slight ringing in ears began after first vaccination. After the second vaccination, the ringing in ears intensified to about an 8 out of 10. This has now been going on for almost a week.
47 2021-04-28 dry eye, eye irritation Chills, tiredness, headache,muscle pain, nausea, cough, dry burning eyes, flushed face and chest.
47 2021-04-28 taste impairment Severe nausea - day 2-7 Bronchospasm day 2- 10 metallic taste in mouth - almost immediately to day ... Read more
Severe nausea - day 2-7 Bronchospasm day 2- 10 metallic taste in mouth - almost immediately to day 7 fatigue and low grade fever day 4 hives = day 5 and 6 - took Benadryl and it controlled the hives
47 2021-04-28 ear swelling Patient (date of birth: 01/27/1974) received the 1st COVID vaccine (PFIZER, Lot #: EW0179, and expir... Read more
Patient (date of birth: 01/27/1974) received the 1st COVID vaccine (PFIZER, Lot #: EW0179, and expiration date: 08/2021) at 11:48AM. EMT made contact with the patient in the observation area around 1225. The patient complained of "right ear redness and swelling" and stated it was a "sign" to her of an impending allergic reaction. EMT visually assessed the patient's ear and saw no swelling, only light redness. Patient was advised to sit in the zero gravity chair for further evaluation. At 1227, baseline vital signs were taken, while patient was sitting: blood pressure: 114/68, heart rate: 77, respiratory rate: 12. Skin was cool, dry, and normal for ethnicity. Nurse then responded to EMT with patient. EMT asked the patient if she was taking any medications. She stated that she is taking WELLBUTRIN and has allergies to gluten and latex. At 1233, a second set of vitals were taken: blood pressure: 118/78, heart rate: 84, respiratory rate: 12. Skin was cool, dry, and normal for ethnicity. Patient was negative for orthostatic pressures. EMT advised the patient to continue to sit in the zero gravity chair for an additional 30 minutes, to observe for additional signs and symptoms. Patient was educated by EMT regarding the signs and symptoms to look out for and when the patient should contact her primary care provider. The patient was also given the information to sign up for V- safe as well as educated regarding the importance of doing so. After the observation time was completed, around 1: 00PM, the patient walked out of the site unassisted and with a steady gait.
47 2021-04-28 eye irritation, eye pain, eye swelling It's 7 days later and I am still not well - face swelling, hot to the touch (similar to when I had s... Read more
It's 7 days later and I am still not well - face swelling, hot to the touch (similar to when I had staph infection) Nausea is new as of today, migraine has come back (was present up until yesterday afternoon and started to dissipate and now back in full force). I have had 17 concussions in my lifetime so it feels like that a bit, foggy, can't stand for long, fatigue. Here are my symptoms by days. Would have sent this sooner but couldn't function or look at screen- really sick. I am still sick and not sure if this is normal or I should be going to the ER or some type of doctor. 4/22/21 ? 2nd Shot at 10:35 am - @ 1:45 pm arm really started to get soar and hard to lift. Chills. Drossy. 4/23/21 ? After I awoke from the 1st night, I couldn't move my entire body's left side, I was dragging my left leg with me and couldn't lift my arm from my body or move it. exhausted felt drugged, like hangover, migraine and getting in car accident all in one. Kept dozing off. Slept a lot. Head felt similar to concussion. Unable to really walk. 4/24/21 ?Slept a lot during day. Arm and leg mobility better and I could finally feel my left fingers. So much pain so I finally took my 1st Tylenol muscle 8 hr at 9:38 am. Took another at 10:30pm. It helped for about 5 hours and then woke up with sharp pains again. At night, shooting pains in legs especially back of legs and burning I?m in a lot of pain so while I can now feel my left side and move my arm a bit better my legs are still in a constant state of shooting spasm and I can?t lay down, sit up, recline or anything. Nothing brings comfort. It?s like taking an electrical prod to my body. Arm still hurts (NOT at injection site) but can move it better now still feels like sinus infection. It?s like muscles are pizza dough and someone is pulling them, stretching them painfully with electrical current when you aren?t moving. Massive spasm all over back of legs hips from bottom down. Eyes really swollen. Did Sinus Rinse. Under my arm put and beside/behind my breast rib cage sore. 4/26/21 - Pain wakes as usual throughout the night but it?s 4:40am and the Tylenol has worn off. Pizza dough pulling and spasms in the legs. I?ve taken more Tylenol in the last 4 days than I have taken in the last 40 years. I felt like I didn?t have a headache when I got up but my legs were still streaming so I took another Tylenol and I have a headache and don?t feel good. I now am able to move arm but extremely painful like a log, I can lift it only 1.5 inches from my body which is more than I could before so it must be getting better. Head still feels similar to concussion with migraine. The headache is causing me to clinch teeth and the headache is not at the level it was but still pretty bad. None of this pre -2nd shot. When I was about 12yrs old I had Rheumatoid arthritis (or that was the drs explanation) and this is what it felt like, I couldn?t move my legs or my arms then. I did not take any Tylenol tonight. Shoot pains only wake me up 3 times although they are constantly there just the strength differs Dr?s have always said I have extremely high threshold for pain. I was finally able to brush my hair, afterwards my arms were shaking muscle wise and fatigued. Rash inside my ear and face blotchy. 4/27/21 ?No real change in symptoms except now I am seeing my face swell and eyes are still burning and painful. My face only on the left side more than right looks like a cabbage patch doll- swelling. Eyes sore and front of head hurts. Stuffy nostril only left one ? so I do another sinus rise today. Still feel drugged. Body is sore. Hard to move neck. Still in pain take Tylenol at 9:20pm. The pain woke me up multiple times and kept me up. It?s like someone is pulling my muscles like pizza dough. It is so painful. No position is comfortable. Woke up at 10:30, 11:45, 12:15, 2:21, 3:52, 4:05 and that was it couldn?t get back to sleep because of this pain. Don?t have a foam roller here but maybe an olive oil bottle I could use in the same manger or a tennis ball. I have to do something I can?t take this pain. 4/28/21 ? 8:32 am having trouble lifting my arm, very heavy fingers numb fatigued like I just lifted something really heavy by myself. I was finally able to move arms enough to was the dishes. Left side of face still swollen. Under my arm put and beside/behind my breast rib cage still sore. Finally, was able to take bath. Not hot because I didn?t want any more swelling. 4/29/21 ? Only woke up a couple of time and slept better so thought I would try to go for a walk outside today. My headache I thought was pretty much gone. I didn?t last more than 8 mins. I felt like I couldn?t stand, exhausted, not strong enough and needed to sit down. My migraine is back and I feel nausea, not hungry, face is swollen still. I have lymphedema and use my machine every night, but it?s almost like the shot increases inflammation all over my body, find the places that have been affected before and gets in there. I only drink water, no coffee, tea or juice and no alcohol since 3 days before my 1st shot and was planning to continue that until 2 months after my 2nd shot.
47 2021-04-28 mouth numbness Within 15 minutes of getting the Pfizer vaccine my upper lip felt numb, also my chin/neck, along my ... Read more
Within 15 minutes of getting the Pfizer vaccine my upper lip felt numb, also my chin/neck, along my face mask, felt puffy but was not visibly puffy. I could swallow and breath. At 25 minutes I went to a RN and had my neck checked to make sure I would be fine to leave. I did not mention the numb upper lip because at 25 minutes it had gone away. At 12:30 AM on 4/20/21 I woke up not feeling well. My upper lip was again numb, and it had spread to my face (it felt puffy but was not visibly puffy), and the numbness had spread to both sides of my face to my ears, up to my eyes, and down to my chin/neck. I went to the ER. When I arrived at the ER, the numbness was not as bad as when I woke up. Since it was not getting worse. and my vitals were good, they released me. My face is still numb. The numbness always includes my upper lip plus other parts of my face. Also, the numbness spread to inside my mouth and to the back of my throat. The degree of numbness varies. Sometimes I think it's getting better, and then it gets worse. I am also still feeling sick, nausea, feeling of unwellness, and I get exhausted doing things that would previously not made me tired. On 4/27/21, around bedtime, inside my body started feeling hot & icy at the same time, that continued all day on 4/28/21, and still feels this way on 4/29/21.
47 2021-04-28 mouth numbness 3 DAYS (4/19) AFTER VACCINE STARTING FEELING NUMBNESS IN LIPS THAT SLOWLY PROGRESSED TO SIDES OF FAC... Read more
3 DAYS (4/19) AFTER VACCINE STARTING FEELING NUMBNESS IN LIPS THAT SLOWLY PROGRESSED TO SIDES OF FACE, FORHEAD, CHIN AND EVENTUALLY IN THE HAIRLINE. WENT TO THE DOCTOR 4/26 WHEN IT BECAME IMPOSSIBLE TO IGNORE, THOUGHT I WAS HAVING POSSIBLE STROKE, THE DOCTOR SENT ME FOR A CT SCAN ON 4/26. I DID NOT REALIZE IT WAS A REACTION TOTHE VACCINE. I WAS LOOKING FOR A RASH OR ACHES WHICH I DID NOT HAVE. I WAS PERSCRIBED A STERIOD REGIME BY MY FAMILY DOCTOR WHICH I STARTED 4/28.
47 2021-04-30 pain in jaw 1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - ... Read more
1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints 2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
47 2021-05-14 ear discomfort nasopharyngeal congestion; ear popping; feverish feeling; night sweats; sob sensation; throbbing in ... Read more
nasopharyngeal congestion; ear popping; feverish feeling; night sweats; sob sensation; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; temperature instability 97-100F; joint pain; achy spine; heel cellulitis; paresthesias; This is a spontaneous report received from contactable physician ((patient) reported for herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Ek9231, expiry date not reported), intramuscular, administered in left arm on 29Dec2020 12:00 (age at vaccination as 47 years old) as first dose, single for COVID-19 immunization. The patient had no medical history and no known allergies. The patient was not pregnant at the time of vaccination and of the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN BAMBINI), zinc chloride, vitamin c (ascorbic acid), vitamin D, and zinc; all taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 08:00 AM, day 1, heel cellulitis and paresthesias started. On day 4, 02Jan2021, nasopharyngeal congestion, ear popping, feverish feeling, night sweats, sob sensation, "throbbing in face, nose, throat, chest, and head", temperature instability 97-100F. On an unknown date in 2021, patient had joint pain, headaches, achy spine for 4 months. Currently, patient was on treatment for heel cellulitis, and have been out of work since vaccine. Patient's symptoms have waxed and waned and still present. The reported events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events reported, which included antibiotics for several times. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, has the patient been tested for COVID-19 which included PCR (nasal swab) on 12Jan2021 which was negative. The outcome of the events was not recovered.; Sender's Comments: The event cellulitis is likely intercurrent and is unrelated to suspect product BNT162B2.
47 2021-05-14 visual impairment within 10 minutes of injection, heart racing, vision vaded to black, face and left side numbness
47 2021-05-18 deafness, ringing in ears Within 5 hrs of vaccination, developed acute and persistent tinnitus. Also some loss of hearing acui... Read more
Within 5 hrs of vaccination, developed acute and persistent tinnitus. Also some loss of hearing acuity.; Within 5 hrs of vaccination, developed acute and persistent tinnitus. Also some loss of hearing acuity.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on 15Apr2021 14:00 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Apr2021 19:00 within 5 hrs of vaccination, the patient developed acute and persistent tinnitus and some loss of hearing acuity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the within 2 weeks of vaccination. Adverse event result in doctor or other healthcare professional office/clinic visit. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19. Information on the lot/batch number has been requested
47 2021-05-18 ringing in ears, swollen tongue Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling... Read more
Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling across face just above upper lip; face and neck turned red and swollen/ arms turned red under sleeves; face and neck turned red and swollen; dizzy; brain fog; Existing Tinnitus in left ear is louder; This is a spontaneous report from a contactable consumer reported for herself. This 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:15 (Batch/Lot Number: Unknown) as single dose (at 47 years old) for COVID-19 immunisation. Medical history included fibromyalgia from (previously diagnosed as Rheumatoid Arthritis). Concomitant medications included fenofibrate, escitalopram, hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), herbal sup, all taken for an unspecified indication, start and stop date were not reported. The patient previously took monosodium glutamate and experienced allergy, hydroxychloroquine sulfate and experienced allergy. On 27Apr2021 15:15, the patient experienced anaphylaxis, vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen/ arms turned red under sleeves, dizzy, brain fog, existing tinnitus in left ear is louder, all with outcome of not recovered (as reported). Therapeutic measures were taken as a result of the events included Diphenhydramine, Epinephrine, Famotidine, Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that: "Sent to ER via ambulance: Diagnosed with Anaphylaxis. Vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen, arms turned red under sleeves, dizzy, brain fog. Existing Tinnitus in left ear is louder, and as of 04May2021, I still have the headache". Seriousness criteria of the events was reported as serious due to disability. The information on the Lot / Batch number has been requested.
47 2021-05-19 mouth tingling, lip swelling, ear swelling Patient reports that during observation period status post vaccine she experienced lip swelling, ton... Read more
Patient reports that during observation period status post vaccine she experienced lip swelling, tongue thickness and difficulty breathing. She denied symptoms other than ear redness and swelling to EMT following dose stating she did not want to be given Benedryl because she drove herself to the site for her vaccine. EMTs observed client and assessed for ear redness, vital signs were stable and client left the site after a 45 minute observation status post first vaccine. Client denied chest pain, dizziness and reported a headache later that evening that lasted 2 days. Client stated symptoms resolved on their own. She denied any other past medical history and stated she had anaphylactic allergies to gluten and latex.
47 2021-05-21 swelling around the eyes Slight pain in right back of throat; Looked like Marge Simpson, felt like Novocaine numbing; Hives o... Read more
Slight pain in right back of throat; Looked like Marge Simpson, felt like Novocaine numbing; Hives on arms, legs, thighs, hips with lots of itching; Hives on arms, legs, thighs, hips with lots of itching; Nose and Upper Lip Angioedema; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:15 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included seasonal allergies to pollen, grasses, weeds. The patient's concomitant medications were not reported. On 26Apr2021, the patient experienced right eye puffy, closed, puckered, creased, on 01May2021, nose and upper lip angioedema, felt like Novocaine numbing; hives on arms, legs, thighs, hips with lots of itching, on 04May2021, lower Lip Angioedema on right side, looked like an asymmetrical fat lip; continued Hives on arms, legs, thighs, hips with lots of itching, on 07May2021, left eye puffy, closed, puckered, creased; continued hives on arms, legs, thighs, hips with lots of itching. slight pain in right back of throat. The patient did not receive any treatment for events. The outcome of events was recovering. Information on lot/batch number has requested.
47 2021-05-23 vision blurred, eye floaters AFTER THE 2ND DOSE I HAD A LARGE FLOATER APPEAR IN MY LEFT EYE.
47 2021-05-24 loss of taste, loss of smell Loss of taste and smell for 24 hours only
47 2021-05-24 visual impairment Patient started to not feel well almost immediately after the vaccine was given per certified pharma... Read more
Patient started to not feel well almost immediately after the vaccine was given per certified pharmacy technician on 5/22/21 around 4:05 P.M. Patient started to experience symptoms not related to anaphylaxis, but more so related to hypotension and/or anxiety. Symptoms include dizziness, body fatigue, pins/needles throughout her body, and also patient started to "see dark spots" when she had her eyes open. No other immediate symptoms were present. Patient's condition improved over time and was able to get up from the chair by herself approximately 15-20 minutes post injection. Patient initially had a normal body temperature of 98.6 F. Temperature was taken every 5 minutes starting from 4:11 P.M for a total of 5 readings, which gradually increased to 100.5 F. Patient's condition started to worsen approximately 30 minutes post injection after improvement and looked like she was going to become unconscious. Ambulance was called due to worsening of symptoms again, and patient's care was transferred over at around 4:45 P.M. Patient was called on 5/25/21 at around 2:40 P.M. for follow-up. Patient has not fully recovered, but is on her way to recovery. Currently, her only symptoms are feelings of pins/needles throughout her body while all other symptoms are gone. Advised patient to follow-up with physician for her current symptom. Patient acknowledged and will see doctor soon. No date was given.
47 2021-05-25 visual impairment Pt said after first dose lymph under arm felt swollen and experienced swelling. After receiving 2nd ... Read more
Pt said after first dose lymph under arm felt swollen and experienced swelling. After receiving 2nd dose 2 weeks later she said her lymph system "blew up". She was in immense pain, had fluid retention and developed fluid blisters, experienced vision impairment and oil glands clogged in eyes, migraines, hair is falling out and fatigue. Patient said doctor gave her high dose steroids. She is still being treated by doctor for this. Still having multiple symptoms and trying to get them under control.
47 2021-05-27 mouth numbness "Tongue and cheek feel numb" Evaluated by EMS-Cleared
47 2021-05-27 feeling of choking, mouth tingling REPORTS ITCHING THROAT,ALTERE SENSATION IN MOUTH AND THROAT. BENADRYL 25MG WAS ADMINISTERD . REASSES... Read more
REPORTS ITCHING THROAT,ALTERE SENSATION IN MOUTH AND THROAT. BENADRYL 25MG WAS ADMINISTERD . REASSESSED HALF HOUR LATER. PATIENT WAS FINE AND ABLE TO DRIVE HOM. NO SOB OR RESP DISTRESS
47 2021-05-27 ringing in ears Flushing sound in my left ear, as if I'm hearing something inside me head, pulsating too. Also felt ... Read more
Flushing sound in my left ear, as if I'm hearing something inside me head, pulsating too. Also felt heart racing two days before this annoying sound began.
47 2021-05-28 mouth numbness Shot was received in my left arm. Within 10 minutes of shot, had severe pain in arm. Nerve pain, p... Read more
Shot was received in my left arm. Within 10 minutes of shot, had severe pain in arm. Nerve pain, pins and needles, ran up and down my arm and hand. Hand and pinky finger had numb areas. Nurse came to waiting area and I asked if this was normal. She said some pain was ok. This was a lot of pain. Pain continued for a couple of days straight and then off and on. Pins and needles in hand never fully stopped. Also had facial numbness on left side of my face, chin and lower lip. Upset stomach continued for a couple of weeks. When I went for the second shot on May 27th, same nurse was there and asked about my pain. She was going to report it. The second shot was worse. The pain started again within 10 minutes. Within 30 minutes was unable to lift my arm to open the car door. Tried to go back to work but needed to take some time off to lay down and immobilize my arm. Pain was excruciating for hours. Still have pain as of today.
47 2021-05-31 dry eye, eye pain eye pain, dry eye
47 2021-05-31 ringing in ears, deafness unilateral Approximately 6 to 8 weeks after receiving my second Pfizer Covid-19 vaccine, I developed tinnitus a... Read more
Approximately 6 to 8 weeks after receiving my second Pfizer Covid-19 vaccine, I developed tinnitus and hearing loss in my left ear.
47 2021-05-31 ringing in ears Tinnitus, high piercing tone heard constantly in ears; This is a spontaneous report from a contactab... Read more
Tinnitus, high piercing tone heard constantly in ears; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at 47-years-old, dose 2 via an unspecified route of administration, administered in left arm on 25Apr2021 at 03:15 PM (Lot Number: EWO172) as single dose for Covid-19 immunisation. Medical history included allergic to dust and mold, fungal infection from an unknown date and unknown if ongoing. The patient was not diagnosed with Covid-19 prior to vaccination and not Covid-19 tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluconazol taken for yeast infection and antibiotic (unspecified) for UTI, start and stop date were not reported. The patient previously took the first dose of bnt162b2 on 03Apr2021 at 03:30 PM (lot number: EP7533), on the left arm, for Covid-19 immunisation. The patient experienced tinnitus, high piercing tone heard constantly in ears on 29Apr2021 with outcome of not recovered. The patient was treated of ear flush, prednisone, and acetyl Lcarnitine. The event resulted in emergency room visit and was assessed as serious due to disability. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-06-01 eye twitching, deafness unilateral, ringing in ears PT CAME FOR 1ST COVID VACCINE DOSE ON 5/7/21. DEVELOPED PAIN / NERVE TINGLING AND HAD SEIZURE LIKE ... Read more
PT CAME FOR 1ST COVID VACCINE DOSE ON 5/7/21. DEVELOPED PAIN / NERVE TINGLING AND HAD SEIZURE LIKE ACTIVITY THAT NIGHT. LEFT SIDE WAS NUMB AND COULD NOT HEAR FROM LEFT EAR. RINGING IN EAR, EYE TWITCHING. ARTHRITIC-LIKE PAIN IN LEFT HANDS (NEVER ON RIGHT SIDE). HAS NOT BEEN TO ER BUT STILL AS EFFECTS ON 5/27/21. NEVER ANY PROBLEMS W OTHER VACCINES
47 2021-06-01 eye swelling, swollen tongue, mouth tingling, mouth swelling, mouth numbness Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Fa... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Pt stated her tongue felt funny a little tingly-Mild, Additional Details: Pt refused 911. stated her tongue felt a little numb and "funny." but not swollen just different feeling
47 2021-06-01 mouth tingling After receiving the covid vaccine the patient experienced lip tingling and tongue fullness. The pati... Read more
After receiving the covid vaccine the patient experienced lip tingling and tongue fullness. The patient does report having a high-risk allergy to oral amoxicillin and Percocet with hives. The patient was given oral Benedryl and the symptoms resolved.
47 2021-06-01 swelling of eyelid Approximately 35 minutes after her 1st dose of Pfizer COVID vaccine, patient's head started hurting... Read more
Approximately 35 minutes after her 1st dose of Pfizer COVID vaccine, patient's head started hurting and her eyes got really hot. She said the symptoms worsened that evening as her eyelids were both really swollen. Patient said she took a picture in case that was a reaction (I do not have that picture). She said it took about two days for her eye symptoms to resolve. Other reported side effects: being super sore and tired, however, the swelling was the concerning symptom for patient. Patient did not go to the ER or PCP or have to take time off.
47 2021-06-02 lip blister, lip swelling, mouth tingling Within 3 hours of vaccination, lips tingling, swelling and blistering noted. Progressively more swel... Read more
Within 3 hours of vaccination, lips tingling, swelling and blistering noted. Progressively more swelling throughout evening. Took 50 mg benadryl and 400 mg ibuprofen before bed on the night of the vaccination. Woke in AM with increased swelling of lips (taut, shiny, scattered hives around lips). Went to urgent care and received a Rx for methylprednisolone 6-day pack. Took first day's dose along with more benadryl and by end of day 2, swelling began to decrease. Was told to follow up with primary care doctor and allergist.
47 2021-06-02 light flashes or floaters in the eye, vision blurred, visual impairment Blurry vision and( flashing light in peripheral vision )right eye the next day after receiving the s... Read more
Blurry vision and( flashing light in peripheral vision )right eye the next day after receiving the second dose on April 27,2021. Flashing light lasted for a week. Afterwards just blurry vision until May 30th vision became distorted and dark. Visited eye specialist 06/04/2021 and was advised to report to the CDC that blood clot was found in right eye. Treatment is now needed that involves injections to the right eye . (3 treatments in span of 10 weeks) with possible laser treatment if injections are not as effective. Eye Specialist -
47 2021-06-02 swollen tongue, mouth tingling Symptoms: Experienced tingling and swelling of throat and tongue about 10 minutes after vaccine. Thi... Read more
Symptoms: Experienced tingling and swelling of throat and tongue about 10 minutes after vaccine. This is a reaction that has never occurred to me with any allergen. I have never needed an Epi-pen before and no allergy test has ever indicated that I have a severe allergy to anything. Treatment: Nurse administered an Epi-pen into left thigh and called 911. Transported to Emergency Department by ambulance. Received IV administration of Benadryl, a steroid, and an antihistamine. Was observed for about two hours and then released at about 3:30 and instructed to take Benadryl for the next 24 hours. Symptoms started to occur again in the ambulance (about 12:40 pm) and again at about 10:00 pm. Emergency Department treatment was after the 12:40 pm occurrence. Took oral Benadryl after the 10:00 pm occurrence. Outcome: I was fine by the next morning and experienced no other symptoms.
47 2021-06-03 dry eye, dry mouth Dry mouth; Extremely dry eyes; This is a spontaneous report from a contactable consumer, the patient... Read more
Dry mouth; Extremely dry eyes; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non--pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot: en6208), via an unspecified route of administration in the right arm on 17Mar2021 at 1:45 PM (at the age of 47-years) as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medications included loratadine (MANUFACTURER UNKNOWN) and BENADRYL. No other vaccine was received within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with covid-19 and was also not tested for COVID-19 since the vaccination. The patient experienced dry mouth and extremely dry eyes on 17Mar2021. No therapeutic measures were taken for the reported events. The clinical outcome of the events dry mouth and dry eyes were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
47 2021-06-03 dry mouth had a very dry mouth; some swelled and itchy hives on the back of my legs; some swelled and itchy hi... Read more
had a very dry mouth; some swelled and itchy hives on the back of my legs; some swelled and itchy hives on the back of my legs; some swelled and itchy hives on the back of my legs; chills; I was getting sick; hot; clammy; This is a spontaneous report from a contactable consumer (Patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 6n6199 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:45, as single dose for COVID-19 immunization. Patient's medical history included asthma, pneumonia, tuberculosis, whooping Cough and allergy to milk. Concomitant medications include Zyrtec, Magnesium, Calcium all taken for unspecified indications. The patient previously took vaccine for Pneumonia via an unspecified route of administration, administered in left arm, vaccine for tuberculosis and whooping cough via an unspecified route of administration, administered in right arm on 18Feb2021. The patient did not had COVID prior vaccination and was not COVID tested post vaccination. On 01Mar2021 08:00 pm, the patient started experiencing some swelled and itchy hives on back of legs, had very dry mouth since getting it (it's been 5 days). On an unknown date in Mar2021, the patient also began to feel like she was getting sick (but 5 days afterward), began to have chills, then hot and clammy. Therapeutic measures were taken as a result of chills, hot and clammy and patient was treated with Tylenol. The outcome of the events was reported as not resolved. No follow-up attempts are possible. No further information is expected.
47 2021-06-03 taste impairment, taste disorder weird taste; Lightheaded; A funny taste in my mouth; This is a spontaneous report from a contactable... Read more
weird taste; Lightheaded; A funny taste in my mouth; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration, on 04Mar2021 at 12:30pm as single dose for covid-19 immunization. Medical history included multiple sclerosis, complex regional pain syndrome, fibromyalgia, hypertension, hypothyroidism, hypokalaemic syndrome, intervertebral disc degeneration, vitamin d deficiency, hypersensitivity. On 04Mar2021 at 13:30pm, the patient was lightheaded for about 4 hours, a funny taste in mouth started about 30 minutes after the vaccine and lasted a few hours but food still has a weird taste the next day. No treatment was received for the events. The outcome of the events was recovered with sequelae. It was reported that patient received no other vaccine in four weeks. In two weeks, patient received other unspecified vaccine first dose on left arm on o4Mar2021. The patient was not diagnosed with covid prior vaccination and not tested for covid post vaccination. The patient had known allergies. No follow up attempts were possible, information about lot/batch number cannot be obtained.
47 2021-06-03 taste impairment, taste disorder Metallic taste within 1 hour after injection with abnormal taste for 30 hours; Metallic taste within... Read more
Metallic taste within 1 hour after injection with abnormal taste for 30 hours; Metallic taste within 1 hour after injection with abnormal taste for 30 hours; This is a spontaneous report from a non-contactable (Patient, self-reported). A 47-years-old (non pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an intramuscular route, administered in right arm on 05Mar2021 13:45 (at the age of 47-years-old), as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergies to Penicillin and previously took doxycycline hyclate and experienced allergy. Concomitant medications included paracetamol (TYLENOL). Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 05Mar2021, 14:15, 1 hour after vaccination, the patient experienced metallic taste and abnormal taste for 30 hours. Patient did not received treatment for adverse events. Outcome of the events was recovering. No follow up attempts are possible. Information about lot/batch number cannot been obtained.
47 2021-06-03 taste impairment metallic taste; salivating black; tongue is stained black; This is a spontaneous report from a conta... Read more
metallic taste; salivating black; tongue is stained black; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscular on the left upper arm on 04Mar2021 at 14:00 (at the age of 47-year old) (Batch/Lot number EL9264) at single dose for Covid-19 immunization. Relevant medical history included allergy to doxycycline described as vomiting from in 1990s or 1990. Concomitant medications were not reported. Starting about 07:45 on 05Mar2021 when she woke up she had a metallic taste in her mouth; she began salivating black, spitting up black saliva which turned her tongue black, tongue was stained black in stripes. She still had the metallic taste in the back of her throat; but was not actively spitting up black saliva any longer. The outcome of metallic taste was recovering, the outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.
47 2021-06-03 bloodshot eyes, swollen tongue swelling of her tongue. She only has swelling to the left side of her tongue. Redness and burning ... Read more
swelling of her tongue. She only has swelling to the left side of her tongue. Redness and burning of her face and bilateral eye redness
47 2021-06-03 mouth tingling, mouth swelling D-EMS was dispatched to the COVID vaccine clinic for a pt whom received her vaccine and was now havi... Read more
D-EMS was dispatched to the COVID vaccine clinic for a pt whom received her vaccine and was now having a reaction to it. C-Allergic reaction to COVID vaccine. H-Pt had her first dose of the COVID vaccine at 1630 and was sitting in the evaluation line. She stated that she began breaking out into hives and called the paramedic. The pt began to feel tingly all over felt as if her mouth was swelling. Paramedic obtained a set of vital signs; placed her onto the 3lead monitor which revealed sinus tach and obtained IV access to administer 50mg of benadryl and 40 mg of pepcid PO. They called for Medic 6 to transport the pt to the ER. A- We found the pt sitting upright a&oX4 skin P/W/D. At the time of our arrival there was no more hives noted on the pt. The pt was nervous and stated that her lips and nose were tingling. She denied shortness of breath or trouble breathing but stated that it was hard for her to swallow. There was no noted swelling to the pts tongue. The pts lung sounds were clear and bilateral. The pt had already recieved a dose of benadryl and pepcid as previously stated. Rx-We obtained a baseline set of vital signs. Paramedic switched the pt from Paramedic 3lead to our own, which revealed sinus tach. We assisted the pt as she stood and sat onto the cot. We secured the pt to the cot per SOGs in the semi fowler position. We loaded the pt into the ambulance. T-We transported the pt routine traffic to TRH via Medic 6. While en route to TRH we continued to monitor the pts vital signs. The pt stated that it didnt feel like she was having trouble breathing but she felt as if she couldnt take a full deep breath. Lung sounds remained clear and bilateral with a o2 sat of 100% on room air. Paramedic administered 125mg of solu medrol. The pt remained stable. The pt denied any other new or worsening symptoms. Once we arrived at TRH we placed the pt into the ER bed in room 7 via 2 person sheet pull. Report was given to the RN. Medic 6 was cleaned and restocked and we returned to service. History of Present Illness This is a 47-year-old Caucasian female who presents to the emergency department by EMS due to symptoms resulting after receiving Pfizer COVID-19 vaccination today. It was her first shot. She developed some tingling in her lips as well as some difficulty swallowing. She did not have any respiratory difficulty. EMS gave her Pepcid, Benadryl, Solu-Medrol prior to arrival. Upon arrival she is still having some symptoms of difficulty swallowing. She is quite anxious. She states that she was feeling fine prior to the vaccination. Imported information including vital signs, nursing notes, allergies, past medical/social/family/surgical history reviewed Routine PPE including gloves if indicated, face mask, eye protection worn during the patient encounter ssessment: Possible adverse reaction to vaccine versus anxiety. Patient was initially seen by Dr. and had medical screening exam performed. He had ordered epinephrine and 0.5 mg of lorazepam. The patient remains tachycardic and states she feels like she is having problems swallowing. On exam there is no stridor. She is able to swallow her secretions. I do not appreciate any neck swelling. Chest is clear. No focal neurologic findings. EKG My EKG interpretation: Sinus tachycardia with a ventricular rate of 110. No acute ST elevation, T wave inversion, ST depression Reexamination/Reevaluation Reevaluation: Patient's potassium is 3.2. CO2 is 19. That is consistent with hyperventilation. Other labs are normal except for glucose of 229. Soft tissue neck x-ray was obtained and that showed some possible airway inflammation and therefore CT scan will be done to more effectively characterize the findings. Patient received potassium replacement as well as additional Ativan. She will also be given some IV fluids since she remains slightly tachycardic. That could be lingering effects of the epinephrine The patient's D-dimer was normal. She felt better after Antivert and Lopressor. Heart rate remained below 100 and but other vital signs were normal. Dizziness was better Diagnosis/Disposition Adverse reaction to vaccine Patient Instructions Drink plenty of fluids. Watch for worsening symptoms of difficulty swallowing, shortness of breath, facial swelling. Antivert for dizziness. Work note for tomorrow. Recheck with your doctor sometime within the next 3 weeks to see if you should get the second dose of the vaccine. Return to the emergency department if worse or new symptoms. RX Given meclizine: 1 tab, PO, TID, dizziness/motion sickness, # 20 tab, 0 Refil(s)
47 2021-06-07 mouth numbness, lip swelling, swollen tongue, mouth swelling allergic reaction; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to he... Read more
allergic reaction; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; face was numb and heavy; face was numb and heavy; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number: 59267100002), via an unspecified route of administration, administered in the left arm on 09Mar2021 at 15:00 at the age of 47 years old (Batch/Lot number: FN6198/EN6198, and Expiration date: unknown) as the 1st dose, single dose for COVID-19 immunization, to protect herself from getting COVID-19. The patient had no medical history. There were no concomitant medications. The patient reportedly experienced swelling and numbness to her mouth, lips, and tongue on an unspecified date in Mar2021. The patient was asking if there was any research to determine what she might have reacted to in the vaccine and also if there was any information about the kind of reaction she had and if that would relate to a specific ingredient. It was further reported that the patient had an allergic reaction to the first dose of the COVID vaccine and did not provide specifics. The patient wanted to know if there were studies on allergic reactions and if there had been any follow ups and would love to know what she was allergic to, since she had never had an anaphylactic reaction and if there had been any research. The patient stated she was seen at the emergency room and did not know if she should share the doctor's information that had seen her in the emergency room or her primary care doctor. She had mouth, tongue, lip swelling and numbness and so she went right away to the emergency room. She never had breathing distress and was given an intravenous (IV) steroid and also a medication to bring down the swelling. The patient stated she had the vaccine around 3pm in the afternoon and she woke up around 3am during the night on an unspecified date in Mar2021 and her face was numb and heavy and her lips were huge and she realized she was breathing ok, but she went to the emergency room. The patient stated she wanted to get the second dose of the vaccine, but the emergency room doctor did not recommend it. She clarified that the symptom of her mouth tongue lip swelling and numbness had actually occurred sometime in Mar2021, and not Feb2021, since she got the vaccine on 09Mar2021. It lasted for about two days until it went down. The patient stated there had been no changes and she had not had anything different to eat. Therapeutic measures were taken as a result of all the events, which included IV steroid and a medication to bring down the swelling. The patient recovered from all the events on an unspecified date in Mar2021.
47 2021-06-07 mouth discomfort On 5/20, patient experienced a sore arm. Then on the same day she developed dizziness, tightness in ... Read more
On 5/20, patient experienced a sore arm. Then on the same day she developed dizziness, tightness in the throat, body aches, a low grade fever, headache, fatigue and it felt like the roof of her mouth was on fire. Now nearly 3 weeks later she still has a low grade fever (99.7.) She has been taking Tylenol and Ibuprofen and is staying very well hydrated. She does not know if her temperature is actually higher than what is registering because she is medicating herself. She also still feels very tired and has an occasional headache. The sore arm barely lasted a day. Her biggest complaint is that the fever has not subsided and she still feels tired.
47 2021-06-09 mouth numbness Client received her second dose of the Pfizer Covid-19 Vaccine (Lot # ER8735 Exp. 07/2021) at 14:07 ... Read more
Client received her second dose of the Pfizer Covid-19 Vaccine (Lot # ER8735 Exp. 07/2021) at 14:07 at Agency. The client, a 47 year old female, came into Agency at approximately 15:00 with a chief complaint of a localized rash to her right arm. Two EMTs and one RN responded. The client drove herself to Agency after driving home and walked in alert and tracking with her eyes with no apparent distress. The client was alert and oriented to person, place, time and event and airway, breathing and circulation were intact. The client had a minor localized rash on her right arm described "numbness" on her lips. She also stated that the symptoms started while she was driving home, approximately 30 minutes after injection. However, EMTs did not notice any swelling, discoloration and/or other signs and symptoms of allergic reaction on her lips. The client denied any allergies or medications. The client stated that she had no reactions to the first dose and there were no signs and symptoms of allergic reaction on her right arm where she received the vaccine. The client agreed to stay an additional 30 minutes for observation and vital signs were taken every 5 minutes. Vital signs are as follows: 1500 blood pressure 128/90 pulse 84 temperature 98.3 O2 100% skins normal. 1505 BP 128/80 P 68 Temp 98.3O2 100% S normal. 1510 BP 128/80 P 71 O2 95% Temp 98.2 S normal. After the client's vital signs were taken she stated that she was feeling better and decided to depart Agency after 10 minutes of observation. The client was given all relevant information regarding normal signs and symptoms as a result of the Pfizer vaccine and was informed to call ED in the event of severe allergic reaction. RN and EMT educated client about the possible signs of an allergic reaction and provided her with the vaccine fact sheet. Client verbalized that she would ?go to the hospital? if the symptoms of an allergic reaction presented. Client departed AGENCY at approximately 1510 in positive disposition with steady gait.
47 2021-06-10 eye swelling Patient reports vaccine given at local pharmacy. 45 min later had rash and eye swelling. resolved ... Read more
Patient reports vaccine given at local pharmacy. 45 min later had rash and eye swelling. resolved over the next couple of days with benadryl. Currently undergoing allergy work up given this reaction and other allergies.
48 2021-01-01 mouth ulceration Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset ... Read more
Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset 12/27. Visit to dentist for worsening pain and mild body aches and chills - dentist felt the pain and swelling, + mild ulceration due to new toothbrush head causing abrasions on gums and hard palate - no treatment prescribed - 12/28. Worsening painful lymphadenopathy (now bilateral cervical), body aches, chills, joint pain, fevers, odynophagia, gum pain/swelling, malaise - visit to respiratory clinic - rapid strep negative; COVID negative, bacterial throat culture negative (VS: HR 120, SBP 168, T 100.7 on Tylenol) - no treatment prescribed - 12/29. Development of shallow, painful ulcers LEFT hard palate, gums and a RIGHT lip ulcer - 12/31. Photos of ulcers reviewed with previous dentist - prescribed acyclovir 400 mg TID and magic mouthwash. 12/31. Taking Ibuprofen and Tylenol regularly. As of today, 1/2, improvement in cervical lymphadenopathy, resolution of constitutional symptoms, and odynophagia. Ongoing mouth pain and ulceration. + left facial numbness/burning pain (V1-3) similar to previous episode of trigeminal neuralgia in 1999.
48 2021-01-04 taste impairment Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin... Read more
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
48 2021-01-04 ear itchiness 30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minu... Read more
30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minutes to 1 hour after the receiving the vaccine I developed some additional spots on my face and my throat felt like something was stuck in it. I purchased some oral Benadryl from the Outpatient pharmacy took 50mg and in 30 minutes my symptoms were resolving.
48 2021-01-04 mouth numbness, ear discomfort, ear pain, eye pain, eye itchiness, hearing loss, mouth tingling Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly... Read more
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
48 2021-01-04 drooling, mouth numbness, mouth tingling Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: em... Read more
Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.
48 2021-01-04 swelling of eyelid Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelli... Read more
Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelling-around mouth and lips, not inside mouth. Administered nasal Flonase 2 pumps each nare and 50 mg Benadryl at 2230. At 0430 next morning 12/29, swelling decreased, eyelids remained swollen and minimal swelling in nasal/sinus area. Continued Benadryl 50 mg every 6 hours x 3 doses, by 1900 on 12/29 swelling resolved
48 2021-01-04 visual impairment I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still fee... Read more
I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still feel like very weak and achy; Pain/achy/aches; Teeth chattering; Shaking all night long and 102 fever; Shaking all night long and 102 fever/low grade fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, reason for no lot number: consumer stated, "I can't even read, it says EK or E something 5730. That's what it looks like."), intramuscular in arm in Dec2020 at single dose for COVID-19 immunisation. Medical history included low thyroid, have had thyroid cancer many years ago. Concomitant medication included levothyroxine sodium (SYNTHROID). Consumer stated, "I just have a question, I had a shot done on Wednesday and I have heard the second shot was worst so I was little concern we are all concerned about getting the first shot to begin with. So I had the shot on 11:30 at work at the hospital on Wednesday. I probably about 1:30 to 2 O'clock in the morning total like flu side effect. I thought I got a flu, aches, pain, teeth chattering, shaking all night long and 102 fever. I haven't been sick at all thank god in a while but it feels like I had, so, I have a new born grandson supposed to go there for Christmas so I'm concerned because I was running a 102 Wednesday night and I was so running a low grade so is it normal to have reaction like that?" Consumer stated, "Yes, let me just get a pen. I just don't want to be around the baby. I thought I was fit but I don't usually when your body gets the vaccination your body fighting against the vaccine so I don't think it is going to affect the baby. I just don't want to get this shot if they got affected and if they are on fever. I just want to make sure before I go over there for Christmas." When probed if calling for the first time in Pfizer drug safety department, consumer stated, "No, actually I was just thinking now before I had out I grab these side effects yesterday and I read it I have fever 102, I was like let me call the number from the paper that they gave me with the shot card, let me call you guys and try to figure out what the hell is going on here and why I'm so freaking sick from this shit." .Height and weight: Consumer stated, "I say about 130 and about 5'6.". LOT#: Consumer stated, "Let me see if I have the card, I know I have it somewhere. May be I'm just thinking I shouldn't get the second shot. I can't even read. it's Pfizer, I can't even read, it says EK or E something 5730. That's what it looks like."Manufacturer name: Consumer stated, "Covid 19 Vaccine and I'm pretty sure it's Pfizer.".Lab work: Consumer stated, "I had all my labs on like you know like regular labs CBC's like everything. I have bad thyroid it goes up and down, I didn't feel well so I went to you know I know when my thyroid is up or down so I went and got the whole blood panel done.".Date of administration of first dose: Consumer stated, "It was probably like December 8th. I had it done on 23rd of December." (Not further clarified).Event date: Consumer stated, "The same day I had the shot.".When probed if still experiencing the events, Consumer stated, "Yes. It's not totally improved but it is better than it was but I still feel like very weak and achy." .Treatment: Consumer stated, "Tylenol and Ibuprofen I keep alternating it."Consumer stated, "I just want to make sure I can go back to my grandson today because I went to my daughter last time she is leaving for (place name) tomorrow and she was nervous and now I'm like still running a low grade fever last night and I know my daughter is going to flip out if I show up. I told her it's okay because it's only vaccination but I just want to make sure with the Covid shot I got." .The outcome of events I still feel like very weak and achy and pain/achy/aches was not recovered. The outcome of events flu / like flu side effect, teeth chattering, shaking all night long and 102 fever, shaking all night long and 102 fever/low grade fever, I'm so freaking sick was Recovering. The outcome of other events was unknown. Information on the lot/batch number has been requested.
48 2021-01-05 loss of smell 12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albutero... Read more
12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albuterol MDI utilized and symptoms subsided. 3:30pm Mild Headache and back pain. Fatigue and lethargic. Pain scale 3-4 5:15pm Headache increased intensity. Fatigue and lethargic. Back pain still the same, took Motrin 600mg-OTC Wheezing, used Albuterol-MDI 7:30pm Headache and back pain increased intensity 12/23/2020 4:54am Woke up with wheezing, headache and back pain. Pain scale 6 Albuterol-MDI utilized 7:42am Wheezing and SOB, Albuterol utilized and symptoms subsided 3:00pm Headache increased intensity throughout the day. Difficulty focusing and multitasking. Loosing train of thought. Fatigue and lethargic. Pain scale7. Motrin OTC 800mg taken with evening medications and went to sleep. 12/24/2020 7:23am Woke up with severe headache and anosmia. 12/25/2020 Headache and anosmia 12/26/2020 Headache and anosmia 12/27/2020 COVID test-Negative result Headache and anosmia 12/28/2020 Headache and anosmia 12/29/2020 Headache and anosmia. Doctor's appointment. Headache treated with Tramadol 12/30/2020 Headache and anosmia. Pain scale 6 12/31/2020 Headache and anosmia Pain scale 3-4 01/01/2020 Headache and anosmia Pain scale 2-3 01/02/2020Headache and anosmia Pain scale 0-2 01/03/2020 Headache and anosmia Pain scale 0-1 01/04/2020 Anosmia 01/05/2020 Headache and anosmia Pain scale 2-3 01/06/2020 Headache and anosmia Pain scale 3-4
48 2021-01-05 eye pain, visual impairment The next day my left eye was painful, like little ice picks going in, it was inflamed. It was diffic... Read more
The next day my left eye was painful, like little ice picks going in, it was inflamed. It was difficult to see . I had Lasik about a year ago and I called my eye Doctor because I was nervous and I went to see him and he told me it looked like a allergic reaction. He put me on steroid drops. When I woke up Saturday morning my eye was fine, so I stopped taking the medicine.
48 2021-01-05 eye swelling, ear discomfort left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at... Read more
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
48 2021-01-05 lip swelling chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpit... Read more
chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling Started within 20-30 minutes of receiving the vaccine Received 25mg of Benadryl with improvement
48 2021-01-05 mouth tingling, swelling of eyelid C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i... Read more
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
48 2021-01-05 mouth tingling After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness ... Read more
After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness in my right cheek/jaw and cold, numbness and tingling in my right hand/forearm. Symptoms improved within 24 hours and were gone in 48 hours.
48 2021-01-05 sensitivity to light Body Aches, Tiredness, Severe Headaches TX-Husband took her to the Urgent Care-5 Jan 2021 two inject... Read more
Body Aches, Tiredness, Severe Headaches TX-Husband took her to the Urgent Care-5 Jan 2021 two injections given to her-Toradol, Zofran, Iv therapy also, prescription for Urrelvy-for migraines-she didn't fill it yet
48 2021-01-05 ringing in ears, deafness unilateral, extreme sound sensitivity At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I exper... Read more
At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I experienced hearing loss in my left ear like I had an ear infection. This morning I woke up and it is worse. I can barely hear out of my ear and I have tinnitus. I am dizzy and feel cautious.
48 2021-01-06 taste impairment After 10 minutes of vaccine administration patient report metallic taste, she was oriented to stay i... Read more
After 10 minutes of vaccine administration patient report metallic taste, she was oriented to stay in the observation area of the vaccine administration site for 10 additional minutes. At 12:00pm patient report throat itching "like chocking". Shock anaphylactic code (RR) was activated. At 12:03pm Epinephrine 0.3mg/1ml was administrated to the left thigh. Venous access was obtained and Solu-Cortef 200mg, Benadryl 50mg and O2 were administrated. Patient vital signs were blood glucose 121mg/dl, Oxygen Saturation 100%, BP 150/90 mmHg. Patient was transfer with the RR code team to the ER for observation.
48 2021-01-06 eye itchiness, bloodshot eyes Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patie... Read more
Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patient reports feeling short of breath but no noted drop in oxygen saturation. Oral diphenhydramine 50mg administered.
48 2021-01-06 taste disorder c/o funny taste 10 min after vaccination Narrative: 10 min after vaccination employee c/o funny tas... Read more
c/o funny taste 10 min after vaccination Narrative: 10 min after vaccination employee c/o funny taste. Denies numbness/tingling to lips or tongue. No difficulty swallowing. Monitored pt for 30 minutes. Emploees states funny taste has resolved.
48 2021-01-07 taste impairment Metal taste in mouth after receiving the vaccine, headache, fatigue, Fever for 12 hours, dizziness
48 2021-01-07 lacrimation increased Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she ... Read more
Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she had flu like symptoms and this morning she has bilateral swollen lymph nodes in the axilla area.
48 2021-01-10 ear pain sore throat, headache, earache. called in sick to work.
48 2021-01-10 eye pain Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and... Read more
Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
48 2021-01-10 swollen tongue, mouth numbness I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever... Read more
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
48 2021-01-11 eye twitching I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt littl... Read more
I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt little bit sick and I picked up food and I started to feel sick. I went to work and my symptoms got worse and I sat in my desk and I felt like fainting. I just felt so sick and I thought it was my diabetes. A coworker saw me and told me i looked deathly pale and felt fainting and they took me to a ER room. They gave me Benadryl and IV fluids. I started seeing the floor and ceiling warped out, I was hallucinating. My legs felt numb as well. My eyes were twitching constantly. My blood pressure 147/95 and pulse was 112. I went home, ate and went to sleep. On Saturday I felt better and went back to work 12-28-2020, I felt weak and stayed working at my shift. On Tuesday I worked 1 hour and still felt super weak. Today I am starting to feel like myself again. I will not get my second dosage due to my symptoms I have experienced.
48 2021-01-11 blindness in both eyes facial swelling, temporary loss of vision in one eye
48 2021-01-11 taste impairment patient complained of metallic taste, body felt heavy, eventually subsided
48 2021-01-11 eye disorder hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to v... Read more
hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to vaccine; hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to vaccine; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # ekj5730), intramuscular at single dose in the right arm on 28Dec2020 13:00 for COVID-19 immunisation. Medical history included migraine, allergies to Codeine, Hydrocodone. Concomitant medications were not reported. On 29Dec2020 11:00, the patient experienced hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to vaccine. The outcome of the events was not recovered. No treatment was performed. The patient was not pregnant at the time of vaccination. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
48 2021-01-11 hearing loss Caller was difficult to hear during call.; Bruise on injection arm; This is a spontaneous report fro... Read more
Caller was difficult to hear during call.; Bruise on injection arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 29Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced bruise on injection arm on 30Dec2020, caller was difficult to hear during call on an unspecified date. The outcome of events was unknown. Information on the Batch/Lot number has been requested.
48 2021-01-12 lip swelling, swollen tongue, mouth numbness Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start... Read more
Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start having bulbar reaction with clearing of throat and tightness of chest; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; This is a spontaneous report from a contactable Other-HCP (patient herself). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 07Jan2021 at 14:15 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 48-year-old. The patient was not pregnant. No other vaccine was received in four weeks.Relevant medical history included COVID 19 complications (prior to vaccination). The patient has allergy to contrast dye, sulfa and molds. Relevant concomitant medications included nebivolol hydrochloride (BYSTOLIC), topiramate (TOPAMAX), atorvastatin (LIPITOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), and acetylsalicylic acid (ASA). After vaccination, within 5 min she started with numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation. Began to start having bulbar reaction with clearing of throat and tightness of chest. She was given diphenhydramine hydrochloride (BENADRYL) total 50 mg, famotidine (PEPCID) 20 mg, dexamethasone (DECADRON) 4 mg and racemic epinephrine. The events required visit at emergency room/department and urgent care. However, the events were reported as non-serious by the reporter. Post-vaccination COVID test was not performed. The patient had not recovered from the events.; Sender's Comments: The reported "numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation", "bulbar reaction with clearing of throat and tightness of chest" developed within 5 min administration of BNT162B2, is likely an allergic reaction to BNT162B2, and considered related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
48 2021-01-12 mouth tingling 11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observa... Read more
11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observation post vaccine. No symptoms during 30 minute observation post vaccine administration. Approximately 12:45pm right hand, tongue, mouth started tingling, and felt tongue was swelling. Reported feeling flush with chills, headache, and generalized weakness in legs. Went back to vaccine clinic to report symptoms at 2:15pm.
48 2021-01-12 thirst Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy an... Read more
Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any distress/discomfort. At 1640, patient complained of itching at injection site. Patient stated she has a history of developing itchy feeling due to adhesive from bandages. Patient removed the bandage. RN administering IM injection inspected site: no swelling, rash, hives, or other s/s of inflammation. Patient still alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any feeling of doom, nausea, vomiting, shortness of breath, elevated heart rate, etc. RN administering injection gave patient an ice pack to apply to left upper arm. Monitoring patient. Patient sitting in chair in vaccine clinic waiting room area. Sipping on H2O due to complaint of feeling thirsty. No difficulty swallowing water. EMS called to Vaccine Clinic for unrelated issue. Once EMS on scene, patient further evaluated by EMS (Biox 98%). Patient asking to be transported to ER. EMS taking patient per patient request.
48 2021-01-13 dry eye, dry mouth Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi... Read more
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
48 2021-01-13 lip swelling Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minu... Read more
Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minutes her upper lip started to swell and redness in the face. Blood pressure was monitored and was high ( around 230/110). Pulse ox was put on her finger. Oxygen levels were stable. Gave patient two benedryl tablets. No throat closing or trouble breathing. Patient went with wife to ER. From what I am told, patient given steroids in the hospital. She was released a few hours later and is at home now. Patient is currently stable at home.
48 2021-01-13 lip swelling FIVE DAYS OF SISTOMES,HEADACHE,MUSCULAR PAIN, CHILLS GANGIOS INFLAMATION ,SWELLING OF LIPS.
48 2021-01-13 pain in jaw Head ache and sharp shooting pains in head neck and jaw every day since vaccine only on left side ... Read more
Head ache and sharp shooting pains in head neck and jaw every day since vaccine only on left side of head comes and goes all day. No relief from otc pain meds
48 2021-01-13 swollen tongue Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx wi... Read more
Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx with Benadryl, Pepcid. solumedrol IV. : with sx resolution - observed for 4 hrs in ED & d/cd
48 2021-01-14 mouth tingling Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed... Read more
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
48 2021-01-14 swelling around the eyes face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat start... Read more
face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat started 24 hours after vaccine . Severe headache and joint pain started 27 hours after vaccine
48 2021-01-15 dry throat About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it ... Read more
About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it was deep and scratchy, The change in voice got worse as i was speaking to my friend so i went to the ED (building next to where I work). I had no problems breathing but was eventually treated for anaphylaxis with epi, prednisone, benadryl, and pepcid
48 2021-01-15 oropharyngeal discomfort L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation res... Read more
L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation resolved following benadryl. tingling still present at 14 hours but has improved.
48 2021-01-16 dry mouth, taste impairment A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccinat... Read more
A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccination. Then I got a really bad headache & very nauseas within 5 min of getting the vaccine. I had pain on the vaccine area. I also felt very tired very exhausted about 4 or 5hrs later. I started getting chills & achiness started the next day on 12/24/2020. On 12/25/2020 I felt nauseas, still had the chills, headaches, still felt fatigue, achiness, sore throat & also had diarrhea. I had all this symptoms all the way till 12/29/2020. Seen doctor on 12/28/2020 and they decided I should get tested for Covid.
48 2021-01-16 mouth tingling Dizzy, weakness, tingling in lips and fingers, increased heart rate
48 2021-01-16 swollen tongue, mouth tingling Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, t... Read more
Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, tachycardia.
48 2021-01-16 swollen tongue, mouth tingling Lips tingling, tongue/throat swelling, flushed, hot flashes, leg weakness, nausea, tachypnea
48 2021-01-17 dry throat Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, ... Read more
Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, throat swelling and hoarse voice. Symptoms started approximately 40 minutes post vaccination at 1320. Pt has hx of food allergies. Pt was treated with epinephrine 0.3mg IM, diphenhydramine 25mg po, and famotidine 20mg po and prednisone 40mg PO. Observed in ED until 1758 and was noted to have no worsening of symptoms and improvement in hoarse voice. Discharged with prescription for prednisone 40mg x4 days.
48 2021-01-17 eye swelling On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell an... Read more
On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell and neck was red and had small bumps on it. Took some Benadryl and went to bed woke up this morning and eyes were swollen and face was a little worse. No record that patient sought medical attention or visited the ED. Patient reported swelling and itching went resolved the weekend of 1/16/21.
48 2021-01-17 mouth numbness, mouth tingling The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went ... Read more
The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went numb, and I became a little bit disoriented while driving home. I also noted a pain in the left side of my chest. I got feeling back in my lips in my face approximately half an hour to 45 minutes later. I did take an Allegra allergy pill when I got home. I had already taken one Allegra allergy pill that morning. I slept for 12 hours on the following Friday night and Sunday night, whereas I typically only sleep approximately 6 to 7 hours per night. I noted significant stuffy nose and fatigue for the 3 to 4 days following the vaccine continuing until today.
48 2021-01-18 mouth numbness, mouth discomfort not sure if might be related to vaccine. Developed numbness , some redness and peeling off skin i... Read more
not sure if might be related to vaccine. Developed numbness , some redness and peeling off skin inside of bottom front of the mouth. When rinsing with Listerine, it burns and white patches of skin come off. Feel of burn like from acidic food(lemon, orange, etc.).
48 2021-01-18 mouth tingling Systemic: TONGUE TINGLING AND FEELING WEEK LIP TINGLING, TOOK BENADRYL WITHOUT CONCERNING PHARMACIST... Read more
Systemic: TONGUE TINGLING AND FEELING WEEK LIP TINGLING, TOOK BENADRYL WITHOUT CONCERNING PHARMACIST BUT FELT BETTER WITH IT. OBSERVED FEW MINUTES
48 2021-01-19 lacrimation increased, bloodshot eyes, eye itchiness Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade feve... Read more
Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade fever and chills all over my body especially the head, extreme weakness. It lasted for 2 days.
48 2021-01-19 mouth tingling, lip swelling body rash, lip swelling and tingling
48 2021-01-20 mouth tingling Felt dizzy and lightheaded, with a heaviness in her head following vaccine administration. Pt also e... Read more
Felt dizzy and lightheaded, with a heaviness in her head following vaccine administration. Pt also experienced tingling to her lips, and then felt as if she was going to pass out. The staff at the vaccination site gave her epinephrine 0.3 mg/0.3 ml IM, and then brought her to the ED. No acute resp distress in ED, given famotidine inj, methylprednisolone and ondansetron in ED. Given 4 days of Prednisone to continue after ED discharge. Seen by allergist and observed during second dose administration with recurrence of symptoms during divided dose administration.
48 2021-01-20 mouth tingling Tingly tongue
48 2021-01-21 lip swelling Patient was given Covid-19 vaccine. No previous reactions to vaccines, allergy to Nitro (swelling). ... Read more
Patient was given Covid-19 vaccine. No previous reactions to vaccines, allergy to Nitro (swelling). She was being monitored and within 15 minutes her upper lip was swelling. She also had redness on her face. Oxygen levels were stable. Blood pressure monitored and was high (200s/ low 100s). Gave patient 2 tablets of Benadryl. Patient had no throat swelling or trouble breathing. She was taken to the local ER. At the ER, the patient was given steroids. She was release from the ER within a few hours. She is currently at home and is stable.
48 2021-01-25 loss of taste, loss of smell I regained my taste. I had Covid 31Dec-10Jan with both loss of smell and taste initially. My smell r... Read more
I regained my taste. I had Covid 31Dec-10Jan with both loss of smell and taste initially. My smell returned quickly but after the 2nd vaccine my taste returned the next day; I had Covid 31Dec-10Jan with both loss of smell and taste initially.; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot-number: EL0104), via an unspecified route of administration in the right arm on 21Dec2020 at 03:00 at a single dose, and the second dose (Lot number: EL3249) via an unspecified route of administration in the right arm on 11Jan2021 at 03:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination, did not have any other vaccine within four weeks, and did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. The patient previously took sertraline (ZOLOFT) and experienced drug hypersensitivity. The patient stated that she regained her taste. She had COVID from 31Dec-10Jan (also reported as on 12Jan2021 at 12:00) with both loss of smell and taste initially. Her smell returned quickly but after the second vaccine, her taste returned the next day. The patient underwent lab tests and procedures which included viral test (nasal swab; Sofia COVID test): positive on 04Jan2021. The patient received no treatment for the events. Outcome of the events was recovered.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
48 2021-01-25 taste impairment headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny ... Read more
headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny taste in the mouth; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 13Jan2021 07:50 at a single dose on Left Upper Arm Muscle for COVID-19 immunization. Medical history included thyroid disorder and antidepressant therapy. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder, duloxetine hydrochloride (CYMBALTA) as Antidepressant and multivitamins. The patient stated that she is calling about the COVID Vaccine, she just had the shot at 7:50AM this morning. After getting the shot she heard that she is not suppose to get the shot if she had tested positive for COVID before the vaccine. She wanted to know if this was true or a rumor. Back around Nov2020 she did test positive for COVID. It was the week before the holidays on Wednesday 18Nov2020 when she lost taste and smell, she then got tested on 19Nov2020 Thursday then got results Friday or Saturday morning, the weekend before the holidays that she was positive. The test was a nasal swab. The girls in the office said she was not suppose to get the shot if it had not been 3 months. When she had COVID shot they didn't tell her if she could take it or not. This morning she woke up everything was fine, she drove over to get vaccine, after they put the vaccine in, they made her wait 15- 30 minute, while waiting she was getting a headache, then the headache went away and she then felt funny in the head. She was a little nauseous then that went away. Then she had this overwhelming feeling of tiredness like she could go to bed. She felt bad a little bit. When she then drove back to work at the school she had this funny taste in the mouth. Her boss wanted to call and see if this is all normal. The date of first dose was 13Jan2021, all the symptoms she experienced occurred within half hour of receiving the vaccine. She thinks she is fine. At the moment she does not have the taste in mouth any longer and her headache left. She still feels funny in head as well as she just feels bad inside, she has the feeling of overwhelming tiredness, she just feels like something is coming on, like she knows she is getting sick. She has no Lot or Expiry to share, she vaccine CDC card is outside in the car and not physically with her. Her drive to get the vaccine was an hour away to a Hospital and all the medication was taken an hour before. She went to the hospital to have the vaccine administered. Then she drove to work at a school. She has had an antibody test, in which they draw blood, it was negative but that was even before she caught COVID, it was back in Aug2020 or Sep2020. She has had no issues with vaccines in the past. The outcome of the event headache, a funny taste in the mouth, and nausea was recovered on 13Jan2021, tiredness/overwhelming feeling of tiredness was unknown, feeling "funny" in the head was not recovered. The events were assessed as non-serious. Information about lot/batch number has been requested.
48 2021-01-25 eye irritation Shortness of Breath, vomiting x 1, body aches, headache, eyes were burning. Stayed in bed x 3 days... Read more
Shortness of Breath, vomiting x 1, body aches, headache, eyes were burning. Stayed in bed x 3 days Did not take any medications or seek medical attention
48 2021-01-25 oropharyngeal discomfort While at vaccine pod patient developed hives on left deltoid and neck/chest region. Patient given B... Read more
While at vaccine pod patient developed hives on left deltoid and neck/chest region. Patient given Benadryl and brought back to first aid tent. Patient developed sore, scratchy throat and headache. No further symptoms before resolve. Give ibprofen.
48 2021-01-25 smell distorsion, mouth numbness My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal B... Read more
My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time with it.
48 2021-01-26 pain in jaw Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest... Read more
Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine
48 2021-01-26 swelling of eyelid My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experienci... Read more
My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experiencing it all.
48 2021-01-26 ringing in ears Vertigo, Ring in ears and pounding headaches Lasting for 5 days. Needed to be treated with steroids ... Read more
Vertigo, Ring in ears and pounding headaches Lasting for 5 days. Needed to be treated with steroids for 6 days. Outcome. Still having dizziness and ringing in ears .
48 2021-01-28 dry mouth, mouth numbness, mouth tingling Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tinglin... Read more
Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tingling of left side of face; numbing and tingling of left side of face and left side of upper/lower lips; numbing and tingling of left side of face and left side of upper/lower lips; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included none. Patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced dry mouth, numbing and tingling of left side of face and left side of upper/lower lips, numb on left side of neck on 06Jan2021. Shot was in left arm. Concerned about getting second vaccine. No treatment received in response to the events. The outcome of the events was recovering. The patient was not pregnant. Facility type vaccine was Public Health Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
48 2021-01-28 sensitivity to light Hours 18-30 after the 2nd dose of covid vaccine, I had bad headache (sensitivity to light), body ach... Read more
Hours 18-30 after the 2nd dose of covid vaccine, I had bad headache (sensitivity to light), body aches, nausea, and very tired. Slept all day, got up for dinner, then went back to bed. Woke up the next day and felt 100% good. I. Other words, had the 2nd dose on Monday morning, Tuesday felt awful, Wednesday felt perfectly fine.
48 2021-01-29 eye twitching After Dose 1 of Pfizer COVID vax (on Jan 5) I developed a mild twitch of left upper eyelid (started ... Read more
After Dose 1 of Pfizer COVID vax (on Jan 5) I developed a mild twitch of left upper eyelid (started on Jan 15, 10 d after vaccine). Persisted, daily - then had dose 2 on Jan 25 and developed more notable twitch of right lower eyelid that was even more persistent and is still ongoing . Never had issues with this before. Not debilitating. Might have nothing to do with vaccine, but thought I'd report in case!
48 2021-01-29 swollen tongue Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and... Read more
Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and tingling in vaccine arm Went to ER for monitoring Ten minutes after started the worst headache of my life and I get migraines Have had pulse racing and slight chest pains all afternoon Went home after 4 hours observing Got a steroid through IV Fever has started after 12 hours
48 2021-01-30 taste impairment Thursday- 25 minutes after injection I started tasting metal and my throat and chest got hot and sta... Read more
Thursday- 25 minutes after injection I started tasting metal and my throat and chest got hot and started to swell. It was a similar feeling to getting contrast through an IV. I took two Benadryl and Ibuprofen to help relieve the symptoms. The metal taste lasted until the next day. Friday- The next morning I woke if with a fever 100° . Minus the mild arm pain, I initially felt ok but as the day went on I felt worse, like the flu. By 11am my heart was racing even at rest. My pulse is usually in the low 60 range (athlete) and it was 95-115 from 11am until late that evening. Saturday- symptoms gone but huge dark circles under my eyes. I felt great though.
48 2021-01-31 taste impairment, eye swelling Metal taste in mouth; slight swelling of eyes; This is a spontaneous report from a contactable nurse... Read more
Metal taste in mouth; slight swelling of eyes; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 21Dec2020 for COVID-19 immunization. On 11Jan2021 02:30 PM, the patient experienced Metal taste in mouth, slight swelling of eyes. No treatment was received. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in Jan2021.
48 2021-02-01 dry mouth Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightn... Read more
Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightness in throat, difficulty swallowing and slight confusion begins - drank more water and began to suck on lollipop 5 minute marker - confusion, tightness in throat worsens and lump in throat begins - I alerted medical staff who attended to me and gave me a cold compress. 10 minute marker - Drank water, self administered 2 children's dissolvable Benadryl 20mg - remained at hospital for one hour under observation. 50 minute marker - throat still tight, lump subsided, difficulty swallowing persists, confusion lessens, extreme dry mouth persists, tingling in extremities comes and goes - self administered 2nd Benadryl 25mg 60 minutes - left clinic 90 minutes - called primary care physician and left a message 3 hours - primary care responded to take prednisone 20 - 40 mg every 6 hours for 2 days. 3 hours 20 minutes - all symptoms described above subsided. Prednisone was taken for 36 hours as tightness in throat, issue swallowing and lump came back when I tried to stop the Prednisone at 48 hours.
48 2021-02-01 ear pain Started by feeling dizzy today around 11:45 am then a headache that I still have, Around 2:00 pm I ... Read more
Started by feeling dizzy today around 11:45 am then a headache that I still have, Around 2:00 pm I started with pain in both ears and feeling tired. No feeling well. Right now I laying in bed.
48 2021-02-02 oropharyngeal discomfort Patient felt light headed and hot. She then c/o scratchiness in her throat and a little shortness of... Read more
Patient felt light headed and hot. She then c/o scratchiness in her throat and a little shortness of breath. Patient was administered Benadryl 50mg IVP and was monitored at the site of vaccination. She refused transport. She stated that she felt much better.
48 2021-02-03 loss of taste, loss of smell Headache ,Fever ,Nausea, joint pain, diarrhea, loss of taste and smell tested positive for Covid 19... Read more
Headache ,Fever ,Nausea, joint pain, diarrhea, loss of taste and smell tested positive for Covid 19 on 12/31/2020
48 2021-02-03 loss of smell, loss of taste Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is ... Read more
Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EF9231; Expiration date was not reported) on 11Jan2021 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included breast cancer and hypertension. The patient's concomitant medications were not reported. On 18Jan2021, the patient had site pain; headache; and was nauseous. On 13Jan2021, the patient had cough. In Jan2021, after the vaccination, the patient had felt congested. In Jan2021, almost two weeks after the vaccination, the patient had no taste or smell. The reported events had resulted in the emergency room/department or urgent care. The outcome of the events, 'site pain', 'headache', 'nauseous', 'cough', 'felt congested' and 'had no taste or smell', was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021, the patient had a nasal swab COVID-19 test, and was negative.
48 2021-02-03 tongue disorder, swollen tongue, taste impairment, eye strain, ear discomfort, mouth tingling Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/di... Read more
Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/dizzy; lightheaded/dizzy like she was going to pass out; Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on; Had a heavy feeling in her chest; Tingling sensation on her lips; Tingling sensation on the right side of her face, and cheek; Severe burning in her right ear; Sore throat on the right side; When she was speaking it sounded like she had a thick tongue; Tongue feels swollen; Pain at the base of her skull on the right side; Pain on the right side of her forehead; Pinpoint pain that went down the right side of her spine; Metallic taste in her mouth; felt off; Pain at the injection site; It was so bad that it would wake her up if she rolled over; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3248), via an unspecified route of administration on 15Jan2021 at single dose (Once by injection in the right arm) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included Hepatitis B vaccine. There were no concomitant medications. On 15Jan2021, after 15 minutes of monitoring she was fine. 5 minutes later or so (after 20 minutes), she had a flushed feeling and was lightheaded/dizzy like she was going to pass out. She returned to her office. She had someone check her blood pressure which was fine. It was 110/60. Normally it runs low in the 90s. Again, she thought she looked flushed. It was reported she had a heavy feeling in her throat and chest and on her face. She had removed her mask but it still felt like she still had it on. She had brought Benadryl with her, as she has had a reaction to the Hepatitis B vaccine before. She took the Benadryl since she felt off. She thinks this first part of what she experienced triggered everything else. By the time she got home, she had a tingling sensation on the right side of her face, on her lips and cheek. She had severe burning in her right ear. She also had a sore throat on the right side. Heaviness in her throat and chest- resolved late Saturday to early Sunday (Jan2021). Her husband noticed on Friday evening (15Jan2021) when she was speaking it sounded like she had a thick tongue. Saturday morning it was more normal. Her tongue does feels swollen. She also developed pain at the base of her skull on the right side. This started about 2 hours after the vaccine. She had pain on the right side of her forehead. She had pinpoint pain that went down the right side of her spine. She also developed a metallic taste in her mouth. She had pain at the injection site. It was so bad that it would wake her up if she rolled over. On 17Jan2021, she slept all day Sunday and also had extreme fatigue. On 18Jan2021, her right eyelid feels heavy on 18Jan2021. She does not think any of these are serious, but stated they are concerning. Vaccination card does not have the NDC or expiration date on it. Patient asked is getting the second dose of the injection recommend. She is leaning towards no but wanted to see what was recommended. She has reached out to her primary care about this. Outcome of the events flushed feeling, lightheaded/dizzy, lightheaded dizzy, like she was going to pass out was recovered on 15Jan2021. Outcome of the events when she was speaking it sounded like she had a thick tongue was recovered on 16Jan2021; Outcome of the events pain at the base of her skull on the right side, pain on the right side of her forehead, pinpoint pain that went down the right side of her spine, extreme fatigue, pain at the injection site was recovered on 17Jan2021; Outcome of the events Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on, and Had a heavy feeling in her chest was recovered on Jan2021. Outcome of the events severe burning in her right ear, sore throat on the ride side, tingling sensation on her lips, tingling sensation on the right side of her face and cheek was recovering. Outcome of the events tongue feels swollen, metallic taste in her mouth, right eyelid feels heavy was not recovered. Outcome of the events it was so bad that it would wake her up if she rolled over, she slept all day Sunday, and felt off was unknown. The reporter considered the events as non-serious. Causality assessment for events for felt off, she slept all day Sunday, It was so bad that it would wake her up if she rolled over was not reported. Causality assessment for all other events was reported as related.
48 2021-02-04 eye pain bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a si... Read more
bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a sinus headache; pain on the right side of the back of her neck that radiated behind her right eye; pain on the right side of the back of her neck that radiated behind her right eye; dizziness; sweating; swollen lymph nodes in her throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 15Jan2021 at 07:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced dizziness, sweating, and swollen lymph nodes in her throat. On 18Jan2021, the patient started to get a really bad headache that felt like migraine and thought it might be a sinus headache. On the same day, the patient also had pain on the right side of the back of her neck that radiated behind her right eye. The patient would like to know if she could take anything for her headache. The outcome of the event bad headache that felt like migraine was not recovered while the other events was unknown. Information about lot/batch number has been requested.
48 2021-02-04 sensitivity to light Woke up the next morning with an extremely bad headache/migraine. Light sensitive to my eyes. I h... Read more
Woke up the next morning with an extremely bad headache/migraine. Light sensitive to my eyes. I had to take ibuprofen and acetaminophen around the clock, and I went back to bed and slept until 1pm that day. Headache remained dull the rest of the day, but I began feeling better. My left arm was also very sore and second day past vaccine now have armpit soreness/pain. Took ibuprofen again today for that.
48 2021-02-04 swollen tongue, mouth numbness, taste impairment it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left ton... Read more
it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-02-05 blindness I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a... Read more
I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a sudden I felt a heat throughout my body and felt on fire while also feeling an urge of diarrhea and nausea. I tried to go to the bathroom, but kept passing out. I could not see, but was conscious. It took me 15 minutes to crawl to the bathroom. I did not vomit and passed watery stool x 2. The episode passed after about 40 minutes. I continued to have a slight elevated temp all day after that episode, but only 99.6 and below. There were no more issues after that brief, horrible reaction. I am 101 lbs.
48 2021-02-07 taste impairment dizziness, anxiety, metallic taste
48 2021-02-07 sensitivity to light Pain in arm headache nausea fever body aches joint aches sensitive to light
48 2021-02-07 toothache Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/c... Read more
Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
48 2021-02-10 lip swelling allergic reaction; severe lip/facial swelling on left side of face and top lip/swelling two days lat... Read more
allergic reaction; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on 30Dec2020 at 09:00 (Lot number: EL0140) in the right arm and second dose on 20Jan2021 (Lot number: EL3246) in the left arm, both at the age of 48-years-old at a single dose for COVID-19 immunization. Medical history included low vitamin D, hypothyroid, Von Willebrand's, and idiopathic anaphylaxis (years ago, outgrew). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications within two weeks of vaccination. The patient previously received botulinum toxin type A (BOTOX) in the forehead years ago. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction on 31Dec2020. The events were reported as non-serious. The clinical course was reported as: The patient woke up with severe lip/facial swelling on left side of face and top lip. The patient went to doctor and they thought it was allergic reaction, but not sure if it was the vaccine. After the patient received the second dose, she had swelling two days later on right bottom side of face and lip. The patient had no lip/facial filler. The patient did not receive any treatment for the events. The clinical outcome of severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction was recovered in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
48 2021-02-11 loss of taste I received the vaccine at 7AM. I started feeling achy and had a headache by 10PM that night. My symp... Read more
I received the vaccine at 7AM. I started feeling achy and had a headache by 10PM that night. My symptoms worsened. By the weekend, I had lost my taste. I went for a covid test, it was negative. The following week I worsened. Cough, headache, body aches and diarrhea. By Friday 1/29/21 morning my daughter took me to the hospital. I do not remember going, I was diagnosed with altered mental status. I was dehydrated and a chest xray showed pneumonia. I was discharged on 1/31/21, diagnosed with vaccine reaction, pneumonia and altered mental status. I currently still have a cough, get easily tired, no energy.
48 2021-02-11 mouth itchiness, swollen tongue, mouth tingling, mouth ulceration Initially had itching about 10 minutes following injection, at the injection site. About five minute... Read more
Initially had itching about 10 minutes following injection, at the injection site. About five minutes following that, developed mild itchiness in the ears, roof of mouth. Never experienced difficulty breathing or swelling of face or throat. Checked in with table monitoring the clinic, described symptoms and was advised to take Benadryl and report to an ER if symptoms worsened. Took 50 mg of liquid Benadryl as soon as I got home around 6pm and again the following morning and evening. Injection site remained itchy until 1/31/21 and began to subside. Mouth then erupted with ulcers and tingling beginning evening of 1/31/21 into 2/1/21 and some minor tongue swelling. When I arrived at work I asked one of the physicians to take a look and tell me what their thoughts were. They were not sure. I was then advised by my Supervisor to notify employee health, which I did with my supervisor present. They recommended to fill out an RL 6 form and seek medical treatment if necessary. I began taking Claritin, Allegra and Pepcid in case this was continued reaction. I messaged PCP to get their thoughts, but they were unfamiliar with what different side effects of vaccine are or how to proceed. I did rinses and mouth care to treat ulcers which have begun to subside as of 2/9/21. Advised to report as no one seems to know if this is something brought about by immune system. Employee health recommends seeing immunology in case of needing to receive vaccine in future, which I do intend to get again if it is required annually. Have not seen anyone yet.
48 2021-02-11 pain in jaw After the first vaccine I experienced some pain on the left side of my neck into my jaw. The day af... Read more
After the first vaccine I experienced some pain on the left side of my neck into my jaw. The day after the second vaccine I noticed a lump above my left clavicle. That evening the lump was larger and visible. The next day the lump became even larger and at one point the swelling in my neck seemed like it might impede my airway. After using a warm compress the swelling came down a little. I called the on-call doctor who recommended a follow up in the office. It wasn't until 2 days later that it wasn't visible anymore but could still be palpated. I had an appointment with my physician on Tuesday just to make sure it was a swollen lymph node. She advised it was soft and moveable and most likely a swollen lymph node but to keep an eye on it and if the swelling didn't go down in two weeks to get further testing.
48 2021-02-16 loss of taste, loss of smell 2-4-21 2000 Nausea/upset stomach 2-5-21 0100 Fever/chills, HA, injection site pain, joint pain, musc... Read more
2-4-21 2000 Nausea/upset stomach 2-5-21 0100 Fever/chills, HA, injection site pain, joint pain, muscle pain, tiredness, nausea/upset stomach, loss of sense of taste and smell 2-6-21 HA, injection site pain/swelling, joint pain, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, nausea/upset stomach, loss of sense of taste and smell 2-7 -21 HA, injection site pain/swelling, joint pain, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, nausea/upset stomach, loss of sense of taste and smell 2-8-21 HA, injection site pain/swelling, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, loss of sense of taste and smell 2-9-21 HA, injection site pain/swelling, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, diarrhea 2-10-21 Fatigue, lymphadenopathy, vertigo 2-11-21 Fatigue, lymphadenopathy, vertigo 2-12-21 Fatigue, lymphadenopathy, vertigo 2-13-21 Fatigue, lymphadenopathy, vertigo 2-14-21 Lymphadenopathy, vertigo 2-15-21 Lymphadenopathy, vertigo 2-16-21 Lymphadenopathy, vertigo 2-17-21 Lymphadenopathy, vertigo
48 2021-02-16 taste impairment Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report... Read more
Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), intramuscular in the left arm on 06Jan2021 14:30 at a single dose for covid-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. On 06Jan2021 at 15:00, the patient experienced dysgeusia 20 min after exam lasting 1 min and left hemicranial numbness times 24 hrs. The patient still has mild residual numbness on left face. The events resulted in doctor or other healthcare professional office/clinic visit. The events were not treated. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events dysgeusia and numbness with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-02-16 eye swelling, vision blurred, eye strain After my first dose on 01,18/2021, I was diagnosed with pink eye on 01/21/2021. Took Polymyxin B-Tem... Read more
After my first dose on 01,18/2021, I was diagnosed with pink eye on 01/21/2021. Took Polymyxin B-Temp eye drops for 7 days. This dose on 02/15/2021, one night after, my right eye again felt heavy, blurry, crusty in corner, and very much like the beginnings of pink eye. Next day, look in mirror, and above iris, there?s a grey discoloration that looks like my iris has shifted down. Upon further investigation, it is swollen. Alrex eye drops prescribed for two days. Return to doctor if not corrected.
48 2021-02-17 eye pain By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headac... Read more
By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headache became really severe - even when walking or chewing. My face was really hurting me; very tender by left eye. I felt so tired. I had to go home from work at 2:30. Felt very cold and I put on really warm clothes and got under three 3 blankets and I slept for three hours. I felt better by that evening, I slept normally that night. Face was very swollen under my eyes - two days after vaccine. (I have filler under my eyes - it's been a year since I had that put in.) Benadryl every six hours. It took 12 hours for pain to go away and for it to decrease. But it did help. Everything resolved.
48 2021-02-18 taste impairment I received my 2nd vaccine at 3:24pm. Around 3:30, I had a bitter taste in my mouth in the back of my... Read more
I received my 2nd vaccine at 3:24pm. Around 3:30, I had a bitter taste in my mouth in the back of my throat. I didn?t associate this with the vaccine. I left the facility around 3:45pm and started driving home. The right side of my face started to feel funny and felt numb. By the time I got home at 4:20, the whole side of my face felt numb. I could smile and talk. It felt like I had received Novocain from the dentist. I immediately started looking for phone numbers to call and tried to figure out what was happening. I left a message with a nurse hotline and left a message with the answering service at my primary care doctor?s office. Doctor FaceTimed with me for 7 minutes at 5:04 and said to go to the hospital.
48 2021-02-19 tongue disorder voice change, cough, wheezing, bumps on tongue
48 2021-02-20 eye swelling In both doses, I had extreme swelling of my eyes. In dose 1 it occurred at the 27 hour mark, first ... Read more
In both doses, I had extreme swelling of my eyes. In dose 1 it occurred at the 27 hour mark, first in my left eye and later in the right eye. In dose 2, I had extreme, sudden onset of swelling in both eyes. I barely got my contacts out before my eyes swelled closed. I took Benadryl and monitored closely to determine if I needed to go to hospital.
48 2021-02-22 feeling of choking Itchy, tingley, throat. Itchy bottom of feet. Drank water. Lasted ~20 minutes. No visible rash.
48 2021-02-23 loss of smell chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactabl... Read more
chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the right arm, on 05Jan2021 10:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications included omeprazole; metoprolol; methocarbamol; vitamin d3; pregabalin; and levothyroxine. The patient did not have Covid prior vaccination. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first shot the patient experienced chills, headache, sore throat, nausea and, loss of smell - all on 08Jan2021. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for these adverse events. At the time of the report, the patient was recovering from the events. The patient had a nasal swab for Covid on 11Jan2021 with results of negative.
48 2021-02-25 lip swelling, swelling of eyelid Pt received first dose of Pfizer covid19 vaccine. After about 40 minutes, pt endorsed of having swel... Read more
Pt received first dose of Pfizer covid19 vaccine. After about 40 minutes, pt endorsed of having swelling in the upper left of lip, swelling in the nose , itchy feeling in the left eyelid and swelling in the right eye lid. Per pt, the swelling is mild and moderately bothersome. We observed the pt for another 60 minutes and pt reported that her symptoms have subsided. However, she still experiences mild nose swelling but she stated that it was much less than before. No medication/treatment was administered. Pt went home and was instructed to contact emergency services if reactions become severe. Pt stated that she may take Benadryl at home.
48 2021-02-27 bloodshot eyes, eye swelling Swollen eyes...red eyes
48 2021-02-27 swollen tongue swollen tongue, difficulty swallowing and breathing, itching, rash, headache, ache, fatigue
48 2021-02-28 mouth swelling, eye swelling Breathing was off, mouth swelling, eye swelling, blood in phlegm
48 2021-02-28 mouth tingling, mouth numbness, ear discomfort I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad an... Read more
I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad and bright flourescent so admittedly I was bothered by them or it could have been the beginning of the whooseyness from the shot. My husband picked me up in the car out front, we were driving and I began to get pressure in my sinuses and mostly the sides of my nose. I did have some head congestion but this feeling had never happened (it should be noted I had negative covid tests to make sure stuffy head was nog covid related). Then I felt pressure in my ears and my face began to feel flush as my cheeks. All of this began at about 35 minutes after the injection. Then my lips began to feel strange. It was a cross between tingly and numb. I made as many faces in the car makeup mirror to make sure my face muscles were moving properly And they were. But there was definitely numbness occurring in my mouth. Tingly-numbness. This all happened within about 10 min of the first onset. Then I noticed some splotchiness on my lower arms. Mostly my left (shot was given in right- no redness at the injection site). I also got some splochiness on my chest and neck. Cheeks were also ruddy and flush. I did NOT have any problem breathing or swallowing at anytime. Nor did my pulse race (other than from a pit of panic from nerves over the reaction). I didnt have a thermometer but don?t think I had a fever either. We pulled over and I called a nurse on call. She told me if things worsened to go to hospital. I did have a little bit of the feeling you get when you are about to pass out and you feel like things are closing in a bit. But it never got past about a 2 on a scale of 1-10. I decided I wanted something to eat (I HAD eatten before) and I went to get a sandwich. I still was a bit light headed but the symptoms did start to subside in about an hour. After that I was only tired and took a nap. Nothing else after those initial reactions.
48 2021-02-28 ringing in ears 5 hours later developed cough, wheezing, lightheadedness, "ringing in head" but not tinnitus
48 2021-03-01 mouth tingling 253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gav... Read more
253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gave diphenhydramine elixir 25 mg x1 307p 120 HR, trouble with BP cuff 313p R arm numbness, legs heavy, face and mouth tingling ? gave diphenhydramine elixir 25 mg x1 315p 142/89, 110 HR ? legs ?wonky?, R arm numbness remains, itching improving 330p symptoms significantly improved, ?feeling better?; family member with patient and able to drive patient at home and continue observation Telephone follow-up performed at 430p. No problems.
48 2021-03-02 eye itchiness, eye swelling Sneezing; swollen, itchy eyes; swollen throat, difficulty swallowing, rash
48 2021-03-02 vision blurred after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 ... Read more
after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 spO2 97% RA. pt was in sitting position. became clammy, diaphoretic, blurred vision, and feeling worse and passed out. pt assisted to floor. MD called to bedside, 0.3 epi pen given to left thigh. no respirstory distress noted. fire and EMS on scene to transfer to ED. pt now a&ox4. VSS now.
48 2021-03-04 ear discomfort About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having dif... Read more
About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having difficulties swallowing, as if there was a lump in my throat......a few mins later my inner ears felt like they were burning and I felt pressure. I asked staff if symptoms were a side effect of vaccine at 15 minute mark from waiting period. They had me sit back down for another 15 mins and paramedic come see me. I told him I felt fine other than my throat feeling like it was as getting tighter and the difficulty swallowing. He offered to take my stats and I asked him to wait to see if symptoms would dissipate. After approx 49 mins of waiting from initial shot dose, my heart felt like it was racing and my throat felt tighter and I was now having a much harder time swallowing and I felt lightheaded. They took me back and hooked me up to get my vitals. About 7 mins later they brought an EPI Pen and I administered the shot in my leg. After approx 10mins +/- I began to feel my throat loosening a little. Then over the next 10 mins or so I felt almost normal with little trouble swallowing. They told me that I needed to go to the ER for further Eval. I arrived at ER approx 15 mins later and they gave me 2 Benadryl and 2 steroid pills and monitored me for the next 4 hrs - I was released shortly after - and again no other pain or side effects after EPI Pen and meds they administered. Sent home with EPI Pen and Steroids and instructions on what to watch for.
48 2021-03-04 eye swelling, thirst, lip itchiness It started out as an itchy area under the band aid. I took the band aid off and the itching got wors... Read more
It started out as an itchy area under the band aid. I took the band aid off and the itching got worse and went down my arm. A minute left after waiting 15 minutes I let the nurse know the reaction I was having ( bad itching), she looked at it and was red. She said it could be a site reaction and gave me an ice pack. Another nurse came to check on, and I told her I was really thirsty. By the time she got back my lips were feeling very heavy, lips itching and difficult to swallow, then my whole chest was covered in a red rash. With in a couple minutes there was a paramedic there and was more difficult to swallow, they tried to give me Benadryl thru an IV and blew my vain. So he asked me for a IM shot of Benadryl, I said yes and took me to the ER. By the time got there the Benadryl wore off and my lips got itchy and they took me right to the room and Dr gave me IV Solumedrol and Benadryl. They watched me for two hour sin the ER , they released me with 3 days of prednisone, Epipen, Benadryl. I went to the pharmacy (15 minute drive from ER) and both my eyes starting swelling, so I took 50mg of Benadryl capsule and the next day I started the prednisone, I had to take Benadryl every 3 hours for the next couple days because my eyes would start swelling.
48 2021-03-04 mouth numbness, swollen tongue tongue felt numb, and then started to swell as well as throat. Felt very weird swallowing. Pharmac... Read more
tongue felt numb, and then started to swell as well as throat. Felt very weird swallowing. Pharmacist gave me benedryl and made me stay there longer.
48 2021-03-04 vision blurred A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJ... Read more
A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJECTION I EXPERIENCED A HEADACHE, CHEST PAIN, DIZZINESS, THROAT SWELLS UP AND IT'S HARD TO SWALLOW, AND BLURRY VISION.I TOOK SOME BENADRYL AND MY THROAT STOPPED CLOSING UP. I WENT HOME AND LAID DOWN. MY ARM IS STILL NUMB BUT THE PAIN HAS RECEDED. MY ARM ALWAYS SWELLS UP WHENEVER I RECEIVE AN INJECTION. 2 HOURS LATER THROAT IS STILL A LITTLE SWOLLEN, AND I HAVE A SLIGHT HEADACHE. CHEST STOPPED HURTING. LEFT ARM IS STILL NUMB.
48 2021-03-05 eye itchiness Mild headache, tired, itchy eyes and face, sneezing, congestion, heart racing
48 2021-03-07 swelling around the eyes beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge o... Read more
beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge of nose, cheeks.
48 2021-03-08 loss of smell mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; C... Read more
mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; Chest tightness/achiness; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL-9261/expiration date: not provided), via intramuscular route of administration, on 30Jan2021 at 09:00 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was reported as none. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin D, cetirizine hydrochloride (ALLERTEC), and paracetamol (TYLENOL) (a few times after vaccine due to symptoms). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 (also reported as "02Jan2021"), the patient experienced chest tightness/achiness. On 03Feb2021, (also reported as "03Jan2021"), the patient experienced mild/partial loss of smell, headache, and sinus discomfort (pressure, ache). The events required an emergency room visit/physician office visit. The patient did not receive any treatment for these events. The patient was assessed by ER on 02Feb2021: EKG, chest X-RAY and bloodwork looked good. It was assumed COVID due to recent exposure, however, 72 hour COVID test nasal swab PCR on 03Feb2021 and rapid test SARS Antigen FIA on 06Feb were negative. The patient had a post vaccination nasal swab, covid test name unsure - NOT rapid, covid test result pending. The outcome of the events chest tightness/achiness, mild/partial loss of smell, headache, and sinus discomfort (pressure, ache) was not recovered.
48 2021-03-09 dry eye Headache, fatigue, joint pain, muscle pain, angioedema (face, neck, arms), dry eyes. Severe pain in ... Read more
Headache, fatigue, joint pain, muscle pain, angioedema (face, neck, arms), dry eyes. Severe pain in neck near implanted surgical metal. Period started 1 week early. Resolved I?m 48 hours with rest, heat packs, Tylenol and Benadryl.
48 2021-03-09 mouth tingling, oropharyngeal discomfort Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakne... Read more
Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakness Requires emergency room visit or hospitalization Shortness of Breath, Myalgia
48 2021-03-09 vision blurred Pt was feeling light headed and experiencing and blurry vision. Staff talked to the pt and took vita... Read more
Pt was feeling light headed and experiencing and blurry vision. Staff talked to the pt and took vitals. Vitals were as followed: P: 98, BP: 149/106, SPO2: unattainable. Pt reported having a history of hypertension and dextrocardia. Pt was breathing well and was able to speak clearly. Pt was AnOx4. Pt stated she has had no food or drink yet today and was nervous for the vaccination. Vaccination site was not raise, inflamed, or warm to touch. Staff concluded pt was most likely experiencing dehydration and anxiety. Staff told pt to monitor symptoms and if any were to return or worsen, to call insurance nursing hotline or 911.
48 2021-03-10 ear pain Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a con... Read more
Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a contactable consumer(patient) reported that. A 48-years-old female patient started to receive bnt162b2 (BNT162B2Formualation:Solution for injection ) ,via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for an unspecified indication .Medical history included sialadenosis from an unknown date and unknown if ongoing , cervix carcinoma from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The patient experienced chills on 28Jan2021 19:00 , pain in hips on 28Jan2021 19:00 cramping in abdomen on 28Jan2021 19:00 pain in left ear on 28Jan2021 19:00 and The patient underwent lab tests and procedures which included body temperature: 97.3 on Temperature under the tongue was 97.3 and outcome of the events was unknown Information on the Lot/Batch number has been requested.
48 2021-03-10 ear pain Severe left ear pain and pain on the left side of the face, including the neck.
48 2021-03-10 swollen tongue MINUTES AFTER VACCINATION PATIENT HAD TONGUE SWELLING, HIVES, AND THEN A SYSTEMIC ALLERGIC REACTION.... Read more
MINUTES AFTER VACCINATION PATIENT HAD TONGUE SWELLING, HIVES, AND THEN A SYSTEMIC ALLERGIC REACTION. EMS ON SITE. PATIENT TRANSPORTED TO ER. GIVEN BENADRYL AND SOLU-MEDROL ON SITE.
48 2021-03-11 mouth tingling Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Im... Read more
Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Immediately afterwards, patient was dizzy, flushed feeling, tingling of my lips, and swelling of the right side of my face. These symptoms were not enough to seek medical attention but were there. After that, I had swelling down my arm and into my right hand, up my neck and face, up and down the right side of my back. I have been extremely tired and weak feeling. Some improvement but I am still really sore and the RSD is starting to act up. I have called into work, been eating well, drinking a lot or water, moving as much as I can, and using Advil and Tylenol for pain management. Called into work for three days.
48 2021-03-11 vision blurred Patient experience brief episode of syncope - blurry vision, dizziness and sweating that was treated... Read more
Patient experience brief episode of syncope - blurry vision, dizziness and sweating that was treated with ice packs. Began at 4:50pm and resolved at 4:58pm
48 2021-03-13 mouth tingling Tingling in roof of mouth, tongue. Patient showed anxiety - emotional about death of cousin. BPs 155... Read more
Tingling in roof of mouth, tongue. Patient showed anxiety - emotional about death of cousin. BPs 155/95 (pulse 79), 136/90 (pulse 79). Given water and rested.
48 2021-03-14 dry mouth, loss of taste pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore... Read more
pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore R arm; LOSS OF TASTE; partial throat swelling 90 min after 2nd injection; drowsy; This is a spontaneous report from a contactable health care professional. A 48-years-old female received 2nd dose, bnt162b2 (BNT162B2) Lot number= Lot EL3247 , intramuscular in right arm, on 29Jan2021 at 15:30 as a single dose for COVID-19 immunization . Medical history included sjogren's syndrome, irritable bowel syndrome , raynaud's phenomenon, fibromyalgia , food allergy to peanuts, honey, oranges, strawberries, lobster, molasses, brown sugar, cinnamon. She had the first dose of COVID-19 on 08Jan2021 at 1545 in the right arm. There were no other vaccinations given in the past 4 weeks. She was not tested for Covid prior to vaccination.Concomitant medication included collagen (COLLAGEN), medium-chain triglycerides (MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]), ergocalciferol (VIT D), fish oil (FISH OIL). The patient previously took gluten and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. Course as follows: On 29Jan2021: partial throat swelling 90 min after 2nd injection. Took 50mg Benadryl. Became very drowsy and went to bed at 7:30pm. 30Jan2021: Woke at 5am w/chills, headache, body aches, sore R arm, temp of 101.3, dry mouth & LOSS OF TASTE. By 11:30am, fever went up to 103.5. Took 400mg ibuprofen. Went and got a Rapid Covid test (It was negative/undetectable). 4pm diarrhea. Took 400mg Ibuprofen at 6pm and 11:30pm. 31Jan2021: fever 100-101, headache, body aches, sore R-arm, diarrhea, loss of taste, sore throat. 01Feb2021: fever 99-100, headache, body aches, sore R-arm, dry mouth, loss of taste, sore throat. Went to get a 2nd Covid Rapid Test to r/o a false negative (It was negative/undetectable again). 02Feb2021: Fever 99-100, headache, dry mouth, loss of taste. 03Feb2021: temp normal, headache, dry mouth, loss of taste. 04Feb2021- 07Feb2021: temp normal, headache, dry mouth, weird continuous hot/cold flashes, pins & needles tingling all persist. Appt w/PCP scheduled for 17Feb2021. The patient was not hospitalized for the events. The patient was tested for Covid-19 on 01Feb2021 and was negative. The outcome of the events was recovering.
48 2021-03-14 ringing in ears On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch soun... Read more
On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch sound like static. It hasn?t gone away since then. Im seeing an ENT on 3/16/21 to have this checked. About 25 minutes after my covid shot I felt a strong cold feeling on the top of my head for about 30 -60 minutes . It went away. Now I wonder if this was also related.
48 2021-03-14 visual impairment out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported ... Read more
out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported sleeping more heavily than usual; woke with her hair wet as if had experienced a fever overnight; anxious; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient started received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient has known allergies to sulfur and penicillin. Concomitant medications were not reported. The patient received first dose of vaccine on 03Feb2021. Immediately following injection, felt as if her heart rate increased; felt as if it remained out of rhythm through Thursday evening eventually returning to a more regular rhythm. She also experienced shortness of breath, impaired vision and some dizziness noted in Feb2021. She also been sleeping more heavily than usual woke with her hair wet as if had experienced a fever overnight. She stated she felt better, but still not at what she would consider her normal self and was anxious about receiving the second dose and wanted to speak with someone to further discuss her concerns. Outcome of anxious was unknown while recovering for the remaining events Information on the Lot/batch number has been requested.
48 2021-03-15 dry mouth 2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via ... Read more
2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via adult face mask sat 100%. vitals; 139/82 HR 98. 2:30 felt, cold & clammy, shakey and tingling body & nausea vitals 125/70 HR 95 O2 sat 100% . By 3:00 previous symptoms subside , new symptoms dry mouth, headache 7/10 and nausea vitals 145/85 HR 105, taken of 2L 02. Called 911, emergency transport to AV emergency room. Patient choose to be driven to AVH emergency room by daughter who was at her mothers bedside during observation.
48 2021-03-15 mouth numbness Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes... Read more
Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes of injections.
48 2021-03-15 mouth tingling tingling in mouth and lips, itchiness on neck, given Benadryl IM with improvement
48 2021-03-16 ringing in ears After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. ... Read more
After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. I stayed at the pharmacy for 30 minutes to ensure I didn't have an allergic reaction like a breathing issue. I had my epi pen with me just in case. It was loud in the pharmacy so I didn't notice it at first but once I got outside and was in the car, my ears were ringing. When we got to the restaurant to eat, we were the only family in there and it was pretty quiet. The ringing was really high pitched and loud. For the following two weeks it did not stop, day and night. I contacted my primary and had a telehealth appt and also went physically in to my ENT's office. I also tried acupuncture to see if that would take away the ringing. The acupuncture seemed to lower the pitch in my ear but it was still present. 2 hours after I left the office the pitch was back to a high pitch ring again. I cancelled my appointment today for 3/18 for the second dose because no one can assure me that this ear ringing will go away and the doctor's are unsure of whether the second dose will trigger a worse condition. I had a hearing test on 3/16 at my ENT's office and I couldn't hear some of the sounds because of the ear ringing but I did pass the test at the very line of baseline normal. My ENT is unsure if I will lose hearing due to this vaccine.
48 2021-03-17 ear pain Headache Ear ache on the right side Fatigue Chills
48 2021-03-17 swollen tongue, mouth tingling, lip swelling 10 minutes after shot first noticed increased pulse, then lips and tongue tingling/slight swelling. ... Read more
10 minutes after shot first noticed increased pulse, then lips and tongue tingling/slight swelling. Throat tight. Some dizziness. Some chest pain. Some itching (especially scalp and sole of feet and then some on arms). Stayed where medical professionals could see me for about 2 hours. Took Benadryl about 3 hours later (after shot) and lingering symptoms mostly cleared up. 8 hours later still some itching and lips feel a little "off" still. Arm is normal vaccine sore. I have a strong history of repeated anaphylaxis (from MCAS) and this didn't get too serious compared to previous reactions I had to be hospitalized for.
48 2021-03-18 taste impairment Metallic taste after first vaccine and after second vaccine. Chills, aches, feverish after second va... Read more
Metallic taste after first vaccine and after second vaccine. Chills, aches, feverish after second vaccine. Hard lump under injection site. Minor redness.
48 2021-03-18 ear pain Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because o... Read more
Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because of nurse negligence and human error she overdose me and injected two shots of vaccine one after the other at the same time. Right after the incident they shifted me to emergency and kept me under observation there for almost 10 hours. I am a healthy person of no underline issues but still went through physical and mental trauma. Right after the dose I got dizzy, disoriented, my BP shot up, my heart rate was on the lower side now I am moved to home but have severe body aches, headaches, ear pain and allergic rashes itch on both arms and neck . I am scared if this would affect my health in future.
48 2021-03-19 eye itchiness 2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip... Read more
2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip, sore 1st rt finger 2/19/21, 2/20/21: sore under rt upper arm 2/21/21: greater pain under rt upper arm, took acetaminophen 2/22/21-3/7/21: pain extending from rt underarm to rt wrist upon extension/reaching 2/24/21-2/26-21: rt carpal tunnel ache 2/28/21: lymph nodes not as sore 2/28/21-3/11/21: puckered skin, rt upper arm
48 2021-03-19 mouth tingling, feeling of choking 10 minutes after vaccine pt complained of throat tingling and lip tingling. No swelling present, no ... Read more
10 minutes after vaccine pt complained of throat tingling and lip tingling. No swelling present, no trouble breathing, no drooling and no trouble speaking. Pt states with her previous allergic reactions this has happened and she needed a steroid shot or a shot of bennadryl (pt couldnt remember which one). Pt had no derm reactions and denied pruritis. We added 15 minutes to her observation time. Symptoms did not progress and they improved a little. She went home and was advised to take an oral benadryl when she got home if symptoms persisted. Pt in agreement with plan.
48 2021-03-19 taste disorder About 30 minutes after the vaccine I got a strange taste in my mouth which lasted about 30 minutes. ... Read more
About 30 minutes after the vaccine I got a strange taste in my mouth which lasted about 30 minutes. Both of my children 24/19 got their first Pfizer vaccine on 3/19/2021 and told me the same thing happened to them too.
48 2021-03-20 eye strain Fever, chills, agitated throat, very fatigue, sore shot area, hard for 4 days at the shot area, brui... Read more
Fever, chills, agitated throat, very fatigue, sore shot area, hard for 4 days at the shot area, bruised, headache for 4 days, eyes tired
48 2021-03-20 taste impairment Metallic taste in mouth, severe fatigue, muscle, joint, and nerve pain, nausea
48 2021-03-21 taste impairment Numbness/tingling in arm where injection occurred - lasting 10 min or so, then a feeling like the me... Read more
Numbness/tingling in arm where injection occurred - lasting 10 min or so, then a feeling like the medication was traveling across my upper chest to my other arm, brief metallic taste in mouth
48 2021-03-21 pain in jaw 3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and n... Read more
3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and neck became very sore and two small bumps appeared on the back of my neck. The bumps became very sore and my lymph nodes began to swell. All symptoms were on the left side of my body, which is the side I received the injection. 3/19: The two bumps multiplied and I had them behind my ear, in my hairline, on the back and front of my neck, trailing to my shoulder and a patch on my back. The bumps were painful and hot. I vomited 4 times that day, ran a 100 temp for a short period of time, had chills, body aches, very swollen lymph node, mild headache, and a very stiff, sore neck. All of this occurred on the left side of my body. 3/20: The bumps continued to increase in size, pain and number. The swollen glands, sore and stiff neck persisted. I was very tired and felt nausea at times. 3/21: I woke with an extremely sore and stiff neck, sore throat and new patches of bumps. I sought medical treatment and was diagnosed with Shingles. I was 100% healthy prior to the shot. I've never had Shingles before. I am now on medication to treat the outbreak.
48 2021-03-21 thirst Received vaccination dose 1 at 5pm. Woke in middle of night with abdominal pain and thirst. Day 1 ... Read more
Received vaccination dose 1 at 5pm. Woke in middle of night with abdominal pain and thirst. Day 1 woke at 6am extremely tired, woozy, nauseous (no fever). I was able to work from home a little but napped several times. Day 2 on a tired but functional, continued abdominal pain turning late in day to diarrhea (about 48 hours post vaccine). Day 3 morning abdominal pain, diarrhea and tired. Day 4 mostly back to normal. I had covid 90 days prior to the vaccination. I'm scared to get the second dose.
48 2021-03-22 loss of smell, loss of taste Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarr... Read more
Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarrhea, chills, disorientation, difficulty breathing
48 2021-03-23 taste impairment, mouth numbness, mouth tingling 30 minutes after my vaccine I started to feel tingling and numbness on my face, mouth and nose. The ... Read more
30 minutes after my vaccine I started to feel tingling and numbness on my face, mouth and nose. The bottom part of my face was numb. I was also nauseous and I had a metal taste in my mouth. Today is the 5 day since my vaccine and the numbness is less. I did not have facial droop.
48 2021-03-23 eye itchiness, mouth itchiness Superficial thrombophlebitis, itching around mouth, eyes, and joints, breathing difficulties - admin... Read more
Superficial thrombophlebitis, itching around mouth, eyes, and joints, breathing difficulties - administered cetirizine HCl 10mg antihistamine at onset of symptoms and 2 puffs Albuterol Sulfate HFA Inhalation Aerosol 90mcg per actuation approx 90 minutes after onset to control symptoms until they fully subsided.
48 2021-03-23 thirst Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lym... Read more
Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lymph node Headache
48 2021-03-24 ear swelling anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and... Read more
anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure and heart rate; elevated blood pressure and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
48 2021-03-24 mouth swelling Client completed 15min observation after vaccine and went out to her car. She noticed a rash on ches... Read more
Client completed 15min observation after vaccine and went out to her car. She noticed a rash on chest, and a dull headache so she came back in. Client was given 50mg of Benadryl PO and was observed for another 15min. Nurse observed a rash on chest that looked like hives and some redness on her right arm. Client's rash decreased but she did complain of a feeling of thickness in her mouth. There was no difficulty swallowing or breathing. Client was released to leave clinic site at 4:06 pm by RN.
48 2021-03-24 ringing in ears severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/o... Read more
severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/off balance, started ~12 hours after injection
48 2021-03-24 tongue disorder, mouth tingling, swollen tongue Injection given at 4 p.m. by 4:03 p.m. my tongue started to tingle and then turned into a burning se... Read more
Injection given at 4 p.m. by 4:03 p.m. my tongue started to tingle and then turned into a burning sensation by 4:10 my tongue had began to adversely swell to twice its size. I inform the nurses and was immediately taken to the ER where they noticed that my tongue was extremely swollen my throat was beginning to swell and that I had raised up bumps and lesions starting to form on the back side of my tongue. ER staff admitted me and began me on a IV steroid treatment accompanied with Pepcid and Benadryl After 2 hours in the ER under close observation my tongue was still swollen and my windpipe was in danger of being closed off so I was transported via ambulance to Hospital and admitted to Intensive Care Unit where they continued to administer steroids and Benadryl. By 2 a.m. my condition had not improved and I was given an EpiPen in my arm. The EpiPen did help but by 6 a.m. my tongue swelling had returned but not as severe. On march 24th The hospital then moved me from the ICU to the cardiac wing to be placed on a heart monitor as they continue to administer steroids, Benadryl, and Pepcid. I was given another Epi Pen by 11 a.m. in the cardiac care unit due to my tongue beginning to severely swell again. As of today, March 25th My tongue continues to swell and they still have me admitted to the hospital as they continue to observe me and continue to administer steroids and Benadryl all via my i.v. port. Today they are going to begin me on an oral Prednisone.
48 2021-03-25 mouth tingling 40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of... Read more
40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of my face swelled first and then 3 minutes later if felt like it generalized to the entire face. (I received the shot on my left side) I also felt some faint tingling in my mouth. Looking in the mirror, I couldn't tell if it was swollen but my sensation of my skin was swollen & tight. After about 10 minutes it felt like it was easing off. A hour later my face felt a little tingly like a Novocain shot had almost worn off. After 3 hours, I felt normal. Then day 2 & 3: a sore arm. Then day 4: muscle aches, fatigue & headache.
48 2021-03-25 vision blurred Blurring in right eye that comes and goes, constant muscle spasms in stomach
48 2021-03-26 loss of taste I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, sympto... Read more
I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, symptoms started to gradually surface that progressed throughout the day, such as: - intense pain at the site of the injection that spread to my underarm and left side of ribcage/breast - chills - low grade fever - aching joints - painful skin surface on my whole body - headache - shortness of breath - neuropathy - nausea - loss of appetite - loss of taste - stuffy nose
48 2021-03-26 ringing in ears Loud tinnitus in both ears but especially the left. Can?t cancel out the sound - it is a constant ... Read more
Loud tinnitus in both ears but especially the left. Can?t cancel out the sound - it is a constant high pitched and loud ring.
48 2021-03-27 ringing in ears Tinnitus in ears
48 2021-03-28 swollen tongue Tongue and Throat swelling
48 2021-03-29 taste impairment Since March 10 a metal taste on going.
48 2021-03-29 mouth tingling, ear itchiness Patient felt an itch at the back of her throat and in her ears, started approximately 10mins after v... Read more
Patient felt an itch at the back of her throat and in her ears, started approximately 10mins after vaccine administration. At about 20minutes started to feel a tingling sensation in her lips. 25mg IM Benadryl administered - symptoms reduced.
48 2021-03-29 ringing in ears, extreme sound sensitivity Tiredness, fever of 99 while taking acetaminophen, head and ear congestion, constant ringing in left... Read more
Tiredness, fever of 99 while taking acetaminophen, head and ear congestion, constant ringing in left ear and increased sensitivity to all sounds.
48 2021-03-30 mouth numbness, taste disorder, mouth tingling Within 5 minutes of receiving the vaccine, the end of my tongue began to tingle and feel numb. I fel... Read more
Within 5 minutes of receiving the vaccine, the end of my tongue began to tingle and feel numb. I felt some hot sensations down my left leg. Then my throat began to feel itchy and irritated. I could still breathe and swallow so I did not alert the pharmacy staff. I took a Benadryl allergy pill and went home. The tongue and throat irritation continued into the night but seemed to be better the next day. Since then, however, I continue to have tongue and throat irritation on a daily basis. The severity can change but the irritation hasn't gone away. My tongue feels like I licked a bad-tasting stamp. My throat isn't sore, it's more of an internal itch/irritation, like how I imagine it would be to have Poison Ivy in my throat. I take Benadryl daily for run-of-the-mill allergies from pollen, hay fever, etc. It's not having an effect. I feel like I want cold, frozen items to soothe my throat. I have not yet seen my family doctor about this, but I may do so if the symptoms worsen or I can no longer tolerate them -- or I become concerned about getting my second dose scheduled for April 10.
48 2021-03-30 mouth numbness 45 min after vaccination my faced turned red and felt very warm. The right sight of my face felt ver... Read more
45 min after vaccination my faced turned red and felt very warm. The right sight of my face felt very tight and the right corner of my lip felt numb. The symptoms went away 1.5-2 hrs after they started
48 2021-03-30 pain in jaw Pfizer First day within 15 minutes. Chest tightness. Throat tightness, jaw pain on left side, naus... Read more
Pfizer First day within 15 minutes. Chest tightness. Throat tightness, jaw pain on left side, nausea and headache, left sore arm and left crampy leg. Pain throughout week. Today I woke up very lightheaded, dizziness and body twitching. Last night took hydroxozine 25 mg. I don't think that caused it.
48 2021-03-30 mouth tingling Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like i... Read more
Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like it was swelling; My tongue and lips started tingling; Both ears red and felt very warm; Both ears red and felt very warm; Slight headache; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration in left arm on 29Jan2021 at 09:15 as a single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products: Penicillin, amoxicillin and codeine. Concomitant medications included esomeprazole magnesium (NEXIUM), ibuprofen (IBUPROFEN) and nature's bounty on unspecified date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The patient experienced second dose roof of mouth felt like it was swelling, y tongue and lips started tingling and both ears red and felt very warm and slight headache for the second dose on 29 Jan2021 at 09:15 AM. The outcome of the events was recovered on an unspecified 2021. Information on the lot/batch number has been requested.
48 2021-03-30 mouth tingling Tachycardia 5 minutes after injection... symptom lasted for about 5 minutes and resolved. 35 minute... Read more
Tachycardia 5 minutes after injection... symptom lasted for about 5 minutes and resolved. 35 minutes after injection, I developed mild tingling in my upper lip and I developed rhinorrhea... these 2 symptoms lasted about 5 minutes and resolved without further incidence. Pain at injection site ... was moderate pain for the first few days and now just slightly tender 1 week after injection.
48 2021-03-30 mouth tingling complaining of /nausea and dry heaves, hot/cold flashes, tingling to fingers/toes, peri-oral with bo... Read more
complaining of /nausea and dry heaves, hot/cold flashes, tingling to fingers/toes, peri-oral with both doses.
48 2021-03-30 swollen tongue Patient reports swollen tongue and urticaria of mouth 30 minutes after receiving the vaccine. Patien... Read more
Patient reports swollen tongue and urticaria of mouth 30 minutes after receiving the vaccine. Patient self-administered oral benadryl at that time, and self-administered every 4 - 6 hrs for 24 hours. Tongue swelling resolved within 24 hours, but urticaria persisted.
48 2021-03-30 visual impairment drive through monitoring area. Nurse practitioner approached the client in her car she was here for ... Read more
drive through monitoring area. Nurse practitioner approached the client in her car she was here for 15 minute post vaccination injection. When I asked her how she was doing, she said she was feeling numbness and tingling in her fingers and seeing white spots in her eyes. She was sitting in the car in the sun for the past five minutes or so I got her a bottle of water and moved car into the shade I asked her if I needed to call the paramedics. We initiated the code green and turned over care to the paramedics. Evaluated by paramedics and released. Patient?s husband drove the patient
48 2021-03-31 eye twitching Face numbness (left side, same side of vaccine administration), starting 5-7 minutes after injection... Read more
Face numbness (left side, same side of vaccine administration), starting 5-7 minutes after injection. Lasted for about 10 minutes. Mild contraction of periocular muscles (right eye) started about 1 hour after shot and have lasted for at least 48 hours after dose.
48 2021-03-31 eye swelling started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in fa... Read more
started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; having arrhythmias and blood pressure issues; having arrhythmias and blood pressure issues; have continued to have. Cardiac issues; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 28Dec2020 06:30 PM into right arm at single dose for COVID-19 immunization in Hospital. Medical history included Migraines, high blood pressure that was controlled. Patient was not Pregnant at the time of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medication (medications the patient received within 2 weeks of vaccination) included hydrochlorothiazide and furosemide (LASIX [FUROSEMIDE]). patient took injection and started swelling in face, hands, eyes. Then started having arrythmias and blood pressure issues. She has continued to have. Cardiac issues as well as blood pressure problems. ill was hospitalized. Duration of hospitalization was 2 days. blood pressure and arrythmias. Patient was currently seeing cardiologist on April 14th to see what can be done. events start date and time was 28Dec2020 06:45 PM. It was unknown if the adverse event result in doctor or other healthcare professional office/clinic visit or Emergency room/department or urgent care. "Location of injection information is available for all vaccines received on the same date". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Lab test included Nasal Swab on 23Jan2021 with negative result. Treatment for the events included medication, in process of seeing a Cardiologist. Outcome of the events was not recovered. Serious criteria is hospitalized and life threatening. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of swelling in face, hands, eyes, arrhythmias, cardiac issue and blood pressure issues cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-03-31 ringing in ears Tinnitus
48 2021-03-31 ringing in ears Ringing in left ear
48 2021-03-31 vision blurred "Pt complained of blurry vision. VS obtained. BP 167/112; HR 76; O2 Sats 98% on RA; Temp 98.0; pt ... Read more
"Pt complained of blurry vision. VS obtained. BP 167/112; HR 76; O2 Sats 98% on RA; Temp 98.0; pt noted hx of hypertension, has not taken medication since 2019. Visual field test. On site MD notified, pt transferred to ER for further evaluation. ED summary: symtoms resolved and pt discharged home. Pt was primary nervous! Upon arrival at ED, BP 141/103; HR 71; blurred vision persists "
48 2021-04-01 ear discomfort The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain beca... Read more
The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain became severe by day 3. Pain spread to my right breast, neck, back, and right scapular area. I have had numbness in my fingers on right side. Today is 16 days. The pain increased every day for about 10 days. Decreases slightly and is now holding. I'm am in terrible pain. I didn't sleep for 6 days when the pain was at is peak and still can barely sleep. It's the worst pain of my life. It feels like my arm is in fire and in a meat grinder. My arm and neck pain worsens when I use my arm or change positions. I am also getting flushed heat feelings on my face intermittently. Since this vaccine I have had allergic reactions to ibuprophen and prednisone which sent me to the ER. Two medications I have received before with no problem. I also felt I was reacting to gargling with listerine which I have used before without issue. I eat eggs regularly and got a small sensation of throat swelling with that too and have not eaten them again. My doctor is having trouble treating me since I am now having so many allergy symptoms to different things. I have been advised by my doctor not to continue with this vaccine or any vaccine in the future. I am still in terrible pain that is limiting me from participating i. my normal life activities. I did not develop any rashes or obvious swelling at the injection site. Twenty minutes after receiving the shot I did get a bit flush feeling and some redness in my face and my ears felt hot and then cold. That resolved within about 45 minutes.
48 2021-04-01 hearing loss I started experiencing muffled hearing in my right ear the next day. It's as if the ear is clogged ... Read more
I started experiencing muffled hearing in my right ear the next day. It's as if the ear is clogged like after being sick with a cold. I also liken the feeling to having water in the ear after swimming. There is no pain and I can hear. It's been like this for 5 days now.
48 2021-04-01 visual impairment On 3/31/21 patient was observed for 15 minutes following vaccination and reported no change to healt... Read more
On 3/31/21 patient was observed for 15 minutes following vaccination and reported no change to health status, so was cleared to leave the clinic area. Patient called the next day (4/1/21) to report that approximately 40 minutes following her vaccination, while driving home, she experienced sudden shortness of breath, muscle spasms, and increased heart rate. Patient reports that she pulled her car over to the side of the road, and then "blacked out". Pt does not know how long she was "out", but upon waking she vomited and called a family member for a ride home. Patient reports that when she got home, she slept for 14 hours. Woke up the next day (4/1/21) and felt sore and exhausted. Vomited a few more times throughout the day, and was on the toilet and she "saw spots" and "blacked out" again. Patient say she did not fall over or collapse. Family member observed this "black out" to last about 30 seconds. As of 4pm that day, more than 24 hours post-vaccination, she was still feeling unwell and not able to keep food down. Patient denies hives, itching, fever, congestion, swollen lips/face. Patient was advised to drink water or electrolyte-drink, rest, and call 911 or her PCP if she experienced another episode of SOB, "black out" period, prolonged vomiting, or new symptoms. Patient agreed to suggested course. Patient has no health insurance, doesn't want to come to a medical clinic for evaluation.
48 2021-04-02 dry mouth with in 12 hrs i awoke to throwing up and dry heaving for two days migraine that last all6 days ,i b... Read more
with in 12 hrs i awoke to throwing up and dry heaving for two days migraine that last all6 days ,i broke out with a rash that resembled a a bad sunburn, that extended from elbow all the way to my scalp, dizziness,and i ached all over had low grade fever and chills that lasted 3 days my mouth went very dry
48 2021-04-02 ringing in ears, deafness unilateral I have developed Tinnitus in my ears since having the vaccine.
48 2021-04-03 taste disorder, smell distorsion 1st shot just had sore arm the next day for a few hours. 2nd shot side effects 6hrs after: sore arm,... Read more
1st shot just had sore arm the next day for a few hours. 2nd shot side effects 6hrs after: sore arm, muscle aches entire body, extreme fatigue, body feels really heavy (like being pulled down), chest feels thick (like full of cotton), headache, alot of nausea, taste and smell are muted (still have both but not as intense as normal). My doctor thinks I was an undiagnosed covid case, early on in the pandemic (had been exposed unknowingly to someone who had traveled 3mths overseas at the pandemic outbreak, the tests they ran came up unknown but all my symptoms were what would turn out to be covid symptoms including complete loss of taste and smell.
48 2021-04-04 eye movement disorder Patient was given dose in right arm; patient bled and stated that she normally doesn't bleed at all;... Read more
Patient was given dose in right arm; patient bled and stated that she normally doesn't bleed at all; held cotton ball in place for 30 seconds then applied bandaid when bleeding stopped; patient went to stand up and immediately felt dizzy and light headed and said this was abnormal. Pharmacist was called into the room to examine patient. ~1 minute later, eyes rolled back in patient's head and she was no longer verbally responsive. Epipen was immediately administered and 911 was called. Pulse was faint but present, breathing was labored, and patient began sweating, Around 1 minute after giving epi, patient was responsive enough to give name, dob, time, etc. She could open her eyes, but was still very dizzy. EMT recommended to go ahead with Benadryl oral dose.. Patient was able to swallow 1 25 mg tablet. EMTs arrived within 5 minutes and took over care; her blood pressure was 80/65 and had improved to 108/80 right before she left. The patient told us that she could hear us talking to her the entire time. However, she did not feel the Epipen injection or realize that she had loss responsiveness. She did agree to go with the EMTs to Medical Center.
48 2021-04-04 ringing in ears Ringing in the left ear.
48 2021-04-05 ear discomfort Within ten minutes of the shot in the left arm, I experienced paresthesia (numbness, burning, and ti... Read more
Within ten minutes of the shot in the left arm, I experienced paresthesia (numbness, burning, and tingling) of Cranial Nerve VII as well as a feeling as if a cotton ball had been inserted toward the front of my ear (no hearing loss or pain, just an odd feeling of fullness). As this was not a reaction I had been told to watch for, I thought I must be imagining it, and did not report to onsite personnel. When it was still happening fifteen hours later, I called the OHSU COVID line for advice.
48 2021-04-05 ear pain, ear discomfort, ringing in ears Fatigue, body aches, that went away after about four days. Ear pain and plugged feeling lasted a few... Read more
Fatigue, body aches, that went away after about four days. Ear pain and plugged feeling lasted a few days. Intermittent ear ringing still continuing. I am reporting because of the continuing ear ringing in both ears.
48 2021-04-05 feeling of choking patient reported tingling in throat and hands 10 minutes after vaccine administration- physician not... Read more
patient reported tingling in throat and hands 10 minutes after vaccine administration- physician notified -administered diphenhydramine 25 mg po and observed addition 30 minutes until symptoms resolved
48 2021-04-06 loss of taste, loss of smell Patient received her first dose of pfizer COVID vaccine on 01/23/2021, her second dose was 02/13/202... Read more
Patient received her first dose of pfizer COVID vaccine on 01/23/2021, her second dose was 02/13/2021. She became symptomatic with new loss of taste and smell, headache, nasal congestion, runny nose and fatigue on 04/03/2021. She reported to our facility on 04/07/2021 for COVID testing due to her symptoms. Now rapid COVID and a PCR were obtained, the rapid returned positive. Her PCR is pending lab, they will run the sample upon receipt and instructions were given to send the specimen on ice to the health dept.
48 2021-04-06 taste impairment Metallic taste in mouth lasted 4+ hours. Fatigue, gas, joint pain lasted 3 days, joint pain has per... Read more
Metallic taste in mouth lasted 4+ hours. Fatigue, gas, joint pain lasted 3 days, joint pain has persisted intermittently for a week+. Headache on day three. Took advil on day 3.
48 2021-04-06 oropharyngeal discomfort patient had first dose of Pfizer around 826am and then after assessing pt around 0845 pt c/o of itch... Read more
patient had first dose of Pfizer around 826am and then after assessing pt around 0845 pt c/o of itchiness and scratchy throat. Notified Doctor on site re: patient's S/S. Doctor asessed and prescribed/given Benadryl 25 mg by mouth around 0850am. observed patient for 30 more mins and pt left stating feeling better. no other symptoms noted.
48 2021-04-06 pain in jaw Received vaccine at 3PM; at 11PM started to have fever and mild arm soreness, by midnight had migrai... Read more
Received vaccine at 3PM; at 11PM started to have fever and mild arm soreness, by midnight had migraine. In the morning at 6AM, had full arm pain at injection site (muscle tight and sore) and fever and migraine continued. At 8 AM, fever was gone, migraine mild, but became puffy (inflamed) in my face and gut. At 1PM my tooth #23 was very sore (just had a filling replaced on that tooth four weeks ago) and entire jaw on right side as very sore.
48 2021-04-06 mouth tingling Five min after vaccination pt felt tingling in tongue, lips, mouth, coughing, flushed skin . Os sat ... Read more
Five min after vaccination pt felt tingling in tongue, lips, mouth, coughing, flushed skin . Os sat was 99% room air, pulse 67, lungs clear bilaterally to auscultation. Sx fully resolved at 3:55 pm without use of medication.
48 2021-04-06 ringing in ears On 3/15/21 approximately 4 hours (8PM) after receiving the second vaccine I noticed a loud ringing i... Read more
On 3/15/21 approximately 4 hours (8PM) after receiving the second vaccine I noticed a loud ringing in my ears. This has continued since at varying tones and volumes. It is centered in the middle of my head, not in one ear or the other. It ranges from the sound of a running toilet to the sound of cicadas. It is constant, varying in intensity throughout the day. Occasionally the intensity seems to cause difficulty breathing , difficulty focusing, and fatigue. Additionally, it seems to be disrupting my ability to sleep.
48 2021-04-07 pain in jaw, toothache Jaw and gum teeth pain, swelling on right side with rash. Felt like open nerves on teeth. It hurt ... Read more
Jaw and gum teeth pain, swelling on right side with rash. Felt like open nerves on teeth. It hurt to move jaws.
48 2021-04-07 thirst 4/2/21 Fever, chills, joint pain (hips, knees, wrists, neck, ankles, some fingers), injection site p... Read more
4/2/21 Fever, chills, joint pain (hips, knees, wrists, neck, ankles, some fingers), injection site pain, fatigue, thirst, headache. Fever and event onset 7am. Rested and fluids until 6pm. Took 1 dose (2 tablets) 500mg each Acetaminophen. Fever broke at 7pm. 4/3/21-4/5/21 minimal injection site pain, minimal joint pain 4/6/21 fatigue, thirst, increased joint pain 4/7/21 no adverse effects 4/8/21 increased joint pain
48 2021-04-07 ringing in ears Within 45 minutes of receiving vaccination I experienced severe tinnitus, headache at the top of m... Read more
Within 45 minutes of receiving vaccination I experienced severe tinnitus, headache at the top of my head, body aches, fatigue, and neck ache. All symptoms lasted about 2 days except severe tinnitus remains.
48 2021-04-07 ringing in ears Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing. ... Read more
Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing. It is a high pitched tone. Mostly my left ear. Hasn't stopped for six weeks now; Upon getting the dose in my left arm, my face immediate got bright red and my ears started ringing. It is a high pitched tone. Mostly my left ear. Hasn't stopped for six weeks now; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6203 and expiration date: Not available), via an unspecified route of administration in the left arm on 25Feb2021 at 04:15 PM as a single dose for COVID-19 immunisation. The patient was not pregnant. The patients medical history included Hashimotos Thyroiditis and Autoimmune Disorder. The patient had Latex, Zythromax, Remeron allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 25Feb2021 at 04:30 PM, the patient experienced face immediate got bright red and my ears started ringing. The tone was reported to be high pitched mostly in the left ear and it has not stopped for six weeks. The patient received Lipo Flavonoid and acupuncture as treatment for the events. The patient underwent hearing test whose reports were not provided. The events resulted in a visit to Doctor or other healthcare professional office/clinic visit, disability, or permanent damage. The clinical outcome of events was not recovered.
48 2021-04-08 mouth tingling Patient received vaccine at 1345 and developed mild throat tightening, lip tingling at 1400 patient ... Read more
Patient received vaccine at 1345 and developed mild throat tightening, lip tingling at 1400 patient states similar symptoms that she developed to her first dose on 3/17 pt did not require medication after first dose- per pt report. Pt was administered 50 mg Benadryl PO at 1440 due to possible slight worsening/ not improving pt was sent top the ER at 1500 due to no improvement, possible slight improvement in symptoms, per pt report.
48 2021-04-08 ringing in ears Developed tinnitus in near-constantly in my right ear and intermittently in my left ear the morning ... Read more
Developed tinnitus in near-constantly in my right ear and intermittently in my left ear the morning after receiving the vaccine. I am currently 12 days post vaccine and it has not subsided.
48 2021-04-08 vision blurred Within 7 minutes she started feeling a very warm sensation in her neck moving upwards which slowed d... Read more
Within 7 minutes she started feeling a very warm sensation in her neck moving upwards which slowed down her breathing. She checked her pulse and it was low. She experienced blurry vision and extreme fatigue for 3 days.
48 2021-04-09 dry mouth, sensitivity to light, vision blurred 3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes h... Read more
3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes headache and photophobia, 12 hours worsening weakness moving into arms, following day diarrhea, blurred vision, by the 2nd day constipation dysuria, worsening ataxia by day 3, 1 week after unable to move R leg, admitted to hospital 4/1 and discharged next day. Readmitted 4/6 unable to move arms and move bowels/urine.
48 2021-04-09 mouth tingling, feeling of choking tongue tingling, bilateral sides of mouth, back of tongue and back of throat. Chest warmth and tigh... Read more
tongue tingling, bilateral sides of mouth, back of tongue and back of throat. Chest warmth and tightness
48 2021-04-09 swollen tongue, mouth numbness Patient vaccinated at 9:29 a.m. and at 9:40 patient reported feeling facial numbness and arm numbnes... Read more
Patient vaccinated at 9:29 a.m. and at 9:40 patient reported feeling facial numbness and arm numbness and swelling in left side and was seen by medical team Patients vitals were stable but the numbness and swelling sensation begun radiating to the right side of face and tongue Patient transferred via ambulance to hospital
48 2021-04-09 ringing in ears Tinnitus in both ears began the following morning after my first dose of the Pfizer vaccination.
48 2021-04-10 eye swelling, bloodshot eyes, swollen tongue My first on 03/19/2021 went smoothly, just sore area of shot. They had me wait 15 minutes after just... Read more
My first on 03/19/2021 went smoothly, just sore area of shot. They had me wait 15 minutes after just in case adverse reaction. On 04/09/2021 came back for second round. The nurse gave me my 2nd shot and said they don?t make patients wait after injections, I left the facility and by the time I reached my car my tongue had swollen up, went home and later that night my husband and kids asked what was wrong with my eyes - both my eyes were bloodshot red and swollen. On 4/10, my left eye was better but not my right. I have had brain fog, not being able to remember short memories all weekend. I plan to call my doctor in the morning. As a woman, I felt morally obligated to share my side effects.
48 2021-04-10 oral mucosal blistering I immediately had a sore throat, a burn/blister spot on roof of my mouth and an instant headache. I ... Read more
I immediately had a sore throat, a burn/blister spot on roof of my mouth and an instant headache. I felt like I was developing hives and felt odd. The shot also burned as it entered my arm.
48 2021-04-10 mouth tingling 48 y.o. female with a history of migraine and HTN (unmedicated) presents to the ED with multiple com... Read more
48 y.o. female with a history of migraine and HTN (unmedicated) presents to the ED with multiple complaints after receiving the first dose of the Pfizer COVID-19 vaccine. She states that while she felt well before the vaccine, approximately 15 minutes after receiving the vaccine, she began to feel dizzy and light-headed, like she was going to faint. Soon after, the patient describes, her tongue started "feeling funny" intermittently, she began to have an intermittent headache, she felt neck pain that radiates to her shoulders, and felt "tight" chest pain localized in her upper left chest. Currently, she states that her combined pain is rated 8/10. The patient notes that she gets itchy after taking amoxicillin or levaquin, but denies a history of symptoms after being vaccinated in the past.
48 2021-04-11 ear pain Earache in right ear began on 04/08/21, by 04/11/21 I experienced some loss of muscle control on the... Read more
Earache in right ear began on 04/08/21, by 04/11/21 I experienced some loss of muscle control on the right side of my face (eye, cheek, mouth). I was diagnosed with Bells Palsy. Blood test for Lyme Disease was negative
48 2021-04-11 eye swelling Patient stated after she waited 30 minutes her face swelled along with her eyes. She went to the phy... Read more
Patient stated after she waited 30 minutes her face swelled along with her eyes. She went to the physician and was given benadryl and prednisone tablets. Advised patient she should not receive the 2nd dose of Pfizer in the series and if she is requiring a 2nd dose she should investigate receiving Janssen.
48 2021-04-11 mouth tingling, tongue discomfort, mouth discomfort I felt achy and lethargic the next day (Thursday) and also had a sensation in my mouth on the right ... Read more
I felt achy and lethargic the next day (Thursday) and also had a sensation in my mouth on the right side of my tongue. The achy/lethargic feeling was gone by Friday but the sensation in my mouth is still there 5 days later. Feels almost like a slight burning/tingling feeling. Hard to describe. The sensation in my mouth has not gotten worse over the 5 days but has persisted.
48 2021-04-11 ringing in ears After 2nd does: loud ringing in left ear. Continue to have constant ringing in left ear.
48 2021-04-11 tongue discomfort, mouth tingling, mouth numbness, mouth discomfort 5 hours after injection face and mouth felt numb and tingly. Throat felt like closing up. Took Zyrt... Read more
5 hours after injection face and mouth felt numb and tingly. Throat felt like closing up. Took Zyrtec at 7pm. Following morning after I ate a protein bar my tongue, mouth and throat felt like burning tingly sensation. Called nurse. Instructed to take Benadryl. If symptoms do not improve by 48 hours after vaccine I am to call back. I also notified store and left a voicemail on VAERS hotline
48 2021-04-12 ear pain, eye twitching Person received #2 dose Pfizer COVID-19 vaccination January 11, 2021. Approximately March 15, 2021 ... Read more
Person received #2 dose Pfizer COVID-19 vaccination January 11, 2021. Approximately March 15, 2021 experienced eye twitching on occasion. Approximately two weeks later she experienced ear pain. She went to Urgent care and seen by the attending physician. It was later, at a meeting with a colleague that it was noticed that her lip was drooping. She contacted a primary care physician who ordered an MRI stat to R/O stroke. MRI performed on 4/9/21 and resulted negative. She contacted her PCP who has scheduled an appointment for her to be seen this Friday 4/16/21. He has in the meantime ordered steriods for her to take based on her reported symptoms and unconfirmed diagnosis of Bells Palsey.
48 2021-04-12 pain in jaw Dose 1 Arm pain tiredness. 2-3 days later diarrhea Dose 2 Arm pain tiredness. Next day tired body a... Read more
Dose 1 Arm pain tiredness. 2-3 days later diarrhea Dose 2 Arm pain tiredness. Next day tired body aches. Like pins were poking me in different places. Mostly left side. An icy hot sort of feeling would also pop up in different places. Everywhere. Left side neck pain and jaw pain. 2-3 days later diarrhea.
48 2021-04-12 pain in jaw Axillary node swelling under vaccinated arm. It has been one month and I still have swelling and pa... Read more
Axillary node swelling under vaccinated arm. It has been one month and I still have swelling and pain under my arm, on the side of my left breast and in my chest. I have radiating pain up my shoulder where I was vaccinated and into my neck and jaw.
48 2021-04-12 mouth tingling Pt developed urticaria and complained of tingling at lips and upper airway. Pt assessed; pt airway ... Read more
Pt developed urticaria and complained of tingling at lips and upper airway. Pt assessed; pt airway patent, breathing normal and non-labored, lungs clear- upper and lower lobes bilaterally. Pt administed 50 mg at 6:11 PM IM Diphenhydramine and then 25mg at 6:19 Diphenhydramine upon worsening urticaria. Emergency Services contacted for transport to hospital.
48 2021-04-12 feeling of choking Pt complained of "throat tingling", stated that she used benadryl with dose #1 and wanted to proceed... Read more
Pt complained of "throat tingling", stated that she used benadryl with dose #1 and wanted to proceed with his treatment. No wheezes auscultated. Pt stated she did not want to use her epi pen.
48 2021-04-12 swollen tongue Swollen tongue Tightening of throat
48 2021-04-12 ringing in ears Tinnitus-ringing in both ears.
48 2021-04-12 ringing in ears THU Day 1. First Shot: About 20 minutes after the injection, I felt like I had received a muscle rel... Read more
THU Day 1. First Shot: About 20 minutes after the injection, I felt like I had received a muscle relaxer. Instant tired. Went to sleep. FRI Day 2. Injection site pain 7/10. Arm mobility severely limited. General muscle and joint aches 6/10 pain. No fever, but felt hot. Still feel hot, with no fever, on Tue Day 6 (which is today). Fatigue 7/10. Persistent feeling of hunger for about 3 days, no matter how much I eat. SAT/SUN/MON. Regained full use of my left arm. Still feel exhausted 5/10. Head, neck and shoulder pains 8/10. Still feel like I have a fever, but no fever. Persistent runny nose for four days and sore throat 3/10 pain. The oddest thing is that I have an occasional ringing in my ears. Mostly my right ear. A constant static-hissing sound, sometimes a full ringing that fades back to a static-hissing. Very odd. TUE Day 6. Feel hot in the head, no fever. Hearing hissing-static/ringing sound on and off. Runny nose, sore throat. Just wanted to share so you can collect more data.
48 2021-04-12 visual impairment, vision blurred, light flashes or floaters in the eye mini stroke; having vision issues; having vision issues, she could not focus and started seeing flas... Read more
mini stroke; having vision issues; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 23Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient received the first dose on 02Mar2021 12:15 on the left arm. The patient medical history was not reported. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) for birth control. The patient previously took erythromycin and experienced allergies. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 24Mar2021 8:15, patient started having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes, this lasted for about 45 min. Her doctor had the patient go to the ER where they did a CT scan thinking of possible mini stroke, no signs of that scan came back clear. AE resulted in emergency room/department or urgent care. No treatment received for the adverse events. Patient recovered from the events on 24Mar2021 09:00. No follow-up attempts are needed. No further information is expected.
48 2021-04-14 dry mouth PAIN LEFT ARM , BACK AND NECK. FEVER AND DRY MOUTH , LEFT ARM EDEMA AREA OF INJECTION, HEADACHE, M... Read more
PAIN LEFT ARM , BACK AND NECK. FEVER AND DRY MOUTH , LEFT ARM EDEMA AREA OF INJECTION, HEADACHE, MALAISE, WEAKNESS, HOARSENESS, NAUSEA AND DIZZINESS TOOK PANADOL
48 2021-04-14 ear discomfort Plugged ears with pressure. Like when on an airplane
48 2021-04-14 mouth numbness Within 5 minutes my lips, tip of tongue and front area of the roof of my mouth were numb. At 15 minu... Read more
Within 5 minutes my lips, tip of tongue and front area of the roof of my mouth were numb. At 15 minutes still occurring and when I got up to leave the facility I had tightened in my chest, not a pain, but like a charley horse. That tightness lasted about 15 seconds. About 25 minutes after shot I noticed my hands were very swollen. Went home, rested and within two hours hands were normal and tongue and roof of mouth were back to normal. Lips stopped tingling but within a couple of days I noticed that around my mouth and my cheeks were numb. This is still happening and it comes and goes. I went to the doctor 4/13. I do have the start of a sinus infection so taking a Z PAC now. The numbness seems less but it still comes and goes. I have no pain just numbness and stiffness. I told the doctor the best I can describe it is it feels like what Botox looks like (I have never had Botox or fillers).
48 2021-04-14 swollen tongue, eye swelling Swelling of the mouth, tongue, throat, eyes and face; chest pains; shortness of breath; body pain; h... Read more
Swelling of the mouth, tongue, throat, eyes and face; chest pains; shortness of breath; body pain; headaches; sore throat; coughing;
48 2021-04-14 taste disorder post vaccine pt reported funny taste in mouth and began to panic. Pt evaluated in tent and recovered... Read more
post vaccine pt reported funny taste in mouth and began to panic. Pt evaluated in tent and recovered.
48 2021-04-14 vision blurred, lacrimation increased, eye itchiness, eye pain No initial symptoms. Arm did not hurt. Felt fine initially. A week later, my left eye started to wat... Read more
No initial symptoms. Arm did not hurt. Felt fine initially. A week later, my left eye started to water profusely and itch as if I'd gotten something in it. Within the hour, lymph nod in front of left ear swelled up to the size of a bean. The next morning, additional nods swelled up under the ear by the jawline. The eye was no longer watering, but was and continues to experience sharp pain like pins stuck in it, very painful. Some blurring of vision. It is only in one eye still. Eye is not red. Eye is not watering. It shows no signs of visible conjunctivitis, but very irritated. The following day the left side of my face is swollen along with swollen glands. Additionally, a rash ahs developed along my hairline, on the upper bridge of my nose, and on forehead. The rash on my nose presents like blisters, almost like poison ivy rash. I was not exposed to poison ivy. I do not have acne, so the outbreak on my forehead is unusual. The rash has gotten progressively worse and spread every day since the onset of these symptoms four days ago. I still have no fever. No armpit swelling. Never experienced this before. There was no clear cause of this nor any known infection. Suspect it could be immune response to 1st covid-19 shot. I was very healthy when I took the first shot. Was advised to take a Covid-19 test as the eye hurting is apparently a rare symptom of the virus. Took test yesterday. Awaiting results. But I have no respiratory symptoms. No fever. Do have some mild diarreah since receiving the vax. Feel fine physically other than these very painful facial symptoms.
48 2021-04-15 ringing in ears Pfizer-BioNTech COVID-19 Vaccine EUA Tinnitus Began day after injection, off and on for two days. T... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Tinnitus Began day after injection, off and on for two days. Third day through now, the 6th day, constant tinnitus all day and night. Causing difficulty sleeping. Causing some dizziness.
48 2021-04-15 vision blurred, thirst Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t qu... Read more
Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t quench my thirst dry mouth unsteadiness
48 2021-04-15 visual impairment About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both... Read more
About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both arms, hands and right legs, dizziness, pins and needles, extreme fatigue, lethargy, feeling the pulse of my heart rate in various part so my body in an opressive kind of way like in my throat, under my right breast, in my back on the ribs usually. All these symptoms never subsided and became noticeably worse a few days after my second dosis on April 8th. My arms are always numb when I get up and become worse when hanging down, of course, but with different intensity. I am feeling extremely dizzy as I walk around and unstable. Walking feels like the ground is further than it is in a way. I do notice a slight shortness of breath but more of an oppression in the rib cage than panting. I have been avoiding walking far or walking my dogs all together. I am not seeing any improvements even after my visit to the Urgency Care where nothing wrong was found on blood work and EKG. I was told to reduce inflammation with dietary supplement and some vitamins. I cannot work of course and what is a bit frightening now is that I am not improving on day 8 of my second dosis! Same rotation of weird symptoms all day (feeling my blood not circulating normally if that can be described even, numbness, pins and needles in arms, and right leg. Sometimes it affects my right cheek. Dizziness and unstability to walk around. Vision is lower as well. Too weak to do anything constructive. My legs feel like they are not reliable (never have had that feeling at my age). It is more than feeling like a zombie, it is feeling too weak to do anything and my head is sometimes spinning. The numbness can be painful as a sudden thrust in an arm ( this does not last more than a few seconds). It has now been going on since week 3 of my first dosis and today is day 7 of my second dosis! I had 0 symptoms on the first 2 weeks of my vaccine, dosis one. Now, I don't see any progress, rather a slight worsening of all the symptoms above. It is freakish not knowing what I have, of course. One can imagine, so stress adds to the mix sometimes during the day. I would not dare to even go walk my dogs now. A short grocery store visit at the most.
48 2021-04-16 taste disorder, loss of smell, loss of taste Thursday, April 8: 1st dose of Pfizer vaccine. Friday & Saturday: No symptoms Sunday, April 11: Seve... Read more
Thursday, April 8: 1st dose of Pfizer vaccine. Friday & Saturday: No symptoms Sunday, April 11: Severely sleepy and fatigued Monday, April 12: Began congestion and a slight cough. Tuesday & Wednesday: Noticing things aren't tasting right. Total loss of smell & no taste with most foods. Sweeter food items taste horrible like bad breath
48 2021-04-17 eye swelling I got my first dose on March 27 Phizer lot number ER8730. In April 11, I saw skin allergic reaction ... Read more
I got my first dose on March 27 Phizer lot number ER8730. In April 11, I saw skin allergic reaction on my skin at my leg (thighs). I got my second dose on April 17 Phizer lot number EW0162 around 3:30 pm. The same date around 7:00 pm I noticed swollen eyes. Similar allergic reaction when I had aspirin. I took Benadryl that night. Today I wake up without swollen eyes. The allergic on my thighs continues. The intend of this report, is to provide to the organization my reaction with the vaccine.
48 2021-04-17 mouth tingling, mouth numbness, eye pain, eye strain Tingly and numbing lower left side of my lip; numbing lower left side of my lip; Eye feel tired; Eye... Read more
Tingly and numbing lower left side of my lip; numbing lower left side of my lip; Eye feel tired; Eye feel tired, low level pain behind them; slight sore throat on the left side; the standard arm feels heavy and a bit achy; This is an initial spontaneous report received from a contactable consumer. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 30Mar2021 16:00 as single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, seasonal allergy and allergy to animal from an unknown date and unknown if ongoing. Concomitant medications included metformin and dulaglutide taken for an unspecified indication, start and stop date were not reported. The patient experienced tingly and numbing lower left side of my lip, eye feeling tired, low level pain behind them, slight sore throat on the left side and the standard arm feels heavy and a bit achy on 30Mar2021 16:30. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-04-17 smell distorsion I had Covid in dec 2020 and lost my sense of taste and smell completely for a few weeks. It had retu... Read more
I had Covid in dec 2020 and lost my sense of taste and smell completely for a few weeks. It had returned partially, but not fully when I got my vaccine in March. I have had severe parosmia since I got my first shot-- after 4 days, everything I ate and drank began to taste and smell like burned rubber/trash combination - and I started to notice that the air I breathed smelled the same way. Worse, this seemed to intensify after my second shot and then I started to smell cigarette smoke with every breath, or a chemical odor-- like paint fumes and sharpie fumes mixed together. And I got a headache as if I was smelling fumes. I was not ever smelling fumes or smoke- I live with 3 kids and a husband and they assure me I'm crazy. I've googled it and learned the word phantosmia. I'm now 7 days after my second shot and panicking that this will never end. More importantly no one told me this could happen, and no one acknowledges that this has happened or could happen. And maybe it's a bizarre coincidence... but I'm reporting it in case others are experiencing it. It would be good to make this known so that people know what is happening and why...
48 2021-04-17 thirst Soreness and body aches set in after going to bed later that night. By 3am, was very weak, thirsty a... Read more
Soreness and body aches set in after going to bed later that night. By 3am, was very weak, thirsty and had increasing pain throughout body, and armpit. Managing pain with tylenol and pain is worse at night when laying down. As of 4/18, armpit is still sore and may be due to enlarged lymph node from vaccine. Cannot lay on it and affects range of motion due to ongoing soreness.
48 2021-04-17 ringing in ears Loud buzzing or ringing in ears that is worse at night
48 2021-04-17 ringing in ears Ringing in ears / tinnitus, began a few days after first dose but has increased significantly after ... Read more
Ringing in ears / tinnitus, began a few days after first dose but has increased significantly after the second dose and is constant.
48 2021-04-17 visual impairment A few minutes after administering the vaccine the patient complained of light headedness, vision bec... Read more
A few minutes after administering the vaccine the patient complained of light headedness, vision became spotty, and she felt like she was going to pass out. She also felt tingly fingers and nausea. After a few minutes her blood pressure was checked and it was normal. The light headedness and nausea subsided. The tingly fingers continued for several minutes but later became normal. She drank some water and we provided a fan to help cool her down.
48 2021-04-18 mouth numbness, dry mouth 48 y/o female, with no past medical history, who presents with pressure to the side of her head/temp... Read more
48 y/o female, with no past medical history, who presents with pressure to the side of her head/temples, weakness, dryness and numbness to mouth post vaccination administration. Patient received her 2nd vaccination to the patients Right deltoid. Patient denies previous reaction with 1st vaccination administration. NP and Paramedics at patient side. Patient appears pale, including her lips. Patient denies sore throat, difficulty breathing, itch or chest pain. Water was provided and patients legs elevated on chair. Patient vitals within normal limits (initial vitals: 136/86 BP, 99%RA, 83 HR, 12 Resp. Vitals prior to discharge: 123/85 BP, 99% RA, 79 HR, 10 Resp. EKG: NSR ). Patient was monitored by the NP with no further interventions needed. Patient returned to baseline, with symptom resolution within 15 mins. Patient cleared to go home in stable condition.
48 2021-04-18 mouth numbness, mouth tingling Immediately after receiving the shot, my tongue became numb and tingly, lasting almost two minutes. ... Read more
Immediately after receiving the shot, my tongue became numb and tingly, lasting almost two minutes. I was just about to call for the nurse when it seemed to subside. I felt fine that afternoon, but the following day I had no energy and slept for 12 hours.
48 2021-04-19 taste impairment, ringing in ears On Monday, 4/12/21, I was given the 2nd dose of the vaccine. There were no immediate symptoms other... Read more
On Monday, 4/12/21, I was given the 2nd dose of the vaccine. There were no immediate symptoms other than a sore arm (from injection site) later that day. Tuesday morning, my left arm was swollen and I experience joint pain in my fingers and wrist. The following afternoon, I began to feel extremely tired and had vertigo. I laid down and slept the entire evening; still feeling the joint pain. The following Wednesday morning, I woke up to a swollen arm with a knot at the injection site, blisters, body rashes, and whelps under my breast and whelps on my shoulder, legs, and feet. I was even more exhausted. I took Benadryl for the rash and Advil for the pain. Thursday, I continued to develop rashes that would come and go on the left side of my body and upper chest. Friday, still experiencing the inflammation and pain, I visited my doctor who told me to continue taking the Benadryl and OTC pain meds. For good measure, we ordered a d-dimer test. Over the weekend, in addition to the other symptoms, I began to have a lot or ringing in my ears, a backache (throbbing sensation), and my hands began to painfully swell with blisters. I could only taste the salt or sugar in foods and was extremely tired. Monday morning, I received a call from my doctor advising me that the d-dimer test came back extremely high (1.23) and needed to have a vascular ultrasound to check for blood clots. I visited an ER and had the test done. No clots were found but I continue to experience ringing in my ears, severe pain in my back that limits my ability to walk and breathe, swelling of various extremities, a rash (and itching), and overall inflammation. The Benadryl isn?t working nor is the OTC pain medication. My doctor has prescribed Prednisone.
48 2021-04-19 mouth tingling, mouth numbness 1122: SPC notified this RN about this pt's ADRs. Upon arrival, pt stated, "my tongue feels tingling,... Read more
1122: SPC notified this RN about this pt's ADRs. Upon arrival, pt stated, "my tongue feels tingling, numb and back of my throat feels like I have phlegm. It feels weird when I swallow." Pt stated she has epi pen for bee sting, and the s/s she is having is similar as with Bee sting. Pt with her daughter in car, and her husband in another vehicle next to her. 1125: V/S obtained. BP 113/69, 98O2 RA, Resp: 18. Frequent throat clearing, c/o closing up airway at back of throat but no SOB. EPI pen administered over clothes immediately to left superior thigh region. 1130: BP 120/80, 98O2 RA, Resp 18. MAJ informed, and at site.
48 2021-04-19 vision blurred POST VACCINE, C/O CHEST TIGHTNESS, SOB, NAUSEA, BLURRED VISION. BROUGHT BACK TO OBS VIA WC AND ASSIS... Read more
POST VACCINE, C/O CHEST TIGHTNESS, SOB, NAUSEA, BLURRED VISION. BROUGHT BACK TO OBS VIA WC AND ASSISTED TO STRETCHER AND PLACED IN TRENDELENBERG. STATES SOME RELIEF AFTER A FEW MINUTES. ADMITS TO HAVING ANXIETY ISSUES. VSS OTHER THAN SATS DROPPING TO HIGH 80'S WHEN TALKING INCREASES. NO DISTRESS NOTED, DEEP BREATHING EXERCISES PERFORMED, RECOVERS IMMEDIATELY. LUNGS CLEAR IN ALL LUNG FIELDS, ADMITS TO DECREASED STAMINA AND INCREASED SOB WITH EXERTION FOR LAST FEW MONTHS AND IS SEEING NEW PCP IN A FEW WEEKS. INSTRUCTED TO SEEK FURTHER TREATMENT/EVAL SOONER IF WORSENS/PERSISTS. ALSO C/O EYES BURNING MILDLY. ALL S/S RESOLVED AFTER LAYING DOWN FOR 30 MINS. VSS WHEN STANDING/AT DEPARTURE. ESCORTED VIA WC TO EXIT AT , AND CRUTCHES RETURNED TO PATIENT TO AMBULATE TO VEHICLE. GAIT STEADY, NOT FURTHER ISSUES OR CONCERNS. 1330 INITIAL BP 148/88 HR 97 RR 18 SATS 100% RA 1335 BP 128/88 HR 104 RR 20 SATS 92% RA 1345 STANDING BP 134/71 HR 99 RR 20 SATS 96% RA
48 2021-04-20 ear discomfort On Saturday April 17th I woke up at 6 in the morning with sever vertigo. I was extremely sick and co... Read more
On Saturday April 17th I woke up at 6 in the morning with sever vertigo. I was extremely sick and could not stand up straight. Room was spinning and I got sick with diarrhea. Was extremely nauseous and the feeling only passed when I was lying down. Eventually the severe symptoms subsided after 2.5 hours and I was able to mostly function with the use of motion bands on my wrist. It was so scary, I paid 200 to rejoin One Medical Group and booked a same day in person appointment. The doctor said my ears were inflamed and did the Epley manuever with me. However, the symptoms are still lingering.I'm dizzy and my ears feel clogged. I can't seem to get them unplugged. It still feels at times as if the room is spinning around me and I'm woozy in a bit of a brain fog. I've been keeping the motion bands on at most times to try to keep the symptoms at bay.
48 2021-04-20 mouth tingling headache, nausea, tongue tingly, EMS evaluated, self resolved, pt. refused transport
48 2021-04-21 eye strain at 1335 pt received 2nd dose of pfizer vaccine and brought to observation area for 30mins to monitor... Read more
at 1335 pt received 2nd dose of pfizer vaccine and brought to observation area for 30mins to monitor by me, escorted by staff, pt already feeling dizzy & hands tingling & heart racing. place in triage chair, vitals measured, assessed, alert and oriented x 3, responds appropriately, clear bilateral equal lung sounds, mild distress with her feeling dizzy asking to lay down on a bed. ask another staff to grab gurney nearby as pt said her dizziness getting worse and eyelids appeared heavier and almost falling off chair while being observed, rapid response called at 1345. pt now on gurney laying supine, Several Vaccine clinic staff assisted me along with Rapid response team, vitals rechecked again at 1350, pt c/o of worsening dizziness and 5/10 headache with hands still tingling, heart still racing. After rapid response team evaluated pt, at 1352 plan to bring pt to ER for further evaluation.
48 2021-04-21 dry throat 48 y/o female, past medical history of Diabetes, Sleep Apnea and HTN, who presents with shortness of... Read more
48 y/o female, past medical history of Diabetes, Sleep Apnea and HTN, who presents with shortness of breath and a dry throat post vaccination. Patient states that this is her second dose in the series and denies previous reaction with first dose. Patient received her second vaccination to her R arm. Patient denies throat pain, swelling, difficulty swallowing or chest pain. NP and Paramedics at patient side. Patient noted to be hypertensive (212/103) but all other vials within normal limits (100% RA, 80 HR, 12 Resp). Patient provided with a bottle of water and legs were elevated on a chair. Patients that she didn't eat prior to arrival. Glucometer not working correctly so glucose was not able to be obtained. Patient provided with a fruit bar, which she ate. Patient placed on 3L O2 via nasal cannula and vitals were continuously monitored. Patient BP decreased (although still hypertensive) to 185/90, 177/90, 171/89, 178/86, all other vitals within normal. Patient symptoms improved post O2, oral hydration and fruit bar. Prior to discharging patient home, patient with no further complaints of shortness of breath or dry throat. Patient O2 sats on RA remained 99%.
48 2021-04-21 sensitivity to light chills, fever, sweating, all over aches, weakness, loss of appetite, nausea, tired but difficulty sl... Read more
chills, fever, sweating, all over aches, weakness, loss of appetite, nausea, tired but difficulty sleeping, heart racing at times, sensitivity to light, hard to do anything for long (sleep, read, watch TV...)...tough to focus. Pain at injection site, too. Came on about 6.50 hours after getting the 2nd dose. Started with tingles and increased pain in injected arm. Worsened through the night. In middle of night was freezing but my back was completely sweaty and sheets covered in sweat. Was miserable like that through the next day. Was better the day after, and better again day 3, but now on day three still have dull headache, difficulty focusing, am exhausted, and have nausea despite pushing fluids, taking ibuprofen, and resting. Pain in left armpit (injected arm) started yesterday and still have it.
48 2021-04-21 swollen tongue Rash on torso and face. Swelling in tongue and back of mouth. Headache.
48 2021-04-21 ringing in ears, extreme sound sensitivity The most disturbing thing is the tinnitus. It began with an intense and unusual headache the morning... Read more
The most disturbing thing is the tinnitus. It began with an intense and unusual headache the morning after I received the vaccine. I have frequent migraines but this was even more intense and on the other side, the side where I received the shot, with a focal point. I heard the loud pumping of blood, I assumed, and a whistling sound. Today the headache has lessened but the ringing remains quite loud plus the pumping sound is still there and distinctly was not there before waking up with that headache. I have also had gastrointestinal symptoms.
48 2021-04-21 ringing in ears Chronic Tinnitus was noticed about a week after 2nd shot. In right ear only. Not pulsating. Not tak... Read more
Chronic Tinnitus was noticed about a week after 2nd shot. In right ear only. Not pulsating. Not taking any meds associated with tinnitus.
48 2021-04-22 mouth tingling Patient received COVID-19 vaccine on 4/18/21 at an outside facility (unknown). About 50 min after re... Read more
Patient received COVID-19 vaccine on 4/18/21 at an outside facility (unknown). About 50 min after receiving vaccine, patient started with itchiness and hives on neck and behind ears, and also developed tingling on upper lip. The tingling resolved by the end of the day, but the rash persisted for several days after. Rash was managed with antihistamines.
48 2021-04-22 ringing in ears Tinnitus, gradually growing more intense as time goes on. It's a wavering, buzzing sound, like cicad... Read more
Tinnitus, gradually growing more intense as time goes on. It's a wavering, buzzing sound, like cicadas.
48 2021-04-23 ear swelling Within 5-10 I felt symptoms. Symptoms- Lump in throat and lump/tightness in chest. Swelling felt ... Read more
Within 5-10 I felt symptoms. Symptoms- Lump in throat and lump/tightness in chest. Swelling felt in ear right ear. I took 25mg of benadryl prior to shot and took liquid Benadryl after aymptoms happened. Blood pressure was taken it was WNL.
48 2021-04-23 lip swelling, lip blister ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and b... Read more
ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and back; Blister of lip; Swollen lips; sore arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on right arm on 12Jan2021 at single dose for covid-19 immunization (to not get symptoms from Covid). Medical history included typically had a strong local reaction to bees or insect bites. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL) for Birth control 1 by daily (had been taking for 15 years and is ongoing). On 12Jan2021, the day patient received the vaccine, she had sore arm which resolved on 13Jan2021. Ten days later on 23Jan2021, she developed a rash with blisters on her hand and back, had blisters/ulcers on the side of her tongue inside her lips and her lips were also swollen and cracked. She states that she treated these symptoms with Benadryl and the rash and swelling resolved. She cannot attribute it to the vaccine. The ulcers in her mouth were better in about a week. She was calling to see if she should receive the second dose of the COVID-19 vaccine and would like to know how effective the Pfizer COVID-19 vaccine is after one dose. Everything that she had seen, this was not a typical reaction. She was wondering if it was safe to get the second dose. She went to the site where she received the vaccine and was unable to get any information. She does not have a physician. The rash has improved. Redness on her skin still can be seen. The blisters on her lips were white places like a canker sore but it was not a canker sore. Her lip was split like mouth ulcers. She took Benadryl and it helped. The outcome of the event ulcers on the side of her tongue was unknown. The outcome was recovered for the events sore arm on 13Jan2021, blister of lip on 31Jan2021 and swollen lips on 01Feb2021. The outcome of the event rash was recovering. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
48 2021-04-23 vision blurred Throat felt like it was closing up. Tightness in chest similar to the feel during an asthma attach.... Read more
Throat felt like it was closing up. Tightness in chest similar to the feel during an asthma attach. Neither resulted in wheezing or extreme difficulty to breath that required immediate attention. Watering of the mouth similar to when you are about to vomit (gum helped with this). Swelling of the hands, feet and legs. For my hand I could push in on the skin which would leave an indent and slowly began to fill back out. I also noticed blurry vision when trying to read while waiting my 15-20 minutes at the location. None of these required immediate medical attention and occurred fairly quickly after the injection and appeared to resolve in 3-4 hours. I reached out to my primary care provider a few days later to determine if I should get the 2nd vaccine. He indicated that it sounded like an allergic reaction and asked if I reported to VAERS.
48 2021-04-24 ear pain Very weak and tired, hot and cold, back of throat and ears soar, under arms and neck sore, nipples... Read more
Very weak and tired, hot and cold, back of throat and ears soar, under arms and neck sore, nipples and bottom of feet burning/stinging. Body aches and nausea. Tylenol, peppermint tea, soak in bath with Epsom salt.
48 2021-04-24 mouth itchiness, eye itchiness Superficial thrombophlebitis; Breathing difficulties; Itching around mouth, eyes, and joints; Itchin... Read more
Superficial thrombophlebitis; Breathing difficulties; Itching around mouth, eyes, and joints; Itching around mouth, eyes, and joints; Itching around mouth, eyes, and joints; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 14:30 (Batch/Lot Number: en6201) at the age of 48 years old, as single dose for covid-19 immunisation. Medical history included asthma, nonalcoholic fatty liver disease (NAFLD), latex allergy, and shellfish allergy; all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included fluticasone propionate (FLOVENT) taken for an unspecified indication, start and stop date were not reported. The patient previously took loratadine (LORTAB) and experienced allergies. On 23Mar2021 14:30, the patient experienced superficial thrombophlebitis, breathing difficulties and itching around mouth, eyes, and joints. Patient was administered with cetirizine HCl 10mg antihistamine at onset of symptoms and 2 puffs Albuterol Sulfate HFA Inhalation Aerosol 90mcg per actuation approximately 90 minutes after onset to control symptoms until they fully subsided. The patient recovered from all the events on unspecified date. The patient has not been tested for COVID post vaccination. No other vaccines received 4 weeks prior to COVID vaccination.
48 2021-04-24 oropharyngeal discomfort Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic sho... Read more
Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
48 2021-04-24 mouth tingling Tingling on tip of tongue about 30 minutes after dose. Lasted several hours and ended. Did not inter... Read more
Tingling on tip of tongue about 30 minutes after dose. Lasted several hours and ended. Did not interfere with any functions. At first dose experienced a more subtle version of light tingling and tongue swelling, though so mild, dismissed as anxiety. More dominant tingling after 2nd dose. Had not heard of this side effect so felt worth reporting. No action was taken since it did not interfere with breathing, eating and went away after a few hours.
48 2021-04-24 ringing in ears I have ringing in my left ear that started the next day.
48 2021-04-25 mouth numbness she had the vaccine at her local pharmacy. I got this information from her today, and as she seemed... Read more
she had the vaccine at her local pharmacy. I got this information from her today, and as she seemed disinclined to report it, I said I would do it for her. not sure if the pharmacy reported as well. She had nearly immediate onset of left sided facial numbness, unable to feel her lip or left side of the face. No weakness or facial droop. The numbness resolved on it's own over course of 2 days, with some tingling as it subsided.
48 2021-04-25 mouth tingling Before I start, I've really tried documenting this to you earlier and it kept timing out on me. Hope... Read more
Before I start, I've really tried documenting this to you earlier and it kept timing out on me. Hopefully the third time is a charm! On Saturday, April 17th at approximately 11:55 am, (45 mins after my shot) I started experiencing partial paralysis to the left side of my face. My cheek bone started to go numb, within the hour, after a weird tingling sensation, it went from my cheek bone down towards my jaw (all becoming numb). This lasted all weekend. I used cold compresses for a little bit at a time just to make the heat coming off of that side feel a little better as my face was flushed. On Monday, April 19th, my lower cheek started to not be so numb. The tingling sensation would come and go from my eye brawl, then the side of my mouth/lip area. I developed a headache that Monday evening. Tuesday morning, my headache was gone. This tingling sensation and partial numbing would last through Wednesday, April 21st. That day, I called my doctor's office and told them about my reaction and to see if they could do some blood work or something. They said that I needed to go to the ER at a hospital for help and to get it documented. Out of all weeks for me to have a side effect, this busy mom had too much going on to schedule an ER visit. My daughter is going into high school and she had auditions and clinics where I had made the choice to figure out I will try to go there on another day. By Thursday, April 22nd, my cheek bone started to become un-numb. The affected side started to feel like the other side of my face. During this entire time, I didn't take any medicine. By Friday, April 23rd, I felt much better. I have more control of my face muscles and I feel like this might be something that was just temporary, but I told myself that if it comes back in any way, I will go to the ER regardless of what is going on in my life. It was a scary thing and now as I look at my card, it reads that the second shot is May 8th at 11:15. I am really scared to get that because who knows what will come from it and I wouldn't want to get anything permanent. I know with traveling, some countries are making it mandatory to be vaccinated. So does this mean that I will not be able to travel if I don't get that second shot. I have no idea what to do with this appointment. Any advice would be great! As of today, April 26th, I feel 95% better on my left side of my face but if I sleep on it for too long, it tends to feel heated at my cheek bone. Aside from that I'm much better. Now onto the second side effect, my left arm muscle was in excruciating pain and I could not lift my arm for two days. It effected my elbow to my shoulder. After Monday, April 19th, my arm started to get better every day. This was the arm that I got my shot in. Today, April 26th, is the first day it seems back to normal. I know you can have a sore arm with this shot, but this was much more than a sore arm. My left side of my face, my left arm, and a headache were the only abnormal events that took place after my first Covid shot. I am thankful to be feeling much better, but will continue to monitor the situation of my face as that is what is most concerning about this vaccination.
48 2021-04-25 ringing in ears Ringing in the Ears, Nausea and Vertigo. Antibiotics 2 rounds, Steroid injection and zpack
48 2021-04-25 ringing in ears Ringing in the ears. Started the day after the 1st dose. Ranges from high pitch sound to a constant ... Read more
Ringing in the ears. Started the day after the 1st dose. Ranges from high pitch sound to a constant buzzing sound.
48 2021-04-25 vision blurred Head on left side gradually got heavy, vision went blurry, left side weakness, and headache. I had ... Read more
Head on left side gradually got heavy, vision went blurry, left side weakness, and headache. I had been having memory loss and searching for words a few weeks before and just thought it was because I was getting older. Similar symptoms as a TIA. I was driving and more worried about pulling my car to the right and back over from crossing the line.
48 2021-04-26 lip swelling, thirst The patient said she vomited once today (4/25/2021) and has been having excessive thirst and urinat... Read more
The patient said she vomited once today (4/25/2021) and has been having excessive thirst and urination. She has chills and dizziness. Patient received her 1st Pfizer COVID-19 vaccine dose on 4/15/21@ 1530. @ 2100 the same day she had swelling between lips and nose and she started feeling chilly. On 4/16/21 her symptoms went away. Last February she said her glucose was 211 mg/dL when she went to the ED. She said she was not diagnosed with diabetes, but she does check her blood sugar daily. The patient has excessive thirst and finds her self drinking a lot of water. The patient was wondering if vomiting a side effect of the Pfizer COVID-19 vaccine? glucose = 172 mg/dL @ 2200 Saturday night 4/24/21 glucose = 77 mg/dL @ 2330 Saturday night 4/24/21 glucose = 90 mg/dL @ 0115 4/25/21 Follow Up with Patient Around 0700 o 4/25/2021 the patient reported her thirst has come down some. Has still been drinking plenty of water but has not had any further vomiting. States she has had an issue with GI sxs since February.
48 2021-04-27 eye swelling, swollen lips First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swoll... Read more
First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swollen injection site, migraine and tired to the point of exhaustion, dizzy. Third day was migraine, dizzy, nose bleed, exhausted, sleepy, rash started on neck then spread to face, chest and forearm, swollen eyes and throat, sores in mouth and on lips. Day 4 went to primary doctor. Day 5 and 6 rash starting to subside with prednisone, Benadryl.
48 2021-04-27 lip itchiness, mouth itchiness About 15 minutes after my vaccine my lips, tongue, gums, and inside of mouth were itching. I notifie... Read more
About 15 minutes after my vaccine my lips, tongue, gums, and inside of mouth were itching. I notified the nurse immediately. By the time I was administered a shot of 50mg Benadryl, I had started a slight itching on my arm and legs. My oxygen saturation level (read with meter on finder) was 99%. The nurse listened to my breathing to ensure I was not wheezing. My throat did not swell and neither did my tongue. I was monitored for about 30-45 minutes longer and released with instruction to take Tylenol as needed and Benadryl if needed again. I was instructed to call 911 with any sign of anaphylaxis. I napped during the day but have had no other symptoms other than a mild headache. I had some slight confusion on the way home but that occurs with any dose of Benadryl I take, so the shot of Benadryl could have caused that.
48 2021-04-27 ringing in ears, dry mouth, dry eye By the afternoon of the first dose, I was tired. At night in bed, I experienced dry mouth, brain fog... Read more
By the afternoon of the first dose, I was tired. At night in bed, I experienced dry mouth, brain fog, faint ringing in ear, tingling in hands and feet, dry eyes, some dizziness. Sensations in muscles, stomach, and bones. It felt like something is circulating around This continued each day 2-4 following this dose. I am concerned about the brain fog and tingling in hands and feet. I am on day 6, and I am experiencing more brain fog, inability to think or remember some things, pain in rib cage, collar bone, and sensitivity in lymph nodes in breasts and throat. I know experiencing longer than average side effects than others. I have seen my doctor on Monday and he is monitoring me for 2 weeks. I am a school teacher. I am concerned. I have had to take 3 consecutive days out this week and need to be at the school to administer state testing by next week. I don't understand why I was not given a good 2 weeks to overcome my effects of vaccination by the school dept. to protect myself, students, and my own family. I took the first dose because others had said that their side effects were minimal lasting only a few days. I had mine done last Thurs of the school vacation. I feel held back from doing my job as a teacher.
48 2021-04-27 ringing in ears Increase in volume of existing tinnitus. This started soon after the shot and has continued for 16 d... Read more
Increase in volume of existing tinnitus. This started soon after the shot and has continued for 16 days and counting.
48 2021-04-28 taste impairment Fatigue, muscle and joint aches, persistent nausea, persistent sweet taste in mouth, headache, incre... Read more
Fatigue, muscle and joint aches, persistent nausea, persistent sweet taste in mouth, headache, increasing nasal congestion and facial pressure
48 2021-04-28 mouth tingling, feeling of choking After first dose 21 days prior, pt reported some tingling in mouth. After this second dose pt develo... Read more
After first dose 21 days prior, pt reported some tingling in mouth. After this second dose pt developed tongue/throat tingling, itching, clearing throat, anxiety, and diaphoresis. Pt given Benadryl and Epipen and was sent to ED.
48 2021-04-29 ear swelling Headache, muscle aches, fever, tiredness, bloody nose, ear inflammation, nausea, loss of appetite.
48 2021-05-04 swollen tongue Red hives starting at neck and chest and radiating to arms and face; Light headed; Swollen tongue; T... Read more
Red hives starting at neck and chest and radiating to arms and face; Light headed; Swollen tongue; This is a spontaneous report received from a contactable other hcp. A 48-years-old female patient received first dose of (Solution for injection), via an unspecified route of administration, administered in Arm Left on 26 Jan 2021 18:30 as single dose for Covid-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Concomitant medications included Hydrochlorothiazide and Betahistine. It was reported that patient was not pregnant at the time event. On 26 Jan 2021, the patient experienced red hives starting at neck and chest and radiating to arms and face, lightheaded and swollen tongue. The events were non-serious. Patient received Benadryl as treatment for events. It was reported that patient was not taken any vaccine in four weeks nor had Covid and tested the same post to vaccination. Outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
48 2021-05-09 permanent deafness Acute left-sided sensorineural hearing loss occurred 7 days after vaccine. ENT visit, no improvemen... Read more
Acute left-sided sensorineural hearing loss occurred 7 days after vaccine. ENT visit, no improvement with prednisone. Planned follow up 5/11/21 with possible steroid injection.
48 2021-05-09 deafness unilateral Sudden, permanent, unilateral hearing loss on same side of injection,
48 2021-05-11 swelling around the eyes, eye swelling Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face w... Read more
Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face was swollen/ cheeks were swollen; eyes started getting puffy; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had side effects which was described as whole face was swollen and both of her eyes and cheeks were swollen in Apr2021. The right side was worse than the left. The patient stated that three days ago, it swelled up a little bit so she put some ice on it, but she woke up this morning and her face was literally swollen. Even yesterday it was swollen but it was not this bad. This morning like it's really really big and it's huge. Right now, her eyes were swollen. She could not really see from it. Few days ago in Apr2021, her eyes started getting puffy. She was kind of ignored it because she put ice on it. But each day it got worse and now this morning, her eyes were closed shut, both of her eyes were swollen. Right eye was more big than the left and her face, her cheeks were swollen. The outcome of events, both of her eyes were swollen/ could not really see from it/ her eyes were closed shut, whole face was swollen/ cheeks were swollen and eyes started getting puffy was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-05-12 eye pain stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and le... Read more
stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and left arm pain/legs hurt/hands were also hurting; not as hard of a pain but it is in the muscles below the knee and in the back of the calf.; neuropathy; whip lash in shoulders and neck; feel radiation or heat; uncomfortable; shoulders became sore; tired; Eyes hurt; vasculitis pain flare up; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in right upper arm, at age 48 years, on 12Apr2021 13:00 (Batch/Lot Number: 9R8732) as second dose, single, for COVID-19 immunization. Relevant medical history includes two autoimmune diseases and two lung diseases further reported as ongoing Post-traumatic stress disorder (PTSD) diagnosed in 2017 because of trauma from vasculitis because both her arms looked like sleeves of nothing but broken blood vessels; Chronic obstructive pulmonary disease (COPD) from unspecified dates; ongoing bronchiolitis from unspecified date that does not go away; ongoing Hepatitis B contracted after vasculitis had gotten back together with her baby daddy and contracted it that way; ongoing small cell vasculitis (CSVV) from Oct2017 is her main disease; immune system weaker than her mom; body is weak; has weak muscles; generalized anxiety disorder; depression; she had fell on both arms, she's had a knee surgery; and she can barely walk because she pulled a back muscle before, her back and her having an injury from 2 years ago in 2019. Patient also usually gives blood at her primary care. Family history includes arthritis, her mom has it. Concomitant medications included tenofovir alafenamide fumarate (VEMLIDY) taken for antibiotic therapy from an unspecified start date and ongoing; meloxicam taken for joint swelling from an unspecified start date and ongoing; alprazolam (XANAX) taken for generalised anxiety disorder from an unspecified start date and ongoing; quetiapine fumarate (SEROQUEL) taken for post-traumatic stress disorder from an unspecified start date and ongoing; pantoprazole taken for ulcer from an unspecified start date and ongoing; sertraline taken for depression from an unspecified start date and ongoing; promethazine taken for prophylaxis of nausea and vomiting from an unspecified start date and ongoing; albuterol sulfate taken for an unspecified indication from an unspecified start date and ongoing; and budesonide taken for lung disorder, start and stop date were not reported. Patient historically took first dose of BNT162B2 (injection, Batch/lot number: EN6202) in the left upper arm at age 47 years on 19Mar2021 at 1:40pm at a clinic for COVID-19 immunization and experienced no adverse event; and an unspecified flu shot last Oct2020 (also reported as last winter). Patient has some 5 or 6 doctors there as specialists or prescribers. She has a liver specialist and a vasculitis specialist, whom she has not seen since the flare up because of her insurance, a main primary that saved her and brought her into remission is not covered with her insurance, and a GI doctor as well. She also reported that her immune system is probably weaker than her mom's because of her own 2 diseases. She also said that she was supposed to be in lung therapy but her body is weak. She stated that every time something hurts, it may be neuropathy. She has weak muscles and they haven't been this weak. She could move around and do things before. Patient was tired from the autoimmune and lung disease, she has had to stop and rest. Patient clarified that she had these prior to COVID coming. Patient wanted to get the vaccine to have more immunity so she could go out. She didn't want to get the Corona virus. The doctors said she wouldn't make it. It was her choice but the doctors recommended it. It was reported that patient has completed vaccination. About a week ago (13Apr2021), started experiencing a lot of pain from a vasculitis flare up. It is as if it just happened and was having a lot of pain in various parts of the body. Patient stated that it didn't start until like the second day (13Apr2021). Patient was not disgruntled, believes in the vaccine. She has an appointment with the tele doc this week and with another doctor at the same office since doctor was not in this week, because of her back and her having an injury from 2 years ago, X-rays, and can't walk right now, is in a lot of pain. She did not know if she can take pain pills, with all her other stuff. Patient stated that both her legs hurt and she can't walk. Her hands were also hurting with it in Apr2021. Patient had knee pain on 19Apr2021, leg pain was still there but getting better and was still hurting when she walks. It is not as hard of a pain but it is in the muscles below the knee and in the back of the calf in Apr2021. On 21Apr2021 or 22Apr2021, right and left arm just hurts all the way down started. They are the same and are still hurting and staying persistent. On 26Apr2021, back pain was added and stated that she got it for complaining about her arm. It started About 3 days after the shot, around 14Apr2021 or 15Apr2021, patient had whiplash in shoulders and the neck. It started in the back of the head and was like she could feel radiation or heat. It would be so uncomfortable, her shoulders became sore. When she looked left or right, it felt like whip lash. It has gotten better. For her arm, she wanted to revert to ice/heat but she hasn't done anything yet. Patient called her primary in hopes that he would give her something for the pain, she was not in pain management but it is hurting so bad. Since the injection, she has been so tired, so she has not been taking her XANAX. She takes them as needed for generalized anxiety disorder and her anxiety has not been up. A lot of the time she does not have to take them. The diseases make her tired and fatigued. If her mind is too racy, she will take to keep as calm as possible, especially with the small cell vasculitis or then she could have a flare. Her main objective is to keep calm. She was already taking 1 XANAX a day when diagnosed with PTSD but they just raised it because then came her PTSD and depression from the vasculitis. Has muscle relaxer cyclobenzaprine hydrochloride (FLEXERIL) at 100mg once a day which she doesn't take. Did not normally take these but has been taking them since this happened. She is in so much pain. Does not generally have high tolerance for pain. Does not like taking opioids because they make her throw up. She can only take them with Phenergan. Does not take if she does not need them because they do not sit well with the liver. She has an inhaler that keeps the lungs dilated for 10 hours, is not Pulmicort but something else. Eyes hurt on Apr2021 and can't read the label because its so little. She has bronchiolitis which is another rare disease with the airways in her lung and medication keeps the lungs dilated. Haven't seen the doctor yet so no tests yet. Since this happened, she can't walk. On 26Apr2021, when she went back down she couldn't walk since. It is her lower back on the right side, above her hip. She had pulled it 2 years ago (2019), above the hip on the right side. She recognized this feeling from a couple of years ago. It seems to be the place where she feels over winded. It may be neuropathy problems, wondering if it's not neuropathy since it's not her muscles (Apr2021). Everything that was wounded has come back and hurts as bad as it does. For can't walk, the pain just hurts. She didn't sleep at all last night (26Apr2021). Tries to turn and get up and if she is on either of her arms. Other than the neck, shoulders and back of her head, she never got a fever. When it started she thought that it was normal. Then, it started hitting in all of these other places and she was barely moving. Patient had the normal feeling like when she would breathe. On an unspecified date, she was having stiffness of the joints, as if they were traveling, then taking a vacation to every place that she has ever hurt itself. She had fell on both arms, she's had a knee surgery and its like going to that. The knee surgery was on the right knee. Like right now its in her back, and she can barely walk because she pulled a back muscle before. She stated that she will enjoy it if she can walk again and she just wanted to make it through this. The adverse events did not require emergency room visit or physician's office visit but was definitely at the point where she will go see the primary or go to the ER. The outcome of the event vasculitis pain flare up, right and left arm pain/legs hurt/hands were also hurting, and ?can't walk was not recovered; for knee pain, whip lash in shoulders and neck, feel radiation or heat, uncomfortable, and shoulders became sore, it was recovering at the time of report; for the other events, it was unknown. No follow-up attempts are needed. No further information is expected.
48 2021-05-12 eye swelling, eye itchiness, lacrimation increased 2 days after 1st shot -both eyes were watery and very itchy, started swelling. Swelled to the poin... Read more
2 days after 1st shot -both eyes were watery and very itchy, started swelling. Swelled to the point of not being able to drive. Took Benadryl, no change. Went to a clinic and they put me on 6 days of prednisone. Swelling decreased. Took 2-3 days.
48 2021-05-14 loss of smell, loss of taste she started to have shortness of breath in the evening; She realized she couldn't do as much as she ... Read more
she started to have shortness of breath in the evening; She realized she couldn't do as much as she normally does. She said she tried; Tested positive for Covid-19 after both doses of Covid-19 Vaccine; she tested positive for the COVID-19 Virus on 05May2021; Now she had zero taste and smell; Now she had zero taste and smell; she had congestion; This is a spontaneous report from a contactable other-HCP. A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1284 and expiration date was not reported), via an unspecified route of administration in deltoid left on 11Jan2021 as 2nd single dose, for COVID-19 immunization. Medical history included hypertension from 2015 and ongoing, hyperthyroidism from Aug2019 and ongoing, ongoing seasonal allergy stated she has had seasonal allergies since she was a kid. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number-EH9899 and expiration date was not reported), via unspecified route of administration on 20Dec2021 for COVID-19 immunization. On 05May2021 the patient experienced tested positive for COVID-19 after both doses of covid-19 vaccine. Upon follow-up received on 07May2021, she tested positive for the covid-19 virus on 05May2021. The patient now she had zero taste and smell (ageusia) (medically significant) the patient the patient with outcome of not recovered, On May2021 the patient experienced now she had zero taste and smell, she said she had congestion and couldn't taste and smell. She said on 06May2021 she started to have shortness of breath in the evening. She said because she was a cardiopulmonary specialist, she thought her shortness of breath was mild, but her family members thought she sounded winded. She said yesterday, she realized she couldn't do as much as she normally does. She said she tried to mop the floor yesterday and couldn't finish mopping the floor because she was short of breath. She said she doesn't feel sick. She realized she couldn't do as much as she normally does. She said she tried to mop the floor yesterday and couldn't finish mopping the floor-Activities of daily living impaired. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05May2021, sars-cov-2 test positive: positive on 05May2021. Therapeutic measures were taken as a result of now she had zero taste and smell (ageusia), now she had zero taste and smell (anosmia), she had congestion (nasal congestion), she started to have shortness of breath in the evening (dyspnoea), she realized she couldn't do as much as she normally does. she said she tried (loss of personal independence in daily activities). The outcome of event was Not recovered. Follow-up(07May2021): New Information received from the contactable consumer includes updated events and dates, Past drug events and allergy and questions regarding events. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Vaccination failure,Covid19,loss of smell,taste. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
48 2021-05-14 deafness Lost of hearing; This is a spontaneous report received from a contactable consumer (patient). A 48-y... Read more
Lost of hearing; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Apr2021 04:00 PM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient was not pregnant. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Lost of hearing (reported on 08Apr2021, pending clarification). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered. Information about Batch/Lot number has been requested.
48 2021-05-19 dry mouth Pt started complaining of being dizzy and dry mouth about 10 minutes after vaccination. Denies SOB/ ... Read more
Pt started complaining of being dizzy and dry mouth about 10 minutes after vaccination. Denies SOB/ difficulty breathing, increased HR, chest pain. No rash or hives. Patient vitals: HR 84, Resp 18, B/P 160/70, O2 94%, BG 191. Patient specified dizzy when her legs are crossed. Expressed she has not eaten since 6 AM and was sitting in the sun for 1 hour prior to arriving for vaccine. After drinking 2 bottles of water , and resting, patient denied EMS services. PT released.
48 2021-05-19 eye pain Called health system call center on 5/5/21. Pt stated she got 2nd covid vaccine Pfizer 4/13/2021 in... Read more
Called health system call center on 5/5/21. Pt stated she got 2nd covid vaccine Pfizer 4/13/2021 in a town not Vaccination site and pt has headache and eye pain 7-8/10 for 2 weeks. Noted 1st covid vaccine 3/23/2021 and pt felt rapid heartbeat. Pt described that pt felt dizziness with both eye pain, nausea, headache 3 times last Friday and pt drank some water and took tylenol but it's not helping. Pt said both eye pain got worse on last Saturday. Pt was advised to go to ED for further evaluaton.
48 2021-05-19 ringing in ears I started noticing a hissing sound in my left ear. Initially noticed it was on and off since ~4/25.... Read more
I started noticing a hissing sound in my left ear. Initially noticed it was on and off since ~4/25. However, it persisted and especially noticeable at night since ~5/4. I tried using Debrox and visited ENT on 5/10. ENT Dr. cleaned wax but "tinnitus" persisted. I have no history of tinnutus and audiology test is also normal.
48 2021-05-23 swollen tongue, mouth tingling, vision blurred, eye itchiness Right after vaccine lips tingled and my vision had a softer focus. In another hour tongue swelled a... Read more
Right after vaccine lips tingled and my vision had a softer focus. In another hour tongue swelled and it was challenging to talk normally, felt like I had drunk two glasses of wine, vision blurry, strong itching around eyes and neck. Eye doctor said my vision changed enough to need prescription readers and distance glasses for driving.
48 2021-05-23 tongue disorder tight throat/thick tongue, 50mg IM Benadryl in left deltoid. HR 101, O2 99% BP 161/69. observed for... Read more
tight throat/thick tongue, 50mg IM Benadryl in left deltoid. HR 101, O2 99% BP 161/69. observed for 45 minutes
48 2021-05-25 taste impairment PATIENT RECIEVED SECOND PFIZER COVID-19 VACCINE TODAY. APPROXIMATELY 1 AND 1/2 HOURS AFTER RECEIVING... Read more
PATIENT RECIEVED SECOND PFIZER COVID-19 VACCINE TODAY. APPROXIMATELY 1 AND 1/2 HOURS AFTER RECEIVING VACCINE, PATIENT CALLED THE PHARMACY REPORTING HORRIBLE METALLIC TASTE IN MOUTH. PER PATIENT "GOES ALL THE WAY DOWN HER THROAT, TASTES LIKE WHEN YOU HAVE A BLOODY NOSE, AND IS MAKING HER GAG." INSTRUCTED PATIENT TO CONTACT DOCTOR AND TO TRY EATING/DRINKING SOMETHING OTHER THAN WATER TO REMOVE TASTE.
48 2021-05-25 mouth numbness Oral lesions appeared all over inside my mouth, on my tongue, cheeks, behind my lower lip, and gums;... Read more
Oral lesions appeared all over inside my mouth, on my tongue, cheeks, behind my lower lip, and gums; It began with a few white-colored sores; my tongue never felt right. It felt as though the top layer was numb; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 07Mar2021 11:45 AM (Batch/Lot Number: EN6199) at the age of 48-years-old as 1st dose, single for COVID-19 immunization at urgent care center. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included asthma, arthritis, and allergies: sensitive to peppers. Concomitant medication included meloxicam taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). On 08Mar2021, oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind her lower lip, and gums. It began with a few white-colored sores. They would heal and new ones would appear. They lasted for 2 weeks. While the sores were gone, her tongue never felt right. It felt as though the top layer was numb. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. A device date of 09May2021 was reported. Therapeutic measures were taken as a result of the events which included valacyclovir hydrochloride (VALTREX), chlorhexidine gluconate (PERIDEX), triamcinolone, and B12. The outcome of the events was recovered with sequelae (recovered with lasting effects).
48 2021-05-25 swollen tongue, mouth numbness, lip swelling that oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind my lower lip, an... Read more
that oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind my lower lip, and gumsbegan with a few white-colored sores; Now the sores are gone and she's pain-free, but still experiencing some numbness; lips and tongue swelled; lips and tongue swelled; Couldn't eat anything but soup or yogurt; lost 15 pounds; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 28Mar2021 11:30 (Batch/Lot Number: ER8732) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included asthma and arthritis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication(s) included meloxicam taken for an unspecified indication, start and stop date were not reported. It was reported that oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind my lower lip, and gums. It began with a few white-colored sores. They would heal and new ones would appear. They lasted for 2 weeks. While the sores were gone, my tongue never felt right. It felt as though the top layer was numb. 8 days after my second dose, the sores reappeared. This time it was much worse. Twice, the entire right-half of the underside of my tongue was white. Sores would move around. She could feel them forming on her tongue at night. Her lips and tongue swelled. She couldn't eat anything but soup and yogurt. It hurt to talk. She lost 15 pounds. Now the sores are gone and she's pain-free, but still experiencing some numbness. The outcome of events was recovered with lasting effects. The outcome of event was reported as Recovered/Resolved with Sequel. The events resulted in emergency room/physician's office visit. Therapeutic measures taken as result of events. Information on Lot/Batch number was available. Additional information has been requested.
48 2021-05-25 vision blurred migraine , blurry vision,drop foot,leg pain, Concentration problems, numbness, weakness, all still e... Read more
migraine , blurry vision,drop foot,leg pain, Concentration problems, numbness, weakness, all still effecting me
48 2021-05-26 loss of smell, loss of taste High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping... Read more
High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; diarrhea (1st dose only); lose of taste and smell; lose of taste and smell; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: E49899, dose 1 via an unspecified route of administration in right arm on 22Dec2020 at 15:15 as 1ST DOSE, SINGLE for covid-19 immunization (48-years-old at the time of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient relevant medical history included asthma, back injury, drug hypersensitivity, allergies: NSAIDS, mushroom allergy, seafood allergy, (Allergies to medications, food, or other products: Yes, sodium benzoate, ASA, NSAIDS, mushrooms, seafood). The patient concomitant medications included Multivitamin, D3, Iron, Mg Citrat and flax seed oil. The patient previously took sodium benzoate and experienced drug hypersensitivity, ASA, and experienced drug hypersensitivity. On 04Jan2021, the patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea (1st dose only), and loss of taste and smell. No treatment received for the adverse event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. On 05Jan2021, the patient underwent lab tests and procedures which included sars-cov-2 test was negative (Covid test type post vaccination was Nasal Swab). Follow-up attempts are completed. No further information is expected.
48 2021-05-26 mouth numbness, drooling, tongue itchiness, taste disorder +10 mins, strange taste in mouth, excess saliva +25 mins, numbness in lower half of face and lips, t... Read more
+10 mins, strange taste in mouth, excess saliva +25 mins, numbness in lower half of face and lips, twinge/cramp feeling in heart area +30 mins, sinus clearing and drainage (still continuing 5 hours later) +45 mins, itching under left side of tongue in thin line from base to tip, might be a nerve, arm getting sore +1 hr, gastro symptoms started, unusual feeling in intestines +2 hr, fatigue, tiredness +5 hr, chills +8 hr, dizziness +9 hr fatigue, tiredness +12 hr lower back pain and tenderness in kidney area, both sides +15 hr severe fatigue, tiredness, arm soreness/pain, other muscle pain +24 hr arm soreness, fatigue, tiredness +25-29 hr severe fatigue, tiredness, fever, couldn?t stay awake +54 hr severe fatigue, tiredness, fever, couldn?t stay awake Days 1-5: gastro system upset, nausea, diarrhea
48 2021-05-26 ringing in ears Tinnitus after the first shot - went away in a few days Constant Tinnitus after the second shot, it'... Read more
Tinnitus after the first shot - went away in a few days Constant Tinnitus after the second shot, it's heavily affecting my sleep and ability to concentrate. Fatigue, Dizziness Swollen Lymph nodes - on left arm, it was the size of half an egg. Lymph nodes are smaller after 6 weeks but still sensitive.
48 2021-05-27 eye movement disorder The patient let us know that she had had a seizure after the first COVID shot and that she has them ... Read more
The patient let us know that she had had a seizure after the first COVID shot and that she has them after every vaccine. This has happened since she was a little girl. The patient was visibly nervous before the vaccine was administered. During her observation time following the vaccine administration, she let provider know that she could feel her left arm tightening up. Provider provided the patient with an ice pack for her neck to try to calm her down. The patient asked for us to not call a rapid response yet and that "I'm trying to calm myself down." observed the patient's left hand starting to grasp and the patient became tearful so asked the patient if she was okay. The patient stated she was okay. Provider asked her to let her know if she felt like she was going to have a seizure. About a minute later, the patient let provider know she felt one coming. Provider called the RRT as the clinic Team Lead, let the patient know she was going to recline her in the chair she had been vaccinated in. Seconds after the chair was reclined, the patient's eyes started to roll back in her head and her eyelids started to flutter. Within about 10 seconds, the patient was jerking up and down in the chair. The clinic staff ensured the patient was safe until the arrival of the RRT. As the RRT arrived, the patient's seizure ended. The patient became alert to talk to the team that arrived to the clinic. She refused being seen by the ED. The clinic staff agreed to monitor her vitals until she felt comfortable to leave. After around 30 minutes after the seizure, the patient was in good spirits and stated she would like to stand and see how she felt. The patient stood up and walked around for a moment before saying she was ready to leave. Provider checked the patient out, and she left the clinic.
48 2021-05-28 eye pain, eye swelling, eye itchiness my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm bec... Read more
my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism and Anemia. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included levothyroxine, ferrous sulfate, fluticasone propionate (FLONASE ALLERGY RELIEF), and ibuprofen. On 12May2021 05:30, the patient experienced arm became hot, red, swollen and painful. The patient also have swollen, painful and itchy eyes. The events cause the patient for emergency room visit. The events were treated with Oral steroid, antibiotic, antihistamine. The outcome of the events was not recovered.
48 2021-05-28 swelling around the eyes Eye lids were puffy; Slept for about 15 hours; Achy; This is a spontaneous report from a contactable... Read more
Eye lids were puffy; Slept for about 15 hours; Achy; This is a spontaneous report from a contactable consumer. A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on right arm on 07May2021 16:30 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 48 years old) for COVID-19 immunisation. Medical history included ongoing migraine, seasonal outdoor allergies and COVID-19 from 26Feb2021. Concomitant medications included sumatriptan (SUMATRIPTAN) taken for migraine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, at 16:45 on the right arm on 15Apr2021 for COVID-19 immunisation The patient stated, "the next morning and couple days following, my eye lids were puffy. I took BENADRYL. 24 hours after the shot, I was achy and slept for about 15 hours. Overall, the 2nd dose reactions were better than having COVID". The outcome of the events was recovered on May2021. Information on the lot/batch number has been requested.
48 2021-05-31 eye strain, vision blurred, ear discomfort Slight pressure like ears and eyes; Slight headache but it had become so bad that I never had; Did n... Read more
Slight pressure like ears and eyes; Slight headache but it had become so bad that I never had; Did not feel well; Vision was blur; Hard to open eyes; it is like a pressure; Still I had at back of my head like a pressure little bit; concentration, everything was gone within like so fast; This is a spontaneous report from a Contactable consumer (patient). A 48-Years-old female consumer received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 as an 1ST DOSE, SINGLE for COVID-19 immunization (age a vaccination 48-Years-old). Medical history and concomitant medications of the patient were none. On 28Jan2021 around one hour after vaccination, the patient had slight pressure like ears and eyes, slight headache but it had become so bad that she never had, hard to open eyes; it was like a pressure, did not feel well, vision was blur, concentration, everything was gone within like so fast, Still I had at back of my head like a pressure little bit. Clinical course was provided as follows: She had her first dose and started having some symptoms right like within an hour or so. It was a slight pressure like ears and eyes and little like slight headache but then it had become like at the end of the day, it was so bad that she never had, (intensity was more than before). It was sudden, and she could not keep her eyes open. It was to that point like hard to open her eyes and it was like a pressure. She went back to the site and checked blood pressure, she recorded it was fine, '100.2 and over' (not further clarified), pulse and everything was fine, but she did not feel well. Even she felt like her vision was blur her concentration, everything was gone within like so fast." She did not receive any medication, but she had sat down and was laid on until she felt normal. Follow-up attempts are completed. No further information is expected.
48 2021-06-01 ear pain Slur of words; tightness R jaw; ear pain; This is a spontaneous report from a contactable Nurse. A 4... Read more
Slur of words; tightness R jaw; ear pain; This is a spontaneous report from a contactable Nurse. A 48-Year-old Non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot number & expiry date not reported) dose 1 via unspecified route of administration on 12Feb2021 (at age of 48years) as 1st dose single for COVID-19 Immunization. Patient medical history and concomitant medications are not reported. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot number & expiry date not reported) dose 2 via unspecified route of administration on 03May2021 as 2nd dose single for Covid-19 immunization.Patient didnt receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was unknown On 12Feb2021, (On day of vaccination),Patient experienced Slur of words, tightness R jaw, Ear Pain. Patient received treatment for the adverse events by Depomedrol shot. Patient had to visit clinic for adverse events. The Clinical outcome of all events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of slurred speech,tightness of jaw muscles,ear pain cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
48 2021-06-02 eye irritation The day of the vaccine I had the return of the dry cough, which I previously with COVID-19. I also... Read more
The day of the vaccine I had the return of the dry cough, which I previously with COVID-19. I also had mild chest pains. I had fatigue and felt sleepy. Within the first 24 hours of the vaccine, I had burning in the eyes. Within the next week I had more fatigue and sleepiness. Within a few weeks I had a more intermediate cough. The cough was not every day but every few days. About a month after the vaccine, I have had a cough every day. The worsening of other conditions, in late February into March, I had worsening of restless legs. I also had increased of my asthma symptoms which I had to increase my medication for the asthma. I had chest tightness until April 10th. On April 29th, I had increased fatigue and montenect jerk of my arm and legs. After a week or so of those symptoms, I saw my Rheumatologist she put me on a steroid of 6 days. The abnormal fatigues and fatigue improved after I started the steroid. I still have a little fatigue and intermediate dry cough. Also, with had a symptom of monocular diplopia, the doctor I saw thinks that was to the increased dry eye symptom. I think the symptoms have increase my autoimmune system to flare up. I still have to use the inhaler also more than I use too.
48 2021-06-02 ringing in ears Constant ringing in ears that started within hours of receiving the vaccine and hasn?t gone away yet... Read more
Constant ringing in ears that started within hours of receiving the vaccine and hasn?t gone away yet.
48 2021-06-02 vision blurred I keep getting these headaches; Neck is stiff; Rash on my neck; Eyes were blurry; This is a spontane... Read more
I keep getting these headaches; Neck is stiff; Rash on my neck; Eyes were blurry; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot no: EW0179, Expiration date is unknown) via an un-specified route of administration on 21May2021 at my left arm as a single dose for covid-19 immunisation. The patient's medical history includes Epilepsy, asthma. Concomitant medications includes Lamotrigine, Proair, Symbicort, Alebe (220mg), to treat the Headache. Patient previously took first dose of vaccine BNT162B2 (Lot number: EWO172) on 29Apr2021 on right arm. On 22 may 2021 the patient experienced keep getting these headaches, Neck is stiff, Rash on my neck, Eyes were blurry, Patient stated that yes, I took my 2nd Pfizer shot on 21st and I have been getting headache so I was taking a pain pill and couple hours later it will comes back but it has been a whole week. Okay, my neck is stiff, I keep getting these headaches. I have a rash on my neck that I have been cleaning with alcohol and I put cream on it. It will go away and then instantly come back and yesterday, my eyes were blurry. When paraphrased, consumer stated, "I want both, I want guidance for it because it won't go away. patient was informed about the Pfizer Medical Information for the concern and was provided with the number as option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and 9am to 3 pm from Saturday and Sunday as per EST. When probed for Healthcare professional, Reporter Stated, "A doctor, No, No, I am cook, I am chef". Consumer added, "I keep having the headache, do I go to the ER. Consumer was again informed to contact for the concern. Patient received treatment included Aleve, 220mg, for headache. Outcome of the events was unknown. Information about Lot/Batch number is obtained. Additional information has been requested.
48 2021-06-03 ear pain sore throat; cough; body aches; headache; ear aches; chills; loss of appetite; This is a spontaneous... Read more
sore throat; cough; body aches; headache; ear aches; chills; loss of appetite; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 17Mar2021 at 13:15 (at the age of 48-years-old), as a single dose for Covid-19 immunisation. Medical history included obesity. Concomitant medications received within two weeks of vaccination was mentioned as yes, however details were not provided. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Mar2021, the patient experienced sore throat, cough, body aches, headache, ear aches, chills, loss of appetite and reported no fever. The patient did not receive treatment for the reported events. The clinical outcome for the events sore throat, cough, body aches, headache, ear aches, chills, loss of appetite was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-06-03 burning mouth syndrome, pain in jaw Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very se... Read more
Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very sensitive and still sensitive; Now I have a knot in my armpit that is very tender; Now I have a knot in my armpit that is very tender; Headache; tired; irritable; My back hurt for days; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 18Feb2021 at 16:30 (at an age of 48-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. She had known allergies and had other medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:15 as 1st dose, single dose for COVID-19 immunisation. She did not take other vaccine in four weeks. She had taken other medications in two weeks. Patient not had COVID prior vaccination and not had COVID tested post vaccination. On 18Feb2021 at 18:00, the patient experienced pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days. The patient did not receive any treatment for the events. The clinical outcome of the pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days were resolving. No follow-up attempts are possible. No further information is expected.
48 2021-06-03 swollen tongue Client, a 27yo female,who reported that following her first dose Pfizer COVID vaccine (LOT EW0182, E... Read more
Client, a 27yo female,who reported that following her first dose Pfizer COVID vaccine (LOT EW0182, Expiration 08/31/2021) received 05/06/2021 she felt her tongue swelling, her face tingling and a headache in her left temporal area. Client denied any other symptoms such as nausea, chest pain or shortness of breath. She stated the onset of symptoms was approximately 5 minutes post vaccine and lasted less than 20 minutes. She did not notify the EMTs at the time and did not notify her primary care provider because the symptoms resolved on their own. Client denied any other medical conditions or regular medication use. She stated positive for allergy to pollen and dust with a non-anaphylactic reaction, denied any other allergies to environment/medication/foods. Lead RN consulted with medical team.
48 2021-06-06 ear swelling, ringing in ears Within 3 days of the vaccine, I was off balance/dizzy, fatigued, brain fog, short term memory issues... Read more
Within 3 days of the vaccine, I was off balance/dizzy, fatigued, brain fog, short term memory issues, nausea and no appetite, left inner ear swollen with fluid, tinnitus/ear ringing constantly. These issues lasted 4 weeks. Tinnitus and a little imbalance still happening.
48 2021-06-06 visual impairment I noticed an aggressive change with my eyesight so I went to a GA eye DR. During the initial part of... Read more
I noticed an aggressive change with my eyesight so I went to a GA eye DR. During the initial part of the visit it was determined that I was a good candidate for surgery. The DR said I had 4th nerve Palsy. My insurance company said I had to go somewhere else for surgery. The DR said there is a lot of things going on with my eye, depth perception issues, torsion issues, and possibly may need 2 surgeries or prism glasses. I had surgery on May 14th 2021. I'm sorry my father in law died during this time so it has been quite crazy. I had a tele visit with the DR again and I see her again in June. I will be retested again on this Friday 6/11/2021 for another eye test to see if I will need a second surgery. The other thing I forgot to mention, I also went to a chiropractor. I had severe neck pain and problems with my neck and shoulders. I even got a massage and haven't had one of those in years. The pain was incredible. I went to the chiropractor the second week of January and saw DR. This DR said there may be a correlation with the Covid vaccine.
48 2021-06-07 blindness loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node... Read more
loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; 103 fever; constant shaking; uncontrollable vomiting; dry heaving; headaches; extreme aching in back and chest; extreme aching in back and chest; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration into left arm on 17May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included allergy to bees (known allergies: Bees). The patient's concomitant medications were none (no other medications the patient received within 2 weeks of vaccination), the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously received first dose of BNT162B2 for COVID-19 Immunization. The patient experienced very hard, large lump has surfaced in her left breast, It is shaped like a straw, over two inches long. it originates from the lymph node in her arm pit and runs to her nipple, Hard lump surfaced on lymph node at base of skull. During 72 hours following second shot: 103 fever, constant shaking, loss of vision, uncontrollable vomiting, dry heaving, headaches, extreme aching in back and chest, all on 18May2021 08:00. the adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures in May2021: blood test, mammogram, sonogram test with unknown results. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. treatment received for the events included Bloodwork, sonogram and mammogram. Outcome of the events was not recovered. It was reported as non-Seriousness. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect were all no. Information on the lot/batch number has been requested.
48 2021-06-07 ringing in ears Patient was nervous about receiving this vaccine (has fainted in the past with previous vaccinations... Read more
Patient was nervous about receiving this vaccine (has fainted in the past with previous vaccinations). Within 5 minutes of receiving the vaccine, she became pale and quiet, and complained of ringing in the ears. The patient was laid down flat and given an ice pack and some water, and felt back to normal within 20 minutes.
48 2021-06-07 vision blurred I was fine at first. A couple hours later I noticed I was fatigued. When I arrived home that even... Read more
I was fine at first. A couple hours later I noticed I was fatigued. When I arrived home that evening, I was still fatigued and I had a low grade temp. I woke up the next morning and was fine and then started to get chest pain which I ignored for a few days and then I woke up Sunday morning with dizziness and blurred vision I checked my blood pressure and it read 180 over 120. I Immediately went to the ER. I was admitted for 24 hours for observation. I was connected to a heart monitor during that time.
48 2021-06-07 vision blurred right sided facial droop; blurred vision; head pressure; This is a spontaneous report from a contact... Read more
right sided facial droop; blurred vision; head pressure; This is a spontaneous report from a contactable healthcare professional. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the left arm on 21May2021 14:45 (02:45 PM) (Batch/Lot Number: EW0171) (at age of 48-years-old) as 1st dose, single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient did not have any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. On 21May2021 14:45 (02:45 PM), the patient experienced right sided facial droop, blurred vision, and head pressure. It was unknown if the patient has been tested for COVID-19 prior to vaccination. Therapeutic measures were taken as a result of the events which included vitals (as reported). The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event right sided facial paralysis, blurred vision, and head discomfort cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-06-08 deafness Mild/Moderate hearing loss
49 2021-01-01 eye itchiness, eye pain, eye irritation 12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , ... Read more
12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead with mild erythema including eyelids, mild circumoral numbness with occasional burning/stinging sensation.
49 2021-01-03 mouth numbness, mouth tingling Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved ... Read more
Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved by scratching. Left hand rash, of the webbing between the thumb and forefinger, raised. Not as severe as the wrist. Numbness or tingling of the lips, intermittent, first occurred an hour after the vaccine and has been infrequent since then. Gradually reducing in frequency; described as an awkward sensation of tingling. Has contacted her PCP for an appointment. Local Pharmacy would not sell or recommend medications due to the patient's history of Pfizer vaccine without her having been diagnosed first.
49 2021-01-03 lip swelling I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around ... Read more
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
49 2021-01-03 mouth tingling, mouth swelling Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mou... Read more
Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.
49 2021-01-03 mouth tingling tingling of the lips/Lips tingled; Throat got tight; This is a spontaneous report from a contactable... Read more
tingling of the lips/Lips tingled; Throat got tight; This is a spontaneous report from a contactable other hcp(patient). The 49-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: 31Mar2021), via an unspecified route of administration at left arm on 21Dec2020 at single dose for COVID-19 immunization. There were no concomitant medications nor medical history. Patient got first dose of the COVID vaccine and experienced her lips tingled/ tingling of the lips and her throat got tight, both on 21Dec2020, led to medically significant, lasted about 20 minutes. They observed her and she did not need any further treatment. Outcome of events was recovered in 21Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of her lips tingled/ tingling of the lips and her throat got tight cannot be excluded, considering the plausible temporal relationship and the known adverse event (anaphylactic adverse reaction) profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
49 2021-01-03 vision blurred, mouth numbness, taste disorder On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste li... Read more
On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste like cotton on the left side of my mouth/ tongue. As the day progress, I noticed I am having numbness left side of my face and mouth, unable to sip from a straw on the left side of my mouth, I am having facial droop that prompted me to to the ER . At ER same day my left eye is not blinking as my right eye. I was prescribed to take antiviral , steroids and eye meds. TODAY- 1/4/21, I am still having same symptoms and my left eye , feels grainy/ needle pricking inside. Left eye vision more blurry.
49 2021-01-04 eye pain, mouth pain, mouth numbness, burning mouth syndrome Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue are... Read more
Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue areas. Affects similar to receiving a Novocain shot. No treatment, went away on its own Lasted four hours-was closely monitored
49 2021-01-04 mouth numbness, mouth tingling I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes af... Read more
I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
49 2021-01-04 oropharyngeal discomfort, mouth tingling Patient received Pfizer COVID vaccine and waited for 30 minutes after to observe for reaction. With... Read more
Patient received Pfizer COVID vaccine and waited for 30 minutes after to observe for reaction. Within the 30 minute waiting period, she felt like her lips and tongue were tingling and her throat was scratchy. She denied shortness of breath, chest pain, difficulty swallowing or difficulty breathing. Vital signs were stable. Due to her history of anaphylaxis reaction with various medications and shellfish, she was taken to the ER. In the ER she received IV Solu-Medrol, Benadryl and Pepcid and her symptoms resolved. She was observed for 6 hours and then released to home.
49 2021-01-04 swelling around the eyes, eye swelling left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some p... Read more
left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.
49 2021-01-04 swollen tongue Woke up to an enlarged tongue - could not close mouth or eat
49 2021-01-05 bloodshot eyes Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat w... Read more
Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.
49 2021-01-05 swelling around the eyes, lip swelling periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than... Read more
periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than 15mins Transported to Emergency Room for evaluation Received Benedryl 50 mg PO
49 2021-01-05 thirst, eye swelling Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did ha... Read more
Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did have a hematoma and bruising, No fever On Jan 1st, I started feeling fatigued again and noticed round reddening approximately 2 inch in diameter appear about a inch under vaccination location which is still bruised. There is no pain or itching at reddened site. Jan 2, 3 and 4th-Fatigue worsened and developed low grade temp never surpassing 100. My throat developed allergy reaction feeling, same reaction I get with nuts. Throat did not swell and benedryl managed the reaction on Jan 3rd. My eyes began swelling and I could not stop sneezing. Developed laryngitis from the post nasal drainage. I was up whole night but still went into work as normal on Jan 4th. Struggled through the days but swelling and itching subsided. I experienced the muscle aches on the 3rd and 4th. On Jan 5th, started feeling better and rested. Still have reddened reaction on arm but is fading. It is faintly visible today on Jan 6th, I feel better, just have the sneezing currently and a mild headache. Benedryl is the only medication besides daily meds I took during the past several days. I did not want to interrupt the immune system's work.
49 2021-01-06 taste impairment Metallic taste in mouth started about 5 minutes after injection. lasted approximately for 1 hour
49 2021-01-06 mouth numbness, vision blurred Numbness of mouth,blurry vision for 24 hrs post vaccine
49 2021-01-06 mouth numbness rt. orbital numbness, lip numbness
49 2021-01-06 mouth tingling Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of ... Read more
Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl.
49 2021-01-06 mouth tingling Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dos... Read more
Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl. Patient reported feeling better and was sent home.
49 2021-01-06 feeling of choking throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallo... Read more
throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
49 2021-01-06 vision blurred @12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained ... Read more
@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained v/s (stable) assisted laying down on stretcher. Bottle water offered and took several sips.   @12:54pm Dr arrived for provisder Assessment and noted stable just continue monitoring. Waiting for longer observation for 20 more minutes. Pt states,"I feel a lot better."   Pt taking Ceftriaxone currently and finished prednisone x2 days after a course of several days.   Pt advise to call if s/sx return or get worse.   Allergies updated and Covid-19 vaccine added, suggested "not recommended for 2nd dose" and 2nd dose appt canceled.
49 2021-01-07 loss of taste, loss of smell Received first vaccine on 12/22/2020. 1/7/21 I developed symptoms of head congestion, headache and... Read more
Received first vaccine on 12/22/2020. 1/7/21 I developed symptoms of head congestion, headache and loss of taste & smell. 1/8/2021 tested positive for Covid.
49 2021-01-07 taste impairment Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching ove... Read more
Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching over the injection side. Later that night had itching throughout body. She has since had a HA.
49 2021-01-07 ear pain Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea S... Read more
Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea Still present 33 hours later
49 2021-01-07 ear pain I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ... Read more
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
49 2021-01-07 eye pain EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ... Read more
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
49 2021-01-07 mouth numbness developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-1... Read more
developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-19 vaccine. By the time of assessment in ED, sxs have resolved other than residual numbness of lips.
49 2021-01-07 mouth numbness Numbness noted left lower lip area noted when woke up the morning after COVID19 Vaccine. The numbne... Read more
Numbness noted left lower lip area noted when woke up the morning after COVID19 Vaccine. The numbness subsided before noon same day
49 2021-01-07 lip swelling, swollen tongue Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepc... Read more
Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
49 2021-01-07 oropharyngeal discomfort Caregiver complained of a "heavy" throat and had redness and itching to her neck and chest area
49 2021-01-08 double vision After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ... Read more
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
49 2021-01-08 lip swelling Angioedema, HYPERtension, Narrative: Lips swollen and hypertension. Lips less after 20 mins
49 2021-01-08 bloodshot eyes, eye pain, vision blurred BlurredVision, Myalgia, Arthralgia, Fever, red painful eye diagnosed as nodular episcleritis Narrati... Read more
BlurredVision, Myalgia, Arthralgia, Fever, red painful eye diagnosed as nodular episcleritis Narrative: Took Tylenol 500mg, 1000mg BID
49 2021-01-08 swollen tongue, mouth itchiness mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vo... Read more
mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.
49 2021-01-08 ringing in ears Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphor... Read more
Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
49 2021-01-09 ringing in ears 1st & 2nd day extreme /Joint & musculoskeletal pain, head ache, fatigue , short of breath, Cough... Read more
1st & 2nd day extreme /Joint & musculoskeletal pain, head ache, fatigue , short of breath, Coughing, runny nose, congestion, fever, ringing in ears, 3rd day musculoskeletal & joint pain, inner ear pain, fatigue, cough, throat pain This is 3rd day and I am still miserable
49 2021-01-10 taste impairment Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte... Read more
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
49 2021-01-11 taste impairment Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sou... Read more
Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.
49 2021-01-11 smell distorsion, deafness Had diminished hearing loss for 1 day, and sense of smell was affected, smelled vomit all day. This ... Read more
Had diminished hearing loss for 1 day, and sense of smell was affected, smelled vomit all day. This was the day after the vaccine. On Friday, I was back to normal. Thank God! No treatment needed.
49 2021-01-11 vision blurred, visual impairment, lip swelling 1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins We... Read more
1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins Wed, Thursday neck shoulders blades hurt, and achy. Friday Chills, no fever, hurt to the bone all over, sick to stomach, noticed some lips swollen, felt foggy in head. Headache constant top of head. 10:45am spots and vision blurry. Felt very sick. Laid head down then woke black spots. Sat occasionally in sun saw black spots. /sun off not looking at computer did not see black spots. Monday increase black spots. Saw an eye doctor.
49 2021-01-12 eye swelling woke up with swollen eyes - both; a similar reaction the medication is Myrbetriq and had an allergic... Read more
woke up with swollen eyes - both; a similar reaction the medication is Myrbetriq and had an allergic reaction; researched and found that Myrbetriq has the same ingredient as in the Covid vaccine; polyethylene glycol; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL1284, expiry date not reported), via an unspecified route of administration on 05Jan2021 16:30 at a single dose in the right arm for COVID 19 immunization. Medical history included COPD, Hashimoto's and celiac (celiac disease gluten), all were ongoing. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medications included levothyroxine sodium (TIROSINT), acetylsalicylic acid (BREOPRIN), indometacin (VANTELIN), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), and cetirizine hydrochloride (ZYRTEC). The patient previously took epinephrine and experienced allergies wherein patient required carbocaine at dentist; and mirabegron (MYRBETRIQ) and patient had an allergic reaction (approximately 2 years ago). The patient had no other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered in the hospital. They kept the patient for 15 minutes to 20 minutes. She began to have symptoms later that night, both eyes looked like she had been punched, swollen shut when she woke up in the morning. It was also reported as he morning after shot, 06Jan2021 06:00, patient woke up with swollen eyes (both); no swelling anywhere else; swelling continued into mid-afternoon when called into nurse line to report at hospital. Patient reported on Pfizer website the adverse effects but forgot to put in the report medication she was taking and had a similar reaction the medication is Myrbetriq and had an allergic reaction to this medication as well (2 years ago). Patient researched and found that Myrbetriq has the same ingredient as in the Covid vaccine; polyethylene glycol. Patient was advised to take benadryl and cold compresses for swollen eyes (both). They told patient to take benadryl one pill and if symptoms didn't subside to take another Benadryl. She took one benadryl and began to see slight improvement. She took the second benadryl and at around the 2 hour mark she was "pretty good, swelling totally gone and feeling totally okay, it took about 6 hours". The patient had no other symptoms. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. Patient stated that no one seemed to be able to tell patient if patient can take the second dose. Patient stated that she found information on CDC website regarding time of onset and ability to take second dose. The event swollen eyes (both) recovered on 06Jan2021; reported as swelling went away by dinner time on 06Jan2021 and eyes were fine at the time of the report. The outcome of the events "allergic reaction" and "researched and found that Myrbetriq has the same ingredient as in the Covid vaccine; polyethylene glycol" was unknown.
49 2021-01-12 mouth tingling Tingling on tongue and lips, fever 101.0, nausea
49 2021-01-12 tunnel vision about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No ... Read more
about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No diarrhea but soft stools. today headache, and fatigue
49 2021-01-12 eye floaters About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She repor... Read more
About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She reported "having waves of dizziness" that "made me feel like she was going to pass out but was clearly not" also reported "dizzy spots" in her vision. She had 3 separate episodes, each lasting about 4-5 minutes each. BP @ onset 100/63, pulse 57, after resolution, 100/62, pulse 62. O2 sat 100%. All symptoms resolved after a total of 30 minutes post vaccination.
49 2021-01-13 taste impairment SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she beg... Read more
SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she began feeling her throat was scratchy, mouth tasted metallic and a flushed felling over her entire body. SM attached to VS machine. Initial set of vitals were HR 77 bpm, spo2 100% on RA, and left arm blood pressure 158/84.
49 2021-01-13 lacrimation increased On 24 I had sinus and watery eyes. I went to ER because I was congested and coughing.
49 2021-01-13 pain in jaw -Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on... Read more
-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain
49 2021-01-13 vision blurred, loss of taste, loss of smell 1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and ches... Read more
1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and chest tightness headache 5:30pm BP 172/109 tachycardia and SOB nausea BP still 185/107 so went to prompt care who sent via ambulance to ER. Given nitro, fluids and morphine. Sent home. Next morning BP 188/118 and 213/122. C/o body aches temp 99 and loss of smell and taste. Saw primary care provider 1/14/21. Added Lisinopril and increased current betablocker and said was vaccine reaction. BP there 209/122 pulse 126. PCP did not test for COVID. Reports she did Binax test herself after visit and was negative
49 2021-01-13 vision blurred blurry vision 1st day. asthma attack 1st night inhaler worked. next morning. Massive severe headac... Read more
blurry vision 1st day. asthma attack 1st night inhaler worked. next morning. Massive severe headache (almost as bad as the spinal headache from my 1st child) , chills, fatigue, nausea. Called PCP and he gave me Tylenol with codeine for the headache and a prednisone for the asthma even though it was under control.
49 2021-01-14 swollen tongue She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm sorenes... Read more
She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm soreness which progress to body aches and tongue swelling. I took 50mg of Benadryl and 40 mg of prednisone that I had at home and my symptoms resolve gradually and I felt better the next day
49 2021-01-16 smell distorsion, taste disorder Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. ... Read more
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities. Treated with meclizine
49 2021-01-17 taste impairment *eyelid area on both sides of face felt tingly/numb for about 20 minutes which started about 40 minu... Read more
*eyelid area on both sides of face felt tingly/numb for about 20 minutes which started about 40 minutes after the shot was administered. *42 hours after administration of vaccine, I woke up with a metalic taste in my mouth which has laste for 6 hours
49 2021-01-17 vision blurred headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp... Read more
headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp 98.9, nausea, blurry vision, pass out once 2-3 mins, feverish at night 99.9
49 2021-01-18 loss of smell, loss of taste covid positive 1 week after 1st injection. chills fever cough loss of smell & taste body aches heada... Read more
covid positive 1 week after 1st injection. chills fever cough loss of smell & taste body aches headache & pain in left arm. some shortness of breath. 2nd injection headache w/ fever some aches still have headaches & a slight cough
49 2021-01-18 mouth numbness Pfizer C19 vaccine given, Patient was a staff member at facility, felt unwell, blood pressure was ta... Read more
Pfizer C19 vaccine given, Patient was a staff member at facility, felt unwell, blood pressure was taken by observer, pt ultimately felt well enough to go back to her office. At some point she contacted her doctor by phone and came back to observation reporting numb tingly lips and cheeks (covered by mask). Requested a diphenhydramine 50mg, which was given at 1400. rated reaction feel as level 5. After 25 minutes asked again and rated level 1. Contacted doctor. He cleared her to go home and would follow up in 2 hours to see how she was doing.
49 2021-01-19 dry mouth I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level ... Read more
I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level was 8 out of 10. When I tried to get out of bed, I was dizzy and had to hold to the walls to make it to the bathroom. I had severe dry mouth, nausea, muscle weakness, loss of appetite and chills. I was unable to go to work. The symptoms did not begin to subside until later in the evening the next day around 6:30pm. Today I am still weak but making it. Still having chills, and some minor muscle aches and spasms.
49 2021-01-19 eye pain Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chil... Read more
Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chills; fever; muscle pain; This is a spontaneous report from a contactable other HCP. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number=EL1284 via an unspecified route of administration on 06Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation dose number=2 vaccine location=Left arm facility type vaccine: Military Base. Medical history included diabetes mellitus, asthma, dry eye, blood cholesterol increased, rubber sensitivity Known allergies: Latex, food allergy: Nuts. Concomitant medication included lactobacillus reuteri (BIOGAIA), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), metformin hydrochloride (GLUCOPHAGE XR) , benazepril hydrochloride (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), magnesium oxide (MAG-OX), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ciclosporin (RESTASIS), montelukast sodium (SINGULAIR) , liraglutide (VICTOZA), ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC). The patient previously took remeron and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity. The first dose of BNT162B2 vaccine for covid-19 immunisation was done on 16Dec2020 08:30 Intramuscular at single dose, Vaccine location Left arm Dose number 1 Lot number=EK5730. On 06Jan2021 13:00 the patient experienced headache outcome of recovered, fatigue outcome of recovered, aches/soreness of the shot outcome of recovered, shortness of breath on 06Jan2021 13:00 with outcome of recovered, eyes hurting on 06Jan2021 13:00 with outcome of recovered, swollen site outcome of recovered, chills outcome of recovered, fever outcome of recovered, muscle pain outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06Aug2020. The action taken was not applicable.
49 2021-01-19 mouth numbness 29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my... Read more
29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my lips. i informed nurse and she began taking blood pressure and oxygen levels while asking if i was breathing ok. i said yes. i then felt the right side of my lips go numb. i felt a faint tightness in my throat but after about two minutes it felt like my right side of the lips started to feel normal and my throat. then all at once i felt the blood rush from my body and tingling all over. i told the nurse i didnt feel good. she layed me down on the floor and put my feet up. she asked what i was feeling and i said i felt like i was going to faint. i was aware that my tongue felt heavy and i wasn't talking clear. another nurse got the allergist or doctor on standby and she asked me what i was feeling. i just rubbed my throat and my cheeks and lips and felt numbness and my throat tight and my tongue very thick. she asked if i was having a hard time swallowing. i nodded so she said they were going to sit me up because they needed to give me an Epipen. i nodded, tgey brought a wheekchair for me and as they helped me stand because i had no strength, a nurse stabbed me with the Epipen then they took me to the emergency room and observed me until 2:30pmish to make sure i didnt have another episode. then i wss discharged and was told to follow up with my primary care doctor within 3 days. An allergist will also see me to do a skin test.
49 2021-01-19 mouth numbness Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard t... Read more
Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard time catching my breath, throat became itchy. This lasted for around 35 minutes.
49 2021-01-19 mouth tingling She stated she felt upper lip tingling and a headache. She said she did not feel itchy or had any di... Read more
She stated she felt upper lip tingling and a headache. She said she did not feel itchy or had any difficulty breathing. I took vital signs: HR: 64, BP 128/92, O2: 100%. Observed for additional 15 minutes. She stated that she felt better and decided to go home. I recommend that she check in with her health care provider if symptoms come back or worsen.
49 2021-01-19 swollen tongue Pt reported tongue feeling swollen 10 minutes after receiving vaccine. Physical exam normal, vital s... Read more
Pt reported tongue feeling swollen 10 minutes after receiving vaccine. Physical exam normal, vital signs stable. Denies SOB, CP, NVD, difficulty swallowing. Monitored for 45 minutes, vital signs remained stable. Gave benadryl 50 mg, symptoms resolved.
49 2021-01-19 swollen tongue Complaints of "tongue feeling fat" kept additional 15 minutes. Symptoms not worse, encouraged to c... Read more
Complaints of "tongue feeling fat" kept additional 15 minutes. Symptoms not worse, encouraged to call md if symptoms got worse and to take Benadryl. She was able to tolerate drinking water with no issues. She wanted to go home as she had worked the night before.
49 2021-01-19 swollen tongue Pt reported feeling like her tongue was swelling 10 minutes after receiving vaccine. Physical exam n... Read more
Pt reported feeling like her tongue was swelling 10 minutes after receiving vaccine. Physical exam normal. Vital signs stable. Benadryl 50 mg PO administered. Vital signs remained stable. Pt monitored by physician, NP and EMS. Pt tolerating liquids. Pt denies chest pain, shortness of breath, numbness/tingling, difficulty swallowing, nausea/vomiting. Pt reported resolution of symptoms within 10 minutes after Benadryl administered.
49 2021-01-19 swollen tongue Tongue swelling, throat and chest tightness
49 2021-01-20 sensitivity to light, taste disorder, smell distorsion Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vo... Read more
Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vomited at 5am on jan 18; Jan18 fever and chills continued, no apetite all day; dizzy; weak; severe body aches; confined to bed all day; severe head ache; very sensitive to light; could not sleep for more than 15-45 minutes at a time; food tasted like chemicals or sickeningly sweet; only rice tasted normal; very sensitive to and repelled by odors. Jan 19: nausea abated, started to eat a few things but eveything still tasted terrible except for rice; got tested: covid negative, flu A &B negative, RSV negative; body aches were much worse; difficult to walk due to shooting pain in feet and back; stayed in bed all day; Jan 20 fever broke, now have right side sore throat; still achy and dizzy; Jan 21 still have headache and mild body aches, not confined to bed but too weak and achy to work
49 2021-01-20 vision blurred Patient started to feel dizzy, blurred vision and pounded headache from 1/17/21 to now.
49 2021-01-21 mouth numbness At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied... Read more
At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied pain. No antidote nor supportive treatment given. After ~40 minutes of observation, minimal numbness and no SOB. Patient left clinic.
49 2021-01-22 ear pain, ear discomfort, ringing in ears The night I had the Covid vaccine, ~ 12 hrs later, I had a sudden onset of intense itching in my rig... Read more
The night I had the Covid vaccine, ~ 12 hrs later, I had a sudden onset of intense itching in my right ear, that extended deep into region of Eustachian tube. This lasted ~ 1 hr and finally subsided just before I was getting ready to take a Benadryl. The itching returned intermittently over the next 3 weeks, and was bothersome. This was accompanied by the feeling of warmth about the ear occasionally. One incidence of tiny pains in the ear occurred. After ~ 18 days, a gradual onset of ringing in the ears began. This worsened on day 19 , becoming twice as loud. At this point , I deferred the second vaccine dose which was scheduled for day 19, 1/22/21.
49 2021-01-22 mouth numbness I did not administer the vaccine. Pt was treated by doctor over the phone following the event and fo... Read more
I did not administer the vaccine. Pt was treated by doctor over the phone following the event and followed up in person 2 days later. She reported a numb/ strange sensation in her lips and tightness in her face that resolved with taking Benadryl.
49 2021-01-24 mouth numbness Facial numbness that started at the hard palate then across cheekbones then upper lip. Numbness pers... Read more
Facial numbness that started at the hard palate then across cheekbones then upper lip. Numbness persisting but is better when taking vitamins. Seems worse in afternoon
49 2021-01-24 visual impairment I received my second Pfizer covid vaccine at 4:00 p.m. on 1/14/2021 from a co-worker. At 2:30 a.m. ... Read more
I received my second Pfizer covid vaccine at 4:00 p.m. on 1/14/2021 from a co-worker. At 2:30 a.m. on 1/15/2021 I woke up with severe rigors that lasted 2 hours. Over the course of the day 1/15/2021 I had a second 2 hour episode of rigors. They were almost violent and seizure-like. In addition, I had severe nausea, dizziness, decreased vision, fever, myalgia, and exhaustion. My temperature reached 103.4 and lasted over 24 hours. Ibuprofen would bring the fever down 1 degree and helped decrease rigors, but did not help the headache. On 1/16/2021 I developed redness and swelling of entire upper left arm, and edema in arm pit. I spent three days unable to work or sit up in a chair. Symptoms began to decrease after three days, but I was unable to resume full work days until 1/22/2021. Vision returned to 100%, and nausea resolved, on 1/23/2021. Decreased appetite and fatigue are still an issue as of 1/25/2021.
49 2021-01-25 eye swelling, lacrimation increased 12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TO... Read more
12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TORSO AND THIGHS- SITE OF ARM- LT SAME DAY UP TO 4TH DAY-WORST OM 1/16/2021 WITH RESTLESS NIGHT WAKING UP EYE MATTED-WAKING UP ITCHYAT SITE/TORSO/THIGHS/LT EYE SWELLING AND RT EYE WITH WATERY LUNG FEELING SEEN AT THE ER AND ORAL STEROIDS CAUSE SOME SWELLING AT OTHER EYE BUT BETTER AFTER 30 MIN.AFTER A NAP RT EYE WAS SWELLING W/O ITCHING PRETTY BAD.AND ORAL MEDROL PACK LAST DOSE 1/19/2021 AND FORGOT THE DOSE ON 1/21/2021 AT WORK HAD EYE SWELLING LT EYE FIRST THEN WENT TOOK A DOSE THEN HAD ON THE RT EYE. SWELLING WITH TORSO AND SITE ITCHING TOO SO TOOK ANOTHER STEROID GETTING BETTER WITH PO BENADRYL 50 MG- FATIGUE BUT PRETTY GOOD.YESTERDAY TIRED TOWARDS THE END OF SHIFT AND THIS AM AFTER 9 HRS WAS FEELING TIRED-FATIGUE- STARTED LATE AND THIS PM SWELLING ON THE LT AND THEN RT (SAW CHIROPRACTOR 1/23/2020). IM DEXAMETHASONE 8 mg IM NOW BETTER AFTER 30 MINUTES BETTER.
49 2021-01-25 mouth numbness Facial numbness that started at the upper palate then progressed across the middle of the face
49 2021-01-26 mouth tingling Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then ... Read more
Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then left the clinic. She returned to the clinic 30 minutes later with complaints of dizziness, chest pressure, and tingling on her tongue. She ambulated in with her husband. She also stated she has a history of anxiety and was not sure if this was related to that or not. Due to the ongoing chest pressure, she was advised to go to the ED for further assessment. Per ED note, patient left the ED prior to receiving a medical screening exam by provider.
49 2021-01-27 taste impairment Dizzy; nauseous; a strong taste of metal in my mouth; Extreme gas; This is a spontaneous report from... Read more
Dizzy; nauseous; a strong taste of metal in my mouth; Extreme gas; This is a spontaneous report from a contactable consumer (patient). This 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 14Jan2021 15:15 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (IBUPROFEN). The patient previously took Augmentin and experienced allergy. On 16Jan2021 07:15, the patient experienced dizzy, nauseous, a strong taste of metal in my mouth, extreme gas. The outcome of the events was unknown. The vaccine was administered at Hospital Facility. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. Information on the Lot/batch number has been requested.
49 2021-01-27 taste impairment Pt developed palpitations(felt like heart was racing) and metallic taste in mouth a few minutes afte... Read more
Pt developed palpitations(felt like heart was racing) and metallic taste in mouth a few minutes after injection. Patient noted that symptoms were mild and were improving. She declined EMS services/hospital evaluation and elected to go home after appx. 30 minutes of observation. HR and BP were both within normal limits.
49 2021-01-27 eye swelling Patient presented to the ED approximately 2 days after receiving the 2nd dose of the COVID 19 vaccin... Read more
Patient presented to the ED approximately 2 days after receiving the 2nd dose of the COVID 19 vaccine. It is unknown where the patient received the vaccine, since it was outside our facility. The ED report states the patient woke up with eye swelling (bilateral). red rash on trunk. After contacting the patient, on 25 January 2021, the patient stated that she also began using a Lotus flower facial cream that she believes may have been the cause of the reaction.
49 2021-01-27 feeling of choking c/o receiving her second vaccine today and notice there was now a rash on her chest and she states s... Read more
c/o receiving her second vaccine today and notice there was now a rash on her chest and she states she is starting to feel tingling in her throat and bilateral arms Transferred to ED. Treated with epinephrine, solumedrol, benadryl and pepcid with resolution of symptoms
49 2021-01-27 swollen tongue Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was... Read more
Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was having a reaction. pt was assisted to the floor. RN assessed pt and noticed her tonge swelling and patient getting red and neck swelling. RN ran to get emergency kit EPI PEN. EPI Pen administered Right thigh. EMS arrived. took patient to the ED for further treatment.
49 2021-01-27 swollen tongue Site: Itching at Injection Site-Severe, Systemic: Exhaustion-Mild, Systemic: Other- Itching,Swollen ... Read more
Site: Itching at Injection Site-Severe, Systemic: Exhaustion-Mild, Systemic: Other- Itching,Swollen tongue, Difficulty in breathing
49 2021-01-27 swollen tongue Injection received in left arm. 1-2 hours later I experienced swelling of throat on the left side, ... Read more
Injection received in left arm. 1-2 hours later I experienced swelling of throat on the left side, swollen tongue, difficulty swallowing, headache, extreme fatigue
49 2021-01-28 loss of taste, loss of smell This is a spontaneous report from a contactable nurse (reported for herself). A 49-years-old female ... Read more
This is a spontaneous report from a contactable nurse (reported for herself). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) intramuscular on 10Jan2021 10:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The first dose of BNT162B2 (Pfizer brand) for COVID-19 immunization was administered on 23Dec2020 08:00 AM intramuscularly in the left arm (at the age of 49 years old). On 15Jan2021, patient was unable to smell or taste at 6 day post injection. No treatments received in response to the events reported. Patient had Covid test post vaccination as Nasal Swab, Pcr on 15Jan2021 with negative result. The outcome of the events unable to smell or taste at 6 day post injection was not recovered. Information about lot/batch number has been requested.
49 2021-01-28 loss of smell, loss of taste At night on the day of the vaccine I started with a headache, a dull headache, nothing sharp, really... Read more
At night on the day of the vaccine I started with a headache, a dull headache, nothing sharp, really tired and my body was achy. My left arm was sore. The next day roughly the same symptoms throughout the day, really tired and just kinda achy. On a Holiday after I had the vaccine, when I took the ibuprofen, my husband realized he lost his sense f taste and smell and he realized he was the same way the day before. He got tested Saturday the day after the Holiday and since I was still achy on Saturday I called employee health and they told me to get tested. I was tested through Employee Health ( employee only testing site). I still get tired really quick, I get winded really quickly even after doing chores at the house, like laundry and even if I am sitting still, I still sometimes am short of breath. The dull headaches are still present. I had lost my sense of taste and smell but those came back.
49 2021-01-28 eye swelling Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph no... Read more
Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph nodes under my armpit/kind of benign; Generalized malaise low grade; Headache; Both eyes are very swollen; inflammatory prosthesis in my eye; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247) via an unspecified route of administration at arm on 15Jan2021 11:00 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Nurse stated that she just wanted to report what she thinks is adverse reaction to the Covid-19 vaccine from Pfizer not sure what to do about it at this point. She was vaccinated Friday 11 o'clock in the afternoon. Both days felt really fine. Last night (16Jan2021) got some fullness under her armpit which was on the same side as the vaccine, which looked like swollen lymph nodes under her armpit which you can see was kind of benign. But in addition to that some generalized malaise lowgrade and headache (Jan2021). Seems totally fine but her both eyes are very swollen (Jan2021). Nurse took some ibuprofen (ADVIL)-600 mg, she was taking Prednisone for inflammatory prosthesis in her eye as treatment (Jan2021). Outcome of the events was unknown. The nurse considered the occurrence of the events are because of COVID-19 Vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Eye inflammation cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-01-28 vision blurred Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my enti... Read more
Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.
49 2021-01-29 mouth numbness Next day noted numbness upper lip and beneath eye. Most pronounced for 1 hr. Has been improving
49 2021-01-31 eye swelling, lip swelling Systemic: Other- facial swelling- lips and eyes-Medium
49 2021-01-31 extreme sound sensitivity, sensitivity to light I had severe headaches for the first 5 days that Tylenol would not help. One day, I had what I woul... Read more
I had severe headaches for the first 5 days that Tylenol would not help. One day, I had what I would consider a migraine (light and sound were painful). I also had bubbly feelings in my stomach that came in waves. The headaches have gotten better in the last 2-3 days.
49 2021-02-01 eye itchiness I had the Pfizer COVID vaccine on 1/28/21, I had no side effects at all, left arm, site of injection... Read more
I had the Pfizer COVID vaccine on 1/28/21, I had no side effects at all, left arm, site of injection was a tad sore, nothing out of the ordinary. Sunday morning my husband noticed I had a rash on my throat/neck and around my eyes. They were not itchy at all or bothering me. My inside of my throat was a little scratchy, but not closing at all. I put hydrocortisone cream on neck & throat Sunday night, Monday, rash, hives, scratchy throat were the same, Monday night after my shower, they were extremely itchy, I again put hydrocortisone cream on my neck and around eyes, it was still itchy and getting onto my eyelid, Monday my face was very blotchy and itchy, I called my doctor, who saw me right away, the doctor told me NOT to get the 2nd vaccine, he is concerned about an anaphylactic reaction and to take Benadryl. Doctor told me he would be researching if I could get another brand, ie. the Johnson & Johnson 2nd dose? Now, I am very nervous to get a 2nd dose and do not know if I should cancel my 2nd dose or not? I do not know who else to talk to about it?
49 2021-02-01 lip swelling Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous repo... Read more
Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) via an unspecified route of administration on 18Dec2020 18:30 at single dose in left arm for COVID-19 immunisation. She received the second dose (lot number: El1283) in right arm on 08Jan2021. Medical history included Idiopathic anaphylaxis and was allergic to penicillin, had COVID-19 from May2020 to an unknown date. Concomitant medication included unspecified birth control pills. The patient experienced anaphalaxis on 19Dec2020 06:00 AM. She talked with her doctor lips swelling and face. Treatment received for events lips swelling and face. But her question is she had an IGG antibody test and it was negative. She had COVID in May2020 and have been tracking her antibodies. She wanted to know 'does this antibody test show the same antibodies?' She had negative after the two vaccines. The patient is not pregnant. Events outcome was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-02-01 vision blurred Blurry vision, dizziness, given water and juice. BP/pulse: 102/63, 73; 97/63, 73. O2 sat 100%. 90 mi... Read more
Blurry vision, dizziness, given water and juice. BP/pulse: 102/63, 73; 97/63, 73. O2 sat 100%. 90 minutes later, feeling better and discharged to home.
49 2021-02-02 eye itchiness, dry mouth Red itchy spots on neck and chest. Took antihistamine for 2 days. Tongue blisters on both side an... Read more
Red itchy spots on neck and chest. Took antihistamine for 2 days. Tongue blisters on both side and felt like it was burned. Resolved in 3 -4 days Dry mouth. Resolved in 3-4 days
49 2021-02-02 mouth tingling Patient stated she had tingly of lips, bp was 170/92. Patient checked by medical officer, opted to s... Read more
Patient stated she had tingly of lips, bp was 170/92. Patient checked by medical officer, opted to stay and be observed another 30 minutes. B/p rechecked 163/85. Patient discharged to home at 13:05. Advised to call PCP with any further problems.
49 2021-02-02 sensitivity to light Had intense headache for 72 hours straight where I could not withstand any light - the best way I co... Read more
Had intense headache for 72 hours straight where I could not withstand any light - the best way I could describe it is my migraine had a migraine. Would get dizzy when I stood up. Nauseous and extreme fatigue for 3 days. Slept for 16 hours within 24 hours of receiving the vaccine, day 2 slept for 12 hours but then was up due to vomiting/diarrhea (for 6 hours) about 56 hours after injection and then slept another 12 hours on day 3 after injection. Had a slight sore throat as well. By day 4 all symptoms had resolved.
49 2021-02-03 ear pain Headache and nausea the 26th and 27th and 28th. Feeling better the 29th. the 30th I was fine until a... Read more
Headache and nausea the 26th and 27th and 28th. Feeling better the 29th. the 30th I was fine until about 5 PM and then I felt very ill. Had a fever (highest was 100.8) (which lasted for days) - at least a week that it was 99.9Pand started getting joint pain and muscle aches; nausea; headache. The 30th was a terrible night. I called the DR. that night and they had me come into a COVID test on the 31st. Terrible head pain and earache - amoxicillin for my ears; Dexamethasone - for steriod for the body aches and pains; Norco - or Hydrocodone - I took that as a half a pill a night for 3 or four nights. Z-pack for three or four nights when I started getting chest congestion. I was off work until 15th when I went back to work. I was not 100% but tired. I'm slowly getting better and second dose of the vaccine on the 19th (and I was sick that night - had a high fever - 101.9). Was 24hours of dry heaving; called in sick on the 20th but felt better by the afternoon. Hospital to get the prescription for the ear pain (it might have been on the 5th or 6th of January in the middle of the night).
49 2021-02-03 mouth tingling Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. S... Read more
Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. She was given Benadryl 50 mg IM at 1117
49 2021-02-04 mouth numbness A little over an hour after shot: Numbness on back of tongue, lasted about 1 hour after shot 3.5 hou... Read more
A little over an hour after shot: Numbness on back of tongue, lasted about 1 hour after shot 3.5 hours after shot: Swelling and small lump formed on left wrist, last appx 16 hours 2 days after shot: Small lump and soreness along the left collar bone area, lump, soreness still ongoing (as of 2/5/2021, date of this report) 2 days after shot: Soreness in both breast, still ongoing (as of 2/5/2021, date of this report)
49 2021-02-04 mouth numbness about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Wok... Read more
about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Woke up feeling better. Appx 3 days later ( 1/15/2021) from shot, soreness in both breasts. This symptom lasted for about a total of 1 week from date of noticing. 1/22/2021.
49 2021-02-04 tongue itchiness Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after CO... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after COVID vaccine she experienced SOB, throat and tongue itching, flushing, very anxious, her BP 144/102, HR 120s, RR 20. She had Epi-pen and we injected it for her per her request. She transferred herself to a wheel chair and went to ER with Crisis Nurse. Symptoms resolved. Patient discharged from ED.
49 2021-02-06 tongue itchiness tachycardia hypertension itchy tongue and throat
49 2021-02-07 dry mouth, taste impairment After receiving COVID injection patient tasted metal in mouth, and developed severe dry mouth. Gave... Read more
After receiving COVID injection patient tasted metal in mouth, and developed severe dry mouth. Gave water and observed for 40 minutes. Oxygen was 98-100% HR 70-78 BP 146-150/96-100s. Symptoms lasted around 1 hour. After arriving home BP was 110/78. Patient felt better. No hospitalization needed. Next day patient felt Body aches, Head ache, fever last 20 hours. Patient feels better today 2/8/2020 the only symptom left is fatigue.
49 2021-02-08 lip swelling Tuesday morning I was very fatigued and my bottom lip was swollen
49 2021-02-08 mouth tingling As reported by patient on 2/6/21: Within 10 minutes of receiving vaccine patient developed pruritis... Read more
As reported by patient on 2/6/21: Within 10 minutes of receiving vaccine patient developed pruritis, urticaria on chest, tongue tingling and thickness in throat. P118 BP 180/100 Treated with diphenhydramine 50mg PO, observed for 40 min, discharged home, told not to get a second COVID vaccine and with the instruction to go to ER if anything else developed. Subsequently she was told by an allergist she could not get a second dose unless there are specialized facilities. She did NOT recieve a second dose. FYI - under our protocol she should have recieved epinephrine
49 2021-02-08 drooling headache, increased salivation, swollen mandibular gland, pain in neck radiating to ear
49 2021-02-09 mouth tingling Shortly after injection, she became light headed with nausea, lip tingling, SOB and felt as if throa... Read more
Shortly after injection, she became light headed with nausea, lip tingling, SOB and felt as if throat was closing. Moved her to the ER where she was given EPI, Benadryl, Pepcid, Steroids, and Zofran Was later discharged home
49 2021-02-10 dry mouth Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation... Read more
Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation. I was laid down and was very nauseous, cold, had a headache and got cotton mouthed. I had an elevated HR and BP as well. I laid there for about 30 minutes and finally the all symptoms except the headache subsided and it finally went away after day 3.
49 2021-02-10 ear pain, mouth tingling Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels ... Read more
Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels yucky all of sudden. My tongue and throat feel fat and weird. Exactly like when she eats shrimp
49 2021-02-10 toothache She said that she rarely gets sick; A soreness in her throat and it was hard to swallow; A soreness ... Read more
She said that she rarely gets sick; A soreness in her throat and it was hard to swallow; A soreness in her throat and it was hard to swallow; The feeling of a tooth ache/ having a toothache currently; Felt like someone punched her arm; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in upper right arm on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included seasonal allergy. There were no concomitant medications. The patient experienced a soreness in her throat and it was hard to swallow, in which she had to get ice to help alleviate the pain in her throat. The pain in her throat resolved a couple of hours later (as reported). She wanted to know if these side effects were from the vaccine. She also reported the feeling of a tooth ache today (26Jan2021), in which she tried to medicate with Tylenol, but was not able to access any while at work. Patient asked what symptoms do people experience within 15 minutes if they have an allergic reaction to the vaccine. The patient got the vaccine 5-6 days ago, but today (26Jan2021) she was on the job in a group setting and was having difficulty swallowing and had a sore throat. She said that she treated it with ice and it is slowly subsiding. She noticed she almost had a like a headache type thing, but it was in the back of the throat. She has had tingling in the back of her throat from seasonal allergies, but nothing like this. Her temp was 97.9 and it was now 98.3. As she swallows, she is feeling pain. She said that the ice helped out. She is having a toothache currently too and stated that she needs to go to the dentist. She noticed her sore throat while she was talking and noticed the sore throat and it hurt and when swallowing. She said that after the injection, she felt like someone punched her in the arm the next day on 22Jan2021. This has resolved at this time. She said that she rarely gets sick. This is the second time she has had some type of symptoms within 2 years. She said that she has not been around anyone and is social distancing. Treatment received for "a soreness in her throat and it was hard to swallow" included ice. The outcome of the events "a soreness in her throat and it was hard to swallow" was recovering (as reported), for event "felt like someone punched her arm" was recovered on an unspecified date and the rest of the events was unknown. Information on the Batch/Lot number has been requested.
49 2021-02-11 hearing loss I am the patient and within five minutes I got extremely hot my hearing started to leave me and then... Read more
I am the patient and within five minutes I got extremely hot my hearing started to leave me and then I passed out I don?t know how long I was out for but staff that were there said I was having a seizure shaking and making gurgling sounds in my throat when I came to I could see people but my hearing took longer to come back. I was then brought to Midstate hospital via ambulance at Midstate I had an EKG and blood work done as well as blood pressure monitored and blood oxygen levels
49 2021-02-11 pain in jaw The late afternoon/evening on the day of the shot, my right side of my face, head, and neck felt sor... Read more
The late afternoon/evening on the day of the shot, my right side of my face, head, and neck felt sore. The next morning when I woke up, my right jaw joint was extremely inflamed and so much so that I could not bite down and my teeth did not touch or fit together. The pain was so bad and I had such limited movement of that area that I couldn't even move my tongue out to lick my lips. Then on Sunday, the pain was even worse and I could still not touch any teeth together and my bite was so off that my lower teeth did protrude out beyond my upper teeth. I went to the doctor the next day (Monday) in which he gave me a prescription for Meloxicam to reduce the inflammation. I had taken ibuprofen the days prior with no effect at all. Meloxicam did not work that much better but did reduce the inflammation a little bit. It was not until Thursday of that week (6 days after vaccine) that the inflammation was reduced enough to actually chew. MY front teeth touched together first and then the other teeth over the next couple of days.
49 2021-02-11 visual impairment 1st vaccine 12/29/20; 2nd dose 2/11/21; developed visual changes 12/12/21, seen and referred to ED, ... Read more
1st vaccine 12/29/20; 2nd dose 2/11/21; developed visual changes 12/12/21, seen and referred to ED, admitted to Hospital.
49 2021-02-12 feeling of choking Pt stated tingling on the back of her throat. Upon assessment lips appeared normal and no swelling w... Read more
Pt stated tingling on the back of her throat. Upon assessment lips appeared normal and no swelling was noticed. No respiratory distress and vitals signs were within normal range. Pt stated stated she was really anxious upon arrival to the clinic. She was alert and oriented and able to keep a normal conversation. Pt requested water and no issues noticed with swallowing . Benadryl 25mg was administered at 1550. Pt stated improvement and was discharged home at 1625 with all symptoms resolved and feeling comfortable going home. Observation total time was 55 minutes
49 2021-02-14 mouth tingling Patient c/o mouth & tongue tingling, lightheadedness. Patient reported taking 1pm insulin and not e... Read more
Patient c/o mouth & tongue tingling, lightheadedness. Patient reported taking 1pm insulin and not eating. Given 2 pieces of candy, coke. EMS called at 1706. EMS arrived, assessed pt and checked FSBS which was 124 after 2 pieces of candy and a coke. Patient declined transport to hospital for further evaluation.
49 2021-02-16 deafness, ringing in ears, bloodshot eyes, hearing loss, eye irritation About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very ver... Read more
About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very very dizzy. I got up and showered and my feet swelled very bad. I did not feel well but I went to work but the feelings never got better. So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well. The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days. The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date. On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work. On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.
49 2021-02-16 eye swelling Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reac... Read more
Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warning signs and symptoms of possible worsening, potential complications and reasons to return to ER. Patient/Family voiced understanding of above instructions. Discussed plan for discharge, as there is no emergent indication for admission. Patient referred to primary care provider for BP management due to today' BP. Pt/family is agreeable and understands need for follow up and repeat testing. Pt is aware that discharge does not mean that nothing is wrong but it indicates no emergency is present that requires admission and they must continue care with follow-up as given below or physician of their choice. Schedule an appointment as soon as possible for a visit in 2 days. Medication List NO changes were made to your prescriptions during this visit. ED Treatment Team. Previous ED Visit: None. ED Arrival Information: Arrival: 08Jan2021 12:27 PM. Means of Arrival: Car. Escorted By: Self. Service: Emergency Medicine Acuity: Emergent. Admission Type: Emergency. ED deposition: Discharged: condition stable. Triage sepsis screen: Row name: Sepsis screen. Documented or Suspected Infection: 0. Documented or Suspected Infection. Indications: None. Acutely Altered Mental Status:0. Temp <96.8 OR > 100.9: 0. Heart Rate >90): 0. Respiratory Rate > 20: SBP < 90:0 MAP < 65:0 Blood Glucose >140(mg/dL)- Not diabetic: WBC <4 or>12 (10*3/mmm3: Unknown Bands >10%. Result of current screen is: Negative. Medication administration from 08Jan2021 12:27 to 09Jan2021 02:02: None. ED Prescription: None. Discharge Orders (From admission, onward): None. Allergies (Reviewed on: 08Jan2021) Agent Bee Venom Severity: High, Shellfish-derived Products, Severity: High Comments: Anaphylaxis. Coconut Comments: Facial swelling. Codeine Comments: Vomiting. Other Severity: Phenofibrates cause Skin hives. Immunizations Administered Name: COVID-19 (PFIZER) Tetanus Up TO Date: None. ED LDA Documentation (to) Patient Lines/Drains/Airways Status Active Airway / Central Venous Catheter Line / Drain / Epidural Line / Intraosseous Line / Peripherally Inserted Central Catheter Line / Peripheral Intravenous Line / Arterial Line: None. Weight: 72.6 kg (160 1b). Height: 157.5 cm (62"). Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02. Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02 (continued) Date and Time 08Jan2021 14:00 (also reported 14: 11) sp02: 96 %. Date and Time 08Jan2021 12:58 Device (Oxygen Therapy: Room air. Date and Time: 08Jan2021 12:54 sp02: 96 % Device (Oxygen Therapy: Room air. Date and Time 08Jan2021 12:29 sp02: 97%. Breathing Date and Time: 08Jan2021 14:00, Date and Time: 08Jan2021, 12:54 Date and Time: 08Jan2021 12:29 were sp02:96 %, sp02:96 % and sp02:99 %. 08Jan2021 14:00 Departure Condition: Stable, Mobility at Departure: Ambulatory Patient Teaching Discharge instructions reviewed; Follow-up care reviewed; Medications discussed; Patient verbalized understanding. ED Events: Date/Time 08Jan2021 12:27 Patient arrival, Arrival info file, 08Jan2021 12:29 Triage Started, Patient roomed in ED, 08Jan2021 12:32 Assign Attending, Assign Provider, First Provider, Evaluation of Patient, 08Jan2021 12:52 Registration Completed 08Jan2021 12:56 Triage Completed, 08Jan2021 14:02 Patient discharged, ED Tracking End. Follow-up Information: Details Schedule an appointrnent as soon as possible for a visit in 2 days. Specialty: Family medicine Discharge Instructions: You have been given emergency department evaluation. This evaluation is intended to rule out life-threatening conditions. Is not a complete evaluation. You could require further testing as determined by your primary care physician or any referred specialist. Please follow-up with all doctors that you are referred to. Please be sure to take your prescribed medications and follow any specific instructions in the discharge instructions. Please follow-up with your primary care physician within 48 hours. Please have your primary care provider recheck your blood pressure. Please return to the emergency department if you experience chest pain, shortness of breath. abdominal pain, fever greater than 102, intractable vomiting. Please return to the emergency department if your symptoms continue or worsen, or if you begin to experience any other concerning symptom.Discharge References/Attachments: Hives Easy-to-Read AVS Reports: Date/Time: 08Jan2021: Report: COVID-19: Overview & Impact. Date/Time: 08Jan2021 Report: ED after Visit Summary. Chart Review Routing History No routing history on file. Case Management registry, Status: Active, First included on: 08Jan2021 2:20 PM, Emergency Encounter Documentation Registry, Status: Active, First included on: 09Jan2021 12:06 AM, Emergency Encounters Registry Status: Active, First included on: 08Jan2021 12:36 PM. Patient was recovering from the events. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of Anaphylactic reaction, hives, itching and Eye swelling cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-02-16 mouth tingling Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. Th... Read more
Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. That was it until later that night I started getting a really bad headache/migraine. I started taking Tylenol but that didn't help much. I got chills and I'm sure a slight fever because I was sweating. I started throwing up also.. After taking Tylenol every 4 hours my headache finally went away and I started to feel better. This was around 2:30 pm the following day. I would say my symptoms lasted for about 22 to 24 hours.
49 2021-02-17 dry mouth Patient's face flushed, mouth got dry, and was feeling hot. She stated this reaction happens often ... Read more
Patient's face flushed, mouth got dry, and was feeling hot. She stated this reaction happens often because of her disorder, but in this case it lasted for an hour and she began to feel light headed and her heart rate was increased. She was given water and a cold compress, before ultimately was brought to an urgent care center by her family members who were present at the facility.
49 2021-02-18 mouth numbness tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of ... Read more
tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of the mouth. Slight swallowing problem. High blood pressure, dizziness, shivering. Got some Benadryl ( chewing tablet) from the paramedic on site. Went to the ED got more Benadryl, steroids and pepsid IV. Tingling subsided after 2 hours and numbness in the mouth too. Next day had major vertigo and heart rate was high and heart palpitations . Had some PVC which is still there. headaches come and go
49 2021-02-18 mouth numbness approximately 5 minutes after the injection my upper lip went numb along with my left side of my fac... Read more
approximately 5 minutes after the injection my upper lip went numb along with my left side of my face, primarily my upper cheek below my eye. Then it slowly moved to the top of my head and the top of my left hand. My heart was racing a bit, but that could be due to me being nervous about my face going numb. An attendant stayed with me until it started to subside, approximately 15 minutes later. Other side effects were mild the following day. A bit of a headache, fatigue and chills. Fatigue lasted a couple days but all minor.
49 2021-02-19 pain in jaw Pain and swelling in armpit. Jaw pain on left side. Bad headache
49 2021-02-21 eye twitching, lacrimation increased Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey.... Read more
Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey. Rx for prednisone.
49 2021-02-24 eye pain, ringing in ears 12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red... Read more
12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red. Felt like burning from the inside, out. Lightheaded and dizzy. Got puffy. Was NOT anaphylactic. 2 Benadryl. I didn't feel good for a couple weeks. 14-20 days, same experience with redness/burning. I took pictures. That happened every day for 4-5 more days. I went to doctor after doctor; ER after ER. About 6-7 times I have been to the ER; SOB, dizzy all the time, panic attack/anxiety, Stomach is not emptying correctly (NOT diabetic), eye keeps twitching, hurting behind my eyes, all my muscles are shrunken now. Blood panel, stress test; gastroparesis; positive; ringing in my ears; SOB; *COVID; negative.
49 2021-02-24 tongue disorder, mouth tingling Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing... Read more
Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing. Could not clear throat. It felt as if I was put inside a CS chamber. Went to ER. Treated with steroid and antihistamine. Coughing stopped with residual tightness in chest. Tingly stopped and reduced itchiness.
49 2021-02-25 swollen tongue Hives, pruritus, and sensation of tongue swelling developed within 10 minutes of receiving 2nd COVID... Read more
Hives, pruritus, and sensation of tongue swelling developed within 10 minutes of receiving 2nd COVID. Transferred to the ED as by rapid response. Diphenhydramine 50 mg IV and prednisone 60 mg PO administered. Monitored for approximately 1 hr 20 minutes in ED. Symptoms improved. Patient released with prescription to continue prednisone 60 mg/day x 5 days and cetirizine 10 mg/day prn at home.
49 2021-02-26 mouth discomfort, mouth numbness Post vax 2wks; numbness on ventral surface of tongue, limited to center of mass. Approximately 5 or... Read more
Post vax 2wks; numbness on ventral surface of tongue, limited to center of mass. Approximately 5 or 6 days in, noticed enlarged papillae limited to numb area. Sense of taste & smell don't appear to be affected, but sensation (i.e. "feeling) is similar to a burned tongue but lasting a week to date.
49 2021-02-26 feeling of choking Throat tingling, flushed, diaphoresis, increased blood pressure to 160's,
49 2021-02-27 sensitivity to light Headache, eyes sensitive to the light, nausea, soar arm.
49 2021-02-27 ringing in ears Fever 100, chills, hot flashes, nausea, splitting headache, low ringing in ears, upset stomach
49 2021-02-28 taste impairment All of these symptoms happened within a few hours of getting the vaccine. MolkMetallic taste in my m... Read more
All of these symptoms happened within a few hours of getting the vaccine. MolkMetallic taste in my mouth, headache, sore arm, itchiness on legs and back, rash on inner thigh
49 2021-02-28 mouth tingling Waited 30 min in vaccine clinic with no problems. Approx 2 hours after vaccination, experienced di... Read more
Waited 30 min in vaccine clinic with no problems. Approx 2 hours after vaccination, experienced diffuse itching with oral paresthesia and cough. No globus or SOB. Seen in Urgent Care. No hives or other rash recorded. Vital signs stable. Treated with oral decadron and benadryl and released after >1 hour observation with resolution of sxms.
49 2021-02-28 mouth tingling Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport t... Read more
Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport to the hospital - patient declined
49 2021-03-01 taste impairment, mouth tingling, mouth numbness, feeling of choking Patient reports approximately 45 minutes after administration of the vaccine she developed a metalli... Read more
Patient reports approximately 45 minutes after administration of the vaccine she developed a metallic taste in her mouth, followed by tingling and numbness in her lips, tongue, and tingling in her throat. She reports she took Benadryl sometime after this, and then eventually the sensation and taste resolved.
49 2021-03-01 lip blister Intensely itchy blisters on inside of upper and lower right lips. Upper roof of mouth as well. Nev... Read more
Intensely itchy blisters on inside of upper and lower right lips. Upper roof of mouth as well. Never had this symptom prior. Took Zyrtec in case it was allergic reaction, but did not get better.
49 2021-03-02 mouth numbness lip going numb four days after vaccination
49 2021-03-03 eye pain Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appet... Read more
Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
49 2021-03-03 mouth numbness Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
49 2021-03-04 dry mouth Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observa... Read more
Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observation by field ops and received by nurse. Nurses alerted immediately and made available to patient. Patient stated she went to the restroom because she ?felt hot and I needed to cool off? but returned to be observed. Vitals taken @ 1:56 pm BP 177/96, Pulse 104, O2 Sat 95%, Temp 99.4 F. Red Rash noted on bilateral arms and chest. Nurses made available to patient. At 2:16 pm vitals reassessed with patient positioned on the floor. BP 144/90, Pulse 78, Temp 97.1, Respirations 20. At 2:19 patient continued to state she felt ?hot?, nauseous, dry mouth and some tightness in the chest. Nurse offered additional help to the patient by calling EMS, but patient refused. Nurses continued to monitor patient. Vitals reassessed with patient upright on chair @ 2:30 156/82, 97.4 Temp, 95% O2 Sat, Pulse 85, Respirations 18. At 2:38 patient stated she is starting to feel less hot and it is easier to breath. Patient requested to use the restroom to refresh herself. Patient accompanied by Nurse. At 2:48 patient states she is feeling better and only feels slightly nauseous. No reports of chest tightness. Rash on arms cleared. Rash on chest significantly improved. Patient refused to stay for additional observation. Patient educated to consult with health care provider prior to receiving second dose. Earlier, patient stated she has had instances where she had to take Benadryl when taking NSAIDS, and also carries EPI Pen. Patient also educated to call 911 if ?chest tightness,? respiratory issues occur. Patient accompanied out by brother-in-law.
49 2021-03-04 dry throat 1435 received vaccine. 1445 warmness to arm and dry mouth, anxiety. 124/80, hr-114, 02 sat 94%ra. Wa... Read more
1435 received vaccine. 1445 warmness to arm and dry mouth, anxiety. 124/80, hr-114, 02 sat 94%ra. Warmness to arm resolved 1500. anxiouness resolved 1505. throat cont to be dry able to drink water w/o difficulty. drank one full bottle of water. Report sensitive and has many allergies. Pt husband is in car and informed of pt condition. 1520 pt condition dryness in needs to take mask off.. went outside totake off and get fresh air. 1540 128/89-hr-122-02 sat 96%ra r-18. Pt instructed to f/u with MD has appointment on tuesday. upon discharge reports tired and dry throat.
49 2021-03-04 taste impairment, mouth tingling, mouth numbness Observed for 30 minutes post vaccination. 45 minutes post vaccination had metallic taste, tingling ... Read more
Observed for 30 minutes post vaccination. 45 minutes post vaccination had metallic taste, tingling and numbness in lips and tongue and scratchy throat/ Contacted PCP.
49 2021-03-04 eye irritation She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling ... Read more
She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling sensation on her upper back which went up to her neck and head/tingling in my neck, face, lips and eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EH9899, Expiration date: not provided), intramuscular on the left arm on 19Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-year-old for COVID-19 immunization. The patient was worried it might be bell's palsy (medically significant) on an unspecified date. she experienced side effects on 22Jan2021 after receiving the vaccine on 19Jan2021. She had a knot at the injection site of her left arm on the first day. After 3 days, she experienced a tingling sensation on her upper back which went up to her neck and head. It was not excruciating pain but had presence to be noticed. It had been there since that day and was not going away. She had been feeling it around her eyes and on her lips. She was worried it might be Bell's Palsy. She was asking for advice and if this had been reported. As soon as she get the second Covid Shot at the 19Jan it was about 2-3 days afterwards, it was on the Friday and it was about 2' O'clock, well she had the knot in my arm, her left arm where she received the IM (Intramuscular) vaccination (Covid Shot) and she had started having the symptoms of like burning and tingling in my neck and in my face and in my lips and in my eyes and that is not gone away and I still have that knot in my arm, I still have the burning and tingling. she had some blood work done like last Thursday to see if she had any kind of like rheumatoid problems to see arthritis or something but other than that no. Consumer stated, "Well I work in the doctor office and the Physician the one he told me to get the blood work and it goes to the doctor office because I work in one. For treatment consumer stated, she had only been taking an Advil and it did not seem to help her. The outcome of the events was not recovered. Comments/Narrative: Patient will follow up with Physician next week. She is currently on vacations.
49 2021-03-05 ear pain congestion, elevated temperature, ear pain
49 2021-03-05 swollen tongue Difficulty breathing, swollen tongue
49 2021-03-06 loss of smell, loss of taste March 4, 2021 new onset nasal congestion, loss of taste & smell. COVID-19 PCR positive.
49 2021-03-06 mouth numbness, mouth discomfort, mouth tingling, taste impairment I received my shot at 1pm on Monday, March 1. Forty five minutes after the shot was administered, I ... Read more
I received my shot at 1pm on Monday, March 1. Forty five minutes after the shot was administered, I started to have a metallic taste in my mouth. Five minutes after that, my lips and tongue started to tingle. Five minutes after that my tongue started to go numb and then a few minutes after that my throat felt sore. Around 3pm, I took two Benadryl. By 5:30pm, my tongue was no longer numb, but my mouth didn't feel right all night. I don't know if this was related, but on Wednesday morning I woke with the start of a migraine. I took something right away and was able to avoid it. I have only had 4-5 migraines in my adult life. I started to feel like I was getting a cold by Friday, but I'm not sure if this is related either.
49 2021-03-07 loss of smell, loss of taste Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable co... Read more
Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on right arm on 04Feb2021 at 12:30 (at the age of 49years) at single dose for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure and high cholesterol. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on right arm on 14Jan2021 at 08:00 (at the age of 49years) at single dose for Covid-19 immunization. The patient experienced loss of taste and smell on 05Feb2021 at 18:00. Treatment was received for the adverse events. The events were considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, non- disabling/incapacitating and no congenital anomaly/birth defect. The facility where the most recent COVID-19 vaccine was administered was in a military base. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
49 2021-03-07 lacrimation increased Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Foll... Read more
Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Followed by swelling of throat, trouble breathing, O2 levels dropped, itching began, selling in face, watery eyes, and other.
49 2021-03-07 swollen tongue Received vaccine at 5:00 pm. At 5:10, noticed heavy/fast breathing; at 5:12, tightness in throat; at... Read more
Received vaccine at 5:00 pm. At 5:10, noticed heavy/fast breathing; at 5:12, tightness in throat; at 5:18, puffy tongue. No medical intervention; symptoms resolved on their own after 30-45 minutes.
49 2021-03-07 vision blurred Pt. reported feeling lightheaded and dizzy, Headache and blurry vision when trying to text within 10... Read more
Pt. reported feeling lightheaded and dizzy, Headache and blurry vision when trying to text within 10 minutes of getting dose of vaccine. Patient was transported to ED. HA and blurred vision resolved. Given toradol and zofran. Discharged stable.
49 2021-03-08 thirst hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he... Read more
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-03-08 thirst The employee waited 30 min after the vaccine because she had her Rituxan infusion 10 days prior to t... Read more
The employee waited 30 min after the vaccine because she had her Rituxan infusion 10 days prior to the vaccine. When walking to her car her throat felt itchy, but she blamed it on the cold weather. During the night she felt excessive thirst and a moderately itchy throat that lasted 2 days post vaccine.
49 2021-03-09 mouth numbness No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extrem... Read more
No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extremities, thick/numb feeling in tongue, coughing. taken to ED and given IV Benadryl and oral prednisone. Given prescription of for prednisone and Zyrtec for home use. At home, shortness of breath with coughing, lightheadedness, numbness/tingling in extremities, itching persisted for the next 5days. Took prednisone as prescribed for 3 days. Did not take allergy medication. Three days later on Thursday 2/22, I fell while going down stairs and suffered a badly sprained ankle. I feel the fall is a result of lingering symptoms of the vaccine.
49 2021-03-10 mouth tingling 20 minutes after receiving the vaccine I got a hot flush and a numb throat. I felt dizzy and medical... Read more
20 minutes after receiving the vaccine I got a hot flush and a numb throat. I felt dizzy and medical staff gave me 25mg of Benadryl and apple juice. I waited another 15 minutes and I felt tingling in the tongue. Dr observed me Pulse and Bp were low to start and became elevated. I received another 25mg of Benadryl and I was observed for another 20 minutes. I woke up that evening feeling tired. I woke up in a few hours feeling like I was beaten up joint pain and muscle pain. Muscle tremors were worse than normal it was difficult to walk. Low grade fever and headache. This lingered for a few days. I developed mouth sores after days and still had a headache. Arm pain and aches and pains. Total time feeling poorly was 9 days. I visited an allergist on the advice of facility, allergist advised Zyrtec before next dose. Second dose caused similar symptoms with severe aches and pains. I had trouble getting up or moving. Tremors on the right side leg and arm were markedly worse than normal. Instability and fatigue lasted three weeks. Mood swings were unusual.
49 2021-03-11 loss of taste, loss of smell Vaccinated 12/20/2020. On 12/21/2020 developed loss of taste/smell, nasal congestion, cough, and ... Read more
Vaccinated 12/20/2020. On 12/21/2020 developed loss of taste/smell, nasal congestion, cough, and shortness of breath. Positive COVID test.
49 2021-03-11 dry mouth About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - ... Read more
About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - each wave lasted about 2 minutes. During that time - I felt a wave/rush of lightheaded/disorientation feeling/ a cold sensation was rushing throughout my body internally/weak-shaky/ dry mouth/ and one of the waves I felt like I had to make myself swallow/like a rush of adrenaline. These subsided - and started again with a couple minutes between each wave. I took a Benadryl once I arrived home - only 2 very minor waves that morning. No other treatment but now afraid and need guidance if I should get the 2nd injection in case the 2nd reaction is worse.
49 2021-03-12 eye itchiness 1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions ... Read more
1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions in the past and was thus observed for 30 minutes following her injection time. 1704 ? Vitals: 99% sp02, 192/101 BP. Patient reported symptoms of itching of face, scalp, eyes, and hands. 25 mg Benadryl given by Observer. Patient placed on continuous sp02 monitor. No SOB, cough, or wheezing at this time. 1710 ? Observers called ED Nurse to let them know we would likely be sending a patient their way. 1715 - Observer was advising patient?s husband to take her to the ED when Coordinators were alerted to situation. contacting ED and allowing patient to transport themselves is not our protocol and Coordinators took control of the situation at this time. 1717 ? 1720 ? Patient moved by wheelchair to private area in the library for further evaluation. Vitals: 99% sp02, 200/119, BP, 90 HR. assessed patient. Rash but not hives are present on her chest. There is mild end-expiratory wheezing consistent with asthma history. No airway edema. No trouble speaking or swallowing. She is mildly diaphoretic but neurologically intact. 1720 ? Rapid response called for transport to ED. Sp02 98 ? 99. 1722 - Patient is starting to have increased wheezing with sp02 holding at 98%. She doesn?t have her inhaler. 1727 ? Rapid response called to say transport is 5 ? 10 minutes away. Patient still on monitor. No visible airway edema. Starting to cough and bilateral upper extremities mildly edematous. She notes her back is itching in addition to chest. 1728 ? After briefly explaining procedure to patient and obtaining verbal consent, 0.3 mg Epi Pen injection given to right lateral thigh. Vitals 192/133 BP, 91 HR, 99% 02. 1731 ? EMS arrives. Itching, wheezing, and cough have improved. Report given to EMS. Patient transported by stretcher to ED. Report had previously been given to ED and updates since then were given to EMS.
49 2021-03-12 mouth numbness c/o HA and numbness in lips and tongue 30mins after vaccination. Pt received Benadryl 50mg po, w/ r... Read more
c/o HA and numbness in lips and tongue 30mins after vaccination. Pt received Benadryl 50mg po, w/ resolved symptoms.
49 2021-03-12 lip swelling At 30 min front lip swelling
49 2021-03-12 visual impairment 02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the... Read more
02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the restroom and almost fainted (lightheaded, nausea, black vision, cold sweat). Blood pressure was 84 over 44. In the afternoon had muscular pain and a low grade fever of 100F for about 2 hours. A little sore at the injection site but all symptoms disappeared on day two 03/13/2021
49 2021-03-14 pain in jaw Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I w... Read more
Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I woke with severe pain all over my body. The worst pain was left arm, neck, back, buttocks, calves. Moderate pain throughout the rest of my body, notably my torso and my jaw. I had terrible headaches throughout the day. I was fatigued/exhausted and slept for several hours intermittently throughout the day. By 9PM I started to feel less fatigued, but the pain was very bad in most of my muscles. I felt like my muscles were battered and beaten, bruised and weak. The next day (3/14) I started to have energy, but not a lot, around 11am, and was still very sore, but the pain had subsided, and no more headaches. Today is 3/15, I am still very tired, but wouldn't call it fatigue, rather less energy than I am used to. I have noticed that my back is still very sore, especially the intercostal muscles. My legs and buttocks are still very sore today. I would not call it pain, but definitely notable and uncomfortable soreness.
49 2021-03-15 loss of smell, loss of taste received 2nd dose of Pfizer COVID vaccine 1/11/2021. On 3/1/2021 developed body aches, headache, c... Read more
received 2nd dose of Pfizer COVID vaccine 1/11/2021. On 3/1/2021 developed body aches, headache, cough, sore throat, rhinorrhea, loss of taste/smell, nausea / emesis
49 2021-03-15 ringing in ears Tinnitus in both ears developed about six hours after receiving the vaccine.
49 2021-03-16 ear discomfort, ear pain That evening, I had body aches and a headache. And a scratchy throat and post nasal drip. Next day... Read more
That evening, I had body aches and a headache. And a scratchy throat and post nasal drip. Next day, (8th), I had a fever - 100.6 (after I took aspirin); body aches; fatigue; dizziness. And ear pain/pressure. That first week, symptoms didn't go away so I went to Urgent care on Friday January 15. I didn't have any sinus issues or infections. For ear pressure/pain and dizziness - they put me on a MEDROL dose pack. I was taking Sudafed and Mucinex and Claritin for it prior to this to help it. In two days, I went to ENT (1/17) and on 1/18, I got on 6 days of Prednisone and they also put me on Flonase nasal spray which still didn't help the ear pain/pressure/popping and dizziness. I went to February 3 ENT physician because it hadn't helped and he another six days of Prednisone - Eustachian Tube Dysfunction > February - 25. The intermittent dizziness f and ear pain/pressure finally went away (almost 7 weeks later). I still have ear popping even today (which isn't usual for me). I'm still taking Flonase because I have the popping ear problem still.
49 2021-03-16 eye pain, dry mouth very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually startin... Read more
very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually starting to subside 1 week after 2nd vaccine . urination urgency. starting 1 week after the 1st vaccine shot. increasing for 1 week. continuing after second dose. gradually subsiding 1-2 weeks after second vaccine dose. eye pain, sensitivity to light only lasting 1-2 days 10 days after second dose. Pervasive anxiety either from circumstances or vaccine. i dont know. and a one time vaginal bleed a week after 2nd dose.
49 2021-03-16 vision blurred, mouth numbness Within 10 minutes got blurred vision and felt like going to faint. happened 3 times during first ... Read more
Within 10 minutes got blurred vision and felt like going to faint. happened 3 times during first 30 minutes happened 3 times. Felt like throat was tight when swallowing . Face started to tingle and numbness lips and tongue for about 5 minutes , Tightness in throat for 2 hours . went back to Cvs and stayed for a an hour . Felt like swelling of throat for the first night . 2 days had a sore throat , little by little went away. took 3 days to swallow normal. Called her doctor for advice on second short
49 2021-03-16 vision blurred Shortly after 1st dose of Pfizer Biontech, pt. c/o "tightness of throat, pressure in left cheek and ... Read more
Shortly after 1st dose of Pfizer Biontech, pt. c/o "tightness of throat, pressure in left cheek and ear, nasal congestion, blurred vision. BP 140/98-77, pulse ox 98%. Was offered & declined Benadryl. Sx's improved in 1 hour at the POD. States sx's completely abated 1 hour after arriving home. Did not seek further tx. Pt. has asthma and takes Brio and an inhaler prn. She has had "a few high BP readings in past" but is not on med.
49 2021-03-17 mouth discomfort, mouth tingling intense tingling in lips and tongue about 30 minutes after shot. Lasted for over 18 hours. Took a... Read more
intense tingling in lips and tongue about 30 minutes after shot. Lasted for over 18 hours. Took a single Benadryl tablet at 5:00pm, monitored blood pressure. Did not seek medical attention. Next morning, lips still burning, no other side affects.
49 2021-03-20 taste impairment Fever, aches, joint pain, headache, weakness, nausea, aftertaste, indigestion
49 2021-03-20 swelling of eyelid I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, M... Read more
I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, March 15th, I noticed a small rash on my right side upper eye lid and the side of my eye but thought it may just be an allergic reaction to something. No pain or itching. I had a couple of similar spots on my scalp but didn?t think much of it. On Thursday, I had a headache but I do get headaches now and then. When I woke up on Friday morning, March 19th, I found my eye lid completely swollen and saw the rash had turned to blisters, and there was a new one by the inner corner of my eye and a very faint rash on my forehead. Still no fever, pain or fatigue but had a lingering headache and a burning sensation on the rash. Saw my opthalmologist right away who diagnosed it as shingles and did a complete eye exam. Luckily no shingles in the eye as that can lead to glaucoma or even blindness in severe cases. I was prescribed Valtrex (1000 mg x 7 days) and prednisone (60 mg x 5 days) by my PCP. Hoping that I was still in the 72 hour window when the antiviral med is effective, I started on the meds immediately. Today is the third day of treatment and the blisters seem to be crusting away and healing faster. Luckily, no new blisters as of now. The prednisone caused my eye area to swell up further so I am gradually tapering off the dosage from 60 mg prescribed to 40-30-20 mg. Keeping a watch for any complications such as ear pain or numbness in the face. Have a follow up appointment with ophthalmologist who will be dilating my eyes for further checks. I was glad to have found the Reddit board and see that there are over 50 cases of people reporting shingles after the first or second covid vaccine. I plan to delay or skip my second Pfizer vaccine for now.
49 2021-03-21 swollen tongue, lip swelling Patient had swelling of lip and tongue, followed by shortness of breath/difficulty breathing for abo... Read more
Patient had swelling of lip and tongue, followed by shortness of breath/difficulty breathing for about 10 minutes, diphenhydramine liquid and 1 dose of epinephrine autoinjector administered, EMS called and assessed patient, no transport to hospital, patient was able to leave on her own at about 9:00am
49 2021-03-22 lip swelling, swollen lips bumps in mouth on first day, face turned read on second day and bumps went away, third day lips beca... Read more
bumps in mouth on first day, face turned read on second day and bumps went away, third day lips became raw and almost wind burned and chapped then fourth and fifth day lips swelled up very large as well as chin and lower face and cheeks. Benadryl, claritin given together as well as epi pen for emergency use.
49 2021-03-22 lip swelling, mouth tingling Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fa... Read more
Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fatigue (on and off for 3 days), injection site pain, red and hot injection site (resolved after 3 days). Within 12 hours of injection: lip swelling (occurred 10 hours after injection, resolved within 24 hours, note: no lip fillers). Within 48 hours of injection: swollen lypmh nodes in left armpit (resolved within 12 hours).
49 2021-03-22 taste disorder, smell distorsion I had an "off" taste when eating & drinking , plus a funny smell when being in our truck. However, I... Read more
I had an "off" taste when eating & drinking , plus a funny smell when being in our truck. However, I was the only person that could smell it. It was like an antiseptic smell & if you could imagine what that might taste like, that is the best way to describe the strange test I got while eating & drinking. This lasted about a week. Plus, my left arm where I received the injection was sore for about 2 - 3 days, but I suppose that's to be expected.
49 2021-03-22 ringing in ears Tinnitus. Still ongoing.
49 2021-03-22 vision blurred 3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head p... Read more
3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head pain. As the day progressed, experienced pain/inflammation in leg muscles and body. Headache worse. Brain fog. Slow to focus eyes.
49 2021-03-23 eye itchiness Symptoms include airway itching and warmth, subjective eyelid closing, eye itching, and localized hi... Read more
Symptoms include airway itching and warmth, subjective eyelid closing, eye itching, and localized hives on left thumb within 30 minutes of dose.
49 2021-03-23 pain in jaw 3/23/21 ER HPI:49 y.o. female who presents with chest pain. Patient reports she was laying in bed t... Read more
3/23/21 ER HPI:49 y.o. female who presents with chest pain. Patient reports she was laying in bed this morning around 4:00 a.m. when she started developing pain to left side of her chest. Patient describes her pain as a sharp pressure that radiated to the left shoulder and jaw. Patient reports pain currently 8/10 and worse was 9/10. Patient reports associated shortness of breath, mild lightheadedness, and nausea. Patient denies any vomiting or diaphoresis. Patient has no known history of coronary artery disease and had a heart catheterization approximately 2 years ago that was negative. Patient's cardiac risk factors include obesity, smoking, and family history. Patient denies any history of DVT or PE
49 2021-03-24 mouth numbness Throat tightness, numbness in the tongue. Benadryl 50mg PO. not getting better after one hour.
49 2021-03-24 mouth tingling, feeling of choking Tingling in throat @ 20 minutes after shot. Then lips felt very tingly but not swollen. Then my enti... Read more
Tingling in throat @ 20 minutes after shot. Then lips felt very tingly but not swollen. Then my entire body (different parts) itched on and off for two days. I contacted my primary doctor who had me take zyrtec to alleviate the itch. Walgreens staff DID NOT make anyone stay for 15 minutes after their shots to make sure there were no reactions. They are also NOT giving the second dose until FOUR WEEKS LATER not the recommended THREE. I wish I had known this before I went there - there are so many other facilities that are doing a wonderful job.
49 2021-03-24 mouth tingling flushing, mouth/lips trembling, and felt a little woozy. Lasted maybe 5-10 minutes, then wooziness w... Read more
flushing, mouth/lips trembling, and felt a little woozy. Lasted maybe 5-10 minutes, then wooziness went away and the trembling/chattering turned into tingling lips. Hours later, my lips still feel weird. Treatment is nothing - it's not a big deal, I just wanted to report this to be helpful. I will call my doctor if this doesn't go away in a few days.
49 2021-03-24 ringing in ears Pfizer BioNTech Covid 19 vaccien Ringing in left ear started 1/27/21 intermittently for a few days ... Read more
Pfizer BioNTech Covid 19 vaccien Ringing in left ear started 1/27/21 intermittently for a few days and then started ringing nonstop and continues nonstop as of current. Significant vertigo, nausea and occasional headache. ENT appointment scheduled 4/13/2021 with Dr.
49 2021-03-25 eye swelling, swollen tongue, mouth swelling Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Me... Read more
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: bp 175/110 hr 76 and bp 15 min later 158/100 hr 72 and on bp meds
49 2021-03-25 lip swelling Patient reports throat swelling and lips slightly swollen. 10 minutes later patient feeling like thi... Read more
Patient reports throat swelling and lips slightly swollen. 10 minutes later patient feeling like things are worsening. Epinephrine 0.3mg given x 1. VSS. Symptoms improved and patient discharged feeling normal. Left with hoarse voice and HA.
49 2021-03-25 mouth tingling On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth ... Read more
On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth on side of neck, the cheek on the left side of my face was numb, my lips tingled, and my heart rate increased to 105 bpm. The facial numbness went away after a few hours and felt like I had received Novicane for dental work. The burning knuckles took 8 days to go away. I called my doctor's office and spoke to the on call nurse who said the reaction was likely due to the vaccine.
49 2021-03-25 swollen tongue Pt got dose of vaccine Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reactio... Read more
Pt got dose of vaccine Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reaction with dizziness, tongue swelling and shortness of breath. Vaccine given in tent. Pt felt she was going to fall and was assisted down. She was diaphoretic and tongue swollen. Epi pen was administered. Pt with history of sever allergic reaction as a child but has never used epi pen in adult life and sensitive to flu vaccine with eggs. Pt taken to ER.
49 2021-03-25 ringing in ears Muscular aches, exhaustion for several days. In the past I?ve had occasional vertigo and that has go... Read more
Muscular aches, exhaustion for several days. In the past I?ve had occasional vertigo and that has gotten severe since the vaccine shot. Also have been suffering tinnitus since the shot, which I thought was just the sound of my lamps or air filter but it?s worse at night wearing ear plugs. Both conditions have been increasing since the vaccine and it dawned on me this evening that it could be vaccine-related.
49 2021-03-26 lacrimation increased Itchiness starting in my shoulders then moving both up my neck and down my back until I was very itc... Read more
Itchiness starting in my shoulders then moving both up my neck and down my back until I was very itchy from head to toe. Fever of 99.5. Felt like an allergy attack with runny watery eyes and itchy ears. Throat felt itchy and dry.
49 2021-03-26 ringing in ears headache (not migraine) and ear ringing began about 20 hours after my second shot, had extreme arm p... Read more
headache (not migraine) and ear ringing began about 20 hours after my second shot, had extreme arm pain as well with both shots. The ear ringing is constant and loud and hasn't stopped since the day after shot 2. The headache seems to come and go.
49 2021-03-26 tongue itchiness Patient complaint of throat and tongue itching. BP 152/92 P-73 Sp02 98%. Gave 50mg of Benadryl. M... Read more
Patient complaint of throat and tongue itching. BP 152/92 P-73 Sp02 98%. Gave 50mg of Benadryl. Monitored patient for 40 minutes, signs and symptoms resolved. Patient discharged in stable condition with spouse driving patient home in private vehicle.
49 2021-03-27 vision blurred Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, ... Read more
Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, severe muscle pain, and large swollen lymph node (size of golf ball under left arm/near injection site) 12 hours after second shot. Adverse events diminished 12 to 48 hours later.
49 2021-03-28 taste impairment Rash like a sunburn up neck and lower face Body aches Metallic taste in back of throat Fatigue Join... Read more
Rash like a sunburn up neck and lower face Body aches Metallic taste in back of throat Fatigue Joint swelling with redness
49 2021-03-28 taste impairment 102°F fever not significantly diminished by Advil : onset ~12hr : duration 25hrs (intermittent lowe... Read more
102°F fever not significantly diminished by Advil : onset ~12hr : duration 25hrs (intermittent lower fever continued another 24hr) severe headache not diminished by Advil: onset ~24hr: duration ~12hrs heart palpitations: onset 36hrs : duration 12hrs nausea and metallic taste: onset 6hrs: duration unresolved
49 2021-03-29 eye strain 40 mins after inoculation, my left arm and hand felt tingly like my arm went to sleep. Lasted for ab... Read more
40 mins after inoculation, my left arm and hand felt tingly like my arm went to sleep. Lasted for about an hour. Left arm sore at the injection. 4 hours after inoculation, eyes were extremely heavy, felt tired and had a slight headache.
49 2021-03-29 taste impairment At 1625 patient started feeling lightheaded and had a metallic taste in mouth and had some tingling... Read more
At 1625 patient started feeling lightheaded and had a metallic taste in mouth and had some tingling in her right knee. Had patient lay in recliner and gave apple juice, she felt much better after 5 minutes and insisted on leaving.
49 2021-03-29 eye itchiness, eye swelling At 10 minutes, tongue irritation. At 25 minutes, hives on palm of hand which resolved after 10 minut... Read more
At 10 minutes, tongue irritation. At 25 minutes, hives on palm of hand which resolved after 10 minutes. At 90 minutes, drop in blood pressure, dizziness, weakness, severe stomach cramps, nausea, vomiting, diarrhea, tightness in chest and head. Took Benadryl, Albuterol and Pepcid. One hour later, 103 fever, severe pain in all joints. Stayed on Benadryl for 24 hours. Once Benadryl was stopped, developed hives all over chest, various spots on arms and stomach, continued dizziness, swollen lymph node in arm pit. Eyes were swollen and itchy. and red. Resumed Benadryl x5 days, every time Benadryl stopped, hives resumed. . Periodic hives still surface as of this date but mostly improved. My MD suggested I report event.
49 2021-03-29 mouth tingling 10 minutes after i received the injection to my right arm the right side of my neck felt tingly, 25 ... Read more
10 minutes after i received the injection to my right arm the right side of my neck felt tingly, 25 minutes after infection the feeling moved to my lips, 40 minutes after injection my whole face felt tingly, (like pins and needles or how your face feels after Novocain). I had no issues with my tongue throat of breathing.
49 2021-03-29 mouth tingling 1204 pm given 1st dose of Pfizer vaccine. at 1220 pt began to complain of nausea, headache, feeli... Read more
1204 pm given 1st dose of Pfizer vaccine. at 1220 pt began to complain of nausea, headache, feeling hot, flushed, & some dizziness. Bp 150/84 , pulse 104, pulse ox 98% on RA; denies shortness of breath. Pt offered some water. At 1225 pm began having tingling lips & throat feeling funny; no lip swelling noted; pt offered EPI and declined; she was offered & took po Benadryl 25 mg. 1227 vitals bp 142/90 pulse ox 95% p 104. At 1229 pt began to state her throat beginning to tighten and EPI pen 0.3mg administered in L thigh by a different RN assisting writer. Stat call made at 1229 also. 1231 Oxygen given 2L per NC as pt stated difficulty breathing. 1232 pt stated she starting to feel better but more nervous now than anything. 1233 pt able to stand & and escorted to the ED with stat team staff.
49 2021-03-30 oropharyngeal discomfort severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; hear... Read more
severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; heart pounding; funny feeling in throat; throat tightening; hacky cough; itchy throat; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: E19264) on 10Feb2021 08:00 AM at Right arm as single dose for covid- 19 immunisation. The patient medical history included Hypothyroidism and hypertension. The patient concomitant medication included Nifedipine, Levothyroxine, Vitamin D, started on unspecified date at an unknown dose and unknown if ongoing. The patient had allergies to bee stings and latex. On 10Feb2021, 09:00 AM, approximately 35-40 minutes after vaccine the patient experienced severe flushing and hot feeling, lightheaded, severe headache, heart pounding, funny feeling in throat. 1 hour after vaccine throat tightening, hacky cough, itchy throat. The patient was treated with allergy medication and famotidine. The outcome of the events was recovered. No follow up attempts are possible. No further information is expected.
49 2021-03-30 ringing in ears Tinnitus
49 2021-03-31 taste impairment Note: I had covid this summer and thought that was bad. This was equally as bad but for a shorter ... Read more
Note: I had covid this summer and thought that was bad. This was equally as bad but for a shorter time. Monday 3/29/21- A few hours after the vaccine around 5:15 pm I had a metal taste in my mouth when I ate dinner. Overall, everything else in my body felt great. Tuesday, 3/30/21- I woke up at 7 am , and when I got out of bed, everything started going downhill. I was dizzy and losing ability to use my arms or hands. My joints started giving out as I was getting breakfast for my son to go to school. By 8:30 am, here were my symptoms, -pain if touched any part of my skin, -inability to move-get dressed -inability to use hands or arms -excruciating pain all over body - fever -excruciating joint pain dizziness -nothing took it away. My pain was 9/10 with 10 being the worst. Wednesday, 3/31/21- Wednesday I woke and still stayed in bed. Around noon- I felt the joint paint leave, and slowly everything started getting better. I could use my hands to text people and started recovering. My fever broke and I could stand and walk slowly by 7 p.m. Thursday, 4/1/21- I am up and short of breath and have tight chest and pain around heart but giving a few hours to see how I'm doing.
49 2021-03-31 mouth tingling, taste impairment Metal taste in the mouth Tingling on roof of mouth Tongue tingling Heart racing
49 2021-03-31 taste disorder, taste impairment Immediately after the injection, I tasted a strange taste near the back of my throat near the sinuse... Read more
Immediately after the injection, I tasted a strange taste near the back of my throat near the sinuses. I don?t know but I want to say maybe a little metallic. My nose/sinuses seemed to drain immediately. Later on in the day I was very tired and slept. The second day after the injection, I developed sharp shooting pain in my arm pits both left and right arm pits. Felt tender. This lasted for two days and then seemed to go away.
49 2021-03-31 taste disorder Very bad taste in mouth (happened within a minute) that is lasting. Overwhelming tiredness within 5... Read more
Very bad taste in mouth (happened within a minute) that is lasting. Overwhelming tiredness within 5-10 minutes.
49 2021-03-31 toothache 1st does - sore arm only. 2nd dose. Injection site swelling, redness and pain that lasted a week. ... Read more
1st does - sore arm only. 2nd dose. Injection site swelling, redness and pain that lasted a week. A week after that had a major toothache that just went away after a week. The next week, nauseated followed by 24 hours of vomiting. Felt ok but tired and run down when on March 11th when I had a horrible Shingles outbreak on my left chest, shoulder, down my arm, neck and head into my hair. Today is April 1st and the break out has still not cleared up 100%. Have had shingles outbreak in the past but only a small lesion on the side of my nose. I have never had a outbreak of this magnitude with the savage pain.
49 2021-04-01 taste impairment Metallic taste in back of mouth Warm flushing sensation in chest Sensation of throat closing
49 2021-04-01 eye swelling, swelling around the eyes Left eye swollen and puffy. Slightly sore arm at area of shot given.
49 2021-04-02 eye discomfort, smell distorsion, eye irritation Burning in left eye when sleeping at night Pressure in left eye during the day Constant cigarette sm... Read more
Burning in left eye when sleeping at night Pressure in left eye during the day Constant cigarette smoke smell all the time
49 2021-04-02 swollen tongue 8:06 am Patient having feeling of swollen tongue and face puffing
49 2021-04-02 ringing in ears, deafness Tinnitus and Hearing Loss
49 2021-04-03 swollen tongue I was given a 30 minute hold due to my medical allergies. About 10 minutes after the injection I st... Read more
I was given a 30 minute hold due to my medical allergies. About 10 minutes after the injection I started to feel like my tongue and throat were swollen. I immediately took some chewable Benadryl that I had. After about 10-15 mintues it seemed like it wasn't getting any worse anymore. I didn't seek medical attention because the symptoms weren't severe. I did wait an extra 10 mintues beyond my 30 minute hold before leaving. It look a few hours before symptoms seemed to subside. My throat still feels constricted, but I can't say if that is due to the vaccine or other allergies (it's still pollen season). I also experienced soreness at the injection site for about three days.
49 2021-04-03 ringing in ears Severe increase in tinnitus.
49 2021-04-04 mouth numbness, taste impairment, mouth tingling Pt. c/o Numbness and tingling of lips. Having a metallic taste in mouth. Took allegra 180mg at 2:3... Read more
Pt. c/o Numbness and tingling of lips. Having a metallic taste in mouth. Took allegra 180mg at 2:30pm. Vital signs: 2:15pm 125/90 82 14 O2 96%; 2:30pm 130/90 84 14 O2 97%; 2:45pm 130/82 77 O2 97%; 3:35pm 125/90 78 O2 98%;
49 2021-04-05 dry throat Patient was being monitored for additional time as she has allergies. About 7-10 minutes patient n... Read more
Patient was being monitored for additional time as she has allergies. About 7-10 minutes patient noted she was feeling "itchy". She was found to be scratching her throat, and arms. Patient was brought to the exam room, she stated she was feeling warm, itchy and a lump in her throat along with dryness. BP at that time was 157/111. Patient reported increasing feeling of a lump in her throat, at that time Epinephrine 0.3 mg injection was administered. Nurse called 911. Patients BP was then noted to be 157/89. Patient stated she was feeling warm, and itchy, felt like she had to cough due to the lump in her throat. About 10 minutes after the first epi injection, patient was feeling nauseous, hot and her throat was still dry with the lump. The second dose of epinephrine 0.3 mg was given. About 2 minutes after the second dose of epinephrine EMS was on scene and patient was transported to Hospital. Nurse called Dr to Update on the patient incident.
49 2021-04-05 mouth tingling, mouth discomfort Lips immediately started tingling. After about 25 lip tingling started to subside and then cheeks mo... Read more
Lips immediately started tingling. After about 25 lip tingling started to subside and then cheeks mouth and tongue feel funny. Top of mouth burns. I feel like when I have an allergic reaction to a cat
49 2021-04-05 taste disorder A couple minutes after the vaccine I developed a feeling of warmth over my body and had a weird tast... Read more
A couple minutes after the vaccine I developed a feeling of warmth over my body and had a weird taste in my mouth. Felt as if my HR elevated and was checked and was 167. My BP was elevated also but I still felt ok. I was transported to the ER for about 5 hrs. where I was observed until my HR lowered.
49 2021-04-06 double vision, taste impairment face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowi... Read more
face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowing; difficulty breathing & swallowing; nausea; metallic taste in mouth; double vision; This is a spontaneous report from a contactable consumer. A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 18Mar2021 at 08:15 (Batch/Lot Number: EP7534) as a single dose at the age of 49, for Covid-19 immunisation. Medical history included juvenile- als, and a sulfa allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 18Mar2021, after use of product patient developed Acute pain in base/spine of neck, dizziness, difficulty breathing & swallowing, nausea, metallic taste in mouth, face felt like plastic, double vision. The patient was not hospitalized nor was treatment received for the events. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. Additional Information has been requested.
49 2021-04-06 taste impairment, smell distorsion, taste disorder I was pretty much fine for 27 hours after vaccine , then developed usual symptoms of fever chills fa... Read more
I was pretty much fine for 27 hours after vaccine , then developed usual symptoms of fever chills fatigue. Also pain with breathing and metal mouth of which I discovered what that was. The following AM (today) I have a very altered sense of taste and smell all day. I can taste sweets but everythig else is very off. I camt really tell if it's still metal mouth or not . And a fierce burning in my chest feeling like heartburn but its not becuuse it does not change or is not able to be relieved
49 2021-04-06 lip swelling, swollen tongue Shot received at 10:15 am 10:45 am palms get hot and itchy. 12:15 pm tongue feels heavy and swollen,... Read more
Shot received at 10:15 am 10:45 am palms get hot and itchy. 12:15 pm tongue feels heavy and swollen, , throat is itchy and a shallow, dry cough devlops, lips swell, itchy palms, rapid heartbeat. Gets better after 30 minutes 3:45 pm same reactions occur again. Resolve when I take 4 Benadryl. Next day, feel better but tongue tingly and slight cough with itchy throat, headache, and overall fatigue.
49 2021-04-06 lip swelling None at time of shot except tenderness in injection area and arm soreness. About 40 hours later, swe... Read more
None at time of shot except tenderness in injection area and arm soreness. About 40 hours later, swelling of face (lips) and hands, high histamine.
49 2021-04-06 oropharyngeal discomfort Client started developing hives and a scratchy throat. She was given 25 mg of Benadryl PO then began... Read more
Client started developing hives and a scratchy throat. She was given 25 mg of Benadryl PO then began to dry heave with no emesis. Then given 0.3 mg of epinephrine IM in right deltoid. A rapid response was called and she was taken to the ED by the house supervisor and respiratory therapist.
49 2021-04-06 mouth tingling, oropharyngeal discomfort, eye itchiness approximately 8-10 minutes after first dose-experienced flushing through head, down throat some sens... Read more
approximately 8-10 minutes after first dose-experienced flushing through head, down throat some sensation in throat, had to take deep breath, went down arms, felt very heavy, improved after about 15 minutes then very mild recurrence about 35-40 minutes after dose Because of throat symptoms took benadryl and pepcid 30 minutes prior to 2nd vaccine. 1hr 40minutes after 2nd, difficulty swallowing water, flowing/flushing sensation then my lips were tingly and eyes itchy briefly. My HR was 90's which is high, my resting is 40's-50's. Arms would feel heavy with this. This happened later in the day again, Very unsettling, was in contact via text with cardiologist I work with ( I am an ARNP) and my Dr that is listed on this form. They told me I could keep taking Benadryl and Pepcid q 6-8hrs. I was also given prescription for prednisone if needed. Following day went about 8 hrs between doses, same symptoms took Prednisone that eve, I believe 10mg this was in addition to Benadryl and Pepcid. These episodes kept happening for about 5-6 days. On Friday, 3 days after 2nd dose, I tried to space out meds. then in afternoon about 4:40 was actually short of breath and felt tight with breathing. So took meds and actually considered using my son's old inhaler. Symptoms resided in about half hour after meds. Last dose of meds was Sunday 8 PM after 2nd vaccine. Ran in morning and HR would not come down, stayed in 110's very unusual for me, I felt SOB. Had EKG when I went to office but just prior to EKG symptoms resolved and I was SR in 70's Had BMP and Mg these were NL. I run daily and had noted increased SOB and HR after first vaccine this continued until just a few weeks ago. We feel this was some type of allergic reaction with possible mast cell activation. I had internal "tightness" no appetite and felt like constant state of adrenaline for about 1-2 weeks. Concerned if booster needed and for my son who is 18 that has some allergies
49 2021-04-06 swollen tongue 5 mins after injection pt felt shortness of breath, throat closing, hoarse voice, tongue swelling p... Read more
5 mins after injection pt felt shortness of breath, throat closing, hoarse voice, tongue swelling pt given 50mg benadyl as well as 0.3mg epi pen, with reduction of throat tightness however pt continued to have sensation and occasional throat clearing/cough
49 2021-04-07 ringing in ears Ears ringing-high pitched, stronger in left ear
49 2021-04-08 lacrimation increased 1:50pm Pt walked from parking lot to vaccine tent to report she felt strange. Complaining of a sens... Read more
1:50pm Pt walked from parking lot to vaccine tent to report she felt strange. Complaining of a sensation that started in her vaccination arm site and seem to spread over her upper body and described it as swimmy eyes and chest tightness. Patient placed in a chair, VS obtained: BP 150/90 in RUE, HR 60/normal, RR 20/normal. Otherwise the patient was calm in appearance in A&O x3. Patient states she hadn't eaten much that day. Provided a bottle of water and a Chewy snack bar. 2:05pm Patient reports symptoms are no worse or better; Nursing Supervisor notified. 2:07pm Medical Director, Doctor notified of patient and subjective/objective data. Order for Benadryl 50mg IM obtained. Along with instructions not to drive post administration of the Benadryl and to call EMS or report to the nearest ED if reported symptoms related to chest tightness did not improve. 2:08pm Benadryl 50mg IM given in right upper extremity. Patients husband has arrived and is standing next to her. Patient remains calm and in no apparent distress other than the symptoms previously reported. 2:18pm Patient states she feels woozy from the Benadryl, but no worse or better than previous. Offered to call EMS, patient and husband declined. 2:30pm Nursing Supervisor onsite. Patient re-evaluated by asking questions related to current symptoms. Patient states chest tightness had resolved. 2:40p Patient reports feeling better. Patient instructed not to drive due to the potential for drowsiness related to the Benadryl administration. 2:45p Patient and husband left the vaccination area together.
49 2021-04-08 bloodshot eyes, eye bleeding Shortly after the patient received the vaccine and left the pharmacy, she started experiencing sever... Read more
Shortly after the patient received the vaccine and left the pharmacy, she started experiencing severe headache and radiating left-sided neck pain. The pain continued throughout the day and morphed into head, neck, and sinus pressure. The next morning, the patient noticed a ruptured blood vessel in her left eye, causing redness. Symptoms lasted for approximately 1 week.
49 2021-04-08 mouth tingling, swollen tongue 49 year old female with no significant medical history presents to the ED with possible allergic rea... Read more
49 year old female with no significant medical history presents to the ED with possible allergic reaction. Patient had to COVID vaccinations at facilitie at 1750 today. She reports lip tingling and tongue swelling, and she was sent to the ED for further evaluation. Patient reports history of reaction to "certain things." She had an "anaphylactic reaction" with a cortisone shot given by orthopedics in her shoulder a few months ago. Patient presented with similar symptoms including tongue swelling and lip swelling. She took a Benadryl and the symptoms resolved. Today symptoms are similar to previous. She was concerned prior to her vaccination about possible allergic reaction, so she took half a 25 mg Benadryl pill prior to vaccination shot. Patient states symptoms have improved. She denies shortness of breath, throat swelling, rash, or other concerns. Allergy to Penicillin and Amoxicillin..
49 2021-04-08 vision blurred Left Eye has blurred vision
49 2021-04-09 mouth numbness, mouth tingling I got the 2nd dose about 2pm. I stayed for over the 15 min because I was talking with a friend and w... Read more
I got the 2nd dose about 2pm. I stayed for over the 15 min because I was talking with a friend and we were there closer to 20 min. I had a headache right after the shot was administered and my arm hurt. I was fine earlier that day. By about 2:25 I was heading home and wanted to get some McDonald?s because I had an hour drive. I noticed in the drive through that my eyes felt they were being sunken in. My right eye and side of nose started to tingle. It started spreading on my right side down to my lips and up to my scalp. Then down my arm to my fingers and down my right leg. I was dizzy and nauseous and confused. I managed to call my boss at triton who said to come back to the office. The nurse met me in the office where I had laid on the floor to try and help the pressure. By then I was numb on my whole face. Teeth and tongue but was able to swallow and talk. They called an ambulance to have me checked out. My blood pressure was high while there. They asked if I had been anxious or having a panic attack. I was neither. I just felt dizzy and numb.
49 2021-04-09 mouth swelling, swollen tongue, lip swelling Swollen lips, swollen mouth, swollen tongue, swollen trachea, irritated gums, facial numbness
49 2021-04-09 mouth tingling From 1:30 am to 7:30 am 4/10/2021 Tachycardia Tightness in chest Possible Difficulty breathing ?? F... Read more
From 1:30 am to 7:30 am 4/10/2021 Tachycardia Tightness in chest Possible Difficulty breathing ?? Fingers and tongue tingling or numb Dizzy and fainting if attempt to get up or sit up ( needed ambulance but could not unlock door or call) Severe pain everywhere Feet cold and numb( no fever) After 7:30 am 4/10/2021 just very mild pain,fever,fatigue.
49 2021-04-09 vision blurred 8 Days after first injection almost fainted while driving. Heart raced and felt hot/clammy/dizzy/bl... Read more
8 Days after first injection almost fainted while driving. Heart raced and felt hot/clammy/dizzy/blurred vision. Lasted for 20 minutes. Continue to feel light headed, occasionally dizzy, and brain fog since then..
49 2021-04-10 ear pain Migraine headaches, nausea, sneezing, conjested, ear ache, body ache, tired
49 2021-04-11 thirst Topical numbness of forehead, nose, and top front teeth. Forehead and tooth numbness Adverse sympto... Read more
Topical numbness of forehead, nose, and top front teeth. Forehead and tooth numbness Adverse symptoms resolved within 18 hours (not noticeable next morning when I woke up at 7 a.m.). Nose numbness duller but persisted for about 24 hours after onset. Numbness can be described akin to Novocain. Additional (common symptoms): Fatigue and thirst on set about 2 hours after injection. Sore arm after about 6 hours of injection. Sore arm persisted for about 4 days. Of note: NO loss of taste or smell. NO fever.
49 2021-04-11 ringing in ears After fever, fatigue, chills, headache, runny nose and nausea for 24+ hours, by Wednesday, March 17,... Read more
After fever, fatigue, chills, headache, runny nose and nausea for 24+ hours, by Wednesday, March 17, 2021 I had most of the symptoms resurface that I had when diagnosed with Covid in July 2020: Neurological symptoms (buzzing in head, trembling hands, tingly scalp, dysgraphia), Respiratory symptoms (shortness of breath, especially with normal activity, coughing, chest tightness, pain in back/ribs, sore throat) and Cardiovascular symptoms (heart racing, skipping beats). Went to Urgent Care on March 18, 2021 and chest x-ray showed opaqueness in both lungs. Given another dose of steroids for inflammation, most symptoms went away except for SOB, coughing and heart racing and skipping beats. SOB lasted for approximately 1 week, heart racing and skipping beats lasted for 3 weeks. Fasting blood work on 3/29/21 showed significant increase in all cholesterol markers (30-40 points) compared to results from previous tests in 2020-2021. A1C also increased to pre-diabetic levels.
49 2021-04-11 ringing in ears Loud screeching sounds both ears Tinnitus! Started after 2nd vaccine approximately March 30,2021
49 2021-04-12 dry eye, eye strain, bloodshot eyes After the first shot, I woke up with a blood red left eye. The eye doctor said it was a burst blood... Read more
After the first shot, I woke up with a blood red left eye. The eye doctor said it was a burst blood vessel (subconjunctival hemorrhage). We didn't think it was related to the vaccine. However, when I got my second dose, I woke up the next morning, and it happened again in the same eye. The left eye felt dry and heavy. The eye doctor gave me drops, and it improved within 2 weeks after the first vaccine. I have not gone to the eye doctor the second time. I am using eyedrops, and it is improving. I informed my primary care physician as well.
49 2021-04-12 ear discomfort pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; short... Read more
pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 27Mar2021 at 09:45 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 at 12:30, the patient experienced vomiting, chills, cough, exhaustion, headache, ears burning, lung pain, shortness of breath and congestion. The patient went to doctor on 30Mar2021 and apparently, she has pneumonia. The patient also mentioned that she barely had a stuffy nose before taking the vaccine. The patient has a rapid response nasal swab COVID test on 29Mar2021 with a negative result and a PCR nasal swab COVID test also on 29Mar2021 with an unknown result. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.
49 2021-04-12 swollen tongue, eye swelling, ear swelling Patient recieved vaccine at 10 AM at a school COVID clinic. She waited 30 minutes and went home. At ... Read more
Patient recieved vaccine at 10 AM at a school COVID clinic. She waited 30 minutes and went home. At around 11 AM, she felt pain in her neck and down her arm. She also stated she felt a little swollen in her throat, tongue, eyes, and ears. She said it was not swelling shut, but just an uncomfortable and never felt in danger. Her hands and chest also had a tightness and swelling to them. Later that night she had a headache behind her eyes. By Saturday she was fine with the "swollen" feeling. However, by Monday, she had a rash begin on her hands and stomach. The rash was described as a chicken pox rash. She said this just went away over the last couple of days and did leave very little scarring.
49 2021-04-12 visual impairment Systemic: Dizziness / Lightheadness-Severe, Systemic: Tachycardia-Medium, Systemic: Visual Changes/D... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: EMS was called due to the patient feeling faint and tachycardia
49 2021-04-13 blindness Horrible Pain in left breast. First occurred at 2 am 4/8. Loss of vision occurred at 3:05. Fell bac... Read more
Horrible Pain in left breast. First occurred at 2 am 4/8. Loss of vision occurred at 3:05. Fell backwards onto floor 3:05 am. Diarrhea, nausea, labored breathing and sweating profusely. Unable to walk. 3:05 am. Thought was having stroke.
49 2021-04-13 ringing in ears Tinnitus, on going since the night after the 2nd vaccine. High pitched ringing in ears. Volume var... Read more
Tinnitus, on going since the night after the 2nd vaccine. High pitched ringing in ears. Volume varies.
49 2021-04-14 eye swelling Sore and achy body, no energy, slept for two days straight. Also right side of my face swelled up an... Read more
Sore and achy body, no energy, slept for two days straight. Also right side of my face swelled up and became super itchy on the day after the vaccine, by the second day it was only my eye (swelled shut and looked like black eye). One day three after swelling down but still looks like black eye. Now on day 4 after- less swollen but still itchy and swollen and black.
49 2021-04-14 mouth tingling, tongue discomfort tingling and burning of tongue started 2 hours after injection and subsiding without intervention 4 ... Read more
tingling and burning of tongue started 2 hours after injection and subsiding without intervention 4 hours after injection
49 2021-04-14 feeling of choking, oropharyngeal discomfort, mouth tingling Pt reported 40 min after the covid vaccine, she had tongue and throat tingling and odd sensation lik... Read more
Pt reported 40 min after the covid vaccine, she had tongue and throat tingling and odd sensation like she had to swallow. She took benadryl, with improvement. 2 hours later, she still had symptoms, so she repeated the dose, and then the symptoms went away.
49 2021-04-14 ringing in ears Dizziness, Vertigo and tinnitus in right ear Nausea
49 2021-04-15 lip swelling Pain at injection site, tingling on left side of face, slight feeling of left lip swelling (but didn... Read more
Pain at injection site, tingling on left side of face, slight feeling of left lip swelling (but didn't swell). On 4.16.21 sore left arm, entire body fatigued.
49 2021-04-15 bloodshot eyes, eye swelling On April 11th, woke up with a swollen left eye and upper cheek, with redness. On April 12th, woke up... Read more
On April 11th, woke up with a swollen left eye and upper cheek, with redness. On April 12th, woke up with left eye nearly swollen shut, and entire left side of face red and puffy. As the day progressed, blisters appeared and began weeping. Which does sound like it could be a poison weed, right? I had zero contact with any poison ivy, sumac, oak, etc. I had not changed my diet, changed any soaps/detergents, etc. Contacted primary care provider who diagnosed issue as poison ivy and prescribed 40 mg of prednisone for 3 days, 20 mg for 2 days. By Thursday April 14th, issue was not improving and my entire face was swollen, red, hot and itchy. Went to the urgent care clinic who conferred with my primary doctor and they decided to increase my prednisone treatment to 60 mg for 3 days, 20 for 3 days. As of today, April 16th, the prednisone treatment does not appear to be helping, as face is still red, swollen, hot and itchy. This has also spread to my neck area, but not any where else on my body.
49 2021-04-15 swollen tongue Face swelling, tongue swelling evening after vaccine. 2 days after vaccine until now, I have had an... Read more
Face swelling, tongue swelling evening after vaccine. 2 days after vaccine until now, I have had an increase in fatigue that I normally have due to long covid (original infection 8/13/2020).
49 2021-04-15 thirst The expected fever, aches, and joint pain started around 11pm on 4/14 and led to a very restless ove... Read more
The expected fever, aches, and joint pain started around 11pm on 4/14 and led to a very restless overnight. I got up around 5am on 4/15 feeling very thirsty and went to the bathroom to get a drink of water. I remember feeling extremely dizzy, nauseous, and lightheaded standing at the bathroom sink with a cup to fill with water. The next thing I remember is sitting on the bathroom floor with the bathroom cup next to me but I didn't know right away where I was (I hadn't turned on the bathroom light so it was dark) and I still don't know how I got there. I must've passed out. It was so difficult getting back to the bed that I had to ask my husband to help me. The fever, aches, and chills continued all day on 4/15 but the lightheadedness improved.
49 2021-04-15 ringing in ears After taking the vaccine on March 25th, 2021 1. Starting 04/04/21, Tinnitus became severe in the ri... Read more
After taking the vaccine on March 25th, 2021 1. Starting 04/04/21, Tinnitus became severe in the right ear (7 on a scale of 10) . Also developed screeching metallic noise 24x7 (2 out of 10 severity). Masking with another sound also did not help. Hissing noise also started in the left year. Visited ENT doctor on 04/08/2021, got prescription for Medrol (Methyl prednisolone 4 mg) -- 6 day tapering dose. Medicine took starting 04/09/21, finished on 04/14/21. No change in symptoms. 2. Starting 04/10/2021 both knees started feeling very hot and painful. Also felt pressure in the back of the head. Unable to sleep. 3. On 04/12/2021 high blood pressure of 160/100 recorded by the primary care physician Dr.. 4. On 04/15/2021, pain and heat started in other joints (elbows and wrists). Pain in knees continues. Tylonol 1000 mg did not give any relief.
49 2021-04-16 blindness Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primar... Read more
Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primary care doctor for further testing, blood labs, endocrinologist visit and additional labs. Vision care for vision loss.
49 2021-04-16 mouth tingling, taste disorder Tingling in tongue within the hour after vaccine Metal taste in mouth day of vaccine 24 hours after ... Read more
Tingling in tongue within the hour after vaccine Metal taste in mouth day of vaccine 24 hours after vaccine, left side of face swelling. I have no fillers. Day 3 face still swollen.
49 2021-04-18 dry throat, lip swelling Pfizer COVID-19 Vaccine EUA. Patient presented to ED with complaints of pruritus, lip swelling, ras... Read more
Pfizer COVID-19 Vaccine EUA. Patient presented to ED with complaints of pruritus, lip swelling, rash to neck,shortness of breath, dry throat, right side of throat swelling and pain. Patient was treated with methylprednisolone 125 mg IV, Diphenhydramine 25 mg IV, Famotidine 20 mg IV. Epinephrine 0.5 mg IM was administered 17 minutes after other medications.
49 2021-04-18 taste impairment Headache and migraine that started within 20-30min from the vaccine shot. Metallic taste in mouth ... Read more
Headache and migraine that started within 20-30min from the vaccine shot. Metallic taste in mouth Increased Heart rate Body chills that began 4 hours after shot
49 2021-04-18 hearing loss Nausea, Dizziness, Lightheadedness, Brain Fog. When I am sitting everything around me seems to be m... Read more
Nausea, Dizziness, Lightheadedness, Brain Fog. When I am sitting everything around me seems to be moving further away, sound gets quieter, things seem strange. Sometimes feels like a floating feeling.
49 2021-04-18 ringing in ears bilateral tinnitus and rigors 15-20 mins post vaccination
49 2021-04-20 loss of taste, loss of smell Patient developed rhinitis, nonproductive cough, and dyspnea on 4/16/21. This progressed and patient... Read more
Patient developed rhinitis, nonproductive cough, and dyspnea on 4/16/21. This progressed and patient went on to lose taste and smell. Patient received positive Covid test on 4/19/21 and was admitted for worsening dyspnea. Patient was discharged on 4/21/21.
49 2021-04-20 lacrimation increased, eye pain, eye itchiness, swelling of eyelid, bloodshot eyes, eye swelling Swelling of eye lids and around the eyes. Red and itchy. watery and stinging of the eyes. red itchy ... Read more
Swelling of eye lids and around the eyes. Red and itchy. watery and stinging of the eyes. red itchy rash under the eyes and on the neck
49 2021-04-20 oropharyngeal discomfort, mouth numbness Face and tongue went numb, slurred speech, fingers went numb both hands, felt like throat was closin... Read more
Face and tongue went numb, slurred speech, fingers went numb both hands, felt like throat was closing
49 2021-04-20 mouth tingling, mouth tingling at 10:57 pt. c/o mild tingling of the lips and tongue, itching of the left upper and lower extremiti... Read more
at 10:57 pt. c/o mild tingling of the lips and tongue, itching of the left upper and lower extremities. Noted flushing on the face and neck. pt. denies any respiratory distress. 25mg Benadryl given via IM on the right deltoid. Rechecked pt. after 5 mins; stated feeling better. pt. stayed for additional 30 mins. after Benadryl was given. pt. symptoms were relieved; left under own power; driven home by partner.
49 2021-04-20 ringing in ears 49 yo female had 2nd dose of vaccine, about 1-2 days developed tinnitus which persisted and getting ... Read more
49 yo female had 2nd dose of vaccine, about 1-2 days developed tinnitus which persisted and getting louder; also developed joint pains to elbow and fingers. I referred to get checked with PCP. 4/19-49 yo female had 2nd dose of vaccine, about 1-2 days developed tinnitus which persisted and getting louder; also developed joint pains to elbow and fingers. I referred to get checked with PCP.
49 2021-04-20 ringing in ears Developed tinnitus one week after receiving my first dose. The tinnitus intensified after my second ... Read more
Developed tinnitus one week after receiving my first dose. The tinnitus intensified after my second dose on January 13, 2021.
49 2021-04-20 ringing in ears Loud tinnitus started day after shot and is still there at day 55 hours. Rest of the symptoms are mo... Read more
Loud tinnitus started day after shot and is still there at day 55 hours. Rest of the symptoms are mostly gone.
49 2021-04-20 ringing in ears Tinnitus occurred the following day and has been present ever since.
49 2021-04-21 deafness unilateral, ear discomfort, ringing in ears Severe hearing loss left ear Tinnitus Ear fullness/pressure
49 2021-04-21 ear discomfort Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore t... Read more
Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore throat Burning when taking a deep breath
49 2021-04-21 ringing in ears About 6 hours after vaccine my right ear started ringing (like a fluorescent light bulb). It continu... Read more
About 6 hours after vaccine my right ear started ringing (like a fluorescent light bulb). It continues today. It comes and goes as far as the volume of it. Seeing an ENT who says it's my eustachian tube and could take up to 3 months to clear. We shall see.
49 2021-04-21 visual impairment 4:45pm later that same day began having numbness in left arm and foot and Cramp in left jawline. Con... Read more
4:45pm later that same day began having numbness in left arm and foot and Cramp in left jawline. Contacted left message. Symptoms continued, I took three baby aspirin and called primary care doctor on duty. She called back and explained that the Pfizer wasn't the same as J&J vaccine and to take a Tylenol for discomfort. I took a Tylenol and went to bed. The next morning when I woke up, I had pain behind neck into right leading up to right side of my head. I took some water and meditated until time to go to work. I called primary care Dr. and left message. Pressure continued and numbness in left extremities continued. Friday when I woke up my lower right leg and foot were numb. I drank a bottle of water and ate a banana. I stayed awake until time for work. I called my primary care and left message with nurse. Primary care called back around 3:35pm. she discussed steroid and meds or ER. I suggested both, go to ER to see what outcome is and then steroid possibly. Numbness and pressure continued while at work. I took two baby aspirin when I got off work. Saturday morning, I went to ER. Ct Scan with and without contrast done on head and neck. Doppler was done and no clotting was detected at that time. I was told by Dr. to see my Primary care physician or come back to see ER if symptoms worsened. I contacted my primary care on Monday and left message. They called back and made appointment to see me in office for Tuesday. Dr. suggested to use steroid and I asked to do therapy. Wednesday night excessive pressure, numbness, tightness in jaw and front of neck. Contacted primary care Dr. and called Clinic to learn for Stroke Neurology. Thursday, saw fire stars twice throughout the day. Called Poison control and put in report. This is second VAERS report that I have made.
49 2021-04-22 ear pain All this on the right side of the body. Injection site was on the right arm. Dizziness and weaknes... Read more
All this on the right side of the body. Injection site was on the right arm. Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin). Parotid gland swollen and painful. Entire right arm swollen with rash, Right check swelled. Right ear pain.
49 2021-04-22 lip swelling Swollen lips. Upper lip left side only, lower lip, whole lip swollen I took 2 Benadryl
49 2021-04-22 bloodshot eyes Red eye and mild headache. Distal portion of right eye is red, but not noticeably itchy or with any ... Read more
Red eye and mild headache. Distal portion of right eye is red, but not noticeably itchy or with any discharge. No tears or changes in vision. Eye is still red 48 hr later, which is uncommon (unprecedented) for me. Headache was very mild and lasted < 1 day, even without medication.
49 2021-04-22 ringing in ears Tinnitus, unresolved. Neuropathy in right foot. Resolved: joint pain, headache, fatigue.
49 2021-04-22 ringing in ears Within five hours of shot developed fever (100.5) which lasted more than 24 hours, chills, headache,... Read more
Within five hours of shot developed fever (100.5) which lasted more than 24 hours, chills, headache, very bad body aches, back pain & ringing in ears. All has resolved except headache and ringing in ears as of 04/23/2021 4 pm
49 2021-04-23 mouth ulceration Mouth ulcers located inside of lip and under tongue; Thrush in mouth; This is a spontaneous report f... Read more
Mouth ulcers located inside of lip and under tongue; Thrush in mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of ad-ministration administered at left arm on 28Jan2021 09:00 PM at single dose for COVID-19 immunisation. Patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered at left arm on 22Feb2021 04:30 PM at single dose for COVID-19 immunisation. The patient medical history included asthma and possible lupus. There were no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications (medications the patient received within 2 weeks of vaccination) included cannabidiol (CBD OIL), montelukast sodium (SINGULAIR), montelukast (MONTELUKAST), colecalciferol (VITAMIN D [COLECALCIFEROL]). On 30Jan2021, the patient experienced mouth ulcers located inside of lip and under tongue, thrush in mouth. Occurred 2nd day after the first shot. Started medication and was under control. Flares up again 2nd day after 2nd shot. The patient was not diagnosed with COVID-19 prior to vaccination and patient was not tested for COVID-19 since the vaccination. Patient received clotrimazole 10mg tablets as treatment for event. Outcome of event for mouth ulcers located inside of lip and under tongue was not recovered and for thrush in mouth it was recovering. Information on the batch/lot number has been requested.
49 2021-04-23 oropharyngeal discomfort Burning/discomfort in throat 10 minutes after vaccine administration. Elevated blood pressure and he... Read more
Burning/discomfort in throat 10 minutes after vaccine administration. Elevated blood pressure and heart rate.
49 2021-04-23 ringing in ears Experienced tinnitus and still experience it a month later.
49 2021-04-23 ringing in ears Headache fatigue ringing ears . Rash all over but concentrated mostly on legs . Puss filled bumps/... Read more
Headache fatigue ringing ears . Rash all over but concentrated mostly on legs . Puss filled bumps/blister little boils ...varying in size but like bug bites, mostly itchy and a little painful. I have used cortisone cream, Calgary lotion and taken benadryl
49 2021-04-24 dry eye, lacrimation increased Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pa... Read more
Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pain in her feet; dry eye and eye watering; Bell's palsy; Legs went numb; Feet burning; Arms went numb; Nausea; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:45 (Batch/Lot Number: ERG213) as a single dose for covid-19 immunisation. The patient's medical history included ongoing systemic lupus erythematosus diagnosed 17 years ago. The patient's concomitant medications were not reported. On 30Mar2021, the patient experienced headache and nausea, arms went numb on 31Mar2021, legs went numb and feet burning on 01Apr2021. On 05Apr2021, the patient was diagnosed with Bell's palsy. It was also reported that before the bell's palsy diagnosis she felt like she was getting a cold. It was further reported that on the first day the patient had a headache and nausea. The second day her legs went numb for 3 days, on 05Apr2021 she got Bell's Palsy. Patient cannot talk, symptoms were not treated in any way. Patient had numbness in her arms first and then it went to her legs. She later clarified her arms and legs are still numb. The headache started soon as she got the vaccine. Her nausea started 2 hours after the vaccine and lasted 8 hours. Her legs still bothering her. She still has pain in her feet. Before the Bell's Palsy diagnosis she felt like she was getting a cold. She had a headache on the right side of the face. Her tongue was numb 3 days ago. She can't close her eye all the way, it was causing headache, dry eye and eye watering. It was going into her nose. Her lip was moving, she cannot talk. She went to urgent care last night after her daughter asked why she was winking. Her lip was sagging and thought it was a stroke. They said the Bells Palsy was definitely from the vaccine. The outcome of the event nausea was recovered on 30Mar2021, Bell's Palsy legs went numb, arms went numb, feet burning was not recovered and unknown outcome for the event before the Bell's Palsy diagnosis she felt like she was getting a cold.
49 2021-04-24 taste impairment felt as if my throat was closing and I had problems swallowing; felt as if my throat was closing and... Read more
felt as if my throat was closing and I had problems swallowing; felt as if my throat was closing and I had problems swallowing; metallic taste in back of mouth first; warm flushing feeling across chest and out arms; This is a spontaneous report from a contactable consumer reported for herself. This 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8734) via unspecified route of administration in left arm on 02Apr2021 08:30 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included celecoxib (CELEXA). The patient previously experienced drug allergy with codeine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 09:00, the patient experienced felt as if her throat was closing and had problems swallowing, metallic taste in back of mouth first, warm flushing feeling across chest and out arms. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included EMS arrived and gave diphenhydramine hydrochloride (BENADRYL). The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The outcome of events was recovered. No follow-up attempts are needed. No further information is expected.
49 2021-04-24 burning mouth syndrome, ringing in ears, ear pain April 14 ongoing intense inner ear pain, headache , neck ache ,pain inside right throat and tongue. ... Read more
April 14 ongoing intense inner ear pain, headache , neck ache ,pain inside right throat and tongue. Nausea vertigo and tinnitus. April 18 -no relief with otc me losing and Advil. Went to urgent care was put on prednisone and zofran . Worried it may be shingles I went to e.r later that same day and was put on valacyclovir and gabapentin. Small vesicular rash on right ear and swollen auricle. Shingles confirmed and to follow up,with ent and neuro. Eye rash appeared But went away photos were taken. saw ent 4-22- and confirmed shingles. Eye dr seen on 4-23. Completed steroid dose pack Currently taking valaclovir and gabapentin along with Advil, and meclizine. To help with intense pain and vertigo. Ice packs to neck and ear to help with headache. Nothing is helping pain or loud ringing. Still wait g to see neuro dr.
49 2021-04-24 lip swelling After sitting at the vaccination clinic for the required 15 minute, on the way home I noticed my li... Read more
After sitting at the vaccination clinic for the required 15 minute, on the way home I noticed my lips started to swell. Shortly thereafter my face started to swell. I asked my husband to take me to the emergency room, and it was noted in my charts that I had had an adverse reaction. I thought that was going to be the only symptom, but later on in the week I experienced vertigo, nausea, and my stomaching lurching. On Friday the week of my vaccination I noticed that my that my lips and face started to swell again, but went down shortly thereafter. My face and lips also started to swell today, but again went down. I told my husband is it happening because of stress or heat? I really do not understand why I am experiencing symptoms a week after my vaccine.
49 2021-04-24 mouth tingling Client received the [1st] COVID vaccine (Pfizer lot #EW0171 and expiration date: 04/24/21) at 2:54pm... Read more
Client received the [1st] COVID vaccine (Pfizer lot #EW0171 and expiration date: 04/24/21) at 2:54pm to right arm. At 9:47 am RN reported that client was reporting symptoms in Spanish that she could not translate. Other RN responded and provided Spanish translation. Client sitting in observation chair complaining of symptoms which she described as heaviness in her tongue and neck pain. Other RN instructed EMT to take client to observation room and lay her in semi-fowler's position. Other RN presented to observation area and requested VS. Client denies shortness of breath, chest pain, itchiness, swelling in other areas of body, hives, or rash. Client denies allergies or medical history. Denies taking medications at this time. Client is alert and oriented to place, time, and date. VS at 9:58 am HR 97, SpO2 95% RA, BP 198/119. Other RN activated emergency number. Paramedics assumed care at 10:05am. Client transported to Hospital. Client's husband alerted of transportation to hospital by other RN.
49 2021-04-25 eye irritation, dry mouth Chest pain, shortness of breath, fatigue, moody, headache, dry mouth, no appetite, eyes bother me, a... Read more
Chest pain, shortness of breath, fatigue, moody, headache, dry mouth, no appetite, eyes bother me, and tired all the time
49 2021-04-25 eye irritation Right arm sore 5-7 days Fevers off and on 15+ days, getting worse, now up to 100.9 degrees Very tir... Read more
Right arm sore 5-7 days Fevers off and on 15+ days, getting worse, now up to 100.9 degrees Very tired Eyes burning Body aches Dizziness when standing up. Nausea Stuffy nose Symptom have persisted since injection, some have worsened.
49 2021-04-25 eye pain Severe leg and muscle weakness severe tiredness eyes hurt and headach
49 2021-04-25 ringing in ears, deafness Slight headache and sore arm day after Woke up on 4/22 with hearing loss and loud tinnitus in right ... Read more
Slight headache and sore arm day after Woke up on 4/22 with hearing loss and loud tinnitus in right ear, moderate tinnitus in left ear, tingly feeling extending from top of head down right side of face into neck. Scheduled appointment with an ENT for later in the day. Ear canals looked fine. She placed me on prednisone, symptoms have diminished (tingling sensation gone) vibrating sensation of eardrum reduced, hearing loss still persistent and still have tinnitus.
49 2021-04-25 ringing in ears lt arm swollen, legs and feet swollen, hissing sound in head, bruising on arm, swollen stomach, swol... Read more
lt arm swollen, legs and feet swollen, hissing sound in head, bruising on arm, swollen stomach, swollen hands, redness aeound neck and breast are
49 2021-04-26 mouth tingling Pt was vaccinated with 1st dose of Pfizer. Pt was waiting in post vaccination observation when at 15... Read more
Pt was vaccinated with 1st dose of Pfizer. Pt was waiting in post vaccination observation when at 1500 she stated of itchy hands. Client brought down to floor from bleachers. 1506 Client endorsed itchiness travelling up to forearm and "tingling to mouth. Aid called and arrived to evaluate Pt. 1510 Client care transferred to Aid for additional evaluation and care. 1530. Client to go home per aid. No further symptoms and symptoms decreased. Pt d/c home per EMTs. Client educated on safety and when to call 911 or go to ED. VS 1503 HR 92 O2 sat 99% on RA VS 1510 HR 84 O2 sat 98% on RA VS 1520 HR 77 O2 sat 99% on RA
49 2021-04-26 ringing in ears Patient reports that she began to experience ringing in the ears after the first dose of the vaccine... Read more
Patient reports that she began to experience ringing in the ears after the first dose of the vaccine and the ringing in the ears has continued.
49 2021-04-27 loss of taste I completely lost my sense of taste and have not regained any sense of taste thus far. I have not g... Read more
I completely lost my sense of taste and have not regained any sense of taste thus far. I have not gone to see my doctor.
49 2021-04-28 lip swelling About 15 minutes after recievieng the vaccine I developed hives on my hands and arms, feet and legs.... Read more
About 15 minutes after recievieng the vaccine I developed hives on my hands and arms, feet and legs. I also had some swelling of my lip and some mild chest tightness. I was treated with oral Pepcid and Oral Zyrtec. My hives resolved after about 15 minutes as did my mild chest tightness. I was observed for an hour. Later that evening about 8, my face and lip began to swell, I had significant chest tightness, with severe coughing and wheezing. I also had hives again on my hands, neck and face. I used my Epipen and albuterol inhaler. My chest was still very tight and my cough was very bad. I went to the emergency room. I was given DuoNeb, Pepcid, Benedryl, and Prednisone. They were unable to start an IV so gave me oral medications. Over the next hour my symptoms resolved and I felt much better. I was discharged about midnight. Today I have a very sore throat from coughing so much and my body is very achy and I have diarrhea. I have had this same issue however the last time I needed to use Epi when I accidentally ate Shrimp.
49 2021-04-28 mouth tingling This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old fem... Read more
This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.
49 2021-04-28 swollen tongue Swelling of tongue, difficulty swallowing, odd feeling in chest. Given epinephrine, decadron, benadr... Read more
Swelling of tongue, difficulty swallowing, odd feeling in chest. Given epinephrine, decadron, benadryl and pepcid. Monitored for 4 hours. Symptoms resolved and was discharged.
49 2021-04-29 ear discomfort, ringing in ears I received my first Covid 19 (Pfizer) vaccine on April 22 and by the next day, began to experience a... Read more
I received my first Covid 19 (Pfizer) vaccine on April 22 and by the next day, began to experience a marked difference in the level of already-present tinnitus in my right ear. Along with the increased volume, I am also experiencing a pressure or "fullness" in that ear that was not present before the vaccine. It's been only a week, but the symptoms have not subsided yet.
49 2021-04-30 eye bleeding Burst blood vessel in left eye; This is a spontaneous report from a contactable consumer (patient). ... Read more
Burst blood vessel in left eye; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 49-years-old via an unspecified route of administration, administered in arm right on 01Apr2021 15:30 (Batch/Lot Number: Fp6955) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included canagliflozin (INVOKANA), metformin and rosuvastatin; taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 (lot number: En6199) at the age of 49-years-old administered on the right arm for covid-19 immunisation. The patient experienced burst blood vessel in left eye on 12Apr2021. No treatment was received for the event. The patient was recovering from the event.
49 2021-04-30 drooping eyelid Thyroid storm; Thyroid eye disease; Graves' disease; Trouble swallowing and eating; Trouble swallowi... Read more
Thyroid storm; Thyroid eye disease; Graves' disease; Trouble swallowing and eating; Trouble swallowing and eating; Throat is scratchy; mild symmetric ptosis; bilateral perinasal sinus disease/nasal problems like sneezing, running nose, and coughing; nasal problems like sneezing, running nose, and coughing; trouble sleeping; This is a spontaneous report from a contactable consumer reported for herself. This 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 49 years old on 06Apr2021 at around 16:50 in the top of her right arm (lot: ER8737) at single dose for COVID-19 immunisation (reported as to protect herself and others). Medical history included ruptured brain aneurysm, it was paraopthalmic from 12Sep2012, HELLP syndrome from 01Sep2012, allergies. Seasonal allergies. Mumps, chicken pox, tetanus, rubella, measles from 1989. She had a ruptured brain aneurysm on 12Sep2012. It was a direct result from pregnancy HELLP syndrome, like toxemia on steroids. On 27Aug2012 her daughter was born, then she was diagnosed with HELLP 5 days later. She was hospitalized for another week. She was released and on 12Sep2012 and had the ruptured brain aneurysm which they say in itself was hereditary, and her blood pressure went up so high that it burst. She was hospitalized for 40 days. She was paralyzed and everything. She went on physical therapy and got everything back, no deficits. Family history included hereditary in her family to have hyperthyroidism/thyroid problems on both sides (her father and mother). Concomitant medications included cetirizine hydrochloride for allergies, it was the generic antihistamine for Zyrtec. She had been taking them for about 20 years. The patient previously received first dose of BNT162B2 at age of 49 years old on 19Mar2021 in the top of her right arm (lot: ERU6208) for COVID-19 immunisation. The patient had an emergency reaction to the second dose of the Covid-19 vaccine. All events required a visit to Emergency Room and Physician Office, and received treatment. She walking into the ER with trouble breathing and swelling to her face after the second Covid shot. She had the second vaccine on 06Apr2021 at around 16:30, and everything went fine. She came home and felt fine. She went to bed that evening at around 23:00. She woke up on 07Apr2021 the morning at around 05:00 and was having excessively rapid heart rate, which is called tachycardia. Her left eye swelled open, and her right eye swelled shut. She took herself to the emergency room. She said that she had a hard time seeing now and had vision loss, and they gave her Iohexol intravenously. They also gave her ketorolac and methylprednisolone sodium succinate. The first one, Iohexol, they told her was iohexol (OMNIPAQUE) for a cerebral CT. They did an orbital CT with contrast. Her vitals were blood pressure 171/86, temperature 98.1, pulse 125, respirations 18, and oxygen saturation 97%. 9 years ago she had a ruptured brain aneurysm, it was paraopthalmic. She thought maybe the vaccine caused some type of brain bleed (Apr2021) because her eye was swelled out. That was the reason for the scan. After she left the ER, they sent her to an emergency ophthalmic appointment, and the ophthalmologist told her that she had to get glasses immediately. She had just had her eyes checked in February. Her vision in her left eye had deteriorated. She had to go and get glasses. Then they sent her to have thyroid lab work done. She had an appointment set up to be seen by her regular ophthalmologist that following Monday. Everything was on Wednesday, 07Apr2021. She was fine until Friday, drove to work and when she got to work at about 08:00 or 09:00 her body started shaking excessively. It was the tachycardia. She thought it was from the pain in her eye and took paracetamol (TYLENOL) but she still didn't feel well. On Monday she saw the regular ophthalmologist and he said that her neck was swollen with a goiter and she had thyroid eye disease and Grave's disease on 07Apr2021. He sent her to her primary care physician within an hour and he concluded the same thing. He immediately sent her to the pharmacy for a heart medication for tachycardia. It was propranolol (INDERAL) 20 mg, and she took it 3 times a day. He set her up with an emergency endocrinologist appointment and he spoke with the endocrinologist on Monday night and went over the charts with her. Everything that he diagnosed her with is at his office. He sent her to the endocrinologist for a final diagnosis. She went to the endocrinologist on Tuesday and she sent her for more lab work. They did a whole panel of labs. She definitely had Grave's disease with a goiter. They put her on methimazole 10 mg tablets, and she took them 2 times a day. That was only temporary until her labs come back. On Monday afternoon her primary doctor sent her to have an ultrasound of her neck. Her neck was swollen and she was having trouble swallowing and eating on 07Apr2021. The radiologist report said that it was strictly thyroid and she had no polyps or lesions. Her doctor suspected, they don't know exactly, but they suspect this happened because it was hereditary in her family to have hyperthyroidism/thyroid problems on both sides, and it was dormant and when she got the vaccine it triggered it to activate. She had thyroid storm (on 07Apr2021), and if she had not gone to the ER it could have been fatal. They were able to see everything during the thyroid storm so they could treat it. She was in thyroid crisis and had thyroid eye disease. Her left eye is permanently disfigured. She has an extremely protruding left eye and a right lazy eye. She had to see an ocular plastic surgeon to get it fixed at some point. She lost so much weight this past week (Apr2021). She had lost 8 pounds since Sunday, and she didn't know how many before that. It hit her hard. Her adrenaline was going so fast. Her throat was scratchy (on 07Apr2021), and she had a lot of nasal problems like sneezing, running nose, and coughing (Apr2021). It was reported that even with medicine, it only kept her heart rate down for a little while. She didn't take Tylenol until Friday morning for eye pain. It wasn't from the pain though, it was from tachycardia. She can close her left eye but she had damaged muscles behind her eye in Apr2021. It was still protruding, but the swelling went down about 80% 2 days after leaving the hospital. Within 24 hours after they injected her eye the swelling went down 80%, but it was still protruding. Her right eye was a lazy eye. It was swollen shut. She couldn't get it moving, so it may have been out of fear. She put cold compresses on her eyes before she went to the hospital. She was able to open her right eye. She can close her left eye but not all the way. She had to keep using eye drops because it got dry (in Apr2021). Her vision has gotten worse since February, especially her left eye. Her doctor sent her to get prescription glasses. The vision center had to adjust them and tilt them because the muscle in her eye won't let her eye move to see through the lens. It is her distance vision, mostly in her left eye. Her right eye droops and her left eye popped out. The shaking made her look like she had Tourette's. After she got medicine at the hospital it went away and her body calmed down. On Thursday it seemed okay. Her doctor said it was because she still had the IV medicine in her body. On Friday the medicine wore off and her heart was racing and it was making her body shake. Doctor said her heart was beating so quickly because her thyroid was causing her to make so much adrenaline and it caused her body to shake. 20 minutes after she took the propranolol it completely stopped. On 07Apr2021 they suspected she had Grave's disease and Thyroid eye disease. The thyroid testing came back as unreadable. It came back as 0.01 UIU/mL. It was thyroid stimulating hormone. It was not a full panel, but that was enough to try to find out if it was her thyroid. The endocrinologist ordered full testing. The goiter was pressing on her throat and she had a hard time swallowing when she was eating. It was scratching her throat. She has gone to soft foods until it was easier to swallow. She can swallow on her own, but it was hard to swallow foods, it got stuck in her throat. They told her she would get better with the thyroid medication. She lost weight so fast and would start to lose muscle. She was losing weight because her adrenaline was up. It had made her weak on 10Apr2021. They gave her a list of supplements and protein drinks. In October she started to exercise and lost a couple pounds between then and January. She was just taking long walks and thought it was going great. She had only lost a couple of pounds. After Wednesday her weight started rapidly changing, and every time she got weighed she had 3 more pounds gone. She started feeling really weak by the weekend. Her heart was making her feel weak, and she hadn't had any medicines yet and felt tired on 10Apr2021. After Wednesday, she started having 2 bowel movements a day which is very strange. Her doctor said it is a symptom of hyperthyroid. Normally it is like clockwork in the morning and that's it. She noticed it on Thursday 08Apr2021. She became hypersensitive after Wednesday and paid attention to everything. She already had seasonal allergies. She stopped any kind of decongestant. She knew with heart palpitations to stay away from that. She just took cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE). Her doctor said her body was used to that to keep her sinuses down, and with her body making so much adrenaline it could be excessive. Wearing a mask over her face was hard to breathe because the heart. She had trouble sleeping, which could be part of the fatigue because it was disturbing her sleep. They confirmed it was her thyroid on Monday and again Tuesday with more extensive labs for the correct level of methimazole. Investigations included: She had a CBC with differential on 07Apr2021. She had a CT orbit sella post fossa W contrast that showed facial swelling and periorbital edema of both eyes on 07Apr2021. The impression on the radiology digital imaging she can provide at a later time. She had mild symmetric ptosis on 07Apr2021 otherwise normal for appearance of orbital content. The impression for the CT scan on 07Apr2021 was bilateral perinasal sinus disease which was her allergies. The rest was stable coiling. She had vascular coiling directly behind her eye from the ruptured aneurysm. The outcome of events Thyroid storm, vaccine caused some type of brain bleed, hyperthyroid, pain in her eye, Lost so much weight, Dry eye, blood pressure 171/86, Hypersensitivity, trouble sleeping, facial swelling, mild symmetric ptosis, trouble breathing was unknown, outcome of events Eye swelling, Tired, Weak was recovering, outcome of event shaking was recovered on 07Apr2021, outcome of other events was not recovered.
49 2021-04-30 ringing in ears idiopathic sudden hearing loss on left ear; severe headache on my left head for full 3 days after th... Read more
idiopathic sudden hearing loss on left ear; severe headache on my left head for full 3 days after the 2nd Vaccine; tinnitus on my left ear on and off; felt extreme fatigue and tired; This is a spontaneous report from a contactable other healthcare professional (reporting for herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), dose 2, via an unspecified route of administration, administered in left arm on 02Feb2021 10:00 A.M. at the age of 49 years old, as a single dose, for COVID-19 immunization. The patient's medical history included hypertension. The patient had no known allergies and no prior COVID vaccination. The patient was not also tested with COVID post vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 vaccine for COVID-19 immunization and experienced minor headache. On 08Feb2021, the patient reported that she experienced severe headache on her left head for full 3 days after the 2nd Vaccine. The patient had a minor headache when she had the first vaccine, but it lasted only a day and it was mild one. About 1 week after the 2nd vaccine, the patient had a tinnitus on her left ear on and off. She thought it was because she was tired. For some reason after the 2nd shot, the patient felt extreme fatigue and tired. The left ear ringing was happening more frequently and getting loud. The patient went to urgent care and also went to ENT, and there it was found out that she was having an idiopathic sudden hearing loss on left ear. The patient was treated with oral steroid and injection but the hearing sensory was not coming back yet. The outcome of the events was not recovered. Information about lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on idiopathic sudden hearing loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
49 2021-05-03 oropharyngeal discomfort light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure... Read more
light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure around 180/123mmhg; Neck stiffness; throat becoming stiff; Very difficult breathing; tightness in her chest; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, administered in left arm on 18Apr2021 11:45 am (at 49-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included hypertension, Covid-19 from 09Jan2021. Tested positive for COVID on 09Jan2021 and have antibodies after infection. Patient took vaccine under 100 days after COVID infection. No known allergies. Concomitant medications included metoprolol; paracetamol (TYLENOL extra strength), and multi vitamin. No other vaccine in four weeks. On 18Apr2021 11:52 (reported as 7 minutes after BNT162B2 1st dose), the patient experienced light headed, heat inside her left arm then her chest, tightness in her chest, felt heart palpitations rapid, high blood pressure around 180/123 mmhg. Neck stiffness and throat becoming stiff. Very difficult breathing after all symptoms were present. The events resulted in emergency room/department or urgent care, hospitalization. The days of hospitalization was 1 day. Therapeutic measures were taken as a result of the events, which included aspirin/ 2 bags of 1000 ml Sodium chloride. The outcome of the events was recovering. No COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-05-04 ringing in ears headache, head spinning, fever, ringing in ears, strange buzzing sound in head, body aches similar... Read more
headache, head spinning, fever, ringing in ears, strange buzzing sound in head, body aches similar to mild flu. Headaches, head spinning and flu like body aches lasted a few days.
49 2021-05-05 ringing in ears Experienced excessive fatigue 6 hrs post vaccination. Not concerned. Following morning noticed an ... Read more
Experienced excessive fatigue 6 hrs post vaccination. Not concerned. Following morning noticed an increase in tinnitus symptoms. I had longstanding, mild tinnitus, in one ear, however, this was whistling in both ears and an order of magnitude worse.
49 2021-05-10 mouth numbness Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet;... Read more
Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; Slurred speech an difficulty swallowing; Slurred speech an difficulty swallowing; Feet felt super heavy and awkward; Significant urination; muscle aches; low-grade fever; very tired; Slight headache; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; blood sugar plummeted; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:45 (Batch/Lot Number: CR8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Type 1 diabetes, Some allergy medications like zyrtec, topamax, Nortriptyline, allergic asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG); bisoprolol (BISOPROLOL); fexofenadine hydrochloride (ALLEGRA). Historical Vaccine included product=COVID 19, brand=Pfizer, lot number=EP7533, administration date: 04Apr2021, administration time =04:00 PM, dose number =1, vaccine location =Left arm for covid-19 Immunization. Reported Event: About 3 hrs after 2nd dose, lower back pain for 20 minutes followed by numbness in tongue, throat, lips, cheeks, hands, feet, slurred speech an difficulty swallowing. Extreme difficulty thinking. Feet felt super heavy and awkward, like they were bricks. She was a type 1 diabetic and her blood sugar plummeted. She had to stop her basal delivery for an hour, then she halved her basal rate for several hours. After laying down for a few hours, symptoms improved, but worsened when standing. Significant urination every 40 - 60 mins for several hours. In the morning, muscle aches throughout body, low-grade fever, very tired. Slight headache. Adverse event start date: 25Apr2021, Adverse event start time: 06: 30 PM, No treatment for AE. Lab data included blood sugar: plummeted on 25Apr2021. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-05-10 sensitivity to light I have had 4 terrible days after the vaccine that I had to spend in bed. I had horrific severe heada... Read more
I have had 4 terrible days after the vaccine that I had to spend in bed. I had horrific severe headaches at the front of my head and at the back starting in less than 24 hours after the vaccine. On the next day I had a fever added to these headaches. I couldn't open eyes and light hurt my eyes. I had a loss of appetite and huge weakeness. I couldn't walk and had literally to crawl to the bathroom. When I stood up from my bed I almost fainted. After 96 hours after vaccine I still have nausea and headaches that diminished a bit. Fever disappeared only after 96 hours. Still I'm very weak, have nausea and can't really do anything except being in bed. I have never had anything like that in my life after a vaccine. and I'm in perfect health and don't smoke, don't drink any alcohol, doing regular gym and my BMI is normal
49 2021-05-11 dry eye was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really h... Read more
was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really hot and dry; slight fogginess; achiness; I tested positive for COVID; Restless body; Nausea; Weakness; Fast heartbeat; Headache; Chills; Muscle pain; Feeling unwell; high fever couldnt shake it at all; got congested/ Stuffy nose; facing joint ache; extremely tired/ Tiredness; Pain in arm/ whole hand just felt achy; Heart hurt when laying on side; Dizziness/ lightheadedness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 15:00 (Batch/Lot Number: EW0164) (at the age of 49 years old) at 1st dose, single for COVID-19 immunisation. Medical history included asthma and hypersensitivity (allergies). Concomitant medications included montelukast sodium (SINGULAIR) taken for hypersensitivity; formoterol fumarate, mometasone furoate (DULERA) taken for asthma; beclometasone dipropionate (QVAR); and levosalbutamol hydrochloride (XOPENEX). On unspecified date in Apr2021, she got pretty sick and swollen lymph nodes. On 23Apr2021, the patient experienced heart hurt when laying on side, high fever couldn't shake it at all, extremely tired/tiredness, headache, chills, muscle pain, feeling unwell, joint pain/ facing joint ache, dizziness/lightheadedness, fast heartbeat, pain in arm and got congested/ stuffy nose. On 24Apr2021, the patient experienced nausea and weakness. On 25Apr2021, the patient experienced restless body, her body also got extremely restless like she had restlessness lesions on whole body. On 26Apr2021, the patient tested positive for COVID-19. On unspecified date, the patient experienced chest pain, she wakes up freezing and her eyes felt really hot and dry and was exhausted, whole hand just felt super achy, slight fogginess and achiness. The patient had vaccination on Friday. On Friday night, she started not feeling well and then was like full blown all the Saturday all the Sunday (as reported). The patient got vaccination last Friday and had a severe reaction to the vaccination. She was extremely upset about it because now she tested positive for COVID. She was not really showing any symptoms and whatsoever before of any COVID like symptoms. Allergy was bothering her but no fever, no chills, no tiredness, no achiness and no nothing. She was nervous because she did realize that it wasn't FDA approved and now she was suffering positive, she started feeling a little better but still tested positive. It was reported that the event started at the time of report, 26Apr2021. The patient had a severe reaction. She had every symptom except that her arm didn't swell. She didn't have any rash in her body. She got pretty sick. She had a high fever couldn't shake it at all, got congested, facing joint ache and extremely tired. Her body also got extremely restless like she had restlessness lesions on whole body she couldn't lay down. The patient reported that it was hurting her so bad and she had to keep moving like she couldn't relax fall free. She had a severe reaction and doctor said she could have COVID knowing it and then got a shot and then came out full blown. The patient stated she was taking Tylenol (50mg, Not clarified), Tylenol Cold and sinus (325mg) for like a flu and Motrin (500mg). She had some time to shake the achiness and the fever was just coming back. She took Tylenol to help rid of fever and achiness, it didn't help and then she tried Tylenol cold and flu that help the little bit then she tried Motrin the Motrin help more with achiness but not hundred percent. The outcome of the events heart hurt when laying on side and fast heartbeat, both recovered on 26Apr2021; events high fever, tiredness, chills, muscle pain, feeling unwell, swollen lymph nodes and dizziness were recovering; events nausea, restless body and stuffy nose were not recovered; and unknown outcome for the other events. No follow-up attempts are needed. No further information is expected.
49 2021-05-11 ringing in ears, deafness Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent vis... Read more
Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent visit this week.; Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent visit this week.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-regnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left leg on 06Apr2021 09:30 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Vaccine facility type was pharmacy/drug store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced tinnitus - 24 hours a day, 7 days a week. that started on 08Apr2021 at 09:00. The patient believed she had hearing loss and was scheduled for ENT visit this week. The patient will have a hearing test (do not know next steps). The outcome of the events was not recovered. Events were reported as non-serious. Information on the batch/lot number has been requested.
49 2021-05-12 mouth tingling swollen lymph nodes left arm (resolved 6 weeks later), nerve pain left arm (resolved), headache (res... Read more
swollen lymph nodes left arm (resolved 6 weeks later), nerve pain left arm (resolved), headache (resolved), tingling in lips (resolved), numbness left side of face (continuing)
49 2021-05-12 tongue discomfort I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at ... Read more
I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at home with OTC Abreva cream, resolved about 1 week later. I also experienced oral discomfort on my hard palate and tongue about 24-48 following both injections. It was similar to a chemo side effect but not as severe, tenderness, kind of raw/burning sensation. Resolved on its own after several days
49 2021-05-14 vision blurred Got diagnosed with mild stroke after a high blood pressure crisis; Got diagnosed with mild stroke af... Read more
Got diagnosed with mild stroke after a high blood pressure crisis; Got diagnosed with mild stroke after a high blood pressure crisis; blurry vision on the left eye; Pins and needles feelings in left body side; headache; memory loss; This is a spontaneous report from a contactable consumer (reporting for herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 at 10:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included high blood pressure, and asthma. The patient's concomitant medications were not reported. On 14Mar2021, the patient was diagnosed with mild stroke after a high blood pressure crisis and the symptoms showed days after the vaccine such as blurry vision on the left eye, pins and needles feeling in left body side, headache and memory loss. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in emergency room/department or urgent care and was admitted in the hospital for 2 day. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
49 2021-05-21 visual impairment herself tested positive for the Covid virus; herself tested positive for the Covid virus; eye sight ... Read more
herself tested positive for the Covid virus; herself tested positive for the Covid virus; eye sight is not right and my sugar level is super high; eye sight is not right and my sugar level is super high; four blood noses; This is a spontaneous report from a contactable consumer (patient husband). A 49-years-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Mar2021 (at the age of 49-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine on 06Mar2021 and she was scheduled to receive the second dose on 27Mar2021. On 23Mar2021, the patient started experiencing a wet cough. She received a positive PCR test on 25Mar2021 and started having some symptoms. The patient entered the hospital on 26Mar2021 and was admitted for nine days due to low oxygen, in which they gave her remdesivir, plasma, and steroids. She was discharged from the hospital on 03Apr2021. She had ended isolation. She is home now. She still cant smell or taste anything. She retested two weeks later as a follow up and was still positive for Covid. Her "eye sight is not right and my sugar level is super high," in which she believes is from the steroids she was given. She had four blood noses last week, in which she has never had a blood nose in her life. The first week she was very tired, using the bathroom constantly, and had no taste or smell. Her infectious disease doctor told her based upon her treatment regiment, she would need to wait until after 04Jul2021 to get vaccinated and that she would need to get the series again, "as if it was new." She still has not received the second dose of the Pfizer Covid-19 vaccine. She was told she couldn't receive the second shot until 03Jul2021. They advised her to wait 3 months before receiving the vaccine. Also read it is recommended to wait 3 months before getting the vaccine if you received a plasma treatment. These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation. Lastly, the interim considerations state that a prior COVID-19 infection may lower the risk of getting infected again (for a certain amount of time) so if vaccine supply is low, some people with a recent COVID-19 infection may choose to wait to receive their first dose of COVID-19 vaccine. You should talk to your doctor or other health care professional about this. Pfizer is independent of these recommendations. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested.
49 2021-05-23 taste impairment Pfizer-BioNTech COVID-19 Vaccine EUA: during follow-up encounter with allergy clinic patient reports... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: during follow-up encounter with allergy clinic patient reports metallic taste within thirty minutes of vaccination. Two hours later developed headache and fatigue. Two days later developed lower extremity swelling, low heart rate (52 beats per minute), blister on neck/upper back, leg pain, neuropathy, and left arm bruising where immunized. Six weeks later symptoms are beginning to resolve. Patient advised to continue current medications for reaction.
49 2021-05-23 oral mucosal blistering Headaches, fever and mouth blisters.
49 2021-05-24 swollen tongue, mouth swelling hives and swelling (whole body including mouth, tongue, face)
49 2021-05-24 vision blurred, blindness Patient came to the pharmacy 5/25/21 at 1:20pm to alert us that she had reactions that started 4-5 d... Read more
Patient came to the pharmacy 5/25/21 at 1:20pm to alert us that she had reactions that started 4-5 days after getting her first dose of Pfizer. She reports that her blood sugar increased >400 and >600 4-5 days after the dose. The patient spoke with her Dr and the Dr told her to increase her Lantus and Apidra. The patient also reports getting pain in her right leg that caused trouble walking, bruising on hip that both started 4-5 days after the dose. Patient reports headache, insomnia due to pain and increased blood sugar. Patient reports now sleeping a lot because of exhaustion and having to check her blood sugar every 2 hours and drink lots of water as directed by her Dr. Patient says she finally got her blood sugar down below 120 on Friday 5/21/21. Patient reports she lost some vision and had blurry vision in her left eye that started 5-6 days after the dose. Patient says her A1C was 5.6 before the Pfizer dose and after the dose her blood sugar was uncontrolled. Patient says her Dr told her to go to the ER if her symptoms continued. Patient also spoke with someone at the CDC and they told her they would follow up with her regarding her symptoms and they will let her know if she should get her second dose.
49 2021-05-25 mouth numbness pain at injection site and surrounding area, numbness to cheek and tongue, no swelling
49 2021-05-26 mouth numbness, lip swelling Unspecified lot, unspecified arm. Pain, swelling. Per patient: MELAS patient. First Shot Pfizer. ... Read more
Unspecified lot, unspecified arm. Pain, swelling. Per patient: MELAS patient. First Shot Pfizer. Pain in arm and chest. Unilateral numness of face/tongue and unilateral swelling of lips. One shot benadryl. Improved swelling.
49 2021-05-26 vision blurred slight sporadic blurriness of vision.; slight headache; Soreness at site of administration; full bod... Read more
slight sporadic blurriness of vision.; slight headache; Soreness at site of administration; full body aches; soreness at site of administration, full body aches; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female the received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 09:45(at the age of 49-years-old), as a second single dose for COVID-19 immunisation. No significant medical history included. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included vitamins D (MANUFACTURER UNKNOWN) and Vitamin B3 (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and unknown if its ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (Lot number: EL3247), in the left arm on 23Feb2021 at 09:45AM (at the age of 49-years-old), as a first single dose for COVID-19 immunisation and experienced general but mild full body aches, Soreness and tenderness at the injection site. On 16Mar2021, the patient was experienced soreness at site of administration, full body aches, slight headache, slight sporadic blurriness of vision. The patient did not receive any treatment for all the events. The clinical outcome of vaccination site pain, general body pain, slight headache, slight sporadic blurriness of vision was recovering. No follow-up attempts are needed. No further information is expected.
49 2021-05-27 vision blurred 49 y/o female without significant PMH other than anaphylaxis from a dental procedure, who presents ... Read more
49 y/o female without significant PMH other than anaphylaxis from a dental procedure, who presents to the emergency room with multiple complaints after receiving her second SARS-CoV-2 Pfizer vaccination today at about 3-3:30 PM, lot number not current available. The patient's significant other/boyfriend was driving when he noticed the patient suddenly started to complain of shortness of breath with chest pain and a maculopapular rash which later was followed by expressive aphasia and left hemiparalysis. She received Pepcid, solumedrol and Benadryl for the rash in the ER with improvement. Code neuro was called and TPA was given. Post TPA she was alert and oriented and she could currently write with her right hand and think of the words she has to say. She had associated blurry vision which has resolved after TPA was administered. She also was not able to move her left lower extremity nor her left upper extremity which is also improving to some extent after TPA administration. So far CT/CTA head and CTA neck are negative and she has been admitted for likely acute cerebral vascular accident.
49 2021-05-28 mouth numbness coughing; face went numb as well as her tongue and hands for two and half days; face went numb as we... Read more
coughing; face went numb as well as her tongue and hands for two and half days; face went numb as well as her tongue and hands for two and half days; maybe she had an allergic reaction to the first one; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events for two patients. This is one for two reports. A 49-year-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04May2021 (Batch/Lot Number: EW0171) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that for the first 15 minutes she was fine but aafter like 25 minutes, her face went numb as well as her tongue and hands for two and half days. She was "feeling like death for two days and a half ." Because she needed to work that day, she took fexofenadine (ALLEGRA 180 mg) because "it's for allergies" and massaged her face, tongue and hands. After that, she felt okay. Her daughter, aged 18 had the same vaccine, and had the same exact reaction but received it at the+3 hospital. Her sister received Pfizer Covid 19 vaccine but in its a 90 day interval between doses. Her doctor told her maybe she had an allergic reaction to the first one and wasn't sure if she should get the second dose. She was told to call Pfizer to see what they recommend. Primary care told her to call Pfizer to make sure if she is supposed to take the second one or if she needed to choose a different kind like Moderna or maybe Johnson and Johnson because of the side effect. Patient also stated "after my shot, I had horrible coughing. I am coughing for like 2 weeks but I don't know if it is related with my vaccine or not. I am going to hospital tonight to check." Outcome of the event coughing was unknown, and of remaining events was recovered on an unspecified date. Additional information has been requested.
49 2021-05-28 ringing in ears Tinnitus. Mild to moderate. Began the next morning and still going on.
49 2021-05-28 vision blurred, lip itchiness, tongue itchiness Blurred vision, itching lips, arms and tongue Facility took vitals and gave me a dose of 25mg Bena... Read more
Blurred vision, itching lips, arms and tongue Facility took vitals and gave me a dose of 25mg Benadryl
49 2021-05-31 swelling around the eyes Herpes Zoster Ophthalmicus (HZO); onset of symptoms 05/02/2021, including painful rash, blisters, fa... Read more
Herpes Zoster Ophthalmicus (HZO); onset of symptoms 05/02/2021, including painful rash, blisters, fatigue, headache, shooting and buring pain, swollen rash along forehead and over left eye.
49 2021-06-01 mouth numbness, mouth tingling numbness/tingling or vibrating feeling in lips; numbness/tingling or vibrating feeling in lips; tire... Read more
numbness/tingling or vibrating feeling in lips; numbness/tingling or vibrating feeling in lips; tiredness; light headedness; tingling sensation has spread to my entire body.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6202, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 02Mar2021 10:00 (at the age of 49-years-old) as unknown, single dose for COVID-19 immunisation. Medical history included diabetes mellitus, arthritis, morbid obesity, alopecia areata, psoriasis and sensitivity to glues used in band aids and other chemical sensitivities; all from an unknown date. Concomitant medications included glyburide, sitagliptin (JANUVIA), insulin aspart (NOVOLOG), insulin detemir (LEVEMIR) and telmisartan all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 02Mar2021 10:30, the patient experienced numbness/tingling or vibrating feeling in lips, tiredness and light headedness; tingling sensation has spread to my entire body on 02Mar2021. It was reported that numbness/tingling or vibrating feeling in lips occurred at just over half hour after dose. By end of the day the tingling sensation has spread to the entire body. The tingling was not over whelming but definitely there. The patient has also experienced tiredness and light headedness but to a minor degree. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible. No further information expected.
49 2021-06-01 swelling of eyelid Why was the patient taking Covid-19 vaccine (Verbatim): because she is diabetic; swelling under eyel... Read more
Why was the patient taking Covid-19 vaccine (Verbatim): because she is diabetic; swelling under eyelids; swelling on chin and left cheek; had an allergic reaction with a rash; rash from neck up on chin and cheeks; This is a spontaneous report from a contactable reporter(patient herself). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, administered in right arm on 29Apr2021 at 14:30 as single dose for COVID-19 immunization. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. AE(s) following prior vaccinations was reported as none. Medical history included type 2 diabetes mellitus. It was reported that she ran out of medication and was not taking anything for diabetes. Family Medical History Relevant to AE(s) included that her father had a positive result after getting the vaccine. Her father has rheumatoid arthritis including pain all over. After getting the vaccine, the pain went away. Her father also had a rash on his arm that cleared up after getting the vaccine. No relevant tests were done as reported. Concomitant medication included Azo from 27 Apr 2021, ongoing and Nervive taken for nerve relief from 27 Apr 2021 and stopped taking it on 03 May 2021. It was reported that she was fine but had an allergic reaction with a rash from her neck up that was on her chin and cheeks around 1700-1800 on 29Apr2021. She had swelling under her eyelids on 30Apr2021 and on the bottom of her cheek on 30Apr2021. It was also reported that the patient took Covid-19 vaccine because she is diabetic. She was scheduled to get the second injection today(20May2021) and was asking if she should get it. She mentioned that she does not have a physician. She thought she had a reaction to it. Lot 1069C95021, Expiry Feb 2023.. The outcome of the events, off label use was unknown and rash from neck up on chin and cheeks and swelling on chin and left cheek was recovered on 11May2021, rash from neck up on chin and cheeks was recovered on 03May2021. Follow up attempts are needed. Further information has been requested.
49 2021-06-02 ear discomfort Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: heavy menstrual flow for 2 pe... Read more
Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: heavy menstrual flow for 2 periods after her 2nd vaccine, ears feel blocked, lump in chest, chest pain
49 2021-06-02 mouth tingling Pt felt whoozy, off, the body felt "weird"/ Dizzy; Heaviness in the brain; Mild nausea; lips were ti... Read more
Pt felt whoozy, off, the body felt "weird"/ Dizzy; Heaviness in the brain; Mild nausea; lips were tingling; This is a spontaneous report from a contactable Physician in response to HCP letter sent in cross reference case that included first dose. A 49-year-old female patient received second dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot Number: EL1283), via an unspecified route of administration on 13Jan2021 (at the age of 49-years) as 2nd dose, single for COVID-19 immunisation. The vaccine given in presence of MD (allergist) at cancer centre. Reportedly, skin test was done which was negative. It was not administered at military facility. Medical history included pernicious anaemia (Parietal Cell Ab+) (Onset date was reported as years), Hx anaphylactic reaction to contrast dye, Hx burning skin with gadolinium, HLD, PND, dysuria, seasonal allergy. Concomitant medications included (VITAMIN B12 [CYANOCOBALAMIN]) 1000 mcg daily SL (sublingual) for Pernicious anemia, Bupropion Hydrochloride (WELLBUTRIN) 150 mg PO (Per oral) BID (twice a day), Budesonide, Formoterol Fumarate (SYMBICORT), ALBUTEROL [SALBUTAMOL] PRN (As needed), Sertraline 75 QD (Once a day), Omeprazole PRN (As needed), Folic PRN (As needed) and vitamins. The patient previously took first dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot Number: EH9899), via an intramuscular route of administration, administered in deltoid left on 22Dec2020 at 10:00 for COVID-19 immunisation at hospital and after 10 minutes, patient experienced light-headed, 30 minutes heavyness, in the brain, lips were tingling. Patient was given epipen, felt in a fog and was taken to ER for observation. Patient felt nauseated before Epi, palp/SOB after Epi. Felt like throat was tight. Reportedly, reactions recurred on readministration of product. On 13Jan2021 (same day of vaccination), patient felt whoozy, off, the body felt weird/ dizzy, heaviness in the brain, mild nausea, lips were tingling. These symptoms occurred almost immediately. After second dose patient was under observation at cancer center. Patient was not admitted to hospital. Causal relationship was yes. Patient did not decease. Therapeutic measures were taken as a result events included Benadryl IV and the symptoms resolved in 30-minutes. Then Patient received completion of dose without symptoms. The patient underwent lab test which included unspecified Skin test: Negative on 13Jan2021, no other relevant tests were done. The reporter considered the Pfizer product had a casual effect to the adverse event. The outcome of all the events was recovered. Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-06-03 mouth numbness Perioral and hand numbness shortly after vax. No actual OP or chest sx. No rash. Pulse 83 Ox 97% ... Read more
Perioral and hand numbness shortly after vax. No actual OP or chest sx. No rash. Pulse 83 Ox 97% Likely vaccine reaction. Felt better with lying down and pushing PO fluids.
49 2021-06-06 ringing in ears Tinnitus
49 2021-06-07 deafness unilateral, permanent deafness Sudden Idiopathic Sensio Neuro Hearing Loss in the my left ear, severe/profound loss
49 2021-06-07 eye pain 6/2/21 A 1/2 inch long bump/rash appeared on the right side of my scalp. It didn't itch or hurt. 6/3... Read more
6/2/21 A 1/2 inch long bump/rash appeared on the right side of my scalp. It didn't itch or hurt. 6/3/21 I woke up with a headache on the right side of my head. Felt like a sinus headache, behind my eyes and sinus cavity. 6/4/21 Still had headache and bump on scalp. The right side of my face from my forehead to my eyelids had a painful burning sensation when even lightly touched, almost like a pins and needles feeling but painful. A linear rash appeared on my right middle forehead. 6/4/21 1:20 Doctor diagnosed shingles. By 3pm I had started a 7 day course of Valacyclovir 1 GM 3 times a day. By evening my head hurt to the point of taking 800mg Ibuprofen for relief every 8 hours. Extreme fatigue for the next 3 days. 6/5/21 Head pain continued, with rash spreading throughout right side of scalp and down right side of face, even on eyelids. 6/7/21 Symptoms began to lessen, but head pain in spurts. 6/8/21 Visit to Ophthalmologist at 11:20 am. No lesions on eye. Prescribed Steroid eye drops 2x a day for 1 week. No pain in eye. Head pain almost gone. Energy returning.
49 2021-06-08 eye swelling I was very tired for several days. My eyes and face were swollen for over a week. My arm has been r... Read more
I was very tired for several days. My eyes and face were swollen for over a week. My arm has been red and tender with a hard long lump to the right of the injection site for almost two weeks since the vaccination.
49 2021-06-08 ringing in ears, deafness unilateral Sudden hearing loss in left ear; Tinnitus; This is a spontaneous report from a contactable consumer ... Read more
Sudden hearing loss in left ear; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:15 (at 49 years old) as 1st dose, single dose for COVID-19 immunization given in an public health department. The patient's medical history was none. Concomitant medication included amitriptyline taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested since vaccination. No known allergies. On 12Apr2021 07:00, the patient experienced sudden hearing loss in left ear and tinnitus. The patient had a physician office visit and was treated with prednisone and steroid injections. The reporter assessed the events as non-serious and the events did not lead to death or life threatening condition, hospitalization, disability, or congenital anomaly. The outcome of the events was not recovered.
49 2021-06-09 eye twitching I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a f... Read more
I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a fever over 101 for 8 days; I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a fever over 101 for 8 days; I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a fever over 101 for 8 days; I ran a fever over 101 for 8 days; I had total loss of apetite with a 7 pound weight loss over 10 days; I had total loss of apetite with a 7 pound weight loss over 10 days; I have extreme fatigue and joint pain that still persists and is debilitating; I have extreme fatigue and joint pain that still persists and is debilitating; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0142) via an unspecified route of administration, in arm left on 13Jan2021 18:15 as first dose, single dose for COVID-19 immunization. Medical history included thyroid cancer, hashimotos, GERD and vitamin d deficiency. Patient had known allergies of penicillin and sulfa. Concomitant medications included levothyroxine sodium (SYNTHROID), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), esomeprazole magnesium (ESOMEPRAZOLE MAGNESIUM) and ampicillin trihydrate (ALPRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On 15Jan2021 the patient had tingling and numbness in arm, hand and face for 10 days with twitching of my eye, ran a fever over 101 for 8 days, total loss of appetite with a 7-pound weight loss over 10 days, extreme fatigue and joint pain that still persists and is debilitating. The patient underwent lab tests and procedures on Jan2021 which included body temperature over 101 and weight: 7-pound weight loss had total loss of appetite, on 20Jan2021 and 27Jan2021 Covid test result: Negative, sars-cov-2 test: negative. The patient was received treatment currently on my second Medrol dose pack. The patient was currently on her second steroid pack with no relief in symptoms. She was advised to wait to take her second shot by her physician. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
49 2021-06-09 double vision Initial nausea and lightheadedness, followed by headaches day of shot and next day. 2 days after sho... Read more
Initial nausea and lightheadedness, followed by headaches day of shot and next day. 2 days after shot incredible dizziness in the a.m. 1 hour after waking which lasted all day. Dizzy sitting and standing. Saw double vision with slight headache. Slight sweating. Not hungry. Urged to go to ER due to possible stroke; however, all tests proved stroke negative. The dr. finally admitted it was a possible vaccination side effect, which I initially told them it was most likely the cause.
49 2021-06-09 ringing in ears I took the first dose of the Pfizer vaccine on 5/4/2021. On 5/5/2021, I began experiencing shortness... Read more
I took the first dose of the Pfizer vaccine on 5/4/2021. On 5/5/2021, I began experiencing shortness of breath, my chest was very tight, and I felt like someone was sitting on my chest. I felt like I was having an out of body experience and didn?t feel well. This continued until 5/14/2021 and seemed to resolve, but returned with a vengeance on 5/21/2021. The shortness of breath was much much worse and so was the tightness and pressure in my chest. I also had ringing in my ears. The day I took the vaccine (on 5/4/2021), my period had started, but stopped that day and didn?t return until 28 days later. I saw my doctor and he ordered an EEG and a stress echo test. The EEG returned normal, but I am waiting to go in for the stress echo test. I do not plan on taking the second dose because I?m very afraid of what might happen to me if I do. I am in excellent health and do not suffer from allergies. These side effects were awful! I didn?t start feeling better until the first week of June. I don?t know if these symptoms will return. I still have ringing in my ears that comes and goes.
49 2021-06-10 mouth tingling 15 minutes after administration of Pfizer Covid19 vaccine, client complaints of slight nausea. Nause... Read more
15 minutes after administration of Pfizer Covid19 vaccine, client complaints of slight nausea. Nausea continued. 30 minutes after administration, became very nauseated, chest tightness, tingling lips, tingling tongue, skin pale, and tip of nose purple in color. Assessed by Dr., onsite doctor. Orders received to give Epinephrine and Benadryl 50mg/ml IM and send to Emergency Room for monitoring. Epi-pen given in right thigh. Benadryl 50 mg/ml given left deltoid IM. Informed spouse to take patient to Emergency Room immediately. Phoned patient @ 4:40pm. States she is currently at Emergency Department. States feels no worse than before, but they were planning to monitor her for at least another hour.
50 2021-01-03 mouth tingling, lip swelling 1 hour after administration, patient's lips tingling and she experienced swelling as well. Patient r... Read more
1 hour after administration, patient's lips tingling and she experienced swelling as well. Patient received 25mg diphenhydramine and was observed for 30 mins. Symptoms resolved over 30 minutes.
50 2021-01-04 mouth numbness, drooling Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and... Read more
Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness. She was given benadryl and pepcid, monitored for 3hrs before discharge from ED. Patient still experiencing same symptoms 1 week later per follow-up (12/29)
50 2021-01-04 taste disorder, taste impairment, loss of taste, dry mouth body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to ex... Read more
body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020 06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date. The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events was unknown.
50 2021-01-04 tongue discomfort, mouth tingling Burning/ tingling tongue
50 2021-01-04 tongue itchiness, mouth tingling 8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and bro... Read more
8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and brought her epi pen with her. Brought her to EMS station. 8:32 Gave epi 8:35 HR126 SPO2 100% 8:38 IV placed 8:39 POC 108 8:39 Benadryl 50mg IV push 8:40 Solumedrol 125 mg IV push Continued tongue/throat/ head itching 8:42 second epi given 8:46 136/64 HR 125 8:48 Transported to Medical Center via EMS
50 2021-01-05 lip swelling Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a t... Read more
Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a thick hoodie and when I pulled my sleeve up, it was covered with hives and welts. My lower lip started to feel full and nose started to feel runny. I was close to a pharmacy when I discovered the hives so I went and bought Tylenol and Benadryl and took it immediately. After that, I headed to the emergency room of the facility where I got my covid 19 -Pfizer injection. When I got there, my right arm started to feel itchy as well and I also broke out in a rash on my left upper chest. They gave me a steroid injection and steroid taper prescription. When I got home that night, my right forearm broke out in hives. The next couple of days, my left arm intermittently had hives.
50 2021-01-05 mouth pain, burning mouth syndrome, toothache Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened ... Read more
Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened with chewing and eating on left side on day one. Symptoms became worse during the day with electric like pain radiating to the maxilla, TMJ and temple. Symptoms persisted as episodic aching and electrical radicular pain 1/5 so I saw my dentist in the afternoon with a negative work up on exam and xray. Pain worsened and pattern expanded to include pain under tongue on left side. There are times there is no pain and then the pain will come on without known cause, but anytime with eating or chewing the pain starts and is exacerbated. Also impacted by hot items/drinks. I have tried ibuprofen and tylenol sinus medications without impact on episodic flares of pain.
50 2021-01-05 pain in jaw, mouth pain . Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the... Read more
. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the jaw line including the roof of my mouth. I took 3 Advil at the time and the woke again a couple hours later and took 2 more. In the morning it seemed fine. I have noticed a very slight change to my lower left eye - it seems lower.
50 2021-01-05 swollen tongue swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w... Read more
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
50 2021-01-06 dry throat, eye swelling The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf... Read more
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
50 2021-01-06 eye pain Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stingin... Read more
Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stinging; extreme lethargy
50 2021-01-06 lip swelling patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 an... Read more
patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 and after 45 minutes, she came back and stated she has chest tightness, lip swelling, chest congestion, shortness of breath, asthma-like symptoms with mucus type in her chest. her BP at that time was 184/109. She was given 1 EpiPen and 2 Benadryl 25mg tablets.
50 2021-01-06 ringing in ears tinnitus, face tingling, lymph pain, general muscle pain
50 2021-01-07 ear discomfort Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear,... Read more
Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear, dizziness.
50 2021-01-07 eye irritation 10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were ... Read more
10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were burning. I went to bed under 3 blankets and couldn't get warm. 5 hours later, the chills went away, but the pain persisted. 3 hours later, I took tylenol for the pain and felt much better 1 hour later.
50 2021-01-07 pain in jaw 01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Ty... Read more
01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Tylenol reduced fever to 100.8, body aches and joints, slight cough
50 2021-01-07 drooling, mouth numbness numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a... Read more
numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular on 22Dec2020 at single dose for Covid-19 immunisation. Patient was not pregnant. The patient medical history was not reported. Concomitant medication included meclizine, ondansetron (ZOFRAN), famotidine. The patient was admitted to emergency room (ER) post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness on 22Dec2020. She was given Benadryl and Pepcid, monitored for 3 hours before discharge from ER. Patient still experiencing same symptoms 1 week later per follow-up (29Dec2020). This case was reported as non-serious. The outcome of events was unknown.
50 2021-01-07 tongue discomfort, burning mouth syndrome sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong... Read more
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
50 2021-01-08 eye pain, eye discomfort 01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and... Read more
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
50 2021-01-08 mouth tingling, tongue discomfort Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. Sh... Read more
Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. She approached writer at 1310 in no apparent distress. She voiced symptoms that were concerning to her. She indicated about 5 minutes after she received the injection, her tongue felt like it was burning and tingling. She also stated her chest was burning. Denies every having these symptoms ever before. She currently denied shortness of breath, chest pain, shoulder pain, nausea, or throat swelling. No changes in voice were observed by writer. Last time patient ate was between 0930 and 1000 this am. Patient shared that she was feeling anxious about having the vaccine and wonders if this is the reason why she is having the symptoms. Vitals taken, all within normal range.   Patient encouraged to remain for 30 for observation. No further concerns were verbalized to writer during her stay. Patient was encouraged to call 911 if she develops shortness of breath, chest pain, throat swelling or other concerning symptoms after she leaves. Patient verbalized understanding and was agreeable with plan.
50 2021-01-08 vision blurred Since administration - Chest pain, Shortness of breath, blurred vision, headache, nausea, and chills
50 2021-01-09 oropharyngeal discomfort STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB,... Read more
STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB, NAUSEA, RASH. I STILL HAVE SOB AND I DONT KNOW IF IT WILL BE TEMP OR PERMANENT.
50 2021-01-09 swollen tongue, lip swelling swollen lips and tongue and rash I woke at 8 am with swollen lips and my tongue felt funny. I took 5... Read more
swollen lips and tongue and rash I woke at 8 am with swollen lips and my tongue felt funny. I took 50 mg of benadryl at 815, at 830 I took zyrtec 10 mg and went to the ER. At 945 they gave me a shot of decahedron and discharged me at 10 30 with prescription for oral steroids, epi pen and instructions to take pepcid, zyrtec twice daily and benadryl as needed.
50 2021-01-10 drooping eyelid I received botox and Juvederm exactly 1 week prior to vaccination. After the Pfizer vaccine I have ... Read more
I received botox and Juvederm exactly 1 week prior to vaccination. After the Pfizer vaccine I have developed a droopy left eye. The droopy eye was not present prior to the vaccination and I was 1 week post botox/juvederm injection . No other facial asymmetry noted. Following up with my primary MD about eye and to discuss my second dose which is scheduled tomorrow 1/12/2021
50 2021-01-10 oropharyngeal discomfort Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER... Read more
Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER visit.
50 2021-01-11 dry throat not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she wa... Read more
not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.
50 2021-01-11 taste impairment, mouth tingling, ear itchiness both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ... Read more
both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date. No follow up attempts are possible. No further information is expected.
50 2021-01-11 mouth numbness, eye pain Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 m... Read more
Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in right deltoid. Pain progressed over the next 5 days to arm and left eye. Dizziness, mouth drooping, and numbness developed. Went to ED and diagnosed with Bell's Palsy. Evaluated in ED for possible causes. Vital signs stable. CVA ruled out. Patient given ketorolac, droperidol, and IV fluids for her headache. Prescribed steroids and acyclovir for Bell's Palsy treatment. Prescriber instructed patient to return to ED immediately if symptoms worsen or additional symptoms develop. Follow up with patient on 1/5/21 with patient reporting some improvement in symptoms. Patient reported having a headache for 2 weeks straight prior to presenting to the ED on 1/3/21. Vaccine was administered on 12/28/21. Unsure if the Bell's Palsy was a result of the vaccine or some other inciting factor.
50 2021-01-11 oropharyngeal discomfort Rash, hives, throat discomfort, treated with 1 dose of IM epinephrine, benadryl, pepcid, solumedrol,... Read more
Rash, hives, throat discomfort, treated with 1 dose of IM epinephrine, benadryl, pepcid, solumedrol, and albuterol
50 2021-01-11 sensitivity to light, extreme sound sensitivity Fever, headache, nausea, muscle spasms, sensitive to noise and light, loss of appetite, very tired
50 2021-01-12 swollen tongue Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with resi... Read more
Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with residual left cheek swelling.
50 2021-01-12 swollen tongue Right-sided tongue swelling 13.5 hours after administration of second dose of the vaccine. Resolvin... Read more
Right-sided tongue swelling 13.5 hours after administration of second dose of the vaccine. Resolving with benadryl and pepcid.
50 2021-01-13 ear discomfort Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours afte... Read more
Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours after vaccine dose. Treated with inhaler, Claritin, Zyrtec and Benadryl. Symptoms reoccurred every 4 hours x3 and then resolved.
50 2021-01-14 eye swelling, eye itchiness Swelling around both eyes, itching around eyes, progressing to general facial itching. Swelling wors... Read more
Swelling around both eyes, itching around eyes, progressing to general facial itching. Swelling worsening over the 5 days after injection leading to Urgent Care visit.
50 2021-01-14 lacrimation increased Employee received vaccine at 10:30 10:40- during post-vaccination observation period, Employee repor... Read more
Employee received vaccine at 10:30 10:40- during post-vaccination observation period, Employee reported sensation in throat while swallowing, eyes watering, occasional cough-Denies troubles breathing, denies swelling of lips tongue or throat. Drank water without difficulties 10:49- Provided 25mg of PO liquid diphenhydramine Observed- continued to have symptoms. Emergency Response Team called 10:55- Pt reports some improvement in symptoms- coughing resolved 11:02- Additional 25mh of PO Liquid diphenhydramine provided. Pt was transported to Emergency Room for Evaluation
50 2021-01-14 mouth tingling 10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing.... Read more
10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing. Is experiencing watering eyes and occasional coughing 10:49- received dose of 25mg diphenhydramine with slight improvement in symptoms, not resolved. 10:52- notes sensation of tingling tongue- Emergency Response Team called 11:02- 2nd dose of 25mg PO diphenhydramine administered Emergency Response Team Staff transports Employee to Emergency Room
50 2021-01-14 mouth tingling Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to ... Read more
Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
50 2021-01-14 feeling of choking Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient beg... Read more
Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient began coughing. Patient reported throat tingling and itching that spread to her face as well. Patient reported a severe headache as well.
50 2021-01-14 swollen tongue, lip swelling We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta... Read more
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
50 2021-01-14 swollen tongue Patient reported feeling throat tight, tongue thick - lightheaded with fluctuating temperature : bp... Read more
Patient reported feeling throat tight, tongue thick - lightheaded with fluctuating temperature : bp 168-144/100-94 during episode with pulse ox 96%. patient was rosy and flush. Administered 1 epinephrine pen and 50 mg oral diphenhydramine . patient monitored from 3 pm until 530 pm and advised to see primary care provider
50 2021-01-14 ringing in ears funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This ... Read more
funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FK4176), intramuscularly on 07Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 13:30 on the right arm for COVID-19 immunization and experienced funky lightheadedness, vertigo, normal tinnitus got louder and oscillating up and down, and sinus headache. Concomitant medication included colecalciferol (VITAMIN D). On 07Jan2021 at 13:30 (as reported), patient experienced funky lightheadedness, weird feelings in head, and tinnitus was noticeably oscillated up and down. The events were assessed as non-serious. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on 07Jan2021 at 15:30.
50 2021-01-14 ringing in ears Funky lightheadedness; Normal tinnitus got louder and oscillating up and down; Sinus headache; Verti... Read more
Funky lightheadedness; Normal tinnitus got louder and oscillating up and down; Sinus headache; Vertigo; This is a spontaneous report from a contactable pharmacist. A 50-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscular at arm right on 17Dec2020 13:30 at single dose for COVID-19 immunization at a Workplace clinic. The patient's medical history was reported as none. No known drug allergies. Concomitant medication (received within 2 weeks of vaccination) included ergocalciferol (VIT D). The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that while getting first dose, patient experienced instant "funky lightheadedness, vertigo. Normal tinnitus got louder and oscillating up and down. Next day after first dose (18Dec2020), patient had sinus headache and vertigo, took meclizine and went back to bed. Felt fine when she woke up. The outcome of the events sinus headache and vertigo was recovered on an unspecified date, for the rest of events was unknown. The reporter consider the evens as non-serious.
50 2021-01-17 swelling of eyelid SEVERE SWELLING OF LEFT EYE LID AND MILD SWELLING LEFT SIDE OF HER FACE. REDNESS.
50 2021-01-18 ear pain low grade fever (99.5), significant left arm pain radiating to neck, ear, hand, and fingers, arthral... Read more
low grade fever (99.5), significant left arm pain radiating to neck, ear, hand, and fingers, arthralgias, myalgias.
50 2021-01-18 mouth numbness, oropharyngeal discomfort, tongue discomfort Numb lips within 15 min, along with chills, headache and nausea. Followed by sore throat and runny n... Read more
Numb lips within 15 min, along with chills, headache and nausea. Followed by sore throat and runny nose. I had taken Benadryl and Prednisone before hand because had all above symptoms with first Pfizer shot (EJ1685). The following days I had severe headaches with nausea and dizziness and lethargy as well as diarrhea. Four days later after the shot on the 1/15 I experienced fluid accumulation in the lungs followed by burning sensation on the tongue, numb lips, and a sensation of swelling in the inner lining of the throat. With Benadryl symptoms subsided.
50 2021-01-19 dry throat Fever, headache, chills, dry throat, body aches
50 2021-01-19 eye swelling, lip swelling Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swell... Read more
Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swelling on cheeks, chin and swelling of lips. Immediately took 25mg of Benadryl. Sought treatment at an UTC for evaluation. I did not have trouble breathing and oxygen saturation was good, always above 97%. Upon reaching clinic 1 hour later, swelling and redness had gone down. Doctor diagnosed it as a localized allergic reaction to vaccine. I was given another 25mg of Benadryl and prescribed prednisone 20mg for 3 days. Swelling and redness has been intermittent since yesterday. All swelling and hives are confined to the face. I have been taking 50mg pf Benadry every 6-8 hours continuing this evening. It should be noted that I pre medicated with Benadryl the 2 nights before vaccination, the morning of, 1 hour after the shot and late evening the day I received the vaccine. I knew with my history of allergies I was at higher risk of allergic reaction. Please note the facial, eye and lip swelling began the following morning, 12 hours AFTER my last dose of Benadryl.
50 2021-01-19 mouth numbness perioral numbness with HA. Difficulty swallowing & breathing. Pt felt it was likely due to the N95... Read more
perioral numbness with HA. Difficulty swallowing & breathing. Pt felt it was likely due to the N95 mask. Given procedural mask and reported improvement of symptoms. Rapid response contacted. No other intervention
50 2021-01-20 inability to speak She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy ... Read more
She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy throat and loss of voice and breathing was 'heavy'. She reports pallor, increased heart rate and near syncope. She denies pruritis, urticaria, flushing, watery eyes, face/tongue or lip swelling, CP, cough. She was seen in ER and treated with zofran, pepcid, solumedrol, monitored and then released. ER records note tachycardia at 107 but otherwise normal VS and exam. .
50 2021-01-20 vision blurred inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); ... Read more
inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient). A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events. Information about Lot/Batch number has been requested.
50 2021-01-21 ear discomfort On the 20th, had significant nausea that improved with zofran, and on the 21st, my ears started burn... Read more
On the 20th, had significant nausea that improved with zofran, and on the 21st, my ears started burning and when I looked in the mirror saw that they were extremely red, and then saw that my neck was red, pulled my long sleeves up and noticed a rash forming and within 5 minutes had a full blown body rash and redness; I was given a Benadryl and then I drove to the Urgent Care Clinic and was treated with Dexamethasone, and a Pepcid which resolved the rash within 20 minutes .
50 2021-01-21 vision blurred Patient experienced dizziness, diaphoresis and blurry vision. Patient was given water, covered with ... Read more
Patient experienced dizziness, diaphoresis and blurry vision. Patient was given water, covered with a blanket and allowed to lie down. Placed on 2lpm via nasal cannula and monitored via blood pressure cuff. Patient recovered after 30 minutes of observation and was safely released. Follow up later in the afternoon and the next morning were done with patient who stated she was doing very well.
50 2021-01-23 vision blurred Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tyleno... Read more
Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tylenol and Ibuprofen.
50 2021-01-24 dry throat 1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes... Read more
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
50 2021-01-24 mouth numbness 1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient... Read more
1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient felt numbness of lips -- > sent to ER
50 2021-01-24 swollen tongue Itchy face, tongue swelling, face swelling
50 2021-01-25 taste impairment 5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injecti... Read more
5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injection site became red, swollen (knot under skin) and grew in size to a silver dollar. My left arm was sore. Redness and swelling dissipated on 4th day and looked like a bruise. About 6pm on 4th day, I was itchy on my stomach. I didn't think twice as had a neoprene/spandex brace around stomach/back from exercise. When I finally took a shower at 8pm, I noticed my torso was completely red. I immediately took 2 Benadryl. Throughout the evening the rash/hives spread to my shoulders. Took 2 more Benadryl at 1am. By morning rash around torso was almost gone, but some spread slightly to wrists, shoulders, breasts and knees. Took 2 more Benadryl at 8 am. Applied Benadryl cream to few spots on body throughout today. Itching mostly gone but splotches on legs, neck and few on back. Will take more Benadryl about 6pm.
50 2021-01-25 hearing loss The day after receiving the second COVID-19 vaccine, I had a massive headache, to the point where I ... Read more
The day after receiving the second COVID-19 vaccine, I had a massive headache, to the point where I stayed in bed and slept all day. I also noticed that my brain was foggy. The next day I was able to move to the couch, but the headache was still severe with continued brain fog. I called by PCP to see if there was anything that I needed to be doing or taking and she told me that I should start feeling better the next week. The headache remains but is mild. I have memory loss and difficulty concentrating. I am a nurse and over my weekend at work, I had difficulty doing my job because I couldn't keep track of what I was supposed to be doing and had difficulty charting. My coworkers even commented that I seemed "really different", that my memory was poor, I had personality changes (according to one person) and that my standard of care was much less than usual. One person also commented that seemed to not be able to hear her and kept asking her to repeat herself. I find myself having to concentrate harder to see when I am reading or typing something. I missed work on January 14 and 15 because of the mental fogginess and headache. I thought I was doing better, but I realized that I wasn't when I returned to work on January 23 and 24. I have spoken to my PCP on the phone once and am awaiting calls from my PCP and neurologist regarding this event.
50 2021-01-25 mouth tingling About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including lef... Read more
About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including left eyelid. It improved over several hours. I had no swelling or drooping of my face, or trouble breathing.
50 2021-01-25 ringing in ears upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is... Read more
upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date: unknown), via an unspecified route of administration on 04Jan2021 10:25 at single dose (left upper arm) for COVID-19 immunization. Medical history included asthma (diagnosed at 8 years old), covid from 2020 (she had Covid last year twice). There were no concomitant medications. The patient experienced nausea, headache, and ringing of the ears/ringing in ears on 04Jan2021; and fatigue on 05Jan2021. This went on for 2.5 days. By day 3 post vaccine (06Jan2021) got upper respiratory infection. Stated she is pre disposed because she is asthmatic. She states she took Zofran to treat the nausea, 8 mg, and that she took 1000mg Tylenol for the headache. States she received the vaccine at her employer, (healthcare center name). States the symptoms resolved after about 3 days, exact dates unknown. She wanted to know if the second vaccination is the exact same as the first. She wanted to know if Pfizer manufactures the Shingrix vaccine. Therapeutic measures were taken as a result of nausea, headache. The outcome of the event upper respiratory infection was unknown, while for other events was recovered on an unspecified date in Jan2021.
50 2021-01-26 eye pain Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surfa... Read more
Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surface areas. About 10pm developed headache, facial flushing, painful eyes, fever 101.3, rigors, and muscle cramps in feet and legs.
50 2021-01-26 mouth numbness Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingl... Read more
Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingling and numbness in my fingers I subsequently chewed three Benadryl tablets; symptoms began to resolve after about 1.5 hrs; fully resolved approximately 48 hours later
50 2021-01-26 oropharyngeal discomfort Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - S... Read more
Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - Solu-Medrol, Benadryl and Famotidine Resolution of symptoms after medication administration. Diagnosis - Allergic reaction to COVID-19 vaccine
50 2021-01-26 mouth tingling, lip swelling Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea;... Read more
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-01-26 mouth tingling, lip swelling involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl... Read more
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-01-28 ear pain Stabbing pain in left ear, facial and eye weakness, new onset Bell's Palsy
50 2021-01-28 mouth numbness pt states that within 10 minutes after vax that she experienced cool tingling sensation down both le... Read more
pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat. Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot. They checked her blood pressure and it was high at that time 153/? Pt was from out of town so transported to Urgent Care via ambulance. Her blood pressure was 170/? at this time. They did an EKG which was normal. Pt was given Benadryl. Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg. Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong. Pt is waiting for her PCP to do tele visit for a FU.
50 2021-01-28 ringing in ears New onset bilateral tinnitus, severe headaches and joint pain. 3 weeks after the injection while th... Read more
New onset bilateral tinnitus, severe headaches and joint pain. 3 weeks after the injection while the headaches had resolved, the joint pain and tinnitus were unchanged.
50 2021-01-31 loss of taste, loss of smell I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very col... Read more
I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very cold, coughing, headache and diarrhea. 36 hours after the shot I began to notice a loss of taste and smell. 48 hours I was very weak and needed to sleep for the next 3 days. Overall loss of appetite, diarrhea and very bad cough continued for at least 1 week.
50 2021-02-01 taste impairment, sensitivity to light metallic taste, hot trachea and esophagus, breathing difficulty, diarrhea, fatigue, extreme headache... Read more
metallic taste, hot trachea and esophagus, breathing difficulty, diarrhea, fatigue, extreme headache, sensitivity to light
50 2021-02-01 ear pain Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower... Read more
Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower left pain under ear, sudden onset; This is a spontaneous report from two contactable consumers. A 50-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, Post-traumatic stress disorder (PTSD), elevated pressure increased (BP), elevated cholesterol, spondylosis with radiculopathy. Known allergies: NSAID's and augmentin. Concomitant medications included hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), hydroxyzine, atorvastatin and ascorbic acid;betacarotene;biotin; calcium; chloride; chromium; copper; folic acid; iodine; iron; magnesium; manganese; molybdenum; nickel; nicotinic acid; pantothenic acid; phosphorus; potassium; pyridoxine hydrochloride; riboflavin; selenium; silicon; thiamine; vanadium; vitamin B12 NOS; vitamin D NOS; vitamin E NOS; vitamin K NOS; xantofyl; zinc (CENTRUM SILVER WOMEN 50+). On 05Jan2021 at 13:00, patient experienced lower left pain under ear, sudden onset. Then, noticed symptoms of a stroke. Left sided face droop. Patient went to ER (emergency room). Patient was diagnosed with Bell's Palsy from Covid-19 injection (1st dose). Patient received treatments for the events included prednisone, acyclovir, ointment to protect eye and eye patch for covering of left eye. Lab test included Nasal Swab: negative on 07Jan2021. Outcome of the events was resolving. Information on Lot/Batch number has been requested.
50 2021-02-01 mouth numbness, mouth tingling, taste impairment Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue;... Read more
Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue; Metal taste; Numbness/tingling in lips and tongue; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia, chicken allergy. Patient was not pregnant at the time of vaccination. Patient previously took BACTRIM and experienced allergy. There were no other medications received within 2 weeks of vaccination. The patient soreness in L arm, L trap, L axilla, LU torso, numbness/tingling in lips and tongue and metal taste on 29Dec2020 09:00. Outcome of the events was recovered. Treatment was not received for the events. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 05Oct2020 and negative on 08Nov2020. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. The events were considered non-serious.
50 2021-02-02 mouth tingling, mouth numbness Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm ... Read more
Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm and L trunk tingling. Tingling these locations resolved. Developed mild perioral tingling. At 1149 mild numbness tongue and lips. At 1155 resolving perioral tingling and numbness.
50 2021-02-03 eye irritation Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extr... Read more
Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extreme tiredness; swelling; woke up with my face swollen it went down after hot shower; Nauseous throughout the day; eyes burning; cold sores on my mouth; This is a spontaneous report from a contactable health care professional nurse, the patient. A 50-year-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), in the right arm on 19Jan2021 13:15 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Public Health Clinic facility. Medical history included asthma, Fibromyalgia and known drug allergy to penicillin. Concomitant medication included diclofenac (DICLOFENAC), clonazepam (KLONOPIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 20:00, the patient experienced pain started at exactly 8:00pm; extreme body aches (worse than my fibromyalgia), a little difficulty to breath, extreme tiredness, swelling, woke up with my face swollen (it went down after hot shower). Nauseous throughout the day, eyes burning and cold sores on my mouth and Headaches. No treatment was received given for the event. The clinical outcome of pain, extreme body aches, difficulty to breath, extreme tiredness, swelling, face swollen, nauseous, eyes burning, cold sores on mouth and Headaches were recovering.
50 2021-02-03 mouth numbness perioral numbness with HA; perioral numbness with HA; Difficulty swallowing & breathing; Difficulty ... Read more
perioral numbness with HA; perioral numbness with HA; Difficulty swallowing & breathing; Difficulty swallowing & breathing; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date not provided), intramuscular in the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergies to garlic. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium. The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies. On 23Dec2020 09:45, the patient experienced perioral numbness with HA, Difficulty swallowing and breathing. The patient felt it was likely due to the N95 mask. She was given procedural mask and reported improvement of symptoms. A Rapid response was contacted. No other intervention was done. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The patient has not tested for COVID post vaccination.
50 2021-02-04 mouth tingling, feeling of choking ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient... Read more
ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient evaluated. Peripheral IV established labs obtained. I do have concern for adverse reaction secondary to the vaccine as her symptoms started she said shortly before an hour after receiving the vaccine is started with tingling in her tongue throat and her body. She has minimal cardiac risk factors. Given she was tachycardic she cannot be perked out. EKG obtained showed no acute ischemic ST elevation or depression. Initial troponin was not elevated. Patient received 500 mL bolus of normal saline she deceived Benadryl and part of Pepcid. While the Benadryl infusion was going on patient reported feeling lightheaded and her heart rate was noted to increase to the 130s briefly. The medications were stopped, the Benadryl had already finished however the Pepcid was not completed. Her heart rate proved quickly and the lightheadedness resolved. Repeat EKG obtained did show some mild ST depression inferiorly. A repeat troponin obtained at 2 hours remain negative D-dimer was elevated to 91 therefore CTA chest was obtained. This showed no evidence of pulmonary embolism there is small groundglass opacity left upper lobe which is likely related to atelectasis do not feel that this is infectious in etiology patient has not had cough fever or chills. She remained on cardiac monitor here without any further tachycardia and her symptoms had resolved. I do believe patient's presentation is secondary to adverse reaction to the vaccination. She was advised to take Benadryl at home and may also try over-the-counter Pepcid at home for her symptoms. Did not feel that steroids were warranted at this time. She is to follow-up closely with her primary care provider. I did advise if she has new or worsening symptoms she should return to the emergency department and she expressed understanding and agreement with this plan.
50 2021-02-05 lacrimation increased 2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, ... Read more
2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, sweating, and nausea for 30 hours. Feel weak and tired now.
50 2021-02-06 sensitivity to light Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then col... Read more
Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then cold & clammy, jumbled though and speech. Soreness at injection site. Extreme tiredness. 2-days after injection, swelling of piriformis muscle in hip, extreme pain, bedridden, unable to walk, fever, for going on 36 hours. Taking 800 mg ibuprofen to sleep. Muscle cream, Epson salt baths to reduce pain.
50 2021-02-07 loss of smell, loss of taste Shakes, severe chills, temp 101.4 extreme fatigue and malaise. Headache, body aches, not smell or ta... Read more
Shakes, severe chills, temp 101.4 extreme fatigue and malaise. Headache, body aches, not smell or taste. Tylenol, fluids Motrin, rest shower and than heated blanket set to high to try and get warm
50 2021-02-07 eye itchiness, eye swelling Hives, rash, headache, itchy swollen eyes
50 2021-02-07 light flashes or floaters in the eye, blindness CENTRAL RETINAL VEIN OCCLUSION RESULTING IN LOSS OF SIGHT TO RIGHT EYE I WAS ON COMPUTER AND HAD BR... Read more
CENTRAL RETINAL VEIN OCCLUSION RESULTING IN LOSS OF SIGHT TO RIGHT EYE I WAS ON COMPUTER AND HAD BRIGHT FLASHES OF LIGHTS THE LOST VISION IN THE EYE ABOUT 2 1/2 HOURS AFTER RECIEVING VACCINE. CRVO IS RARE IN MY AGE WITH NO HEALTH PROBLEMS. SAW ER DOCTOR THAT NIGHT THEN OPTHAMOLOGIST THE NEXT MORNING WHO DIAGNOSED ME. I AM CURREENTLY PRESCRIBED A BABY ASPIRIN AND WILL HAVE TO GET INJECTIONS IN MY EYE WHEN MACULAR EDEMA OCCURS, AN EXPECTED OCCURRENCE WITH A BLOOD CLOT IN THE RETINAL VEIN
50 2021-02-08 smell distorsion I started with chill, fever of 101, head ache, tired, nauseated, achy for two days, the third day se... Read more
I started with chill, fever of 101, head ache, tired, nauseated, achy for two days, the third day severe stomach cramps from 10:00 AM to 6:00 PM, no appetite during that time, no diarrhea, the next day head ache, tired, heaviness on my head, tired, this lasted for three days. During the fourth day started perceiving a strange smell on and off, it has been 14 days and still have the smell like someone is smoking a cigar rate while in a toilet pooping. I have never smoke and hate the smell of smoke. This last symptom has been driving me insane. This is the only symptom since vaccine is lingering and is bothersome. My next shot will be on Monday the 15 of February, and I am concern, haven't been able to reach the Health Department to report or make questions, called my physician and she is out of the country, reported to the Medical Assistant who answered the phone. I only took motrin and Tylenol during the six days with the first side effects, have done nothing about the smell that is still there.
50 2021-02-09 mouth itchiness, tongue itchiness Patient received first dose of Pfizer COVID vaccine and after 20 minutes complained of tongue as wel... Read more
Patient received first dose of Pfizer COVID vaccine and after 20 minutes complained of tongue as well as roof of mouth itching. Nurse administered oral diphenhydramine 50 mg x 1 dose
50 2021-02-10 mouth ulceration, lip blister, sensitivity to light, eye pain, loss of taste, loss of smell I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on ... Read more
I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on Friday 12/18/20. On Saturday, 12/19/20, I developed severe pharyngitis, swollen glands in my neck and jaw, blisters and ulcerations on my lips and area surrounding my mouth, intra-oral and buccal lesions, severe headache, photophobia and eye pain, myalgia, skin sensitivity, GI upset consisting of nausea and diarrhea, and lost my sense of taste and smell for 48 hours. I was not febrile. The symptoms were severe on 12/19 and 12/20, with improvement on Monday 12/21. I completed an event form with Pfizer documenting the hyper-reactivity.
50 2021-02-10 bloodshot eyes Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmare... Read more
Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine. The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.
50 2021-02-10 swollen tongue tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the... Read more
tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the tongue; panicky, uncomfortable feeling; panicky, uncomfortable feeling; headache; Sore throat; Extreme tiredness; achy joints; sore muscles; generally feeling sick/unwell; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 23Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism (has had for 15 years or so). The patient's concomitant medications were not reported. The patient previously took glycerin and had allergy (has been allergic to glycerin for at least ten years). The patient received the Covid-19 vaccine on Saturday. About 10-15 seconds after receiving it, she felt like it was moving up her arm. She also had a headache and sore throat on the same day. About 20 minutes later at 13:50, she had a tightening and swelling in her throat. It was a panicky, uncomfortable feeling. She reported a "narrowing of my airway" and slight swelling of the tongue/back-of throat. She was unsure if she should wait or go to the emergency room. She took some deep breaths and waited it out. It went away 40 minutes later. She also reported feeling extreme tiredness, achy joints, sore muscles, a headache, and generally feeling sick/unwell in Jan2021. The events did not require a visit to Emergency Room and Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event headache and sore throat was recovering; event tightening and slight swelling of the tongue/swelling of throat was recovered/resolved with sequel on 23Jan2021; and unknown outcome for the other events. Information on the lot/ batch number has been requested.
50 2021-02-11 swollen tongue reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day d... Read more
reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day developed myalgias but then came into the ED due to a feeling of tongue swelling and swelling of the neck, no n/v/d, no sob/wheezing/stridor
50 2021-02-12 ear pain Numbness tingling and shooting pains in bilateral arms starting day after each shot. Seems to be wor... Read more
Numbness tingling and shooting pains in bilateral arms starting day after each shot. Seems to be worse after second dose. Pain is worse. Feels like bone pain. Had fever, nausea, body aches, neck pain , ear pain, headaches, and chills starting 12hours after 2nd dose.
50 2021-02-14 eye itchiness She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vacc... Read more
She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms. She also was hypertensive. The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine. ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below). She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine. She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia. No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
50 2021-02-14 mouth numbness 1500 Pt informed RN @ 1450, 5 min after injection her tongue went numb. States her chest was tight ... Read more
1500 Pt informed RN @ 1450, 5 min after injection her tongue went numb. States her chest was tight but she was asthma as well and took her Albuterol which helped. NO chest tightness at this time. Numbness improving.
50 2021-02-15 ringing in ears Received P vaccine instead of M. C/o ringing in the ears after vaccine
50 2021-02-15 visual impairment From occupational health note: patient was asked by her supervisor to call. Received vaccine on 1/1... Read more
From occupational health note: patient was asked by her supervisor to call. Received vaccine on 1/14, had dizziness, seeing spots in her eyes, lethargy and was sent to to ED and discharged. Generalized itching the next day. All sxs have resolved since yesterday. Scheduled to work on Friday, 1/22. From ED note: 50 yo f c/o mild dizziness and light-headedness today, worse with standing up. No n/v/d/f/c. Describes sx as typical early flu like sx today but slightly worse that her usual feeling from flu vaccines. Received the covid vaccine yesterday and friend experienced same symptoms. Felt "difficulty concentrating at work", which was very busy. No weakness, pre-syncope, numbness, cp, sob. No unsteady gait, vision changes. occ vision spots assoc with standing up. H/o anemia, h/o gastric bypass 2005. Often gets routine labs q 6 months but has not had any yet since COVID.
50 2021-02-16 ear discomfort, lip swelling Fourteen minutes after the administration, I felt my right ear plugged and the left side of my face ... Read more
Fourteen minutes after the administration, I felt my right ear plugged and the left side of my face went numb. The reaction passed but at home the numbness continued intermittently for up to three days and at some point I also felt my lips swollen. What worries me the most is that I do not know if I should go to administer the second dose.
50 2021-02-16 lip swelling, swollen tongue Flush face chest, swollen checks , lips, tongue, had issues talking
50 2021-02-18 ear pain 2/04/21, 1:00 PM, chilled "to the bone", temp of 101 degrees, very tired, nauseous - at 3PM took Adv... Read more
2/04/21, 1:00 PM, chilled "to the bone", temp of 101 degrees, very tired, nauseous - at 3PM took Advil and got a little relief - fever broke early morning of 2/05/21, remained nauseous for two days and exhausted for two weeks with brain fog Sore throat off and on, swollen glands off and on, occasional ear pain - this could be related to drainage, cause unknown 2/15/21 (about) sores began showing up - first two on the back of my left hand, then one on my left upper arm, today one on my right upper arm
50 2021-02-18 ear pain On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling rig... Read more
On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling right. There was a pressure in my head, along with sinus and ear pain and a fuzzy feeling in my face. By Monday, Feb, 1, 2021, the pain was worse now with a fatigued feeling after sleeping 20 of the last 24 hours. I went to my Dr on 2/1/2021 and recognized a slide on the left side of my face. From my forehead not wrinkling up the same as right side, left eye wasn't closing as tight and the left cheek and side of mouth were sliding. He said it was Bells Palsy. He prescribed 10 days of prednisone and an antivirus medicine to be taken 3 times a day. That week I slept a lot and wasn't able to sit up much due to the head pain and the lightening bolt feeling in my face. By the 2nd week I was able to sit up more, but still very tired/fatigued. I was off work for 2 weeks, returning to work on 2/14/2021. There is still a slight slide on the left side in the eye and cheek.
50 2021-02-18 mouth tingling Patient had high anxiety entering into vaccination chair. Talked at length about current data and al... Read more
Patient had high anxiety entering into vaccination chair. Talked at length about current data and allergy reactions. After about 10 min post dose resident reported feeling dizzy and that jaw "felt weird" . Took patients blood pressure at 11:15am - reading was 184 / mmHg and pulse was 106. Upon further discussion jaw felt "tight" - verified with patient that it did not feel like it was closing, and that roof of mouth was tingling. Benadryl offered, and patient declined. She stated she would like fresh air, and went outside and took a walk with a nurse. Blood pressure rechecked at 11:33am BP was 188 / 111 mmHg pulse 96. Resident states that her normal BP is around 145/90. Automatic BP checked again at 12:51pm was 188 / 112 mmHg and pulse 89. Had checked with pharmacy intern manually and reading was 166/104 mmHg. Patient stated she felt "better" jaw was ok and tingling in mouth was subsiding. Discussed importance of calling her PCP to discuss potential diagnosis of hypertension.
50 2021-02-21 ear discomfort, ear pain dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, ni... Read more
dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, night sweats, severe fatigue, sinus congestion, runny nose, post nasal drip, sore arm
50 2021-02-23 swollen lips, mouth tingling, lip swelling SWELLING OF LIPS x 3 different occasions since the second dose. My lips got puffy and tingly, they w... Read more
SWELLING OF LIPS x 3 different occasions since the second dose. My lips got puffy and tingly, they were red, swollen and very irritated for days after the initial second dose and then again two different occasions during the month of February. Treatment was taking antihistamine when I got home. After the third reaction of lip swelling I called my primary doctor to let him know about my symptoms and he recommended an over the counter anti-histamine, which I am currently taking.
50 2021-02-23 ear pain Side effects emerged approximately 12 hours after vaccinated. 1) temp that fluctuates from regula... Read more
Side effects emerged approximately 12 hours after vaccinated. 1) temp that fluctuates from regular to 101F. 20 hrs after vaccination, T100.7F, then persisted up and down for about a week. 2) Musculoskeletal pain to Left side of body: Mainly left upper body. -- 17 hrs after, woke up with severe pain to Lt shoulder and clavicle (thought it was broken somewhere.) The injected site was sore but mild. The Musculoskeletal pain still continues, and the pain comes in various sites, various forms, and in various level. It can be at Left shoulder, scapula, armpit, rib, lumber, hip, knee, and foot. Once in a while, Left ear pain. Mostly Lt shoulder, scapula, armpit, rib lately (today is 0224/2021.) Level changes depends on how it hurts; severe-moderate/shooting and needle pain, moderate/radiating pain, moderate-mild/dull pain, mild/annoying persistent uncomfortable pain. 3) neck and jaw joint stiffness only on left side. Current. 4) Extreme fatigue and brain fog--Extreme fatigue started on the next day and persisted for 3 days, then it became randomly daily. No warning signs given, suddenly feels extremely tired. This fatigue often comes with intermittent confusion. When severe, unable to move while laying. Today is 3rd week from vaccinated and unresolved completely.
50 2021-02-24 mouth numbness Tongue feels numb. Breathing without difficulties. b/p 150/60 continued to monitor. Refused an... Read more
Tongue feels numb. Breathing without difficulties. b/p 150/60 continued to monitor. Refused any further treatment. b/p140/80
50 2021-02-24 tongue disorder, mouth tingling I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face f... Read more
I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face felt very hot and was flushed and the right side of my tongue felt thick for a day or more. Yesterday was one week ago from my vaccine and my tongue intermittently still feels thick. My tongue feels like it does when novocaine starts to wears off from the dentist. My right arm also felt sore and puffy; however, there was no skin reaction. The next day or so the right side of my neck was sore. As to be expected, my arm was also sore.
50 2021-02-25 ear swelling, eye irritation, dry eye, mouth pain Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflamm... Read more
Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.
50 2021-02-28 mouth numbness her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high bloo... Read more
her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.
50 2021-03-02 hearing loss, ear discomfort, ear pain, extreme sound sensitivity decrease hearing to rt ear, discomfort related to normal sound , pain from loud and high pitch sound
50 2021-03-02 lip swelling, eye swelling "The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since ... Read more
"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since it shouldn?t cause any discomfort at all. Other than immediate onset of a painful injection site no other symptoms occurred until later in the evening. I started feeling kind of yucky before I left work but nothing specific. By the early evening I was running a low grade fever and having muscle and joint pain. I didn?t sleep very well due to body aches and severe organ pain. At one point I woke up because my heart was beating so hard and fast I could feel it in my forehead. My lips and eyes were swollen and my neck was visibly swollen as well, I think due to the lymph nodes in my neck. My throat was some swollen but not enough to cause a breathing issue. The heartbeat issue didn?t last terribly long. I took a Benadryl to try and stop the reaction. I ran fever of a 102 give or take a few degrees either way for 2 ½ days. In addition, the injection site and whole shoulder area was swollen and hot with redness that wrapped around the front of my arm."
50 2021-03-03 taste impairment, tunnel vision funny taste in mouth, felt buzzed, headache, confused, tunnel vision, pale, fainted, rash on torso
50 2021-03-03 taste impairment METAL TASTE IN MOUTH 5 MINS AFTER INJECTION NO TREATMENT
50 2021-03-03 eye pain Within approximately 56 hours from 1st injection, I got an intense left eye pain. Went to the ER w... Read more
Within approximately 56 hours from 1st injection, I got an intense left eye pain. Went to the ER where they flushed it, numbed it, and prescribed drops for conjunctivitis. I had no symptoms prior. Completed treatment and seemed fine. Within 13 hours of second dose (3/3/21 @ 2:00 pm), I woke up with eye pain in the left eye and used part of the remaining drops; thankfully did not get as bad as the first one, so far.
50 2021-03-04 mouth tingling Tingling in lips. Evaluated by EMS-Cleared
50 2021-03-04 swollen tongue Within 3 minutes of injection, my pulse became tachycardia, my throat and tongue started to swell. I... Read more
Within 3 minutes of injection, my pulse became tachycardia, my throat and tongue started to swell. I started to cough. It never progressed beyond that. I felt well enough to leave after the 15 min observation period. When I got home, I took 25mg Benadryl.
50 2021-03-05 loss of taste, loss of smell 12 hours after injection fever, chills, ague, extreme fatigue lasting 12 hours. 15 hours later loss ... Read more
12 hours after injection fever, chills, ague, extreme fatigue lasting 12 hours. 15 hours later loss of taste & smell lasted for 6 hours. Ague & extreme tiredness lasted 48 hours
50 2021-03-05 dry mouth Chest tightness, shortness of breath, dry mouth.
50 2021-03-05 bloodshot eyes, lacrimation increased, eye itchiness Appx 24 hours after the injection, the site of injection started itching very badly and a bright red... Read more
Appx 24 hours after the injection, the site of injection started itching very badly and a bright red solid spot appeared and a lump that was sore to touch. Redness was just smaller than a quarter at first. That was about 5:10pm 3/5 and then appx 8-9 hours later, while sleeping, I developed a severe cough and my nose was completely stopped up. Eyes were itching with drainage too. My husband got up and gave me a Benadryl and that calmed everything down so I could sleep again. This morning, my eyes were pretty red and still had some drainage. My cough is there but very faint and less frequent. My arm hasn?t stopped itching and the red spot is slightly larger at appx 1.5 inches tall and 1 inch wide. Still with a lump and soreness. I expected the lump and soreness.
50 2021-03-07 mouth swelling, mouth tingling tongue tingling, throat and mouth feels swollen, flushing. Evaluated by EMS-Cleared
50 2021-03-09 taste impairment Facial twitches and numbness (mild, on and off) on side vaccine was given. Warm feeling in throat an... Read more
Facial twitches and numbness (mild, on and off) on side vaccine was given. Warm feeling in throat and metal taste in mouth (both of these have gone). Twitches and mild numbness still happening.
50 2021-03-09 taste impairment metallic taste same as experienced when receiving chemo last year; mild pain at injection; This is a... Read more
metallic taste same as experienced when receiving chemo last year; mild pain at injection; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3247, via an unspecified route of administration on 24Feb2021 14:00 at a single dose in the right arm for COVID-19 immunization. Medical history included early breast cancer, metallic taste when receiving chemo last year in 2020. The patient had no allergies to medications, food, or other products. Concomitant medication included anastrozole and calcium carbonate, vitamin D. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced metallic taste same as experienced when receiving chemo last year and mild pain at injection on 24Feb2021 17:00. No treatment was received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested positive for COVID-19 since the vaccination. The outcome of the events was not recovered.
50 2021-03-12 swollen tongue, mouth swelling Swollen tongue and mouth a few minutes after injection. Not severe. No trouble breathing. Lasted ... Read more
Swollen tongue and mouth a few minutes after injection. Not severe. No trouble breathing. Lasted a few hours.
50 2021-03-13 deafness, ringing in ears Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second v... Read more
Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second vaccine, but I wanted to update as to my experience. I got sick with the first one from about 4ish hours after until the next mid morning maybe? Then I felt bad again that second night. I had my vaccine (second) yesterday at 4 PM, and I felt OK going to bed but had a pretty pitiful night. I woke up at 5 AM and I felt horrible. That felt like someone took a pair of metal cymbals and slammed them together on my head. The tinnitus was strong. I also had body aches and joint pain and felt like I had the flu. I felt a little better around 1 PM, but felt bad again around 330. Now I'm miserable again with terrible body aches and chills (this was at 7:38 PM). I'm sure I will feel better in the morning, just wanted to share my experience." Sadly, since then, I have had tinnitus with a metallic ringing in both ears along with hearing loss. I had some vertigo one day but unsure if this was related. The tinnitus makes me very sad. I am a hospitalist and am happy to have been vaccinated, still. It has been 2 months today, and it remains, unrelenting. It is worse in the morning and at night. The hearing loss is difficult.
50 2021-03-13 taste impairment, mouth tingling tingling lips, one to two hours, subsiding to slight only on left side intermittently tingling left ... Read more
tingling lips, one to two hours, subsiding to slight only on left side intermittently tingling left side of tongue, one to two hours slighter tingling next to left eye, intermittent for days very strong metallic taste in mouth, subsided to slight metallic taste after a few hours
50 2021-03-13 mouth tingling, ear discomfort Developed scratchy throat and then itchy rash at approximately 15 minutes post dose. Patient given ... Read more
Developed scratchy throat and then itchy rash at approximately 15 minutes post dose. Patient given 50 mg oral Benadryl and monitored for over 30 minutes. Patient has a history of epi pen usage due to history of allergies to sulfa, flaxseed and environmental triggers. She has received flu vaccine in the past with minimal reactions. Given oral benadryl 50mg x 1 and monitored for at least an additional 30 minutes. Per pt on my chart in March: tingling of the tongue was mild. The right ear and right side of my head was intense with pressure and it did feel like it wanted to explode. After the Benadryl it started to subside. It lasted about 50 minutes. The rash were not like hives. The rash was on my neck , arms and face. It lasted about 2 days and was a mild case. Not over body. No fainting, no low grade fever.
50 2021-03-13 mouth tingling, swollen tongue The patient was vaccinated at 09:12AM, and began experiencing tongue tingling and swelling on the ri... Read more
The patient was vaccinated at 09:12AM, and began experiencing tongue tingling and swelling on the right side after 20 minutes. The patient reported that the tingling only lasted about a minute with the swelling occurring after. Vital signs taken at 09:20AM. The patient reported decrease in swelling at 10:18AM - "less swollen, more room." Repeat vital signs at 10:20AM. The patient reported resolution of symptoms and indicated that her tongue felt the same as it did prior to vaccination at 11:23AM.
50 2021-03-14 eye swelling Patient was sitting in observation and her daughter noticed the left eye was swollen. She told us th... Read more
Patient was sitting in observation and her daughter noticed the left eye was swollen. She told us that her mom gets botox and fillers all in her face. She gets the hyaluronic acid filler apriline. She declined treatment and felt fine otherwise. She will contact her doctor.
50 2021-03-14 ringing in ears, tongue disorder Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to... Read more
Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to sinus headache); after approximately 15 minutes, I experienced a ringing in my ears. I told the attending person, but she said it was probably due to being anxious about getting the shot. I left after being in the waiting area for 30 minutes and began driving home. My face felt very warm, so I opened the car window. I touched the side of my face and felt hives. My tongue felt thick, but I did not feel hives going down my throat. My torso started to itch and I had hives there as well. There was no raised area at the injection site. I became very itchy on my head, neck, and arms. When I arrived home, I took a dose of benadryl. Four hours later, I took a dose of zyrtec. My hives subsided and my tongue returned to normal, but I was still itchy. The next morning, I took a dose of claritin and called my doctor. In the afternoon, I took benadryl. In the evening, I took zyrtec. I continued this for 2 more days. The day after my vaccine, a node between my thumb and forefinger on my left hand was swollen and painful to the touch. My hand was swollen and my finger joints ached. I went to the doctor for an examination. The swelling and pain in my hand continued to worsen during the day and overnight. I kept ice packs on my hand and it felt better after 3 days.
50 2021-03-14 vision blurred Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. ... Read more
Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. Noticeably sore at injection spot. Joints started aching, tired, noticeably sore up through neck on L side. Was driving at night- distance vision was blurry (could have been dry eyes, not sure related to vaccine). Slept 14 hours. Woke with muscles still achy, not quite as much as day before. Neck still sore. Injection site only sore to touch. Still very tired, could have slept more. Woke up today, feel pretty normal. A bit tired.
50 2021-03-15 lip swelling, mouth tingling, mouth numbness 15 minutes after the injection I noticed that my heart was beating fast and I felt anxious. When I... Read more
15 minutes after the injection I noticed that my heart was beating fast and I felt anxious. When I got up an started walking I felt slightly unbalanced. 15minutes later I felt like my lips were swelling and my throat felt tight. On route to the emergency room my lips , tongue and mouth felt numb and tingling. I arrived at ER at 0930 and was given IV Benadryl and prednisone by mouth by ER Dr.
50 2021-03-15 swelling around the eyes, mouth tingling 20 minutes after vaccine injection Patient C/O tongue tingling, feeling swollen and puffy eyes. Pati... Read more
20 minutes after vaccine injection Patient C/O tongue tingling, feeling swollen and puffy eyes. Patient mildly swollen around eyes. VS Stable. IM Benadryl 50MG administered to right deltoid. O2 at 2L per NC administered. Improved for 10 minutes and then tingling and swelling returned. C/O of feeling lightheaded. Medicated with Epi pen to left thigh. Patient improved/stable and was sent via EMS to hospital for evaluation and treatment.
50 2021-03-15 taste disorder After getting the shot I had instant metal/ chemical taste in my mouth, it lasted all day. I also fe... Read more
After getting the shot I had instant metal/ chemical taste in my mouth, it lasted all day. I also felt it go into my body like a warm rush throughout. I got a little light headed.
50 2021-03-16 eye pain, eye discomfort, bloodshot eyes, sensitivity to light Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she lo... Read more
Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she looked in the mirror and was red/blotchy all over. She took 25mg benadryl as she was driving home and took another 25mg benadryl 20-30 min later when she arrived home. She continued to feel hot and itchy so took benadryl for the next 48 hours before those symptoms resolved. On day 4 after vaccine (2/29/01) pt began to notice redness in her right eye. The eye became more "bloodshot" as the day progressed and started feeling painful and "pressure" sensation. She went to see ophthalmologist urgently who diagnosed it as acute scleritis. She is currently on NSAIDs and topical steroid. She notes that the eye is very photosensitive and has significant "pressure" sensation. She is still experiencing these symptoms almost 3 weeks later.
50 2021-03-16 bloodshot eyes RIGHT AFTER VACCINATED, PATIENTS START TO PRESENT A SEVERE RASH IN HER BODY, AND HER EYES WERE VERY ... Read more
RIGHT AFTER VACCINATED, PATIENTS START TO PRESENT A SEVERE RASH IN HER BODY, AND HER EYES WERE VERY RED. PATIENTS DID NOT SHOW ANY SIGH OF SWELLING AND WAS ABLE TO BREATH. AFTER REASSES OF THE SITUATUION, PROCEED TO INJECT DIPHENHYDRAMINE 50MG/ML VIAL. PROCEED TO CALL 911, WHEN THE PARAMEDICS ARRIVED, VITAL SIGNS WERE TAKEN. AFTER 15 MINUTES OF THE ADMINISTRATION ALL RASH AND RED IN HER SKIN STARTED TO IMPROVISED. PATIENTS WAS OBSERVED FOR 30 MORE MINUTES AND THE PARAMEDICS PROCEED TO DISCHARGE HER HOME.
50 2021-03-17 loss of smell, tongue discomfort, mouth ulceration, loss of taste 1st Covid vaccine 12/19/20 Pfizer EH9899 @ 0930 2nd Covid vaccine 1/9/2021 Pfizer EL3246 @ 0930 2/26... Read more
1st Covid vaccine 12/19/20 Pfizer EH9899 @ 0930 2nd Covid vaccine 1/9/2021 Pfizer EL3246 @ 0930 2/26 Covid symptoms 3/2 tested positive for Covid, lost taste/smell, had covid tongue with ulcers in mouth - seeking medical attention
50 2021-03-17 mouth tingling Patient complained of tingling of tip of tongue and palpitations. 5:52 132/90 HR 99 RR20 SpO2 99% 6:... Read more
Patient complained of tingling of tip of tongue and palpitations. 5:52 132/90 HR 99 RR20 SpO2 99% 6:00 122/86 HR 88 RR20 SpO2 99% 6:00 Benadryl 25 mg given by mouth, patient stated relief after 5 minutes, no SOB, no c/o of chest tightness, no swelling noted prior to medication administration, lungs clear to auscultation.
50 2021-03-17 mouth tingling Patient waited the 15 minutes post vaccine and felt fine. After 40 minutes patient returned to the p... Read more
Patient waited the 15 minutes post vaccine and felt fine. After 40 minutes patient returned to the pharmacy light headed, flushed, and claimed mouth, lips and tongue were tingling. No signs of facial swelling. Nurse practitioner attached to the pharmacy examined the patient before sending her home in her husband's care.
50 2021-03-17 taste disorder, tongue discomfort, ringing in ears, smell distorsion I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted ... Read more
I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted to be sure to send this along to you as well as, to the adverse effect website. It?s almost as if I?ve had a stroke. Initially (after the shot), I was a little lightheaded but as the rest of the day wore on, (say around 6 hours later), I started to get foggy in my brain - like I had to remember to even breathe - and tightness in my chest like asthma. There was a high pitch scream in my ears and I was more or less, kind of out of it. My hands and feet were sweating profusely. My tongue kind of reacted, too and got a little burned, like when I eat pineapple. It was then that I noticed difficulty swallowing. My sister (a medical professional) suggested Benadryl for the mouth and tongue sensation and she kept an eye on me the rest of the night. She also warned that I should not get a second shot (I totally agree). Being a trooper, I thought all of the weird stuff would blow over in a day or two, so I decided to power on and not report my issues. Today is day 6 post vaccine and I can now see a pattern to the symptoms or episodes which are still present, on and off: 1. The ringing in my ears will intensify, and then I stare off into space, my words get garbled (I have to really concentrate on being present), my tongue gets very dry and then the swallowing issue returns (it?s like slow motion swallowing, so I bite my tongue to stay in the moment). 2. The tightness in my chest intensifies and my breathing gets shallow. I must focus and breath through it despite discomfort. Note, since the shot, I keep a Benydryl and my inhaler with me, although I haven?t used Benadryl since day 3. I used my inhaler yesterday, day 5 because of discomfort and that seemed to help, but using it triggered an ear ringing/screaming episode that came and went the rest of the day. 3. I also have nasal constriction throughout the day. The nasal passage just inflames and then relaxes. I also have phantom smells and my sense of taste got a little off on day 1, but recovered. ________________ March 18, 2021 Update Saturday, 3/13 went to the ER because the cognitive issues had advanced. I found myself staring off into space, losing my train of thought, and unable to speak. When I did speak I stammered or stuttered. They wanted to make sure I did not have a stroke or that I was not in the middle of one, so they did some tests. They also recommended that I go ahead and take the prednisone. After my ER visit the cognitive issues continued, but began to be not-so-frequent by Sunday afternoon. I felt like I was on the road to recovery and so delayed again, taking the prednisone. On Tuesday (3/16), I had what I would call an asthma attack. I was having very strong bronchial spasms that would not abate. I used my rescue inhaler to try to mitigate the symptoms, but that did not work. At the same time, the cognitive issues sort of returned and the big loud ringing and whooshing in my ears was really really noticeable. I am having a protracted allergic reaction to the vaccine. I am not normally allergic to things, but I have noticed new allergies since this all began. Certain food items seem to bother me now and push me into the lung seizing, raw tongue, neurological, ear ringing event.
50 2021-03-17 ringing in ears Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Ac... Read more
Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Achiness in my legs. Ringing in both ears. Took 800 mg ibuprofen 3.12.2021 @ 12:30am. All symptoms resolved by 2:00pm on 3.12.2021 with the exception of Ringing in my ears. that is ongoing.
50 2021-03-18 taste impairment Strong metallic taste in mouth
50 2021-03-18 eye itchiness, pain in jaw Got vaccine around 10:00 a.m. About 30 minutes after shot, I suddenly felt very exhausted, but it pa... Read more
Got vaccine around 10:00 a.m. About 30 minutes after shot, I suddenly felt very exhausted, but it passed within another 30 minutes. A few hours later, pain in upper arm got pretty intense. Then around midnight, the pain in my upper arm had grown so severe that it was spreading into my shoulder and neck. By 2:00 a.m., I woke up in sever pain in my face, not able to open my mouth because my jaw hurt so much. I went back to sleepI was not able to open my mouth until I repeatedly coaxed it open, around 8:00 a.m. By 10:00 a.m., my eyes itched like crazy and were red. My jaw getting stuck shut and my eyes itching insanely are why I'm completing this form.
50 2021-03-18 lip swelling, mouth tingling Fifteen mins after Pfizer dose #1, Pt. noted tingling of tongue. ARNP noted slight swelling of righ... Read more
Fifteen mins after Pfizer dose #1, Pt. noted tingling of tongue. ARNP noted slight swelling of right lower lip. Pt. received Benadryl 50 mg IM. Tingling resolved after 15 minutes. Pt. felt fully recovered at that time, and later did not have any systemic side effects from the Covid vaccine. She admits to feeling anxious with injections and venipuncture.
50 2021-03-18 mouth tingling Was waiting 30 minutes due to previous anaphylaxis and tongue started to feel tingly, we administere... Read more
Was waiting 30 minutes due to previous anaphylaxis and tongue started to feel tingly, we administered 50mg of benadryl generic and held for 2 hour observation. No sequelae.
50 2021-03-19 tongue itchiness 10:50 Pt c/o "severe itching", mostly on extremities, but some "mild itching" on tongue. Denies sho... Read more
10:50 Pt c/o "severe itching", mostly on extremities, but some "mild itching" on tongue. Denies shortness of breath, difficulty breathing throughout episode, observed unlabored breathing, appropriate verbal responses
50 2021-03-21 taste impairment Patient stated " bad taste in mouth" denied trouble swallowing several times. All resolved after 2-3... Read more
Patient stated " bad taste in mouth" denied trouble swallowing several times. All resolved after 2-3 minutes
50 2021-03-21 swollen tongue collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnor... Read more
collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnormality; chest pain; increased swelling; skin changes; This is a spontaneous report from a non-contactable other hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date) at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, collapse, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Treatment included: antihistamines. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
50 2021-03-21 ringing in ears Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and need... Read more
Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
50 2021-03-22 taste impairment, mouth tingling Facial flushing, trouble swallowing, metallic taste, lip tingling
50 2021-03-22 eye swelling, ear pain On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morn... Read more
On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morning (18th), I had a small Shingles lesion along with those symptoms. . I went to the doctor's office and saw the NP, who diagnosed me with an ear infection--right Otis externa. On Wed (19th) my right eye was swollen and my scalp, right forehead and eye were covered in shingles. On the 20th, I was diagnosed with having Ocular Shingles. I was put on steroids and sent to an emergent appointment with ophthalmologist because they were concerned that I would lose my sight. He put me on Acyclovir 800mg, 5 times a day and increased my steroids to: 40mg a day for 2 days, 30mg for 3 days and 20mg for 3 days and 10mg for 4 days. Fortunately the branch that goes into my cornea was not affected. I was in bed the entire time. I still had lesions when I went back to see him, which is why he kept me off work until Feb 1st. I continued to have neuralgia (nerve pain) and then I started itching. I went back to quick care and put on Atarax. I took that every 4 hours for about a week. Then I tapered it down to about twice a day. It eventually got better, but I do itch sometimes. Looking back, I did have a little right ear pain after the 1st dose of the vaccine.
50 2021-03-22 mouth tingling, tongue itchiness Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After... Read more
Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After bringing patient to UC patient felt itching of tongue, feeling like throat is swelling, shortness of breath, dizziness, slurred speech, loss of consciousness, and chest heaviness.
50 2021-03-22 feeling of choking Symptoms began with tingling in back of throat on left side. Within 30 minutes I was having difficu... Read more
Symptoms began with tingling in back of throat on left side. Within 30 minutes I was having difficulty swallowing and hives began to appear on chest and arms. I was given Benadryl through IV about 10:45. I was taken by ambulance to hospital and remained there for about an hour and a half until symptoms subsided
50 2021-03-23 dry eye Very sore arm, muscle aches, fatigue, slight off and on headache, dry eyes, slight nausea, tickle in... Read more
Very sore arm, muscle aches, fatigue, slight off and on headache, dry eyes, slight nausea, tickle in throat with light coughing.
50 2021-03-23 smell distorsion Weird or changed sense of smell Patient reporting smells which are non existent or are wrong
50 2021-03-23 ringing in ears Tinnitus in left ear. Started about 10 days after 1st dose. It's progressively getting worse. I rec... Read more
Tinnitus in left ear. Started about 10 days after 1st dose. It's progressively getting worse. I received my 2nd dose on 3/17
50 2021-03-23 tongue disorder Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pai... Read more
Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pain, and a welt on my tongue. Blood sugar high in 300s The next day tongue was a bit better other symptoms the same and heart felt fluttery, and my left breast and center between felt like bruises and small lumps. Headache finally gone by Tuesday and sugars in high 200s but the rest is about the same. Less tired though
50 2021-03-24 loss of taste, loss of smell Everything started with heaviness in the arm, Headache, changes in the skin pigmentation, dizziness,... Read more
Everything started with heaviness in the arm, Headache, changes in the skin pigmentation, dizziness, chest pressure, shortness of breath, extreme tiredness. Everyday passing I was feeling worse, adding radical mood swings. Today March the 25/2021 I am still with taste loss, with chills, with the mood swings (the ones that had me partially hospitalized), the skin pigmentation changes is not the same, and tiredness.
50 2021-03-24 lip swelling evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen... Read more
evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen lip and face, lethargy, sleepy Ever have a reaction to a previous vaccine? If yes, what? no- usually gets 3 vaccines each month for allergies she didnt take the third dose this month because she was getting the COVID vaccine, area of injection usually gets swollen when she gets these vaccines and it goes away within a few hours Recommendations: please contact your PCP for recommendations since he has your medical records available, see what he recommends for you to take whether it be your prescribed allergy medication or any OTC items. If you are currently experiencing any Shortness of breath please visit your nearest Emergency Department, otherwise inform your PCP that you are experiencing swelling on your lips and that you experienced a swollen face that subsided. Consult with him on whether you should or shouldn't get the second dose vaccine, one of the contraindications for the vaccine is anaphylaxis so its better to take precaution.
50 2021-03-24 mouth discomfort 11am - jaw felt odd, tingling on left side 1pm - rt side of lower back of head felt like ice, tingli... Read more
11am - jaw felt odd, tingling on left side 1pm - rt side of lower back of head felt like ice, tingling on rt side of head over next few hours ( I wouldn't call this a headache) 4pm- roof of mouth burning 10pm - went to sleep but only one side of head felt like fire/ice along with mouth 7am - upper body and head feels like on fire/ice Never had a fever
50 2021-03-24 thirst Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot ... Read more
Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot at 8:48am, symptoms began at 12:30pm while on a bike ride. I finished the ride but was too weak to do anything the rest of the day. That night I couldn?t stop shaking and lay in bed wide awake until about 2am. I felt dizzy like I was spinning when I closed my eyes. I slept off and on until 6:30am. Today I?m feeling slightly better but still can?t sleep. I am drinking an excessive amount of water and herbal tea.
50 2021-03-24 ringing in ears Vaccine administered at 1425, patient did not have any tinnitus at time of vaccine. At 1730 she bega... Read more
Vaccine administered at 1425, patient did not have any tinnitus at time of vaccine. At 1730 she began to experience bilateral pulsatile tinnitus that has been consistent to this moment. She reports it as high-pitched ringing like turning on an old TV. Around that same time she began to experience a bilateral throbbing headache at her temples. The headache resolved when she went to sleep. The tinnitus has been persistent.
50 2021-03-25 ringing in ears Injection site pain, arm pain extending down to the hand, swelling and welps, difficulty breathing, ... Read more
Injection site pain, arm pain extending down to the hand, swelling and welps, difficulty breathing, dizziness, ringing of ears
50 2021-03-26 mouth numbness Pt developed numbness in R arm, radiating to hand progressing to L arm, face and tongue. Medical con... Read more
Pt developed numbness in R arm, radiating to hand progressing to L arm, face and tongue. Medical consultation recommended transport BP 104/80, HR 60, SpO2 100%, RR 12 EMT arrived 10:45am, pt transported.
50 2021-03-26 taste disorder Diarrhea, vomiting, chills, shivering, headache, dizziness aches, foggy memory, strange taste in mou... Read more
Diarrhea, vomiting, chills, shivering, headache, dizziness aches, foggy memory, strange taste in mouth
50 2021-03-27 mouth numbness SOB, anxiety, pain in neck that radiated to head, intermittent numbness in lips; vomited at 0925. BP... Read more
SOB, anxiety, pain in neck that radiated to head, intermittent numbness in lips; vomited at 0925. BP 130/84, HR 64; breath sounds clear. Medics on site at 0932. Signed out AMA.
50 2021-03-27 oropharyngeal discomfort Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my bod... Read more
Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my body 1-2 days All of my body ached 1-2 days Headache for a day or two (not extreme) Scratchy throat off and on for a few days Nauseous/ nothing sounded good to eat 3-5 days Upset stomach and rolling stomach with borderline diarrhea about 3 days Itchy all over (no rash at all) for a solid two weeks and now just occasionally Left hand and joints swelled slightly 2 weeks+ Tightness in chest 2 days and periodically for 2 days more
50 2021-03-27 smell distorsion, taste impairment For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell.... Read more
For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell. After two days I got a canker sore. 7 days later my resting heart rate is 158-163. prior to the shot my resting heart rate was 168.
50 2021-03-27 ringing in ears, ear discomfort Within minutes - shot upper arm hurt. Wrist on shot arm hurt. LOUD Ringing in my ears. Pressure in e... Read more
Within minutes - shot upper arm hurt. Wrist on shot arm hurt. LOUD Ringing in my ears. Pressure in ears. Ringing ended day of shot. Wrist hurt for a day. Arm still hurts as of now
50 2021-03-27 tongue discomfort, loss of taste 45 hours after 1st vaccination, had a burning sensation on the tongue as if I drank a very hot drink... Read more
45 hours after 1st vaccination, had a burning sensation on the tongue as if I drank a very hot drink and burned my tongue. I had lost my sense of taste after that. I took a benadryl, and then next morning my sense of taste had returned. My sense of smell was never affected.
50 2021-03-28 swollen lips, lip swelling, dry mouth, mouth tingling, mouth discomfort Started with tingling lips, then lips swelled to twice the normal size. Blister, cracks, and burning... Read more
Started with tingling lips, then lips swelled to twice the normal size. Blister, cracks, and burning. That lasted3 day and then swelling started to go down. Now have severe raw, dryness around the entire mouth, what looks like a deflated blister on L bottom lip, severe cuts to both corners of my mouth, and red spots (now 10 of them) around my jawline and neck. I can barely open my mouth to eat (only having jello) or drink. I have also had a sore throat on and off, but a runny nose every day.
50 2021-03-28 taste impairment Metal taste in mouth and throat numbness post vaccination Vital Signs: B/P: 138/86 HR: 82 then 104 ... Read more
Metal taste in mouth and throat numbness post vaccination Vital Signs: B/P: 138/86 HR: 82 then 104 due to dark nail polish O2Sat: 91 then 98 due to dark nail polish c/o HA with 1st shot x 1 day C/O being overheated , Face flushed Circulation: Unable to assess due to dark nail polish Resp.: Breath sounds clear bilaterally Treatment: Assessed then observed by RN until symptoms subsided Reassessment: 13:41 Vitals: B/P:118/86 HR: 80 Resp.: 12 O2Sat: 97 Notes: Patient drove self to clinic. D/C from triage on own accord @ 13:45. Steady gait. Denies dizziness. Conversing appropriately.
50 2021-03-28 hearing loss, ringing in ears, ear discomfort, ear pain, deafness On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constan... Read more
On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it. On 17Jan, I had pain in left ear but it went away. My left ear still is clogged; has decreased hearing/decreased hearing of lower register; On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it. On 17Jan, I had pain in left ear but it went away. My left ear still is clogged; On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it. On 17Jan, I had pain in left ear but it went away. My left ear still is clogged; On 16Jan2021, both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it. On 17Jan, I had pain in left ear but it went away. My left ear still is clogged; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), via an unspecified route of administration administered in left arm in the hospital on 08Jan2021 07:30 as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had unspecified medical history and concomitant medications in two weeks. The patient had no known allergies. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730) administered in left arm on 18Dec2020 at 06:30 PM for COVID-19 immunisation. On 16Jan2021, both ears were clogged but patient couldn't hear well out of left ear and there was a constant hum in it on 16Jan2021 at 06:00 AM. On 17Jan2021, the patient had pain in left ear but it went away. Her left ear still was clogged, has constant hum and has decreased hearing on 17Jan2021. Right ear hearing was always fine and clogged feeling went away in two weeks. The patient saw ear, nose, and throat (ENT) on 19Jan2021, patient was started on steroids. The patient had magnetic resonance imaging (MRI)and several types of hearing tests on 19Jan2021. MRI was normal. Hearing tests showed decreased hearing of lower register. One doctor thought she should mention it since it happened within 8 days of receiving her second vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all events which includes MRI, steroids, and hearing test. The patient recovered from ear pain on an unspecified date while outcome of the rest of the events was not yet recovered.; Sender's Comments: Based on the information provided, and on plausible temporal association, the Company assessed that a reasonable possibility could not be completely excluded that the reported event Hearing loss (both ears were clogged but I couldn't hear well out of left ear and there is a constant hum in it) was related to the PFIZER-BIONTECH COVID-19 VACCINE. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
50 2021-03-28 mouth numbness, mouth tingling "Pfizer-BioNTech COVID-19 Vaccine EUA" Numbing/Tingling sensation on left side of body (i.e., left s... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" Numbing/Tingling sensation on left side of body (i.e., left side of face to corner of mouth, down arm to fingertips and left leg)
50 2021-03-28 mouth ulceration was prescribed Valtrex and Zovirax same day which has caused the cold sores to subside; however, I s... Read more
was prescribed Valtrex and Zovirax same day which has caused the cold sores to subside; however, I still have issues with mouth ulcers
50 2021-03-28 swollen tongue Systemic: swollen tongue/slurred speach-Medium
50 2021-03-28 ringing in ears Approx two days after the 2nd vaccine, I developed bilateral, very high frequency tinnitus. It has r... Read more
Approx two days after the 2nd vaccine, I developed bilateral, very high frequency tinnitus. It has remained persistent and seems to be getting louder over time. It is even audible in the presence of background noise. I?m considering the use of a steroid dose pack to try and reduce this auditory side effect.
50 2021-03-29 ear discomfort funny feeling in throat, burning in ears and chest lasted for just few minutes, funny feeling in t... Read more
funny feeling in throat, burning in ears and chest lasted for just few minutes, funny feeling in throat subsided before i arrived
50 2021-03-29 eye pain, vision blurred It started with chills then my body got completely stiff and sore I had to get help to the bed when ... Read more
It started with chills then my body got completely stiff and sore I had to get help to the bed when I got in the bed I was there for four days during that. I had extreme body pain from the feet to the top of the head my eyes hurt I started sweating about three days in to the point where I mean my mattress was soaking wet my sweat smelled horrible I started having Hallucinations about two times seeing things that were not there my vision was very very cloudy and blurry I can hardly speak I have cramps in my feet on the fifth day I woke up yeah my body didn?t hurts I was no longer sweating but I had a headache. I also did not eat anything and could not eat anything for all those days it wasn?t until six days later that I was able to move around And feel somewhat back to normal my vision is still cloudy
50 2021-03-29 eye itchiness Facial numbing, itchy ears and eyes for approximately two hours after the shot.
50 2021-03-29 mouth numbness I had a lot of muscle pain, joint (like flu symptoms) and lips went numb lasting less than 24 hours.... Read more
I had a lot of muscle pain, joint (like flu symptoms) and lips went numb lasting less than 24 hours. I took two Tylenol and I was fine after that.
50 2021-03-29 swollen tongue, vision blurred Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic no... Read more
Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic nodes, difficulty to breath and to swallow, weakness, disoriented, pain in body, difficulty to urinate, dizziness, blurry vision, nausea, tachardia, pulse rate increase, blood pressure increase, fatigue, body and muscle pain.
50 2021-03-30 taste impairment Mild dizziness, metallic taste in mouth, flushing and urge to clear throat 13 minutes post 2nd dose ... Read more
Mild dizziness, metallic taste in mouth, flushing and urge to clear throat 13 minutes post 2nd dose vaccine. Symptoms resolved within 30 minutes and client left on own with steady gait.
50 2021-03-30 eye swelling Eye and face swelling. Sore muscles, fatigue
50 2021-03-30 mouth tingling 1726-Vaccinated 1734-C/o dizziness, flushing, lightheadedness, sweating, palpitation, anxious/jitte... Read more
1726-Vaccinated 1734-C/o dizziness, flushing, lightheadedness, sweating, palpitation, anxious/jittery, sleepy, tingling-tongue. 1820 c/o chest tightening. Patient refused Epi. Benadryl 50 mg/IM given, Patient was transferred to ER.
50 2021-03-30 ringing in ears Felt about to pass out about 5 minutes after injection, felt woozy, ears starting ringing about 15 m... Read more
Felt about to pass out about 5 minutes after injection, felt woozy, ears starting ringing about 15 minutes after shot. Ear ringing has gotten progressively worse. Pronounced ear ringing on March 30-31 and continues. Had fever for 3 days starting within 2 hours of receiving shot.
50 2021-03-30 ringing in ears After getting my first dose of Pfizer vaccine I developed ringing in my ears that same day. It has ... Read more
After getting my first dose of Pfizer vaccine I developed ringing in my ears that same day. It has now been a week since my vaccine and the ringing has not stopped, it is constant.
50 2021-03-30 vision blurred I did not follow-up with the doctor as I slept for two days with difficulty. Severe allergic reacti... Read more
I did not follow-up with the doctor as I slept for two days with difficulty. Severe allergic reaction. My right side lymph node became severely swollen disrupting my ability to breath and very itchy. This lymph node on the front side of the neck was protruding making it difficult to swallow. Used breathing inhalers. Immediately leaving the vaccination site my temperature went high and I had to take off my shirt while I began to sweat profusely. When I arrive home I checked my temperature it would fluctuate between 98.6 and 101. My vision became extremely blurred for two days. I could barely see so I had to lay down and close my eyes and rest as I thought I was losing my vision. These symptoms were adverse while standing. General feeling of be unwell.
50 2021-03-31 loss of smell, loss of taste AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being f... Read more
AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/2020.pfizer Lot#EL0142 2nd dose:01/20/21.pfizerLot#EL3247 Diagnosed covid positive: 03/22/21 Exposure: Home Exposure Symptoms:Fatigue,insomia,cold sore, headache, chills, runny nose, loss of taste/smell
50 2021-03-31 lip swelling My face began to tingle (specifically the left cheek) and my lips began to swell (similar to "liver ... Read more
My face began to tingle (specifically the left cheek) and my lips began to swell (similar to "liver lip" when I take hydrochlorothiazide). This began 20 minutes after the injection. I contacted a nurse (?) who was said to wait and she would return to check on me. After 10 minutes no one came back and things did not get worse so I left. The lip swelling remained for a couple of hours. It looked like I had botox (bad botox) on my lips.
50 2021-03-31 ringing in ears Immediate ear ringing and feeling fuzzy. Later chills body ache muscle aches. Next morning woke with... Read more
Immediate ear ringing and feeling fuzzy. Later chills body ache muscle aches. Next morning woke with red rash from chin to chest.still have dry bumps from rash today 4-1-2021
50 2021-04-02 loss of smell, loss of taste On April 3, in the middle of the night, I experienced nausea, vomiting, and chills. In the morning I... Read more
On April 3, in the middle of the night, I experienced nausea, vomiting, and chills. In the morning I no longer felt vomiting or nausea. Symptoms now has changed to headache and continuing chills (but not as badly), and loss of smell and taste. The loss of smell and taste is new and very unusual for me, and I haven't heard that that is a vaccine side effect, so I am reporting it. I have not reported it to my primary care physician; the advice line told me that if I'm still experiencing symptoms on Monday (today is Saturday) to call my doctor.
50 2021-04-02 double vision Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Syst... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Additional Details: Patient received vaccine and reported feeling dizzy upon standing after the 15 minute observation period. Pt complained of dizziness, headache, double vision, and feeling a cold sensation in her body. After the patient started feeling symptoms, the family reported that she is menstruating, fasting, and has not eaten since 2 am. EMS was called and patient was taken to the ER.
50 2021-04-02 ringing in ears right side of nose feels like it went numb congested, but no congestion/Whole right side of nose and... Read more
right side of nose feels like it went numb congested, but no congestion/Whole right side of nose and nostril went numb/could not feel/It was like it was numb on inside but not on outside; right side of nose feels like it went numb congested, but no congestion/It is congested in a weird way/ cannot blow nose; Headache; Pain at injection site; Weird tingling and ringing in right ear; Weird tingling and ringing in right ear; Nausea; Anxiety /Anxiety worsened/spiked when she could not feel her nose; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in the left arm, on 09Feb2021 13:00, as single dose, for prevention/COVID-19 immunization. Medical history included severe allergies to environmental, sensitivities to some foods, anemia and severe asthma diagnosed in 1973. The patient reported that her dad has COPD, emphysema, high blood pressure, asthma and allergies. Concomitant medications included azelastine hydrochloride (AZELASTINE) taken for allergies from Dec2020; fluticasone propionate (FLONASE) taken for allergies; and an unspecified steroid for asthma. Historical vaccine included live flu vaccine received 20-30 years ago and she was severely ill and sicker than she has ever been as on the brink of going to the ER, but she did not go. On 09Feb2021 at 13:20, 20 minutes after the vaccination, the patient experienced nausea which lasted for 2 hours; and anxiety. The patient never vomited. On 09Feb2021 at 16:00, 3 hours after the vaccination, the patient experienced pain at injection site and weird tingling and ringing in right ear. On 09Feb2021 at 17:00, 4 hours after the vaccination, the patient experienced headache. On 10Feb2021 at 11:00, the patient's right side of nose felt like it went numb congested, but no congestion, could not feel. The whole right side of nose and nostril went numb. It was congested in a weird way and could not blow her nose. The congestion felt like it was plugged but it was different from congestion. It was like it was numb on inside but not on outside. She wanted to know if this was normal. It was reported that her anxiety worsened/spiked when she could not feel her nose. The patient wanted to get shingles vaccine and asked if she should wait, if she should get the second dose of the COVID-19 vaccine and does she have increased risk because of her first dose experience. The patient had negative COVID test in Jan2021. The patient recovered from the event nausea on 09Feb2021 at 15:20; was recovering from pain at injection site, "weird tingling and ringing in right ear", headache, "right side of nose feels like it went numb congested, but no congestion/whole right side of nose and nostril went numb/could not feel/it was like it was numb on inside but not on outside" and "right side of nose feels like it went numb congested, but no congestion/it is congested in a weird way/ cannot blow nose". The outcome of the event "anxiety /anxiety worsened/spiked when she could not feel her nose" was not recovered. Information on the lot/batch number has been requested.
50 2021-04-02 ringing in ears Ringing in ears
50 2021-04-04 loss of taste Less than 24 hours after injection I had all over body aches, fever, fatigue and headache. This con... Read more
Less than 24 hours after injection I had all over body aches, fever, fatigue and headache. This continued until after 48 hours following the injection. I was still running a fever just over 100. On this date, I noticed diminished to absent sense of taste. I have no sinus congestion or drainage or allergies. I can still smell. I have not taken any medication since the injection accept Tylenol. I have no covid symptoms or difficulty breathing. Over all I do feel better than the past 4 days. Fever is gone and stamina is coming back, just noticed today I am not able to taste and do not have any other explanation for his. I called the place I received my vaccine and they had not heard of this side affect. I would like to know if this is a known side affect and if my taste will return.
50 2021-04-04 drooping eyelid, eye swelling My left eye was swollen shut the morning after the vaccine. The swelling has gone down to droopy ... Read more
My left eye was swollen shut the morning after the vaccine. The swelling has gone down to droopy eyelid as of now, 3 days after the vaccine. But is still not back to normal.
50 2021-04-04 hearing loss On March 23 I first noticed reduced hearing in my right ear. Went to doc on March 25. Doc said aller... Read more
On March 23 I first noticed reduced hearing in my right ear. Went to doc on March 25. Doc said allergies and had me start Flonase. No change in hearing. Back to doc on March 31. She performed a warm water wash in my ear and said infection and prescribed amoxicillin. April 3 woke up and hearing was worse.
50 2021-04-04 mouth tingling, mouth numbness 2/11/21, Received shot on Thurs, no immediate side affects other than slight tingling on tip of tong... Read more
2/11/21, Received shot on Thurs, no immediate side affects other than slight tingling on tip of tongue and upper lip, extremely small red spots on my right wrist and soreness of right arm near injection. 2/12/21. Friday evening. Fever, chills and headache. Continued numbness/tingles on my tongue and lips. Tongue only slightly swelled three times. 2 weeks following: Drug rash/hives continued to try to appear every evening daily right before I took another Zyrtec. Needle pricks or itchy on my skin. Continued tingling/numbness sensation on tip of tongue and around mouth. Allergist had me on three 24-hour antihistamines. 8am Allegra, 2pm Zyretec, 8pm Zyrtec. 3/12/21 - Drsuggested going down to 2 Zyrec's per day 8am and 8pm. Did and was fine except continued on/off tingles/numbness on my tongue. Also increased facial tingles and numbness. The pink splotches on skin only appeared late one evening and went away, no full blown drug rash or hives, just a few needle pricking sensations on arms. 3/23/21 - Decreased to 1 Zyrtec @ 8pm per allergist. I am still feeling continued face and tongue pricks, tingles, numbness. 4/4/21 - A little tongue swelling late evening along with tongue and face tingle sensations. Finally went away and started again on 4/5/21. I am still taking only 1 Zyrtec every evening @ 8pm. Still throughout the day I continue to suffer with face/nerve tingles, pricks, tightness on my entire face, chin and throat. Tip of tongue on/off numbness. Submitting as Drhas not sent VAERS my latest allergic reaction report so said I will submit. I am getting very nervous and worried that symptoms have not gone away at almost exactly 2 months after my 2nd shot.
50 2021-04-04 ringing in ears Tinnitus- loud roaring, hearing acuity.,
50 2021-04-04 tongue disorder, taste impairment Within a few seconds of getting shot I had immediate strong metallic taste in my mouth. My left arm ... Read more
Within a few seconds of getting shot I had immediate strong metallic taste in my mouth. My left arm ( arm that received vaccine) turned red and splotchy , chest and face then turned red and splotchy. I felt lightheaded and my tongue and throat felt thick and like ?fuzzy? feeling. EMT put me on stretcher, gave me O2 and took BP...BP was higher than normal but not so high that was concerning. O2 was ok. I was monitored for 30 min then released. I felt weak the remainder of the day. The next day I was very ill, fatigued , body/joint aches, chills, sweats, bad headache, nausea, diarrhea- no fever. This lasted three days.
50 2021-04-05 taste impairment Patient reported metallic taste in mouth after and feeling light headed when driving away from vacci... Read more
Patient reported metallic taste in mouth after and feeling light headed when driving away from vaccine tent. Patient reports history of Bipolar Disorder and she was anxious prior to receiving vaccine fearing it would trigger an episode BP 138/88, Pulse 76
50 2021-04-05 oropharyngeal discomfort Pt. received the Covid-19 vaccine. She reports symptoms of "feeling her throat weird" pt stated she ... Read more
Pt. received the Covid-19 vaccine. She reports symptoms of "feeling her throat weird" pt stated she has a hx of anxiety and was very nervous. RN had Epi on hand pt sat with RN, pt drank water and pt's HR was 88 when she stated she did not feel well at 3:52pm, 15 min after her vaccine was given. Treatment/intervention: Pt was given water and sat and additional 30 mins after initially feeling unwell. Pt stated she feel fine at 4:08pm. Pt denies any throat or tongue swelling. Pt states she feels fine. At 4:15pm: HR: 76 O2: 99% BP: 120/80 At 4:30pm: HR: 73 O2 100% BP: 118/78 Pt stated she felt well, she did not have any swelling in face or tongue or difficulty breathing.
50 2021-04-05 pain in jaw Swollen lymph nodes left armpit, pain along arm, some pain in jaw Extreme tiredness, lots of naps, b... Read more
Swollen lymph nodes left armpit, pain along arm, some pain in jaw Extreme tiredness, lots of naps, bit of brain fog
50 2021-04-05 pain in jaw Immediately experienced intense erratic nerve pulsations along left cheek. Left side of cheek and ja... Read more
Immediately experienced intense erratic nerve pulsations along left cheek. Left side of cheek and jaw felt numb and tingly. Jaw felt sore. I could feel the nerve pulsations with my fingertips very strong. The Pulsations continued on and off and subsided but the numbness tightness soreness and tingling feeling on the left side of my face lasted for about 36 hours until it completely resolved. 72 hours later the left side of my cheek still feels mildly sore or like a little tense at the jar hinge and under the skin. I also experienced dizziness and that lasted for most of the day I had trouble for instance focusing on things up close like washing dishes. I had to look further away. I also experienced an intense headache on the left side of my skull like a hammer pounding ten times at about 9 PM. Then it went away then the pounding came back again so Itook 500 mg Tylenol which seem to help but I still had a little bit of an ache in my jaw a few hours later so I took another 500 mg and that seem to resolve the headache and jaw pain. The next morning my face was still a little numb tingly and tight all day. It wasn?t until Sunday that it felt like it had finally resolved itself.
50 2021-04-05 ringing in ears Humming in both ears for 6 days on the 7th day louder.
50 2021-04-05 ringing in ears A sudden on set of dizziness or feeling of vertigo, loud buzz in my head, nausea, pain at back base... Read more
A sudden on set of dizziness or feeling of vertigo, loud buzz in my head, nausea, pain at back base of neck, numbness and tingling in face and hands, strange feeling in throat almost like a lump, extreme fatigue . It was not debilitating but I did not feel well enough to drive my car. Symptoms started March 22 and all have dissipated except feeling dizziness and buzz noise in my head.
50 2021-04-06 eye swelling, eye pain On 4/5/21 I got nausea and chills for about an hour. I woke up on 4/6/21 and my right eye and all bo... Read more
On 4/5/21 I got nausea and chills for about an hour. I woke up on 4/6/21 and my right eye and all bone structure on the left side were very painful. It did get worse throughout the day. I woke up on 4/7/21 and the same symptoms with my face and eye but appear to be lessened. But as I am trying to fill out the form it is starting to hurt a little more. Slight swelling in the left eye.
50 2021-04-06 ringing in ears Ringing in ears (tinnitus) began the evening of April 6. I've never had this problem before.
50 2021-04-07 loss of smell body aches; fatigue; ill; Test: Covid Date:Result: Positive; Lost Sense of smell; chills; Fever reac... Read more
body aches; fatigue; ill; Test: Covid Date:Result: Positive; Lost Sense of smell; chills; Fever reaching 100..8F; feeling sick; This is a spontaneous report received from a contactable nurse. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL8982) intramuscularly to left arm on 04Feb2021 1:30 at a single dose for COVID-19 Immunization. On 01 Jan2019, patient had started concomitant medications Metformin used for the indication Diabetes, Lovastatin used for the indication cholesterol and Montelukast used for the indication sinus allergy. past medical history pollen and bed bug allergies. On Jan 2021, patient had CXR, Hemoglobin resulted 11.2 and vitamin D. On 09 Feb2021, patient had Covid test and resulted positive On the 04Feb2021 22:30 the patient had experienced Fever and chills. The patient assessed the events as non-serious. She started feeling sick that evening. body aches, chills, and a fever reaching 100.8F. She is still experiencing fatigue. At the time of reporting the events chills, Fever reaching 100..8F were recovering and fatigue was not recovered and body aches, feeling sick, Lost Sense of smell and ill were unknown.
50 2021-04-07 taste impairment On both shots I have a taste of metallic in my mouth. It was like this bizarre metallic taste as soo... Read more
On both shots I have a taste of metallic in my mouth. It was like this bizarre metallic taste as soon as I was injected with the vaccine the second one was more prominent and lasted a little longer. I felt nauseous when I got home
50 2021-04-07 ear discomfort, pain in jaw, toothache 10 hours after injection, the adverse event started with sinus pressure and ear pressure and gums/te... Read more
10 hours after injection, the adverse event started with sinus pressure and ear pressure and gums/teeth hurting. Within an hour, my whole body hurt. My joints felt like they were being crushed in a vice (elbows, hands, knees). My muscles ached and my back ached. My jaw ached. My neck was very sore and I had a headache. I didn't take any medication (800mg ibuprofen) until 6:30am in the morning (had temperature of 100.4 degrees). I slept for several hours and felt much better by 10am (approx 22 hours from original injection time). I was still very tired for another 6 hours, but I was fine after that.
50 2021-04-07 ear pain, vision blurred She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My fac... Read more
She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown. Information about lot number has been requested.
50 2021-04-07 ear pain Patient developed a fever, nasal congestion and ear ache on 4.7.2021 and a positive COVID-19 test on... Read more
Patient developed a fever, nasal congestion and ear ache on 4.7.2021 and a positive COVID-19 test on 4.8.2021
50 2021-04-07 swollen tongue, tongue itchiness Swollen and itchy tongue; Swollen and itchy tongue; This is a spontaneous report from a contactable ... Read more
Swollen and itchy tongue; Swollen and itchy tongue; This is a spontaneous report from a contactable Nurse (patient). A 50-Year-old non-pregnant female patient received first dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581, Expiry date: unknown) via unspecified route of administration on 31Jan2021 at 10:45 AM (at the age of 50-years-old) at a single dose for covid-19 immunisation. Medical history included Known allergies, never had allergic reaction before. Concomitant medication patient received within 2 weeks of vaccination included 50 mcg Levothyroxine, 10mg lisinopril, 67mg Fenofibrate. The patient experienced Swollen and itchy tongue on 31Jan2021 at 11:30 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of all the events was recovered in 2021.
50 2021-04-07 ringing in ears About 2 weeks after my first dose, i began experiencing tinnitus in my left ear. It is so annoying ... Read more
About 2 weeks after my first dose, i began experiencing tinnitus in my left ear. It is so annoying and is still there a week now already!
50 2021-04-07 ringing in ears Migraine D1, Migraine D2, D3 chills, shortness of breath, heart palpitations, tinnitus; called MD at... Read more
Migraine D1, Migraine D2, D3 chills, shortness of breath, heart palpitations, tinnitus; called MD at Clinic, RN spoke to told me to go to the ER since I had to keep pausing conversation to breathe. SOB lasted 3-4hrs and was gradually improving as I drove to ER. Tinnitus not improved, Chills improved, SOB severe improved but still occasional mild SOB, Palpitations improved, Migraines improved
50 2021-04-08 double vision Pain and rash/heat at injection site. Aching Joints, Low fever, Nausea, Double vision. 24 hours afte... Read more
Pain and rash/heat at injection site. Aching Joints, Low fever, Nausea, Double vision. 24 hours after shot, better by 48 hours.
50 2021-04-08 ear pain headache, nasal congestion, otalgia, sore throat, productive cough, shortness of breath with exertio... Read more
headache, nasal congestion, otalgia, sore throat, productive cough, shortness of breath with exertion, body aches, nausea vomiting diarrhea, went to outside ER, diagnosed with bronchitis and prescribed antibiotics, steroids, inhaler, CT with "abnormal nodule in her lungs"
50 2021-04-08 eye pain, vision blurred, pain in jaw 4 am: 2 hours of chills and violent trembling. My teeth were clenched so tight for so long, my jaw a... Read more
4 am: 2 hours of chills and violent trembling. My teeth were clenched so tight for so long, my jaw ached. 6 am: I couldn?t lift a glass of water. Someone brought my cup and straw, which I nestled between my face and pillow. I sipped what I could. 6:30: Sleep 8:am: Woke up thinking it was 6pm. I couldn?t roll over. Dizzy and weak, I collapsed back into bed from trying to stand. Someone walked me to the bathroom. Once there, I wheezed and gasped for air. Then I got scared and cried, which made it even harder to breathe. It felt like my body wasn?t absorbing the oxygen it took in. 8:05: Sleep 9 am: Woke up hoping the day was almost over and I slept through it. The cruelest part is sleeping what felt like the deepest sleep only to wake up an hour later ? over and over again. My spine and neck ached, which made my head hurt ? or my head hurt all on its own. 12 pm: Sharp abdominal pains with any movement. If I did move, I had fits of gasping for air. Had to ask Someone for the phone sitting just a foot away. I couldn?t look at the screen. My eyeballs were too sore, head too achy, and brain too fogged. The phone was only to ask for help while someone worked in the other room. 12:30: Abdomen sore to touch. Hard to talk. My bowels became so shut down it hurt(s) to move straight water through them. The rest is kind of a blur. Lots of sleep. In the afternoon, someone walked me to the bathroom. Back in bed, I had another breathing fit. My abdominal pain felt inescapable. Through was happy for his company, I think I fell asleep during our conversation. At some point, someone brought me broth but I didn?t get much down. By evening, I could walk to the bathroom alone, albeit hunched like a 120 year old in need of a walker. My guts just hurt too much to stand upright. Day 2: I still suffer from abdominal pain, a headache and muscle aches, but I CAN roll over, lift a glass of water, and focus on a screen for short stints. (I documented this in stages.) I can walk slowly but still painfully to the bathroom without help, but I get winded beyond that. I?m afraid to eat with my digestive tract so inflamed, but I have far more energy today, 32 hours after my last meal, than I did yesterday. I?ve also lost 6 pounds. Day. 3: 10 pounds down, still with diarrhea, but eating again. Restless sleep. Significantlt winded and dizzy after mild activity, like walking from one side of the house to the other.
50 2021-04-09 eye pain Chills for 3 hours, followed by high fever. Low fever next morning and splitting headache and pain ... Read more
Chills for 3 hours, followed by high fever. Low fever next morning and splitting headache and pain behind eyes.
50 2021-04-09 lip blister, bloodshot eyes Nausea within an hour of shot. Body aches, Headache, arm pain and 3 days after shot hives on arm/ ... Read more
Nausea within an hour of shot. Body aches, Headache, arm pain and 3 days after shot hives on arm/ looking like mosquito bites all over that arm. took Benadryl and used benadryl cream for the itching, it was gone in about 24 hours after use of benadryl. After second vaccine ~ no reactions except headache. but I am having allergic reactions to all kinds of antibiotics that I have NEVER been allergic to before. Red face and eyes, Peeling and blistering skin, lips and face, major itching, rashes (on face).
50 2021-04-09 thirst Arm vaccine given swollen and red and hot, had fever 100-102 within hours for 5 days, joints hurt, s... Read more
Arm vaccine given swollen and red and hot, had fever 100-102 within hours for 5 days, joints hurt, shakes to point of not able to pick up glass of water, headache, extreme thirst, extreme tiredness and sleepy. I had vaccine on Wed. and had all of these symptoms until I stopped my Lithium Sunday and by Wed. I was feeling better. I drank as much water as I could and restarted my Lithium due to the side effects I had from stopping and I no vaccine issues today 4/9/2021 my issues from medication is starting to settle down. I only stopped the Lithium which is 600mg a day - I take 4 pills that are 150mg each.
50 2021-04-09 ringing in ears Tinnitus
50 2021-04-09 ringing in ears Patient is complaining of ringing in her ears since vaccine and tightness in her throat (not anaphyl... Read more
Patient is complaining of ringing in her ears since vaccine and tightness in her throat (not anaphylaxis type tightness)
50 2021-04-10 eye twitching eye twitching
50 2021-04-10 permanent deafness, ringing in ears Adverse events: -Sudden sensorineural hearing loss (SNHL) of right ear -Tinnitus Treatment: -Predn... Read more
Adverse events: -Sudden sensorineural hearing loss (SNHL) of right ear -Tinnitus Treatment: -Prednisone 60 mg/day for 2 weeks
50 2021-04-10 deafness, ear discomfort Left ear plugged, then a few hours later right ear, with minimal hearing loss
50 2021-04-10 oropharyngeal discomfort No treatments as of yet started taking Benadryl for safety reasons as soon as Benadryl wears off not... Read more
No treatments as of yet started taking Benadryl for safety reasons as soon as Benadryl wears off not this back and throat have an appointment to see my primary doctor on Tuesday the 13th 2021
50 2021-04-10 ringing in ears Tinnitus, stronger in right ear.
50 2021-04-11 dry throat Headache, fever, nausea, dry throat, mild cough
50 2021-04-11 eye itchiness, taste impairment near immediate lump in throat that increased to a sensation that I might not be able to swallow with... Read more
near immediate lump in throat that increased to a sensation that I might not be able to swallow within approximately 20 minutes. I maintained the ability to swallow. Shortly after the throat swelling, my eyes began to itch. This was followed by general face itching. I also experienced a metallic taste in my mouth within 15 minutes of the dose. I took a Benadryl at around 8 PM after my throat and the itching had not resolved. The benadryl resolved the itching and ease the swollen throat. My throat remained tight feeling the next day, but was normal feeling by 4/11/21.
50 2021-04-11 eye itchiness ITCHY EYE(S), NOSE AND OROPHARYNX WITHOUT REDNESS,SWELLING OR DYSPNEA - ADMINISTERED 25MG DIPHENHYDR... Read more
ITCHY EYE(S), NOSE AND OROPHARYNX WITHOUT REDNESS,SWELLING OR DYSPNEA - ADMINISTERED 25MG DIPHENHYDRAMINE BY IM ROUTE LEFT DELTOID: NEG CHEST PAIN, BLEEDING, RESTRICTIVE BREATING B/P 142/80mmHg, O2 sat 99%, HR 101, RR 18 - resolved in 30 minutes sent home feeling better - and to pretreat 25mg Benadryl/20mg Pepcid 30-45minute before second Covid vaccine and to ask for (Name)
50 2021-04-11 mouth tingling Tightness in the throat , Numbness in fingers. tingling on the lips and tongue symptoms were gone in... Read more
Tightness in the throat , Numbness in fingers. tingling on the lips and tongue symptoms were gone in a matter of 30 minutes no treatment.
50 2021-04-11 ringing in ears, deafness unilateral I woke up in the morning and couldn't hear out of my right ear. There is also a buzzing sound.
50 2021-04-11 tongue disorder Patient reports adverse event was mild. Approximately 5 minutes after vaccination patient's tongue f... Read more
Patient reports adverse event was mild. Approximately 5 minutes after vaccination patient's tongue felt thicker and she reports feeling a sensation. Patient's throat also felt scratchy. Benadryl 25 mg was given to patient at 2:27 PM.
50 2021-04-12 deafness, ringing in ears Constant tinnitus began on March 4th. It has continued and worsened over the last month. It never st... Read more
Constant tinnitus began on March 4th. It has continued and worsened over the last month. It never stops and interrupts concentration and sleep. EL9267
50 2021-04-12 dry throat lightheaded "felt drunk", dry throat. Evaluated by EMS-Refusal to transport.
50 2021-04-12 swelling of eyelid There were no side effects with the 1st dose. The 2nd dose resulted in the following: 4 hrs in: ... Read more
There were no side effects with the 1st dose. The 2nd dose resulted in the following: 4 hrs in: 2 hives on thigh 12 hrs in: More hives/welts on torso, feet, knees, elbows, hands, face, thighs 24 hrs in: fever, chills, body aches (expected) and extensive amount of welts, hives all over the body and swollen hands/feet, wrists/ankles to include itching and pain. The 2nd dose has triggered my Chronic Urticaria, which I first got in 2019 from what I believe was an ingredient in sunscreen (octinoxate). At that time it took me 1 long year to completely get rid of those hives and that was successful by using a series of prednisone (which was damaging to my system and hard to get off of) and then finally Xolair. I have not been off of the Xolair for even a year at this point and now, I am back to where I started. I believe that the PEGs in the Pfizer vaccine has activated my urticaria. I am now suffering with severe welts/hives and swollen hands. Prednisone is not an option due to it mixing with the vaccine and I managed to get a low dose of Xolair yesterday (4/12/21) but that shot is slow-absorbing and I might not see relief for 7-8 days. Additionally, my blood pressure was 160/100, which is consistent with presence of these welts/hives. This includes a rapid heart beat as well. Had I known this was a even a remote possibility, I would not have received the Pfizer vaccine. Chronic Hives is a life-altering issue as I have used a lot of sick time and missed events due to discomfort and swollen eyelids.
50 2021-04-12 swollen tongue pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 ... Read more
pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518, was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later, after multiple cardiac arrests and multiple rounds of ACLS were performed, the pt was pronounced dead at 0127 on 4/12
50 2021-04-12 vision blurred, eye movement disorder, mouth tingling, tunnel vision On 4/5/21, two days after my second injection, I was sitting at my desk working (at home) when I not... Read more
On 4/5/21, two days after my second injection, I was sitting at my desk working (at home) when I noticed my vision wasn't clear even with my glasses on. I had been feeling nauseous for a few hours and then my eyes started bouncing back and forth uncontrollably. I was unable to see correctly or move from my chair. Once my eyes stopped moving my vision became tunnel vision and everything around it became foggy. I felt weak and dizzy. I started getting a headache. I didn't think I could even call out for help as I was unsure my voice would work. Once it all calmed down I figured it must be part of a migraine, even though nothing this extreme had ever happened before. I moved to my bed as I was suddenly completely exhausted, and immediately fell asleep for almost 3 hours. Once I got up I was still very groggy and had to force myself my. I stayed up for about 3 hours and went back to bed for the night. The next morning I woke and was feeling better so I figured it must have been a migraine. However a few hours later the same problems started back up again. I was having a hard time seeing my computer screen, I had a foggy head and was finding it hard to concentrate and do work. My headache started again and my vision started as foggy and became tunnel vision again. This time my eyes did not bounce, but my lips started tingling. This lasted for about 1 minute. This time with everything I was making sure to take a mental note of everything going on because I was scared I was going to have to call 911. Because I was home alone I opened my phone to dial if it got any worse. The event backed off enough that I took myself to the ER. By the time I was in the waiting room my head felt like a balloon and my whole body just felt "off." I can't explain how it felt, it just didn't feel normal. My headache never got overly severe like it does with a migraine, but I was worried about a stroke. The ER did a CT scan and did rule out a stroke, but was unsure of what it exactly what it was, but guessed it was an abnormal migraine attack and told me to follow up with my PCM in a couple of days and to keep my appointment with my neurologist on April 15th. The symptoms lasted a full week off and on every day, with a tampering down of severity of symptoms.
50 2021-04-13 taste impairment, smell distorsion About an hour afterwards I could taste it. Whenever I get IVs I can taste and smell them. I did not ... Read more
About an hour afterwards I could taste it. Whenever I get IVs I can taste and smell them. I did not expect the same reaction from an intramuscular shot, but I suppose once it got into my bloodstream and got to my olfactory areas, it started up. It really does produce the same taste as when I get an IV. For the past four days since I've gotten the shot, about once a day I get this same taste and smell. It happened again today a few minutes ago, so I thought I would report that after four days as it's going through my system and is still detectable physically. In addition, last night on 4/13/2021, I was a little congested, so I coughed hard to bring up some phlegm. There were two small spots of blood in the phlegm. I coughed five times and had the same amount of blood. I waited a few minutes and coughed again, and it turned into a pink-tinged mucus. Then it cleared up and it hasn't happened again. It was very tiny and I can't say it was from the vaccine, because nothing else has happened. It could be my age and thin tissue and a broken vein from a very deep cough, but yeah. it was very scary and I thought I would report it in case something more happens.
50 2021-04-13 ear discomfort headache, burning on face, chest and ear about 2-3 min after vaccine. Took benadryl
50 2021-04-13 eye pain I did not know this could possibly be a side effect of the vaccine until my school nurse alerted me ... Read more
I did not know this could possibly be a side effect of the vaccine until my school nurse alerted me to the possibility and advised me to report my reaction. I developed sinus congestion that I did not think was serious in the weeks after the vaccine. I had headaches and nasal congestion. many weeks after the vaccine, I sniffled and a large mass went down my throat, again I thought nothing of it. Last weekend, I got a very painful headache behind my other eye. I massaged my brown-bone and a large walnut sized and shaped mass, brown and red in color, shaped exactly like a shelled walnut with lobes came out of my nose. My school nurse told me this sounds like it was a sinus blood clot and to alert the clinic. The clinic in town where I got my vaccine said because I am not ethnicity, I had to report it myself on VAERS.
50 2021-04-14 loss of taste, loss of smell PT RECIEVED VACCINE ON 4/09/2021, AND CALLS ON 4/15/2021 STATING THE FOLLOWING SYMPTOMS. PT HAD HEAD... Read more
PT RECIEVED VACCINE ON 4/09/2021, AND CALLS ON 4/15/2021 STATING THE FOLLOWING SYMPTOMS. PT HAD HEADACHE, DIZZY, NAUSEOUS, AND ARM HURTING 45 MINUTES AFTER GETTING VACCINE, THE NEXT DAY 4/10/2015 PT STATED SHE JUST FELT BLAH WITH FLU LIKE SYMPTOMS, HURTING ALL OVER, THEN ON 4/12/2021 PT STATED SHE LOST TASTE AND SMELL WITH SOME COUGHING. PT STILL HAS FLU LIKE SYMPTOMS AS OF TODAY. PT STATED SHE HAS A DR APPOINTMENT ON 4/16/2021.
50 2021-04-14 taste impairment blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, sho... Read more
blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, shortness of breath, extreme blood pressure immediately upon injection for 1 hour. Continued reactions 48 hours, extreme fatigue, blood pressure, dizziness, metal and bitter taste in the mouth, migraine, stomach upset, red polka dots on hands, itchiness underarms, cough, sore throat, and fever
50 2021-04-14 mouth numbness numbness of tongue and lip, clinching of teeth, left sided dropping of mouth
50 2021-04-14 sensitivity to light When i took the first does, i passed out the morning after the vaccine and had fever for 2 days. I ... Read more
When i took the first does, i passed out the morning after the vaccine and had fever for 2 days. I also had body ache and a light cough. The second dose, i had sever chills starting within 3 hours of the injections. Thru out the night i was freezing but my skin was hot to the touch and i had a fever. The second day i was very sensitive to light and sounds. I couldn't keep my eyes open and had no energy to do anything. I had chills the whole day. I was bundled in 3 blanket and still shivering. The following day i couldn't remember the event of the prior day. It felt as if i was in fog the whole day. Note: I have COVID end of January 2021
50 2021-04-14 swollen tongue Approximately 20 minutes after waiting my entire body including my face and mouth became numb. Ther... Read more
Approximately 20 minutes after waiting my entire body including my face and mouth became numb. There was some swelling of tongue but mainly just felt dry. I was advised that I should go to the ER by ambulance. I had no anaphylactic symptoms. They took a metabolic panel which was fine. After 2 hours they sent me home. The full body numbness lasted 24 hours with residual numbness on my left side especially my left forearm and hand lasting a few days. Since then my fingers have felt sore at time kind of like an arthritic pain.
50 2021-04-14 visual impairment Vertigo and Visual Disturbances
50 2021-04-15 pain in jaw Within 15-minutes of vaccination, the patient reported headache, nausea, and malaise. Paramedics eva... Read more
Within 15-minutes of vaccination, the patient reported headache, nausea, and malaise. Paramedics evaluated the patient on-site. The patient was hypertensive (229/129). EKG demonstrated NSR, rate 85 bpm, no ST elevation. Paramedics transported the patient to Emergency Department. In the ED, the patient developed centralized chest pain, diaphoresis, and right jaw pain, but denies shortness of breath, nausea/vomiting, focal weakness, fever or chills. The patient remained hypertensive (184/85). Physician administered 325mg PO Aspirin, 0.2mg PO Clonidine, and 1 inch topical Nitroglycerin. The labs and imaging did not present evidence of myocardial infarct or intracranial hemorrhage. Due to symptoms on presentation, the patient was admitted to rule out ACS. Upon admission, the patient stated the chest pain "comes and goes", but is not currently having any chest discomfort. Admitting physician administered 5mg PO Amlodipine, 5mg PO Lisinopril, labetalol 10mg IV, and prophylactic Lovenox. As of 4/16, the patient had not been discharged, but their hypertensive urgency and chest pain have resolved and will be treated outpatient. Internist planning patient's discharge.
50 2021-04-15 swollen tongue Woke at 4 am with a the right side of my tongue swollen; This is a spontaneous report from a contact... Read more
Woke at 4 am with a the right side of my tongue swollen; This is a spontaneous report from a contactable 50-year-old non-pregnant female consumer reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318, Expiration date: unknown) via an unspecified route of administration on Left arm on 02Feb2021 at 20.45 at single dose for COVID-19 Immunization. The patient medical history included thyroid disease and Allergies to Augmentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Concomitant medication included Levothyroxine sodium (88mcg). On 03Feb2021 04:00 am, the patient waited for 15 minutes required and did not feel anything, patient went home, went to bed. Woke at 4 am with a the right side of my tongue swollen. The patient did not receive any treatment. The outcome for event was recovering.
50 2021-04-15 ringing in ears severe tinnitus onset at 35 hours (permanent and continious), chills started at 30 hours and lasted... Read more
severe tinnitus onset at 35 hours (permanent and continious), chills started at 30 hours and lasted 6 hours
50 2021-04-15 tongue discomfort, ringing in ears Day 1: 3PM Sore throat, 11PM facial swelling, 4AM panic attack Day 2: 2PM, lasting for 3+ hours: N... Read more
Day 1: 3PM Sore throat, 11PM facial swelling, 4AM panic attack Day 2: 2PM, lasting for 3+ hours: Nausea, dizzy/faint/weakness, rapid heart rate (120-150 BPM), elevated blood pressure, chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus ; 5PM chills, temp up to 101.5, intense lower back pain, headache, anxiety Day 3: intense headache, lower back pain Day 4: Mild headache, depression and fever blister later in the day Day 5: Deep depression, feeling of impending doom Days 6-16: Elevated anxiety, chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus, GERD, esophageal spasms
50 2021-04-16 double vision Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoi... Read more
Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoing since time of second dose administration
50 2021-04-16 taste disorder, taste impairment Pfizer-BioNTech COVID-19 Vaccine EUA: About 15 minutes after receiving shot during my post-shot wa... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: About 15 minutes after receiving shot during my post-shot wait time in the store, I noticed the taste of metal in my mouth, it started from the back right and swept over it to the left and over my tongue (it was weirdly specific and noticeable). It wasn't crazy strong, but it was distinctly a metal taste. It kind of went away for a bit, but kept coming back intermittently throughout the day. It's been two weeks and it still happens a little, but now mostly my sense of taste is messed up. Feels like on certain parts of my tongue things either don't taste right or I can't taste them at all. Hoping it goes away eventually as I REALLY love food. And coffee.
50 2021-04-16 ringing in ears Ringing in ears or head I am not sure. It didn't stop , continuous.
50 2021-04-17 ear discomfort More swelling in left hand; Increase in joint pain; Common cold symptoms; Right ear felt weird; Incr... Read more
More swelling in left hand; Increase in joint pain; Common cold symptoms; Right ear felt weird; Increase blood pressure within 15minutes of the injection; This is a spontaneous report received from a contactable consumer (reporting on herself). A 50-years-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration in Arm Right on 23Mar2021 16:15, as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis, hypothyroidism, hypertension all from an unknown date and unknown if ongoing. Concomitant medication(s) included prednisone (PREDNISONE) and meloxicam (MELOXICAM) both taken for an unspecified indication, start and stop date were not reported. The historical vaccine includes flu vaccine on an unspecified date. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 23-MAR-2021 18:00, more swelling in left hand, increase in joint pain, common cold symptoms, increase blood pressure Within 15minutes of the injection. Right ear felt weird. Patient was not received any treatment for the adverse reactions. Since the vaccination, patient was not tested for COVID-19. The outcome of the events recovered with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-04-17 toothache Swollen lymph node under arm are left side; hot flashes and teeth aching on left side
50 2021-04-18 deafness, ringing in ears Developed bilateral tinnitus one day after receiving 2nd vaccination. No tinnitus prior to vaccinati... Read more
Developed bilateral tinnitus one day after receiving 2nd vaccination. No tinnitus prior to vaccination (or at any other time). Still experiencing tinnitus two weeks later. The ringing is almost constant.
50 2021-04-18 eye swelling, vision blurred, sensitivity to light, eye pain 24 hours after second Pfizer vaccination, began to experience eye pain and swelling in the right eye... Read more
24 hours after second Pfizer vaccination, began to experience eye pain and swelling in the right eye / conjunctivitis; which escalated dramatically on 4/14/2021. on 4/15/2021 eye pain continued to escalate and began experiencing severe light sensitivity. Saw opthalmologist on 04/15/2021 and began taking steroid drops to reduce eye inflammation. Pain reduced, but experiencing fuzzy vision on 04/17/2021 and 04/18/21. Unsure yet of resolution. 24 hours after second Pfizer vaccination experienced fever of 101.2 before reducing with tylenol (lasted from about 5pm to 9pm on 04/13/2021). Extremely tired with brain fog throughout the week (and still experiencing as of 04/19/2021)
50 2021-04-18 mouth ulceration Sore in back of mouth on right side, Itchy bumps X4 on left arm Itchy bumps X2 above left side of st... Read more
Sore in back of mouth on right side, Itchy bumps X4 on left arm Itchy bumps X2 above left side of stomach and 2 more right side of lower abdomen
50 2021-04-18 mouth tingling after 4 hours of iniitial dose, had the followinig symptms on day 1...tingling lips, swollen, gums, ... Read more
after 4 hours of iniitial dose, had the followinig symptms on day 1...tingling lips, swollen, gums, tightening of throat, hours later, hives on face & itching all over..took benadrly, day 2...fever of 102.9, chiils, extreme fatigue, nausea, dareahea & vomiting...took tylenol..day 3, feel better, but some stomach discomfort still and slight headache
50 2021-04-18 thirst, mouth tingling, dry throat Within 1 second of injection completion - hot pain seared down from injection site to wrist. 30-60 ... Read more
Within 1 second of injection completion - hot pain seared down from injection site to wrist. 30-60 seconds later while seated, roof of mouth and face began to tingle, throat felt extremely dry and itchy and intense thirst, a very strong surge of nausea, dizziness/vertigo, weakness of limbs- especially the hands. 60-120 seconds later body shaking, teeth chattering (but not from cold). 30-60 minutes later Mild headache. Allergic reaction symptoms came in waves of intensity for approximately 8-10 hours.
50 2021-04-18 vision blurred Patient has been experiencing constant tiredness, dizziness, difficult and blur speech , face numbne... Read more
Patient has been experiencing constant tiredness, dizziness, difficult and blur speech , face numbness, and blurred vision a day after getting the vaccine. Patient also experienced hot and cold episodes that went away after taking Tylenol, but they came back when the medicine wore off.
50 2021-04-19 ringing in ears Loud ringing in both ears started around 5:00 pm the day of the vaccine. Gradually got better over ... Read more
Loud ringing in both ears started around 5:00 pm the day of the vaccine. Gradually got better over course of two weeks, but still experiencing ringing. Tingling/ numbness/neuropathy in right arm, right hand, right leg, right foot started day after the vaccine. Left arm, hand neuropathy, as well.
50 2021-04-20 taste impairment Metallic taste for several days
50 2021-04-20 mouth numbness Facial numbness and prickling for couple of minutes on4/1/21. Woke up with facial numbness on 4/2/21... Read more
Facial numbness and prickling for couple of minutes on4/1/21. Woke up with facial numbness on 4/2/21 and later in the day felt the roof of my mouth and portions of my tongue felt numb. Continued till 4/4/21 where in only my forehead and around my mouth felt numb and prickly. Then it has been on and off till date
50 2021-04-20 ringing in ears severe tinnitus developed approximately 72 hours after receiving vaccine. No prior history of tinnit... Read more
severe tinnitus developed approximately 72 hours after receiving vaccine. No prior history of tinnitus. Has not resolved.
50 2021-04-20 ringing in ears hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus... Read more
hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2, COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 13:45 (Batch/Lot Number: EN6204) as single dose for covid-19 immunization. Patient was not received any other vaccine in four weeks, Vitamin B12 received in two weeks. Concomitant medication included cyanocobalamin (VITAMIN B12). Patient was not pregnant. The patient experienced difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus, hot flashes, could not focus on 31Mar2021 13:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included allergies to shellfish (though allergy test says otherwise, wool, poison ivy, jewelry not identified why, heart rate fast on 31Mar2021. There was no covid prior vaccination, no covid tested post vaccination. Therapeutic measures were taken as a result of hot flashes, difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus. The events outcome were resolved with sequel. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. No follow-up attempts are needed. No further information is expected.
50 2021-04-21 eye itchiness, vision blurred blurred vision & itchy eyes - this actually started yesterday afternoon and is continuing today sev... Read more
blurred vision & itchy eyes - this actually started yesterday afternoon and is continuing today severe joint and muscle pain - took aleve - did not help - so far all morning shortness of breath and chest pains - so far all morning - don't know of anything to do lethargy and brain fog - so far all morning - don't know of anything to do severe pain at injection site
50 2021-04-21 hearing loss Severe runny eyes. Severely of runny noses I've ever had. Fatigue. Head pressure. Severe night sweat... Read more
Severe runny eyes. Severely of runny noses I've ever had. Fatigue. Head pressure. Severe night sweats that disappear and reappear quickly. Taste and hearing has decreased by 50%. Miserable.
50 2021-04-22 inability to speak, loss of taste Fever, chills, green diarrhea, loss of taste, excessive coughing for loss of voice, throat swollen... Read more
Fever, chills, green diarrhea, loss of taste, excessive coughing for loss of voice, throat swollen, loss of appetite, sugar lows, coughing fits, wheezing. Out of work Self quarantined
50 2021-04-22 ear discomfort Chills, 102 fever, jack-hammering headaches, body aches, chest pain, dizziness, plugged ears, stiff ... Read more
Chills, 102 fever, jack-hammering headaches, body aches, chest pain, dizziness, plugged ears, stiff harm, sore lymph nodes. All finally went away after day 5 except still have chest pains.
50 2021-04-22 eye itchiness About 15 minutes after itchy eyes, rhinorrhea, itchy skin, hives, throat tightness, hard to swallow ... Read more
About 15 minutes after itchy eyes, rhinorrhea, itchy skin, hives, throat tightness, hard to swallow and evaluated in the ER
50 2021-04-22 lip swelling ?Pfizer-BioNTech COVID-19 Vaccine EUA: patient present to clinic staing one day after vaccination ex... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA: patient present to clinic staing one day after vaccination experienced swollen, purple, and burning lips. Patient administered diphenhdramine and symptoms resolved over 1-2 days. Patient also reports nausea, decreased appetite. diarrhea, body aches, and frequent urination. Patient denies shortness of breath or fever. Patient advised to continue home management.
50 2021-04-22 mouth itchiness 0837 30 MIN S/P 2ND PFIZER INJECTION. COMPLAIN OF MOUTH ITCHING. NO RASH NO SOB. BENADRYL 25MG PO GI... Read more
0837 30 MIN S/P 2ND PFIZER INJECTION. COMPLAIN OF MOUTH ITCHING. NO RASH NO SOB. BENADRYL 25MG PO GIVEN AND WILL OBSERVE. 0906 STATES "BETTER" DENIES SOB, RASH. RETURN TO WORK WITH INSTRUCTIONS TO SEEK MEDICAL ATTENTION IF NEEDED
50 2021-04-22 oropharyngeal discomfort Pt reports having following symptoms: poking in the throat, headace, fatigue, dizzy, feeling out of ... Read more
Pt reports having following symptoms: poking in the throat, headace, fatigue, dizzy, feeling out of it, coughs, and runny nose; pt described it as "strong cold-like symptoms" all started on Wednesday 4/14/2021 in the morning time (over a 1.5 week of post-vaccination). What happened as a result of the adverse event? Pt reported she started taking Tylenol on 4/15/2021 PRN for her headache which helped; reports staying hydrated by drinking plenty of water and hot tea. Pt reports she is going to get tested for covid-19 today. ***NOTES*** Advised pt that symptoms such as coughs and runny nose are symptoms or covid-19 or another infection which are not consistent with post-vaccination symptoms. Recommend pt to contact her MD if her symptoms are not getting better and to continue to stay hydrated. Advised pt if her covid-19 test results comes back positive, recommend pt to quarantine for 14 days. Advised pt that if she tested positive for covid-19 and is still experiencing covid symptoms or not feeling well to make sure she recovers and complete her quarantine period before getting her second dose. Provided pt with contact information to reschedule her 2nd dose if needed.
50 2021-04-22 pain in jaw I experienced jaw pain separate from a headache in mid-afternoon following my first injection of the... Read more
I experienced jaw pain separate from a headache in mid-afternoon following my first injection of the vaccine.
50 2021-04-22 mouth tingling PT WAS FEELING A LITTLE TIGHT IN HER CHEST AND MIGHT FEEL A TINGLE ON THE BACK OF HER TONGUR. PT WA... Read more
PT WAS FEELING A LITTLE TIGHT IN HER CHEST AND MIGHT FEEL A TINGLE ON THE BACK OF HER TONGUR. PT WAS ASSESSED BY EMS. VITALS WNL AT BASELINE. PT WAS GIVEN WATER TO DRINK AND MONITORED FOR 15 MINUTES BY EMS. SYMPTOMS REPORTED CLEAR BY PT. VITALS REASSESSED AND PT GIVEN MEDICAL INFORMATION FOR ANY PROBLEMS THAT MAY ARISE FOLLOWING HER DEPARTURE.
50 2021-04-22 swelling around the eyes Dizziness, rolling pain throughout the body, cold sweats, fever, nausea for approximately 15 hours. ... Read more
Dizziness, rolling pain throughout the body, cold sweats, fever, nausea for approximately 15 hours. Approximately a few hours later that same day facial pain on the right side of the face became swollen around the eye and check. The swelling lasted approximately 30 hours before subsiding.
50 2021-04-22 thirst Excessive thirst night of vaccine. I?d had no period since 9/20 and 3 weeks after 2nd dose I got a p... Read more
Excessive thirst night of vaccine. I?d had no period since 9/20 and 3 weeks after 2nd dose I got a period with exaggerated pms symptoms.
50 2021-04-22 vision blurred, dry mouth Blurry vision/Nausea/Dizziness/Extreme Fatigue/Dry Mouth/Swollen Lymph nodes under injection arm/ wi... Read more
Blurry vision/Nausea/Dizziness/Extreme Fatigue/Dry Mouth/Swollen Lymph nodes under injection arm/ widespread body aches/eye twitch right eye/facial numbness/swollen hands/weakness(difficulty getting out of bed) Currently on day 5 and showing marked improvement in most areas. Still some fatigue/weakness, swollen hands, and eye twitch/facial numbness but much better than previous days. Never had fever or significant headache like many have reported.
50 2021-04-23 loss of smell, loss of taste Lost sense of taste and smell; Lost sense of taste and smell; This is a spontaneous report from a co... Read more
Lost sense of taste and smell; Lost sense of taste and smell; This is a spontaneous report from a contactable other HCP (patient herself). An 50-year-old female patient non pregnant)received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number:EN6201 and expiration date: unknown) via intramuscular route of administration in left arm on 11Feb2021 at 09:00 AM as single dose for COVID-19 immunisation. The medical history included Depression and allergy to cephalosporins. Concomitant medications were not reported. Patient did not take any other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 11Feb2021 at 19:00, the patient experienced lost sense of taste and smell. The patient did not take any corrective treatment for the adverse event. The outcome of the events was not recovered.
50 2021-04-23 ear pain, hearing loss, ringing in ears On or about the fourth day after the vaccine, I experienced what I would describe as "cranial" pain.... Read more
On or about the fourth day after the vaccine, I experienced what I would describe as "cranial" pain. It occurred only in two particular areas of my cranium. The pain was severe, but localized. It lasted for about 48 hrs. on and off. I was very tired and sleepy for most of the week following the injection. Sleeping seemed to help my cranial pain, somewhat. Then, on or about the 10th day after the vaccine, I developed congestion in my right Eustachian tube, causing my hearing to be compromised in the right ear. On about the 12th day, I developed a mechanical-type hissing noise that is bothersome, particularly at night; I believe it to be tinnitus. As of today, 18 days post 1st. vacc, cranial pain has disappeared, but I'm still experiencing pain in and around the inner ear/eustachian tube of my right ear. Plus, I continue to have persistent, low-level tinnitus most of the day. The hearing on the right ear is not what it was before the Pfizer vaccine. I certainly hope neither the tinnitus, nor the hearing loss is permanent. I'm really wondering if it's contra indicated for me to get the second vaccination.
50 2021-04-23 ear swelling Throat and inner left ear felt like it was swelling, extremely rapid heart beat, both within a minut... Read more
Throat and inner left ear felt like it was swelling, extremely rapid heart beat, both within a minute or two immediately following the vaccination. The rapid heartbeat seemed to go away after about 30 seconds but the throat/ear closure sensation lasted about 2 hours after the vaccination. I drank a lot of water prior and after the vaccination to flush out my system. I felt like I do when I incidentally eat something with cornstarch in it, and usually just drinking tons of water helps, which it did in this case. Sometimes I have to gargle Benedryl but I did not have to in this case. I contacted my PCP and plan to see an allergist before taking 2nd dose.
50 2021-04-23 mouth numbness, vision blurred Severe headache, blurr vision, dizziness, lips were numb, 103.7 temperature, chills, body aches, arm... Read more
Severe headache, blurr vision, dizziness, lips were numb, 103.7 temperature, chills, body aches, arm life both sides sore, joint pain, nausea, hard to walk because headache was that bad.. This happened the next day on the 23 rd. Following the headache day before. Sought help at ER at 2:30 am on April 24th. Given iv fluid and norco and nausea med. For headache. As of 8:45 still have painful body aches chills and tiredness and arm pit pain.
50 2021-04-23 light flashes or floaters in the eye Lightheadedness seeing specks
50 2021-04-24 ear discomfort, ringing in ears, extreme sound sensitivity, ear pain hearing is also coming and going periodically in both ears; I also felt like I was going to pass out... Read more
hearing is also coming and going periodically in both ears; I also felt like I was going to pass out about 5 minutes after the shot; Tinnitus in both ears started within about a half hour; I also have some facial numbness/tightness; I also have some facial numbness/tightness; intermittent ear pain; My joints in my feet and the bottom of my feet hurt.; ear fullness; very sensitive to sound; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 10:15 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. Medical history included Lyme disease from an unknown date. The patient has no known allergies. The patient is not pregnant. Concomitant medications included colecalciferol (VITAMIN D); probiotics; fish oil all taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 at 10:30 AM, the patient reported of tinnitus in both ears started within about a half hour of receiving first dose. The patient also felt like she was going to pass out about 5 minutes after the shot. The patient also has some facial numbness/tightness that started the same day as her shot (after the shot). The tinnitus, intermittent ear pain, ear fullness was reported as still continuing. The patient reported that her hearing is also coming and going periodically in both ears. The patient was also very sensitive to sound now. The patient's joints in her feet and the bottom of her feet hurt. Therapeutic measures were taken as a result of the events. Treatment of antihistamine and nasal spray was recommended. The patient do not have covid prior to vaccination and was not tested for covid post vaccination. The patient has not recovered from the events.
50 2021-04-24 pain in jaw her right foot keeps falling asleep; feels like she was vibrating all over; burning of head from nec... Read more
her right foot keeps falling asleep; feels like she was vibrating all over; burning of head from neck up, felt like sunburn/ocasional burning or icing sensations throughout entire body; back of head felt like ice/ocasional burning or icing sensations throughout entire body/feels like ice was running through veins; tingling in head/paresthesia; jaw hurt; This is a spontaneous report from a contactable consumer reported for herself that a 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er8727) at the age of 50-years, via an unspecified route of administration in left arm on 24Mar2021 07:30 AM at single dose for COVID-19 immunization. Medical history included allergies to dust and mold. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No other medications the patient received within 2 weeks of vaccination. Patient reported that on 24Mar2021 10:00 AM (day 1), back of head felt like ice, tingling in head, jaw hurt; on 25Mar2021 (day 2), burning of head from neck up, felt like sunburn, back of head burned along with palms; day 3 and 4 - seemed better; day 5-8 - feels like ice was running through veins, feels like she was vibrating all over, ocasional burning or icing sensations throughout entire body. Patient also reported that received 1st dose of vaccine on 24 Mar2021. 15 days later she had paresthesia and her head was burning on the back. Also, the day her right foot keeps falling asleep. She would like to participate in any studies of side effects from this vaccine. She was concerned about receiving the second dose. No treatment received for the adverse events. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
50 2021-04-24 vision blurred Severe muscle cramps like extensor muscles locking up in back , arms & legs , severe nausea, blurred... Read more
Severe muscle cramps like extensor muscles locking up in back , arms & legs , severe nausea, blurred vision , light headness . With the 2nd shot the same again but add rash , increased BP ( high! ) . The pain in my muscles lasted 4 months ( 24/7) in my arms , legs & back, proprioception issues with my R leg , then it for the most part stopped and remained in my ankles & feet, and I feel like some cognitive issues . I still get waves of pain all over lasts for a couple of hours verses 24/7, I have a strange sensation constantly if my arms , legs & back .
50 2021-04-25 pupils dilated Out of body feeling Small pupils with dizziness Severe body aches Mild nausea Feeling of being hi... Read more
Out of body feeling Small pupils with dizziness Severe body aches Mild nausea Feeling of being high Can?t focus
50 2021-04-25 oropharyngeal discomfort Patient is a 50 year old female in the observation area presenting with "funny feeling on her throat... Read more
Patient is a 50 year old female in the observation area presenting with "funny feeling on her throat" post vaccination. Denies SOB, CP, swelling of tongue or lips. Physical exam unremarkable. Initial BP with HTN, but endorsed that she haven't taken her BP med today. Otherwise, pt is nervous and anxious because of the possible allergic reaction she might have. Given Cetirizine and felt better. Symptoms resolved. Referred to Allergy clinic given unverified if allergic reaction. Sent home stable and in no distress.
50 2021-04-26 dry throat 50 y/o female, past medical history of Adult Onset Diabetes and Hypercholesterolemia who presents wi... Read more
50 y/o female, past medical history of Adult Onset Diabetes and Hypercholesterolemia who presents with dry throat and itchy rash to her neck and abdomen onset post vaccination. Patient states that this is her second dose in 2 dose series. Patient denies previous reaction to vaccinations. NP and Paramedics at patient side. A red, macular rash was noted to the anterior neck. Patient provided a bottle of water and 25mg of Benadryl PO x1. Patient vitals obtained, patient noted with slightly elevated BP (157/94) and all other vitals within normal limits (99% RA, 87 HR, 12 Resp). Glucose was noted to be 165, patient discloses that she didn?t eat or take her Metformin this am. Patient provided with a protein bar and took her pending dose of Metformin. Patient was observed by the NP and Paramedics for 20 minutes with resolution of symptoms, rash resolved and no further complaints of throat irritation. Patient cleared to go home and aware of concerning signs and symptoms that would necessitate further evaluation by emergency providers.
50 2021-04-26 mouth numbness Numbness in left side of face/lips beginning 15-20min. after injection. Called health provider after... Read more
Numbness in left side of face/lips beginning 15-20min. after injection. Called health provider after an hour, who recommended taking an antihistamine. Took a 10mg antihistamine pill. The numbness subsided in about 30min.
50 2021-04-26 ringing in ears Noticed ringing in my ear the second day following the 2nd dose. It has continued at the same level ... Read more
Noticed ringing in my ear the second day following the 2nd dose. It has continued at the same level since. Only notice when room quiet or I think about it. I also experienced arm pain at the injection site and was extremely tired for 3 days following both doses. I also had a few instances of dizziness that were mild and tingling in my hand fingers in the arm of the injection.
50 2021-04-26 ringing in ears Ringing in ears started about 10 minutes after the shot was given.
50 2021-04-27 mouth numbness 15 minutes s/p injection patient c/o "numbness" isolated to the "tip of her tongue." Patient was gi... Read more
15 minutes s/p injection patient c/o "numbness" isolated to the "tip of her tongue." Patient was given 25 mg PO of liquid diphenhydramine. There was no swelling of the lips or tongue. No signs of respiratory distress. Respirations even and unlabored. Patient able to speak in full sentences and manage secretions. Patient transferred to "urgent care" to be evaluated by a provider.
50 2021-04-27 thirst Was menstruating at time of second shot, but near end of bleeding stage Within 4 hours of second sh... Read more
Was menstruating at time of second shot, but near end of bleeding stage Within 4 hours of second shot: pain in vaccine arm (right arm), veins at wrist of vaccine arm (right arm) also began hurting/throbbing; off and on pins and needles feeling in thighs; began feeling strange -- just feeling that things were happening inside my body; headache when playing with child Within 16 hours of second shot: feeling of malaise, sadness, lethargy, lack of appetite, extreme thirst. Redness at vaccination entry site (had this after first shot as well) Within 20 hours of second shot: feeling of malaise, sadness/crying, lethargy, really tired, lack of appetite, extreme thirst, very very cold extremities (especially fingers), chills, body aches, weakness, nausea, low grade fever, pain in vaccine arm, several hours of alternating shaking chills and sweats Fever broke and chills, sweats, nausea subsided by 26 hour mark since second shot. Lack of appetite, weakness, tiredness continued. 40 hours post second shot: all major symptoms subsided, except feeling of apathy, lack of energy By 48 hours post second shot feeling mostly better. 5 days post second shot: STILL BLEEDING FROM PERIOD!!! Unheard of. Never had something like this happen. Also had blinding, excruciating, utterly debilitating pain in vaccine arm upon waking from overnight sleep. The most horrible pain; was sobbing with the pain. Could not lift arm, intense muscle pain in upper arm on vaccine arm (right arm). Mostly subsided after about an hour of massaging, but still have dull pain and do not have full range of motion 2+ hours later.
50 2021-04-27 ringing in ears, ear pain, ear discomfort, deafness Fullness in ear and headache that led to ear pain and ringing and now told have hearing loss and con... Read more
Fullness in ear and headache that led to ear pain and ringing and now told have hearing loss and constant ringing
50 2021-04-27 ringing in ears severe tinnitus/tinnitus was reported as worsened; This is a spontaneous report from a contactable o... Read more
severe tinnitus/tinnitus was reported as worsened; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the left upper arm on 19Mar2021 (batch/lot number: EN6207; expiration date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included ongoing arthritis, ongoing intermittent tinnitus - she has a history of noise exposure and intermittent tinnitus in the past but was certainly unremarkable, she shrunk before the vaccine - she was five seven her whole life and then thinks she was only five six. Family history included hearing loss in her mother, grandmother, and uncle but that was with advanced age. There were no concomitant medications. Historical vaccine included BNT162B2 first dose on 26Feb2021 via injection in her left upper arm (lot number: E and then either I or 1 9266; expiration date unknown) for COVID-19 immunisation. The patient experienced severe tinnitus on Mar2021, tinnitus was reported as worsened. She received the second dose of the Covid vaccine on 19Mar2021 and reported a day or two later, she started experiencing tinnitus. She stated that she has been on and off steroids for the tinnitus. She asked if there has been a correlation identified between the vaccine and tinnitus. She asked was this a side effect of the vaccine. She was asking for any information such as studies, articles, awareness and frequency, regarding tinnitus being experienced after the vaccine. She was calling about the COVID 19 vaccine. She stated she was formally a retired audiologist she was calling because she was wondering what information Pfizer has about the onset of tinnitus. She stated after the second vaccine, she has developed significant tinnitus and as an audiologist she has trained people about tinnitus. She asked was this a symptom of the vaccine. She stated she knows tinnitus was a side effect of the COVID virus but was unsure if it was a side effect of the vaccine. She stated as a matter of fact she went to the national adverse reaction to report her reaction but not the particular Pfizer website. She stated she turns 51 next week and was currently 50. She stated she was five six as she has shrunk. She clarified she shrunk before the vaccine and stated she was five seven her whole life and then thinks she was only five six. She stated her doctor does not know she has this side effect. She stated she was going to see an ear nose throat friend but she was waiting. Severe tinnitus: She stated this started between 1 and 2 days after she received the vaccine which was on 19Mar2021 so either 20Mar2021 or 21Mar2021. She stated it may have got worse she had taken a short round of steroids and the tinnitus got better after the first two days and then the tinnitus returned and had no response to the steroids and she has done this twice. She stated the first two days of steroid usage she feels relief then the tinnitus comes back and she said to heck with it and stopped the steroid. She stated the tinnitus was a constant bilateral high frequency pure tone just very high pitch. She stated this was medically significant because it was a significant finding but not life-threatening. First dose was an injection in her left upper arm and received on 26Feb2021 unknown NDC number and expiry date. She stated the lot number was E and then either I or 1 9266. She stated it was actually not her turn in to get the vaccine but School System had extra doses and opened it up to anyone and everyone not just 1A or 1B. She stated she was 50 with no medical significant comorbidities other than arthritis and since the vaccine was opened up to the general public she was also eligible to get the second dose. She stated she believes the COVID 19 vaccine was related to the severe tinnitus because the onset was immediate and she has had tinnitus from other noise exposure but this was very different and not intermittent and does not come and go it was a different pitch too. She stated there has been no changes, no medication changes so everything else remained steady almost immediately after the vaccine her ears started ringing and she sort of ignored it and her ears were screaming loud a significant very loud even in the presence of background noise just a constant high pitch noise. She stated the tinnitus was impacted only 2 days from the steroids and then no impact after. She stated she considered taking a third dose and was still doing experiments. She stated was this something Pfizer was aware of and was there any information about monitoring people. She stated she knows there has not been a vaccine for that long and there may not be long term resolution but she wanted to report and ask what information Pfizer may already have. She stated the first steroid she started approximately 9 days after the onset and she had Medrol left over from her knee. She clarified the name as Medrol dose packs. She stated she thinks it was a 6, 5, 4, 3, 2, 1 Medrol dose pack that she had left over and she was able to set a series of 4, 3, 2, 2, and 1 but she threw packaging away and it was not a current medication as it was dated a couple years ago but she figured she would see if it would work and the first couple days it did but then not so much. Medrol dose packs unknown manufacturer, NDC number, lot number, expiry date. She stated moving forward her husband was a doctor and wrote Prednisone 10 mg and she was supposed to take 30 mg twice a day for 10 days and she took 30 mg once a day since she did not read the bottle and so she took 30 mg once a day for 5 days. She stated the same thing happened the first two days resolved and then nothing. Prednisone unknown manufacturer, NDC number, lot number, expiry date. She stated so she was actually considering taking 60 mg for 10 days and try to hit the tinnitus to see if she has an impact. She stated her concern/whole point to take the vaccine was to get antibodies and the body can recognize it but now a week and 2 weeks out she has taken a steroid which was suppressing her immune system and what does that do to the immune system. She stated the tinnitus was significant and she does not have a quiet moment and it was a cruel injustice as she used to train people and spent hours and hours counseling and now she was experiencing it. She stated it was significant enough to call and see if there was anything Pfizer knows more. She stated the first dose was given at 12:30 to 13:00 and the second dose was around 11:45 to 12:00. The adverse event did not require a visit to the emergency room and physician's office. No prior vaccinations (within 4 weeks). The outcome of the event was not recovered.
50 2021-04-28 mouth pain, pain in jaw, toothache Extreme throat, mouth, soft pallate, jaw, and tooth pain (all teeth), headache, fever
50 2021-04-28 swollen tongue Pt presents for possible reaction after first COVID vaccine. She developed hive, tongue swelling, an... Read more
Pt presents for possible reaction after first COVID vaccine. She developed hive, tongue swelling, and numbness to face. 50-year-old female with history of having a Guyon Barré type syndrome after flu vaccine who had her initial Covid vaccination today, she was given the Pfizer vaccine and approximately 5 hours later began developing hives on the left side of her neck and left tongue numbness. Patient denies headache, no trouble swallowing, no shortness of breath. She denies any chest pain. Patient has no numbness or tingling in her arms or legs. She did take 50 mg of Benadryl prior to my evaluation with minimal improvement of symptoms.
50 2021-04-28 ringing in ears I had a very mild case of tinnitis that I have had for numerous years but starting 2 days after I re... Read more
I had a very mild case of tinnitis that I have had for numerous years but starting 2 days after I received the vaccine, I developed ringing in the ears much more severe so that I am now aware of it at almost all times. It wakes me up in my sleep and affects me going to sleep.
50 2021-04-29 eye discomfort COVID-19 illness after receiving dose one and dose 2 of COVID vaccine (Pfizer). On 4/27 developed th... Read more
COVID-19 illness after receiving dose one and dose 2 of COVID vaccine (Pfizer). On 4/27 developed the following symptoms: cough, headache, sore/scratchy throat, congestion, runny nose, eye pressure, and myalgia. COVID test confirmed COVID-19 infection. Vaccinated with Pfizer COVID vaccine as follows: dose 1 on 12/18/2020, dose 2 on 1/8/2021.
50 2021-04-29 mouth tingling tingling in back of tongue approximately 30 minutes after injection, resolved on its own at approxim... Read more
tingling in back of tongue approximately 30 minutes after injection, resolved on its own at approximately 90 minutes after injection
50 2021-04-29 visual impairment Wednesday 4/28/2021 I was foggy and tired. Thursday 4/29/2021 I woke up feeling like I had the flu... Read more
Wednesday 4/28/2021 I was foggy and tired. Thursday 4/29/2021 I woke up feeling like I had the flu. At approximately 1pm on Thursday 4/29/2021 I was in the bathroom and started seating and seeing white spots. I went to my bedroom to lay down in front of the cold air and passed out. I woke up about an hour later. I slept the rest of the day and woke up Friday 4/30/2021 feeling fine
50 2021-05-03 thirst, vision blurred, dry throat fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation do... Read more
fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
50 2021-05-04 swollen tongue, lip swelling Patient reports the vaccine around 1330 and about 30 minutes after she got it, she started feeling s... Read more
Patient reports the vaccine around 1330 and about 30 minutes after she got it, she started feeling swelling in her lips and tongue. She then became short of breath and had difficulty breathing with swallowing. At the clinic she was given Benadryl, famotidine, and a dose of epinephrine. EMS was called and during transport to our hospital, she had difficulty swallowing and felt like she had some swelling in the throat again and received a second dose of IM epinephrine. Patient was then admitted to our hospital for observation overnight. At our hospital she was given Benadryl, and methylprednisolone and was then discharged home the following day.
50 2021-05-10 ringing in ears 24/7 RINGING IN BOTH OF MY EARS. I NEVER HAD ANY ISSUES AT ALL WITH MY EARS BEFORE THE VACINNE AND N... Read more
24/7 RINGING IN BOTH OF MY EARS. I NEVER HAD ANY ISSUES AT ALL WITH MY EARS BEFORE THE VACINNE AND NOW I HAVE A CONTSTANT RINGING IN BOTH OF MY EARS. IT IS SO OVERWHELMING AND I AM BESIDES MYSELF
50 2021-05-11 taste impairment I walked over to another chair & sat down to be monitored for 15 minutes after injection. Within a m... Read more
I walked over to another chair & sat down to be monitored for 15 minutes after injection. Within a minute a tasted a metallic taste & felt tingly in my chest i ignored for like another minute then i felt my heart pounding i notified staff. My blood pressure was checked 180/108 heart rate 103(average bp 110/70 hr 68). i was given benadryl 50 mg by mouth. I was confused as why i would taste medicine injection given properly shouldnt have entered my bloodstream so quickly. I was monitored for an additional 15 minutes w repeated bp/hr checks at 30 minutes bp still elevated at 160/90 hr 78 i didnt have tingling in chest didnt have pounding in chest bp still elevated but had lowered some.my husband present firefighter/ emt.i had reaction to 5fu chemo med and had same with elevated hr & bp but worse had to receive iv steroids& this was after 3 months of chemo. My bp & hr also ekevate if i eat gluten. I am aware being an RN and having had previos reactions that the second shot msy cause a more ssvere reaction.i will not be taking any further covid vaccine until i know what caused this reaction. My son took his vaccine at same location without incident that day he has no allergies. I only felt heache & slight nausea feeling flush approximately 2 hours after i left place of vaccination.no other problems since.
50 2021-05-14 taste impairment, mouth numbness Bell's palsy; metallic, numb sensation on end of tongue; metallic, numb sensation on end of tongue; ... Read more
Bell's palsy; metallic, numb sensation on end of tongue; metallic, numb sensation on end of tongue; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Apr2021 at 09:45 AM (at the age of 50 years old) (Lot Number: ew0162, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history included chronic atopic dermatitis, mild asthma, sulfa allergies, latex allergies, allergies of peanuts and almond, banana peel allergies, allergy to tomatoes, sesame allergy, and shrimp allergy. Concomitant medications included dupilumab (DUPIXENT); hydroxyzine hcl; and ibuprofen. The patient experienced metallic, numb sensation on end of tongue and Bell's palsy on 23Apr2021. The events resulted in emergency room/department or urgent care visit. The patient received prednisone and valacyclovir as treatment for the events. No other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.
50 2021-05-18 eye disorder, eye bleeding Blood stain in her right eye; Felt her right eye was pounding a little; Her arm was hurting a little... Read more
Blood stain in her right eye; Felt her right eye was pounding a little; Her arm was hurting a little bit; Her arm was very hot, extremely hot; Headache; A lot of pressure to her head; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 01May2021 16:10 as 1st dose, single for COVID -19 immunization. Medical history and concomitant medications were not reported. The patient reported she had her COVID vaccine on 01May2021 at 16:10 in the afternoon and about an hour later the headache started. In some occasions it felt like a lot of pressure to her head. On 03May2021, she felt her right eye was pounding a little and then when she woke up in the morning of 04May2021, she saw the blood stain in her right eye. The pounding in her eye was not pounding as much in the afternoon for quite a while but then it stopped that same day on 03May2021. On 01May2021, it was also reported that her arm was hurting a little bit and it stopped on 03May2021; and on 01May2021, her arm was very hot, extremely hot. No events required a visit to emergency room or physician office. The outcome of the events headache, "blood stain in her eye", and "a lot of pressure to her head" was not recovered, "felt her right eye was pounding a little " and "her arm was hurting a little bit" recovered on 03May2021, and "her arm was very hot, extremely hot" recovered on 01May2021. Information on the batch/lot number has been requested.
50 2021-05-18 mouth tingling, mouth numbness pt states she was nauseated and then started getting the severe flu like symptoms. She was achy, he... Read more
pt states she was nauseated and then started getting the severe flu like symptoms. She was achy, her tongue was tingling and numb. She had a sore throat, was light headed, and had a 101 temp. She was having heart palpitations and fast heart rate and felt out of it. On 5/19/21 she is feeling better with a slight head ache. Pt will contact PCP if symptoms do not improve.
50 2021-05-18 swollen tongue, lip swelling Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, to... Read more
Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; This is a spontaneous report received from a contactable female consumer (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6207, Expiration date was not reported), via an unspecified route of administration on 27Mar2021 09:00 first dose single for covid-19 immunisation. Medical history included fatty liver, diverticulitis, migraine and cigarette smoke. The patient concomitant medications were not reported. The patient previously took sulfonamide (Sulfa / FQ drugs) allergy to sulphonaminde and histamine allergy to histamine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination of antioxidant Green Tea and Liver Cleanse Tea and Vitamin C. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced Tingling and Swelling of lower face, lips, tongue, throat on 28Mar2021 02:30 AM. Patient visited the emergency room. As per the reporter seriousness criteria for the events swelling of lower face, lips, tongue, throat was medically significant. Patient received treatment of Benadryl-self-administered prior to ER. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021430745 similar report from same reporter
50 2021-05-24 ear pain A MCAS flare that was manageable for the first 5 days and then unbareable for the next 10 days. Ear... Read more
A MCAS flare that was manageable for the first 5 days and then unbareable for the next 10 days. Ear ache. Low grade fever. Exhaustion. Nasal drip. Sore throat. Respiratory steaming. Elevated heart rate. Diaphragm pain. Brain fog.
50 2021-05-24 mouth tingling Shortness of breath, tongue feels funny, generally not feeling well
50 2021-05-24 ringing in ears Itching of hands and swelling of hands on day 2. of 1st vaccine. Headache, tinnitus, body aches, ra... Read more
Itching of hands and swelling of hands on day 2. of 1st vaccine. Headache, tinnitus, body aches, rash, and overall tiredness. Itching on feet ,hands, arms, and hives on back, ribs, core body and neck with second vaccine
50 2021-05-25 loss of smell muscle ache; decrease smell; Arm immediately became heavy; headache; brain fog; complete exhaustion;... Read more
muscle ache; decrease smell; Arm immediately became heavy; headache; brain fog; complete exhaustion; This is a spontaneous report from a contactable other HCP. A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 22Jan2021 14:00 (Lot Number: EL3302) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid tested post vaccination. The patient experienced arm immediately became heavy (and lasted for apprx 24 hours) on 22Jan2021 14:30. Within 20-30 min of injection patient developed headache (circular around head -temple level), brain fog, complete exhaustion all on 22Jan2021. All symptoms lasted for 6 days. The events recovered on 28Jan2021. Other brief 2-3 hour symptoms were muscle ache between neck and shoulders, decrease smell. These last events recovered on an unknown date No follow-up attempts are possible. No further information is expected
50 2021-05-25 ear discomfort throat felt tight; ears started burning,; began vomiting; became nauseous; This is a spontaneous rep... Read more
throat felt tight; ears started burning,; began vomiting; became nauseous; This is a spontaneous report from a contactable non-health care professional. A 50-year-old, non-pregnant female patient received BNT162B2 (BNT162B2), Lot Number: em9809, via unspecified route of administration on left arm on 21Feb2021 at 11:30, (at the age of 50-years-old), as first dose, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. The patient had no allergy to food or other products but was allergic to penicillin and sulfa drugs. Concomitant medications included fluoxetine 40 mg, letrozole 2.5 mg and eliquis 5 mg. On 23Feb2021, the patient experienced nausea and vomiting. The patient told that she had eaten eggs her entire life several times a week. On 23Feb2021, two days after the patient had the vaccine, she ate an egg for breakfast and within two hours the patient became nauseous and then began vomiting. A week and a half later the patient had an egg for breakfast, and the exact same thing happened. The patient waited one more week, ate nothing other than an egg for breakfast, and immediately her ears started burning, throat felt tight, and within 20 minutes she began to vomit. The patient did not receive any treatment for the events. The outcome of the events was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-05-25 mouth tingling, lip swelling, swollen tongue, mouth numbness Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb t... Read more
Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; sore arm; This is a spontaneous report from a contactable consumer (the patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0151), dose 1, single dose via an unspecified route of administration, administered in arm left on 14Apr2021 for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Past drug event included allergy to ampicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced minor allergic reaction, swollen, tingling, and numb tougue and lips and sore arm on 14Apr2021. Therapeutic measures taken as a result of minor allergic reaction, swollen, tingling, and numb tougue and lips. and sore arm included diphenhydramine (BENADRYL). The outcome of minor allergic reaction, swollen, tingling, and numb tongue and lips, sore arm was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of minor allergic reaction cannot be excluded.
50 2021-05-25 ringing in ears Tinnitus - began within the car ride home. To date have not sought treatment as I had thought this ... Read more
Tinnitus - began within the car ride home. To date have not sought treatment as I had thought this would go away by now. It has not. Most extreme in morning and night when it?s quiet - however, it is present 24/7 - always there.
50 2021-05-26 visual impairment Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Me... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium
50 2021-05-27 lip swelling Rash all over body similar to shingles. Swollen lymph nodes. Was in ER two different times due to th... Read more
Rash all over body similar to shingles. Swollen lymph nodes. Was in ER two different times due to the rash, and face swelling. Lip was swollen on right side similar to a very large cold sore that has lasted for 8 weeks. Very painful. Doctors also have tested me for an autoimmune disease, that has come back positive. ANA Titer 1:1280. Possibly this has brought to surface an underlying autoimmune disease due to the fact that I had Covid-19 so bad. Was hospitalized with it, and had neurological issues along with GI problems. No respiratory problems.
50 2021-05-27 visual impairment "Pfizer-BioNTech Covid 19 vaccine EUA": About 24 hours after my second shot, I felt strong nausea, l... Read more
"Pfizer-BioNTech Covid 19 vaccine EUA": About 24 hours after my second shot, I felt strong nausea, losing control of the environment, feeling very unwell, weak, blood pressure must have dropped, my vision had darkened, I was about to collapse on the floor had I not reached my bed quickly. Couple of minutes later I had the urge to vomit but nothing came out, and then I had a normal bowl movement. After all that, I felt like the pressure had been released, took 1 tylenol, and went back to bed to rest. It's been 4 days now since the fainting symptoms, and I've been fine so far. The scary part was really the fainting symptoms, I wasn't expecting that.
50 2021-05-28 loss of taste, taste disorder flavors started changing; loss of taste; This is a spontaneous report from a contactable consumer (p... Read more
flavors started changing; loss of taste; This is a spontaneous report from a contactable consumer (patient). A 50-year-old (she just turned 50) female patient received bnt162b2 (BNT162B2), dose 1 on an unspecified date (Batch/Lot number was not reported) as single dose (at age not specified if 49- or 50-year-old), and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 50-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included: bnt162b2 (BNT162B2), dose 1 on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient experienced flavors started changing on her and they continued to change, loss of taste on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included ear, nose and throat examination: normal. The course of events was as follows: She started to notice a decrease in her taste after her first dose but it was not much, she was still able to taste salty things but for example she was eating a sandwich and she was not sure what kind of sandwich it was, she was having in and out with salt and sweet. Then she had her second dose and she noticed as time passed that her sense of taste has become less and less and not it was hard for her to taste salt, everything just became dull and duller and duller. She cannot tell if she was eating something crunchy like an apple or a turnip or something. She went to an ENT on 12May2021as she realized flavors started changing on her and they continued to change and they put a tube up her nose and into her ears and said that visually everything looked normal and that there did not appear to be any cause for this loss of taste upon their exam. Now, it was hard to decipher to her what she is eating. She was concerned. The doctor said they are going to give her some vitamins and see if it helps. They asked if she had been vaccinated and when she said yes they told her to contact Pfizer as Pfizer would know more information that they did because the doctor said it was not on side effects listed. She wished to know if this has been reported and queried how long can this side effects last and if it is temporary. She stated no misconduct was done in administering the vaccine. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
50 2021-05-28 ear discomfort, eye discomfort dizziness since 3rd day after shot., ear pressure, eye pressure. Today is 35th day of Dizziness 24/7
50 2021-05-28 lip swelling an allergic reaction to the Pfizer; face swelling/She says she was like a actor doing the clump. She... Read more
an allergic reaction to the Pfizer; face swelling/She says she was like a actor doing the clump. She says her lip and jaw looked just like that; She says she was like a actor doing the clump. She says her lip and jaw looked just like that.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 11:00 (at the age of 50-year-old) as 1st dose, single for covid-19 immunisation. Medical history included ongoing high blood pressure, blood clot on her right kidney from 2016, high cholesterol from 2016. Concomitant medications included warfarin; cholesterol. The patient was calling about the Pfizer COVID-19 vaccine. She says she had both of them. She says she had an allergic reaction to the Pfizer; she is assuming it was the Pfizer. She says the 15th through the 19th she was like a actor doing the clump. She says her lip and jaw looked just like that. She says it was at a the pharmacy. She says she went to Urgent Care, they gave her Benadryl, and admitted her to the hospital because they thought her throat was going to close(it started 20Apr2021 or 21Apr2021 and ended on 21Apr2021). The patient stated she was started on a high blood pressure medication after the first time of being in the hospital with face swelling. Prior Vaccinations (within 4 weeks) there is no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There is no AE following prior vaccinations. The patient says she has no allergies and was not sick at the time of either vaccination. There is no Family Medical History Relevant to AE. The outcome of the events was unknown.
50 2021-05-28 oropharyngeal discomfort, lip swelling Her throat was swollen; Bruise under chin/Her throat had bruising; She had an allergic reaction; Str... Read more
Her throat was swollen; Bruise under chin/Her throat had bruising; She had an allergic reaction; Strep throat.; She couldn't swallow water; she would jerk if she swallowed water and it was a hurting feeling going down. Her throat was so swollen she could hardly eat; Lip, Jaw and face swollen; Lip, Jaw and face swollen; Throat was going to close; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0150) 17Apr2021 at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included ongoing hypertension, ongoing from 2016 Blood clot on her right kidney, ongoing from 2016 high cholesterol. The patient received first dose of BNT162B2 (Lot Number: ER8730) on 21Mar2021 around 11:00am on left arm and experienced allergic reaction, Face swollen, she was like the Nutty Professor doing the clump (as reported). Concomitant medications included warfarin for Blood clot on her right kidney and an unspecified product for cholesterol control. Patient reported her lip, jaw, and whole face were swollen around 19Apr2021 or 20Apr2021 until 22Apr2021. She says she went to Urgent Care, they gave her Benadryl, and admitted her to the hospital because they thought her throat was going to close starting from 20Apr2021 or 21Apr2021 until 21Apr2021. Starting from 09May2021 in the afternoon until 10May2021 in the night patient reported she couldn't swallow water; she would jerk if she swallowed water and it was a hurting feeling going down, she thought it was strep throat. Patient also reported under her chin was like a frog out on a log when they inhale and exhale (as such). Starting from Sunday night on 10May2021 her throat was so big and she presented a bruise under chin like someone put their hands up in there and choked her (as reported). Patient informed that her chin was swollen also. Patient went to the hospital where they tested her for strep and released her out of the hospital around 4:00pm. Patient reported she was admitted for one day on 10May2021 and they gave her Benadryl again, another medicine, throughout the day they even did a CAT scan. She says through the day she could start swallowing again. Patient got up Monday (11May2021) and went to the emergency room. She reported that under her chin was swollen where is throat. Her throat had bruising under it and her throat was swollen and she had to go back to the hospital. They gave her Benadryl for her swelling. During call about the Pfizer COVID-19 vaccine, patient reported she had both doses and had an allergic reaction to vaccine, she was assuming it was for BNT162B2. At the time of the reporting outcome for 'Bruise under chin' and 'She had an allergic reaction' was unknown. The patient recovered from Lip, Jaw and face swollen on 2Apr2021, from 'Strep throat' and from 'She couldn't swallow water; she would jerk if she swallowed water and it was a hurting feeling going down. The patient recovered from 'Her throat was so swollen she could hardly eat' and 'Strep throat' on 10May2021, from 'Throat was going to close' on 21Apr2021, while had not yet recovered from other reported events.
50 2021-05-29 ringing in ears Right inner ear whooshing coinciding with heartbeat began 6d post 1st Covid shot (had on April 15, 2... Read more
Right inner ear whooshing coinciding with heartbeat began 6d post 1st Covid shot (had on April 15, 2021). Persistent and constant. Coupled with extremely high blood pressure; atypical for patient. Ear whooshing went away 2 weeks after 2nd Covid shot. Intermittently returning 3+ weeks after 2nd Covid shot. Three days post 2nd shot (May 9th), awoken at night with repeated intense 'adrenaline' rushes/panic attack like feelings, which prevented sleep. The events seemed to occur at the moment the patient was about to fall asleep, then would jolt patient up. These INTENSE events continued for 4.5 hours. Patient tried deep breathing exercises to no avail. Patient eventually rose from bed and did multiple 'full body shakes' to try and relax. Finally was able to sleep. Patient experienced 2nd menstrual cycle in one month. Atypical for this person, who had never had any anomalous or difficult cycles in her life. May 29. This night again experienced same adrenaline rush/panic symptoms overnight, again wholly preventing sleep. Patient took ibuprofen to relax muscles, to no effect. Patient again tried full body shakeout 2x. After 2nd time, was able to sleep after 4-5h of insomnia--complete inability to fall asleep.
50 2021-05-31 ear discomfort A few minutes after injection felt a burning sensation in face and ears. Felt tired that evening ... Read more
A few minutes after injection felt a burning sensation in face and ears. Felt tired that evening with muscle aches and sore arm. The next morning work up with intense body aches, headache, diarrhea and nausea. Have had diarrhea, nausea and tired for now for (4) four days. Cannot eat without having diarrhea and a general unwell feeling. I called my doctor who said that it?s unpleasant vaccine systemic side effects and to take Imodium AD and Tylenol. Go into the office if it does not resolve in a week. This seriously has me reconsidering the second dose.
50 2021-05-31 lip swelling patient started having itchiness on body and swollen lips
50 2021-06-01 eye twitching Pt experienced R eye twitch. BP 144/90; HR 80; RR 18. Pt was stable & released from vaccination site
50 2021-06-01 feeling of choking, mouth tingling Patient experienced tingling in mouth (roof of mouth, lips, and some in tongue) and back of throat.
50 2021-06-01 taste disorder Also felt a mucus feeling in the back of my throat; I had a strange taste in the back of my throat; ... Read more
Also felt a mucus feeling in the back of my throat; I had a strange taste in the back of my throat; This is a spontaneous report from a contactable consumer (Patient). This consumer reported in response to Non-HCP follow-up letter sent in cross-referenced case which included Patient Age at Time of Vaccination in Months: or Years: 50. This is the second of the two cases. A 50-year-old female patient received second dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, lot number: EK9231; Expiration Date: 30Apr2021), via an unspecified route of administration on 08Jan2021 (at the age of 50-years-old) as single dose for COVID-19 immunisation. Medical history included ongoing mild dog allergies and takes occasional Claritin, ongoing dust allergies and takes occasional Claritin. Patient had wheezing after taking intrauterine contrast dye in 2014 that lasted for about 30 min, and required Albuterol. There were no concomitant medications. The patient previously took first dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, lot number: EH9899; Expiration Date: 31Mar2021), via an unspecified route of administration on 19Dec2020 (at 09:00 (24 hour clock) Approximate) as single dose for COVID-19 immunisation and at 09:05, experienced feeling of swelling of the upper lip and throat, brief tongue tingling, palms felt sweaty/felt sweaty, throat felt dry, mildly dizzy, strange taste feeling in the back of my throat and patient treated with Benadryl and Claritin. The patient visited allergist where she was informed that she does not have any allergic reaction. The patient took Claritin the night prior ans that day (Forward arrow sign) No feeling of swelling of lip or tingling. On an unspecified date, patient had a strange taste in the back of throat but none of the other symptoms. It started a few minutes after + lasted about 1 minute. On an unspecified date, patient had mucus feeling in the back of throat, but this may be due to chronic allergies to dog/dust. The patient's allergist did not feel that patient had an allergic reaction. The outcome of the event strange taste in the back of throat was recovered and for the event mucus feeling in the back of throat, it was unknown. Follow-up attempts are completed. No further information is expected.
50 2021-06-02 vision blurred heart rate elevated; muscle pain; blood cell counts abnormal; equilibrium off; Blurred vision; Diarr... Read more
heart rate elevated; muscle pain; blood cell counts abnormal; equilibrium off; Blurred vision; Diarrhea; felt sick all day; sinuses feel off; pressure from headaches; Feeling hot and cold; Chill; fever 101.7 up to 103/ fever 103°F; foggy; Nauseous; tired; Light-headed; pain in arm; couldn't sleep; pain in arm; couldn't sleep; left arm sore and inflammed; swelling; headaches; This is a spontaneous report from contactable consumer (patient) or other non HCP. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch number/Lot number: EW0162, Expiration date: unknown), via unspecified route of administration in arm left on 09Apr2021, at 1ST DOSE, SINGLE for COVID-19 immunization. Patient medical history included ongoing prediabetic , Chronic sinusitis on unspecified date in 2014 and patient had undergone sinus surgery on unspecified date in 2014, COVID-19, acid reflux, patient had family history of father had a heart attack and mother had a heart attack and they are both diabetic. Concomitant medication included pantoprazole (PANTOPRAZOLE) on unspecified date at 2021 to ongoing for acid reflex which was diagnosed years ago, but has been actively taking for 3 months until now, multivitamin on unspecified date. Patient did not received any other vaccines Prior to that Vaccinations within 4 weeks. Patient had no know illness at the time of vaccination. 09Apr2021 patient experienced headaches, Light-headed, pain in arm; couldn't sleep, left arm sore and inflammed; swelling, on 10Apr2021 patient experienced chills, fever 101.7 up to 103/ fever 103°F, foggy, Nauseous, tired, Diarrhea, felt sick all day, sinuses feel off; pressure from headaches, Feeling hot and cold. on 12Apr2021 patient experienced equilibrium off, Blurred vision. on an unspecified date patient experienced heart rate elevated, muscle pain, blood cell counts abnormal. Patient reported that she had her Pfizer BioNTech vaccine on Friday 09Apr2021 and has had some serious side effects. patient wants to understand why she had such bad side effects compared to other people. Husband and other people she knows didn't have any side effects and she did. She states her next shot on 30Apr2021 and when she got the Pfizer COVID-19 vaccine, she felt fine as stayed the wait time at the facility but got lightheaded when she got to her car. She reported that on 09Apr2021 she had the lightheadedness comes and goes and she also experienced a headache and her arm soreness inflammed; swelling on 09Apr2021 in Friday. She reported that her arm pain was so bad that she couldn't not sleep. She could not lay on it. she states it is a little better now, it still hurts, but she is able to roll off of it and get some sleep. Patient experienced chills and a fever from 101.7 up to 103 degrees and Feeling hot and cold on Saturday 10Apr2021. she stated that she was taking Ibuprofen for pain and fever, and was told she shouldn't take Ibuprofen, she should take Tylenol to break the fever and she took some Tylenol and her fever broke after taking Tylenol. Patient stated that on 10Apr2021 she had also felt foggy, nauseous and tired. She reported that she had COVID in Jun2020 and felt like COVID all over again. she had the same symptoms; really tired, could sleep for days. patient thinks she had a bit of an allergic reaction on her arm. It has improved, but now she has a red swollen splotch on her arm, and it is not even where they put the needle it is down a little bit lower. Patient reported that her heart rate was elevated as well. Patient reported that 12Apr2021 she felt like equilibrium is off, and had blurred vision, feels fine right now, but all she has done was slept since she got home from work yesterday and hasn't exerted herself today yet and right now she is not tired, she slept for 12 hours. Patient reported that she felt sick all-day and had diarrhea on 10 Apr2021 in Saturday, nausea started on Saturday, all she could eat was chicken noodle soup and she experienced it yesterday. she states yesterday she took some Tylenol, and got a chicken sandwich, since she had taken some medication, and then wanted to throw it up when she got home and she is not foggy now, but it comes and goes, the symptoms are intermittent, she doesn't know if she will be ok. she can still feel on 10 Apr2021 her had sinuses feel off and she had chronic sinusitis and whenever she gets sick her sinuses get attacked. she states she didn't think she would get side effects because she already had COVID, but apparently it is the opposite. Patient reported that she was being told so many different things and now she was scared to get the second shot and is freaking out. she reported that she had to cancel all the appointments at work yesterday day because of the events and she thought she would have the weekend to recover from any side effects but couldn't do her job yesterday. Patient was not their in-Emergency Room nor visited physician office. It was reported that blood cell counts abnormal, so her doctor has her going to see a hematology doctor on Thursday. It could be nothing but sending there to check. The patient underwent lab test and procedure which include blood cell counts abnormal on 10 Apr2021 Outcome of events headache, chills, fever, foggy, nausea, tired, equilibrium off, Blurred vision, felt sick all day, sinuses feel off; pressure from headaches, heart rate elevated, muscle pain were unknown, light-headed, Diarrhea, Feeling hot and cold were not resolved, pain in arm; couldn't sleep, left arm sore and inflammed; swelling, were resolving, Follow up (13Apr2021): This is a follow-up spontaneous report from contactable consumer. A 50-year-old female patient reported new information received which included event detail, relevant medical history, concomitant medication. No Follow-up attempts are needed. No further information is expected
50 2021-06-03 mouth pain, pain in jaw my face was swollen; right side of my mouth and jaw hurting; right side of my mouth and jaw hurting;... Read more
my face was swollen; right side of my mouth and jaw hurting; right side of my mouth and jaw hurting; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0186), dose 2 via an unspecified route of administration, administered in left arm on 16May2021 at 08:45 as 2nd dose, single for COVID-19 immunization (at the age of 50-years). Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0175), dose 1 via an unspecified route of administration, administered in left arm on 25Apr2021 as 1st dose, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Neither the patient diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received no other medications within 2 weeks of vaccination. On 18May2021, the patient woke up with the right side of my mouth and jaw hurting and her face was swollen. The first day, she tried to rinse with salt water and applied hot compresses to her face it didn't do anything. So she decided to do a tele doc video call the after the second day it wasn't getting better. The doctor prescribed antibiotics and told to her it was her tooth, however, she knew that it wasn't her tooth. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582710 different patient, same drug and event
50 2021-06-03 vision blurred, ringing in ears Tinnitus Vertigo Fatigue Blurred vision
50 2021-06-06 dry throat Esporádic severe headache pressure pain, treatment: Tylenol Traquea swollen and dry, unable to bre... Read more
Esporádic severe headache pressure pain, treatment: Tylenol Traquea swollen and dry, unable to breath only while sleeping head up. Treatment: drink some water and sleep on the side
50 2021-06-06 mouth numbness, mouth tingling Tingling/numb feeling on left side of face only. Forehead, cheek, left eye, left side of my lips.
50 2021-06-06 thirst 1:08pm client c/o feeling dizzy and thirsty. Patient was offered water. 1:15pm Patient found on fl... Read more
1:08pm client c/o feeling dizzy and thirsty. Patient was offered water. 1:15pm Patient found on floor. Patient was monitored and EMS called. 162/110, HR 88. EMS arrived, patient refused transportation, was accompanied home by husband. Patient was advised to call 911 or contact medical doctor if still experiencing symptoms. Understanding verbalized. 13:40 Patient left site, accompanied by husband.
50 2021-06-07 ear discomfort, ear pain This is a spontaneous report from a contactable consumer (reporting herself). This 50-year-old femal... Read more
This is a spontaneous report from a contactable consumer (reporting herself). This 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8729), via an unspecified route of administration in left arm on 14Apr2021 at 14:00 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included migraines (she takes migraine medication as needed). The patient's concomitant medications were not reported. None of the additional vaccines administered on same date of the Pfizer suspect. The patient received no other vaccination with 4 weeks of COVID vaccination. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7537, ER7534 or ER753U (lot number was handwritten on her vaccine record card, and she cannot read the last character), via an unspecified route of administration in left arm on 24 Mar 2021 at 14:00 as a single dose for COVID-19 immunization and experienced her arm was sore, Her period stopped after she got the covid vaccine and It has been almost 80 days, and she is still having extreme pain, in every part of her joints. On an unspecified date in Apr2021, the patient was experiencing joint pain throughout her body, was worse right after the vaccine but has gotten better but still experiencing pain, was wondering if this was a side effect of the vaccine. States she has already spoken with the safety department. On 15Apr2021, the patient's top left ear was in pain: Her ear was hurting on the same side she received the covid vaccine, her left side. Clarifies that her ear only hurt at the top, her cartilage part was what hurt. It was really odd, and very weird. It lasted for 4 or 5 days. On 15Apr2021, the patient's ear felt like it was burning and hurt painful. On an unspecified date in Apr2021, the patient was noticed a lymph node on the side of her neck on the same side she received the covid vaccine. On an unspecified date in Apr2021, every single point of her body hurt, every knuckle, finger and toe and it lasted about two weeks where it was very painful, but the patient still had it now. It began 2 or 3 days after she received the second dose of the covid vaccine. Now it has subsisted into feeling like a dull joint pain. Every point of her joints was weird, even padding of her feet hurt. Before her pain was a sharp joint pain. On an unknown date in 2021, the patient's having normal menstrual cycle till then but since receiving the vaccine she has not had one. She had spoked with her OB/GYN (obstetrics and gynaecology) and was advised to report to Pfizer, to which caller states she had already spoked with the safety department. The patient did not undergo any laboratory test. Event having normal menstrual cycle till then but since receiving the vaccine she has not had one resulted in Physician Office Visit. The outcome of the events Joint pain throughout her body, a lymph node on the side of her neck and every single point of her body hurt, every knuckle, finger and toe was resolving, top left ear was in pain and her ear felt like it was burning was resolved in Apr2021 and having normal menstrual cycle till then but since receiving the vaccine she has not had one was unknown. Followup attempts are possible, additional information has been requested.
50 2021-06-07 ringing in ears Within 12-24 hrs. I was experiencing the RA flare up again. It was not as bad as the flare up after ... Read more
Within 12-24 hrs. I was experiencing the RA flare up again. It was not as bad as the flare up after the 1st dose. I was on 20mg prednisone This lasted for about 3 days. I also had difficulty walking again. I also developed intermittent ringing in my ears which has continued and is still happening.
50 2021-06-08 loss of smell, loss of taste lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable consumer... Read more
lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable consumer (patient) or other non hcp reported. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 28Jan2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (the patient works for Doctor's office). The patient received the first dose of BNT162B2 on 06Jan2021, and had headache and was tired. The patient medical history and concomitant medications were not reported. The patient experienced lost taste and smell on an unknown date in Jan2021 (3 days after she lost taste and smell and are still gone. The patient feel fine. The patient just wish she could taste food and smell the perfume). She was wondering if we have any information on how long this might last. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
50 2021-06-08 deafness, ringing in ears hearing loss; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-yea... Read more
hearing loss; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant at time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03May2021 16:45 (Lot Number: ER8730) as single dose (at the age of 50-years-old) for COVID-19 immunization. Medical history included asthma, migraine, and back pain. The patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced tinnitus/hearing loss. Got the shot on 03May2021 and it started right before leaving the facility, reported it to the staff. Started out mild and has gotten progressively worse each day. Adverse event start date started on 03May2021 05:00 PM. No treatment received for adverse events. The outcome of the events was not recovered. Reporter did not consider events as serious. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 24May2021 Information on lot/batch number was available. Additional information has been requested.
50 2021-06-08 eye floaters, dry mouth, ringing in ears Wednesday, May 19, 2021 1st COVID-19 vaccination shot Summary: Wednesday, May 19, 2021 received my ... Read more
Wednesday, May 19, 2021 1st COVID-19 vaccination shot Summary: Wednesday, May 19, 2021 received my 1st COVID-19 vaccination shot. My body tried to reject it. I threw up 5 times. Ensued many unwanted side effects. I don?t think it would be good to get the 2nd vaccine dose. Given I am not fully vaccinated, I need an alternative solution to prevent being infected with the virus. Help!!!! Please Help!!! Bad Side Effects: Stuffy Nose Congested Nose Headaches Vomiting Nauseous Upset Stomach Unsettled Stomach Unusual Perspiration Pain in Left Arm Abnormal Period Menstrual Blood Clots Shoulder Pain/Tension Upper Back Pain/Tension Chest Pain/Tension Shooting Pain in Chest Heart Palpitations? Numbness Runny Nose Sneezing Profusely Allergies? Hoarse Voice Winded Dry Mouth Existing Worsened: Cold Sores Stomach Noises Snoring? Foot Numbness Ear Ringing Eye Floaters Joints Popping Sound Other Observations: Stomach Bloated Increased Flatulence Pseudo Conclusion: Given my body?s adverse reaction I don?t think it is wise to get the 2nd shot. It is obvious my body does not like it. I am disappointed because I really did not plan to get vaccinated; however, I felt I had no other option when the government made the announcement. When the government announced No masks for those vaccinated, I know there would be some NOT vaccinated & NOT wearing a mask thus putting me at risk. I am okay with wearing a mask for another year or even for the next 5 years. The doctors have said me wearing a mask is protecting others not necessarily myself. I concluded even if I continue to wear a mask there would be others (NO mask & NOT vaccinated) not following the rules potentially exposing me to the virus. Hence the only way to protect myself is to get vaccinated. The vaccine appears to have affected so many areas of my body. I regret getting the 1st shot, I want to remove every trace of it from my anatomy. Please let me know if it is possible to rid the vaccine along with all the bad side effects from my body. I do not want to subject my body to anymore of this vaccine; however, I still need a reliable solution to avoid being infected with the virus. I don?t know what to do. Details: Wednesday, May 19, 2021, I received my 1st COVID-19 vaccination shot around 3:30pm. The medical staff had all those being vaccinated to sit for at least 15 minutes for observation to be monitored. I stayed for monitoring for close to an hour (wearing my masks). I felt fine, I noticed my right nostril felt stuffy, congested with a slight burn sensation. I noticed a slight headache when I left. I had about 3 errands to do. 2 hours later I wasn?t feeling well. In addition to a stronger headache my stomach felt queasy. Around 6:30pm I had to pullover to vomit; I threw off my mask and threw up once and then a 2nd time. I sat in my car taking deep breaths until I felt I could make it home. I make it home around 7pm in time to throw up 3 more times, for a total of 5 times. The vomit tasted acidic, sour, citrusy, and metallic at times, and salty. I was only throwing up the vaccine it was mostly clear with white alka seltzer looking deposits. I last ate some crackers around 12 noon. Vomiting is NOT normal for me. I can?t remember the last time I threw up, many many many years ago. l had a headache, queazy stomach, and was exhausted; about 7:30pm tried to sleep. I got up around 10:30pm ate a few saltines and drank a little water but I still didn?t feel good so I didn?t eat anything else. Rough night trying to sleep, tossing and turning. Next day (Thursday day 2) I felt slightly better, not comfortable enough for real food so I drank plenty of water in small amounts and ate saltines; headache subsided. I also had more than usual underarm perspiration with a strong unfamiliar odor. Wednesday, May 19, 2021 1st COVID-19 vaccination shot It appears the vaccine affected my menstrual cycle. My period usually lasts for 3-5 days max, usually light blood flow on days 4 and 5. It was a normal light day 5 when I received the vaccine. After the vaccine, I began having heavy blood flow. The heavy blood flow is accompanied by blood clots. In the past I?ve had a blood clot here and there but not like this. Menstrual blood clots for 9 days after being vaccinated. This is NOT normal for my body. My period was 14 days. Prior to being vaccinated, I NEVER had a period last this long. To my surprise the vaccine affected my female organs. I am right handed, so the nurse recommended using my left arm for vaccination. Left arm where vaccine injected was very sore. Arm pain subsided after 3 days. Pain soreness tension primarily on my left side, shoulder, upper back, chest area. There is a shooting pain on left shoulder, down back to breast, chest heart area; pain comes and goes. Heart palpitations? Experienced this for over a week about 10 days. Numbness in left hand when I sleep on my left side, wake with my left hand numb. Numbness in both hands when I try to sleep on my back. Numbness in my feet after standing for about 15 minutes. Numbness in my leg and buttocks, primarily left side after sitting for an extended period of time. Before being vaccinated I only experienced numbness in my right foot after being on my feet for an extended period of over 4 hours. Last year my right foot/heel would began to hurt after being on my feet for an extended period of time (> 4 hours). Then there would be pins and needles sensation. The solution would be to rest and elevate my feet. I also replaced my shoes (proper support). Post vaccination even before the time my feet would hurt now my right foot goes numb within 30 minutes of standing even while wearing supportive shoes. My left butt cheek goes numb when I am sitting with my legs elevated; this was my most comfortable position pre-vaccination. Since the vaccine my stomach feels upset or unsettled especially in the morning. I am also noticing bloating and more gas than usual. My stomach is also excessively more noisy. Before the vaccine my stomach would make noises when I was hungry or hadn?t eaten, but now there are so many stomach noises almost nonstop all day and night long all the time My nose is feeling congested with a slight burn sensation since getting the vaccination. Immediately after getting the shot my right nostril felt stuffy, congested with a slight burn sensation. This congested feeling comes and goes, especially noticeable when wearing a mask. Prior to being vaccinated I had not experience this issue even as I have worn multiple masks for over a year with NO stuffy nose. Saturday, May 29, 2021 (day 10 post vaccination) I get cold symptoms; runny nose and sneezing. I haven?t had a cold in years; I don?t really get colds; if so the symptoms are mild and quickly dissipate. Now my nose has been running pretty much non-stop causing me to blow my nose just as often. I am also sneezing a lot. This is NOT normal for me. I drank plenty of liquids; however, running nose and sneezing continued leading to hoarse voice. These symptoms prevented me from sleeping. I don?t know if these are cold or allergy symptoms. I had NO allergies before the vaccine. These symptoms finally subsided after 3 or 4 days. My neighbors are waking up in the middle of the night (2am, 3am, 4am, 5am). I began to wonder if I am waking my neighbors possibly with snoring. I don?t really know, no evidence. Throat feels winded and dry when talking especially when I try to whisper. I have to drink a lot of water. Ringing in my ear started In 2019. I thought this phantom sound went away; however, post vaccination I?m hearing the ringing sound again. It seems worse than before. 2018 diagnosed with eye floaters. I am noticing floaters more since getting the vaccine. I usually see the eye floaters when going to light from dark. Post vaccination I am noticing the floaters even in dim light; not normal. I started getting Cold sores in 2006. I thought I had them somewhat under control. Since the vaccine l keep getting cold sores, this may be due to my menstruation. Recently within the past year, my shoulder and elbow joints sometimes make this popping sound when I exercise/move my arm. Post vaccination my shoulders and elbows are making the popping sound every time I move my arm. Now sometimes my knees and ankles are also making a popping .
51 2020-12-31 lip itchiness, eye itchiness ITCHING OF EYES AND LIPS. 97.6, 130/76, 81. 25MG BENADRYL GIVEN PO. 0909 STATES NO MORE S/S PER PT.
51 2021-01-03 ear pain, ear discomfort Ear pain pulling sensation, down my neck numbness jaw locking on same side of injection
51 2021-01-04 taste impairment, taste disorder Taste alteration; Funny taste; This is a spontaneous report from a contactable Pharmacist. A 51-yea... Read more
Taste alteration; Funny taste; This is a spontaneous report from a contactable Pharmacist. A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 28Dec2020 at 03:15 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at workplace clinic, age at vaccination was 51-years-old (reported also as 49-years-old, to be clarified). No other vaccine was received in four weeks. Medical history included thryoid disease, and current tx for pulmonary embolism (PE, 3months). Concomitant medications included levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS). On 28Dec2020 at 03:15 PM, the patient experienced taste alteration - funny taste upon injection. Transient. Lasted 10 seconds or so. The event was reported as non-serious. Outcome of the event was recovered on 28Dec2020. No treatment was received for the event. Information on the lot/batch number has been requested.
51 2021-01-04 mouth numbness swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), to... Read more
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
51 2021-01-04 lip swelling, mouth numbness, mouth tingling lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/... Read more
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
51 2021-01-04 mouth itchiness, mouth numbness numbness and itching in the roof of mouth; numbness and itching in the roof of mouth; This is a spon... Read more
numbness and itching in the roof of mouth; numbness and itching in the roof of mouth; This is a spontaneous report from a contactable healthcare professional. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685), intramuscular on the left arm on Dec2020 at single dose for COVID-19 immunisation. Medical history included hypertension and GERD. Concomitant medication included metoprolol, dexlansoprazole, ondansetron and propranolol. The patient previously took gadolinium and midazolam and experienced known allergies: gadolinium and midazolam. The patient experienced numbness and itching in the roof of mouth on Dec2020. Patient received BENADRYL as treatment. The outcome of the events was recovering.
51 2021-01-05 mouth tingling 15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but ... Read more
15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given
51 2021-01-05 mouth tingling COUGH, TOUNGE TINGLING , SCRATCHY THROAT 15 MIN POST VACCINE. EPI AND BENADRLY GIVEN IN CLINIC EME... Read more
COUGH, TOUNGE TINGLING , SCRATCHY THROAT 15 MIN POST VACCINE. EPI AND BENADRLY GIVEN IN CLINIC EMERGENCY DEPT GAVE DECADRON
51 2021-01-05 swelling around the eyes, eye swelling Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Eyes start... Read more
Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Swelling around mouth; Aching in my mid back; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Batch/Lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included montelukast, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); colecalciferol (vitamin D), and bumetanide (BUMEX). The nurse stated that she got the Pfizer COVID Vaccine yesterday (28Dec2020) and she didn't know if she should report the side effects but she didn't yesterday and she was going to today (29Dec2020). It didn't happen right away, it was like throughout the day, her eyes started swelling around them, she had swelling around her mouth, she still has it actually. She didn't have any breathing issues but there was a lot of aching in her mid back which was gone now, the aching part, but it was the swelling that concerned her. They were around her eye, the left one. She had a question herself though because this was just her first vaccine. She meant it wasn't bad enough that she had breathing issues because she monitored it and it's already in there now. She asks if it would it be okay to get the next one. As treatment, the patient took Tylenol and a Benadryl. The patient also mentioned that she has been extremely tired too. What she meant was she was sitting at her desk at work yesterday and she was nodding off. According to her, it was just offered through work and they went to a hospital to get it. The patient said that she did not have to seek medical treatment for it, so it was not like life threatening. When clarified if the swelling around eyes was still there, the patient stated that it was not as prominent, it was more around the eyes it's worse. She further stated that it has improved, she was still tired but the swelling had improved. The patient was also asked regarding the route of administration and she stated that she believes it was long enough to be, it looked like IM, she was not sure. It might have been a SubQ but she means it wasn't like a huge long needle but it wasn't like the real short ones either. Outcome of the events "Eyes started swelling, around my eye the left one, it is more around the eyes it's worse", "Swelling around mouth", "Aching in my mid back", was recovering/resolving; for the event 'Fatigue' was not recovered, while for 'Somnolence' was unknown. Causality assessment of the reporter between the events 'eye swelling', 'swelling around mouth', 'aching in my mid back', and 'I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of' and BNT162B2 was reported as related.
51 2021-01-06 oropharyngeal discomfort Patient had her first dose of Pfizer covid 19 vaccine. She was observed for 30 minutes, 15 minutes ... Read more
Patient had her first dose of Pfizer covid 19 vaccine. She was observed for 30 minutes, 15 minutes longer than normal as a precaution, due to her allergies. Patient continued to moniter her oxygenation saturation and did not report a drop in oxygen saturation, however, she reported a funny feeling in her throat, difficulty swallowing and shortness of breath. She was escorted to the emergency department via wheelchair for further observation and treatment.
51 2021-01-07 lip blister Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches ... Read more
Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches and weakness that evening, took tylenol with relief. 1/8/21 patient woke up in the middle of the night with fever, blister on the inside of her lip, and her right cheek twitching. 1/8/21 patient went to PCP to be checked out. Discovered redness and bruising at the injection site. Patient has had relief with tylenol and zyrtec.
51 2021-01-07 pain in jaw I started few hours later started feeling thought it was stress. The next morning around 9am high mo... Read more
I started few hours later started feeling thought it was stress. The next morning around 9am high moderate pain left leg jaw, chest hurt, sudden panic attack and I had to calm down for minutes. I informed my coworker I was having a reaction and then it stopped. Then I scheduled an appt with my PCP had lab work, EKG results was normal. On 12/24 still exp high mild left jaw pain, heart racing and chest pain .I was scheduled stress test on 12/30 was normal.
51 2021-01-07 ringing in ears Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achine... Read more
Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achiness, soreness at injection site
51 2021-01-08 dry mouth After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. ... Read more
After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. I sat and monitored what was happening and then notified the staff that it was not improving. I was directed to go to the ER for further evaluation and went. They monitored me and it resolved after about 3 hours and went home. No other issues occurred.
51 2021-01-08 lip swelling lip swelling, facial hives/erythema, burning
51 2021-01-09 eye pain, loss of taste 1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 13... Read more
1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest. 2 Tylenol taken. I was required to check into the ER for Observation. oxygen saturation checked for 2 hours. no change in symptoms, no worsening. I then left work in the ER and went home. At approx. 1800 ate dinner, no real taste, but needed to eat. At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol Through the night I slept very poorly, tossed and turned, woke frequently. Body and joints with extreme pain everywhere it touched the mattress. I have a screw in my left foot, it felt like it was on fire at some point during the night. My left leg ached up into my hip. On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea. Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran. 1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe. 1300 - 2 Tylenol Slept better, just sore January 8 night. January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea. 2 more tylenol around 1800 January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea
51 2021-01-09 eye swelling Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left b... Read more
Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left back of shoulder, neck, face pain , moderate severe headache. SOB.
51 2021-01-09 mouth tingling, tongue discomfort Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to h... Read more
Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to her nose and other ear/jaw area. Then she experienced tongue heaviness and tingling. She was transported to the ED for further evaluation.
51 2021-01-11 eye itchiness 1628 itching at site of injection, Benadryl 25mg given po, 1643 little itching of ear same side as i... Read more
1628 itching at site of injection, Benadryl 25mg given po, 1643 little itching of ear same side as injection, 1648 itching inner eyes, monitoring patient another 15 minutes, 1703 no increase in itching, "not any different, not progressing", denies rash, patient left after discussing with NP.
51 2021-01-11 mouth numbness Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Sy... Read more
Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Symptoms increased day 2 with swelling as big as a lemon fruit. Day 3 - aside from pain & swelling at the injection site, I developed Left axillary lymphadenopathy. Day 4 - severe headache lip numbness & body ache Took Ibuprofen 400 mg each day
51 2021-01-11 lip swelling, tongue disorder "EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro ... Read more
"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro EOHD location. She stayed 15 minutes for observation and was feeling fine, however 30 minutes after vaccine administration started feeling her left upper lip was swollen and tip of her tongue felt thick. When she looked in the mirror her lip and tongue appeared normal, but she had the sensation they were swollen. She then took 50 mg of PO Benadryl and about 4 hours later felt swelling had resolved. Today, feels normal. Pt denies hx of allergies but her mother has a hx of anaphylaxis with IV contrast. EE denies throat tightness, SOB, wheezing. Numbness on left leg. Advised EE to go to ER if she experiences throat tightness and itchyness, SOB, or wheezing. Advised pt that she should consult her PCP to decide whether or not the benefits of recieving the second dose of the vaccine outweigh the risks and if she should pre-medicate with benadryl for the second dose if she choses to recieve it. "
51 2021-01-11 mouth pain, toothache Nausea, body aches, dizziness, mouth/tooth pain
51 2021-01-11 feeling of choking anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry... Read more
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-12 loss of smell, ear pain 1/3/21 Sinus pressure, loss of smell, cough, SOA with exertion, HA, fatigue, sore throat, ear pain
51 2021-01-12 taste impairment Scratchy throat and metallic taste in mouth 10 min following injection
51 2021-01-12 ear pain, loss of smell 1/3/21 sinus pressure, loss of smell, cough, SOA with exertion, HA, fatigue, sore throat, ear pain
51 2021-01-12 eye swelling Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ... Read more
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
51 2021-01-12 mouth tingling Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ea... Read more
Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ear and arm felt funny
51 2021-01-12 tongue discomfort, swollen tongue I received the vaccine on Monday at 4:30, around 5:30 I noticed my tongue feeling weird, no difficul... Read more
I received the vaccine on Monday at 4:30, around 5:30 I noticed my tongue feeling weird, no difficulty swallowing, no resp issue and no rash. I took 25 of Benadryl and went about my evening. Tuesday around 12:00 I had that same sensation but a little stronger, I would call it a tongue swelling but no resp issues or swallowing problems. I called my PCP and he recommended me to take Zyrtec (which I take 1 daily) BID and Benadryl prn. I took 3 doses of Benadryl Tuesday and a Zyrtec Tuesday night and one Wednesday and around 8:15 had the same sensation, tongue swelling but milder. I immediately took 50 mg of Benadryl and called my Dr again and he recommended a steroid pack and Benadryl prn and to not take the 2nd dose.
51 2021-01-13 double vision Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30a... Read more
Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision. I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand. I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
51 2021-01-13 eye itchiness, feeling of choking, mouth tingling, mouth itchiness Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ea... Read more
Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ears, swollen lymph nodes in neck and groin area
51 2021-01-13 pain in jaw Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , g... Read more
Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , given morphine, Valium,zofran, dexamethasone and norco and discharge home. No relief with med. lower feet noted trace of swelling, jaw pain and epigastric discomfort. Leg pain subside after 3 days but with muscular pain esp the upper arms. Extreme fatigue and mild tenderness on the back of head. It?s been 3 weeks now and I have the fatigue, epigastric discomfort, loss 10 lbs of wt. muscle easily get sore.
51 2021-01-14 ear pain, pain in jaw Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syn... Read more
Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syndrome), it lasted 5 hours and dissipated after. Also developed right ear pain and jaw pain, which is still present. At the same time my right side of my face was numb which lasted a couple days.
51 2021-01-14 eye irritation, eye itchiness body itching, eye itching and irritation, body warmth, chest tightness, bradycardia
51 2021-01-14 eye irritation Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my... Read more
Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my eyes; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 04Jan2021 03:45 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient did not have any known allergies to medications, food, or other products. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021, at 05:00 AM, the patient experienced shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes. Treatment received for the events included an inhaler and acetaminophen (TYLENOL). The outcome of the events shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
51 2021-01-14 eye itchiness, eye irritation body itching, eye itching and irritation, body warm, chest tightness, bradycardia
51 2021-01-14 eye swelling Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling... Read more
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
51 2021-01-14 feeling of choking Patient felt a sense of fullness and tingling in throat shortly after vaccination (10 minutes), and ... Read more
Patient felt a sense of fullness and tingling in throat shortly after vaccination (10 minutes), and was transferred to urgent care for closer monitoring. She did not experience any dyspnea, and vital signs remained stable until she was cleared to discharge. No other complications noted during the 2 hours patient was observed in urgent care.
51 2021-01-14 swollen tongue Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic re... Read more
Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic reaction.,
51 2021-01-14 tongue itchiness Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness... Read more
Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness spread to parts of patients body like the back of her throat and tongue; itchiness spread to parts of the patients body like the back of their throat and tongue; itching to the area of the leg, the face, the head; This is a spontaneous report from a contactable consumer (patient). The 51-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (upper left arm), on 21Dec2020, at a single dose, for COVID-19 immunization/ prophylaxis. Relevant medical history included root canal. The patient has no concomitant medications. The patient previously took thimerosal (preservative) and experienced allergy. Patient knows the vaccine is preservative free. The patient received the first dose on 21Dec2020. She had a slight allergic reaction where she experienced itchiness immediately after the injection in the injection area (itching in the arm) and the itchiness spread to parts of her body like the back of her throat, tongue, area of the leg, the face, the head. She took three Benadryl as treatment for these events. The patient recovered completely that same evening (on 21Dec2020) before she went to bed around 10 or 11 that night after her third Benadryl. She was due to go back to get her second dose between 11Jan2021 and 13Jan2021, next week. She is concerned about getting the second dose since she had somewhat of a reaction with the first dose. She had to have a root canal and she was taking an antibiotic which she clarifies as a Z-pack, azithromycin. States her last antibiotic pill is due to be taken on Monday, 11Jan2021. She was asking if she can get the second dose. She is also concerned about how she may react to the 2nd dose of the vaccine while taking Azithromycin. They were informed at work that the 2nd dose of the vaccine should be administered between days 21 and 23 after the first one. Information about lot/batch number has been requested.
51 2021-01-16 mouth tingling 01/17/2021 @11:41 am Covid Vax in Left Deltoid @12:03 pm stated tongue was ?tingly? and had a headac... Read more
01/17/2021 @11:41 am Covid Vax in Left Deltoid @12:03 pm stated tongue was ?tingly? and had a headache 5/10. She took 1000mg Tylenol. Given history of allergies, I gave her 50mg oral diphenhydramine ? liquid. She also took an Ativan 1mg. She was nervous and upset, but no further reaction except ?tingly tongue?. No rash, examined arms, torso, face, lips. 12:15pm BP 152/82, admitted to some anxiety 12:30 ?feels good?, still some tongue tingling 12:36 BP 140/80 tongue/mouth nothing remarkable I advised her not to drive and sister came to pick her up at 1:30. No further incidents I advised her to talk to her dr about 2nd vaccine and consider an allergist due to prior allergies.
51 2021-01-17 eye pain Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati... Read more
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
51 2021-01-17 mouth tingling Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue ti... Read more
Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue tingling. Started having symptoms a couple of hours after 2 dose of vaccine. Feels like nerves are burning in these areas. Intense headache 24 hrs after shot. Took Tylenol 500 mg with no relief. Took naproxen 550 mg Tuesday night around 10 pm. Resolved headache but not burning sensation around mucus membranes. Got progressively worse. Saw MD on Friday who did pelvic exam. Confirmed vaginitis. Prescribed Medrol dosepak, refresh vaginal lubricant and topical desitin. Currently on day 4 on Medrol dospak with some relief. Burning sensation now comes and goes and is not constant. Again, the burning sensation feels like the nerves in the areas of mucus membranes are inflamed.
51 2021-01-17 mouth tingling Tight throat, thick tongue
51 2021-01-17 sensitivity to light BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe ... Read more
BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe nausea (but could be from headache).; Possible migraine; Mild photophobia; Mild photophobia; This is a spontaneous report from a contactable Physician who reported for herself. A 51-year-old female patient received her second single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EL3249) at left arm at 17:30 06Jan2021 for Covid-19 immunization in a hospital. She had her first injection at 07:15 PM 18Dec2020 and experienced mild photophobia within 5-10 min. The patient had a medical histroy of allergic rhinitis and was allergic to cashews. Concomitant medications included fexofenadine, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to her first COVID vaccine. Within 5-10 minutes of 2nd injection, the patient had mild photophobia (also after 1st injection but patient did not recognize the symptom at that time). About 20 hours after 2nd injection, the patient developed severe sharp headache behind left eye, severe nausea (but could be from headache/ possible migraine). The patient stated that she had no prior history of migraines or frequent headaches. Three days after 2nd dose, the patient's lingering intermittent mild left-sided headache persisted. The patient self-administered OTC oral analgesics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events headache, nausea, migraine, photophobia at the time of last observation was resolving. The patient considered that the events were non-serious.
51 2021-01-18 oropharyngeal discomfort Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit i... Read more
Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit itchy? and her ?nose was closing up?. Vitals taken at 3:48- 129/75 BP, 98 HR, 98% O2. Continuing complaint of ?itching?. 1 mL of Benadryl (Lot #080010, Exp 08/22) given at 3:52. Vitals taken again at 3:54- 150/84 BP, 92 HR, 97% O2. Patient sipped water and speaking with responding nurses at 3:55. At 4:00, reported ?throat itching? and had hoarseness, coughing, and congestion. 4:01, 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:06 patient reported her tongue was less ?itchy? and decreased congestion. 4:14 vitals were 123/72 BP, 106 HR, 98% O2 & patient reported no improvement of symptoms. 4:15, Dr. was called at which time recommended to call EMS. 4:16, RN called EMS. 4:18 patient reports ?someone is pushing on my throat?. 4:20 a 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:22 vitals were 126/81 BP, 107 HR, 96% O2. 4:26 EMS arrived at clinic and left via stretcher. EMS provided with medications given to patient.
51 2021-01-18 mouth tingling Patient expressed burning sensation in throat / tingling on tip of tongue shortly after vaccine. Wa... Read more
Patient expressed burning sensation in throat / tingling on tip of tongue shortly after vaccine. Was evaluated by MD, taken for observation. Dispo was to home.
51 2021-01-18 mouth tingling Tingling of Lips and face
51 2021-01-18 sensitivity to light Mild photophobia; This is a spontaneous report from a contactable physician (patient). A 51-year-old... Read more
Mild photophobia; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 18Dec2020 (19:15) at a single dose on the left arm for COVID-19 immunization at the hospital. Medical history included allergic rhinitis and cashew allergy. Concomitant medications included fexofenadine, ergocalciferol (VIT D) and cyanocobalamin (VITAMIN B12). On 06Jan2021 (17:45), the patient had mild photophobia within 5 to 10 minutes of the first dose of vaccination. The patient did not recognize the symptom at the time. The patient had self-administered over-the-counter (OTC) oral analgesics as treatment for the event. The outcome of the event, mild photophobia, was recovering. The patient did not have COVID-19 prior to the vaccination, and had not been tested positive for COVID-19 since the vaccination. Information regarding lot/batch number has been requested.
51 2021-01-18 thirst Pain at injection site, diarrhea, loss of appetite, thirst, joint pains, fatigue, chills
51 2021-01-19 taste impairment immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday mornin... Read more
immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday morning 1.9.21; foggy mind body aches Symptoms subsided Tuesday morning 1.12.21
51 2021-01-19 pain in jaw Fever of 99.6 and 99.4 which likely began overnight (but first logged at 5:00 am) and ended by after... Read more
Fever of 99.6 and 99.4 which likely began overnight (but first logged at 5:00 am) and ended by afternoon of 1/19/21. Arm pain and body aches resolved around same time. Significant left jaw pain which began evening of 1/19/21 and continue into 1/20/21. All symptoms alleviated by ibuprofen.
51 2021-01-20 ear pain Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) bod... Read more
Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El3248), via an unspecified route of administration in the left arm on 09Jan2021 06:30 at single dose for COVID-19 immunisation at hospital. Medical history included asthma, seasonal allergy, milk allergy, eucalyptus allergy. Concomitant medication included montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL), ciclosporin (RESTASIS, eye drop). The patient previously took tetanus vaccine and experienced drug hypersensitivity. The patient experienced low grade fever (99.9 F) body aches, nerve pain chills, headache, ear pain on 10Jan2021 08:00 with outcome of recovered. The patient took diphenhydramine hydrochloride (BENADRYL) 25mg every 6 hours and it relieved all symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
51 2021-01-20 eye pain, loss of taste feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattre... Read more
feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattress; no real taste; chest pressure/tightness/ general pressure in the chest; SOB/ SOB with movement; Body and joints with extreme pain everywhere it touched the mattress; a screw in left foot, it felt like it was on fire at some point during the night; My left leg ached up into my hip; fever 99.9; HA; eye pain; intermittent nausea; This is a spontaneous report from a contactable nurse (patient). This 51-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) on 07Jan2021 at 11:15, in right arm, for COVID-19 immunisation. Medical history included asthma, allergies to latex, banana, kiwi and acetylsalicylic acid (ASPIRIN). The patient received the first dose of BNT162B2 vaccine on 17Dec2020 at 19:45, lot number EJ1685, in right arm. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. COVID was not tested post vaccination. Concomitant medications included thyroid (ARMOUR THYROID) and escitalopram. On 07Jan2021 at 12:30 the patient began experiencing SOB; assumed it was asthma, 2 puffs of albuterol were taken. At 13:30 she had still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 14:15 reported to the vaccination clinic and told them of symptoms, SOB with movement and general pressure in the chest. 2 paracetamol (TYLENOL) were taken. She had to check into the ER for observation. Oxygen saturation was checked for 2 hours. No change in symptoms, no worsening. She then left work in the ER and went home. At approximately 18:00 she ate dinner, no real taste, but needed to eat. At 18:30 she showered, at 20:00 she went to bed just feeling malaise, continued pressure in the chest and general soreness. 2 Tylenol. Body and joints with extreme pain everywhere it touched the mattress. She had a screw in her left foot, it felt like it was on fire at some point during the night. Her left leg ached up into her hip, she had fever 99.9, continued to 10Jan2021 with malaise, HA, eye pain, intermittent nausea. The events had not yet resolved at the time of report.
51 2021-01-20 taste disorder Starting 1 week after the vaccine she began experiencing intermittent chills with no fever. On 1/17/... Read more
Starting 1 week after the vaccine she began experiencing intermittent chills with no fever. On 1/17/21 she started to have itching from the waist up and she is taking Zyrtec. She has also notice some taste changes but no loss of taste or smell.
51 2021-01-20 taste disorder Since 1 week after the vaccine she has been experiencing intermittent chills without fever, pruritis... Read more
Since 1 week after the vaccine she has been experiencing intermittent chills without fever, pruritis from the waist up starting 1/17/21 and changes in her taste with no loss of taste or smell.
51 2021-01-21 loss of smell I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-work... Read more
I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-worker told me my voice was strange, was hoarse. I was feeling fine. The next day I lost my sense of smell. Talked to my PCP and he told me to get tested for COVID, to my surprise I was positive. That was on the 28 or 29 of December. I also developed a lump on my neck on the right side and my PCP prescribed a Z Pack. I finished it but it never went away. I developed another lump on my left side when I took the second dose and I am taking Doxycicline for it.
51 2021-01-21 eye irritation An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tyl... Read more
An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tylenol as soon as I got home due to symptoms getting worse. That night I went to bed at 10pm and didn?t wake up till 7:45am (I was dead tired, I didn?t even hear my alarm). Jan/19/21. Soon as I got up, I experienced headache, vertigo, and this time with mild body aches/heavy feeling and mental fog (Tylenol helped relieved symptoms). Towards the afternoon, I also felt mild burning sensation in my eyes and somehow I felt hot flashes around my face only. Been taking my temperature with normal results. Jan/20/21 Still experiencing off/on headaches and light headedness, otherwise feels okay. All symptoms gone by end of the day.
51 2021-01-21 mouth numbness Minor Face and Throat swelling. Irregular eye lid movement. Lips num and felt twisted.
51 2021-01-21 lip itchiness Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly it... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly itch, pinpoint itch at my scalp and different parts of my body, fine rash in my bilateral forearm near my wrist, immediately I took Zyrtec, my rash started to fade but every now and then I fell fine itch in different parts of my body more than 2 hours now.
51 2021-01-24 lip swelling Swelling above upper lip where I have derma filler. Very minor but still noticeable the day after th... Read more
Swelling above upper lip where I have derma filler. Very minor but still noticeable the day after the vaccine injection.
51 2021-01-24 swollen tongue Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fir... Read more
Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fire, short of breath. 2 doses of PO Benadryl at clinic, transferred to ED where she received epinephrine and 4 days of prednisone and allergy consult. Nausea began evening of 1/21/21 with headache. Fever 100.6 began 1/22/21. Headache and nausea still remain, not fully recovered.
51 2021-01-24 ringing in ears n/t arm and leg immediately after vaccine- numb /ting arm on follow up call next day. Pt felt immu... Read more
n/t arm and leg immediately after vaccine- numb /ting arm on follow up call next day. Pt felt immunization was administered too high on arm/shoulder. 1/25 pt is to get dose #2 this week and concerned re: still some numbness but also some ringing in the ear. Tells staff has had some ringing in the ear previous to vaccine mostly at night- this has now intensified to where she is also hearing it during the day. She has d/w her PCP- she is very unsure if she should get vaccine #2 or not.
51 2021-01-25 mouth tingling warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and t... Read more
warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour. Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes. I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal. I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons. I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart. I am on day 6 now and I have joint pain and headache.
51 2021-01-25 thirst headache body ache chills very thirsty
51 2021-01-26 inability to speak nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressu... Read more
nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressure. I was administered solumedrol intravenous, Benadryl intravenous, Pepcid intravenous and Zofran sublingual and NSS 0.9 to 10 ml per hour.
51 2021-01-26 taste impairment Chemical taste in mouth; This is a spontaneous report from a non-contactable other hcp (patient). A ... Read more
Chemical taste in mouth; This is a spontaneous report from a non-contactable other hcp (patient). A 51-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek9231, expiry date not reported), via an unspecified route of administration on 13Jan2021 13:30 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included fluoxetine hydrochloride (PROZAC). The patient experienced chemical taste in mouth on 13Jan2021 14:00. The patient did not have COVID prior to vaccination and has not tested positive post vaccination. The patient was recovering from the event. No follow up attempts are possible. No further information is expected.
51 2021-01-26 taste impairment metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went t... Read more
metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily. There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
51 2021-01-26 oropharyngeal discomfort, eye itchiness Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, d... Read more
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
51 2021-01-27 taste impairment slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuf... Read more
slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
51 2021-01-28 dry throat Pt came to clinic for Covid-19 vaccine. Allergies reviewed. Pt had seen allergist for allergic reac... Read more
Pt came to clinic for Covid-19 vaccine. Allergies reviewed. Pt had seen allergist for allergic reaction associated with treatment of kidney stones. Allergist believed reaction was related to flomax or oxycodone (neither of these are injectable therapies. Vaccination given. Pt came to staff during the waiting period stating starting just minutes after the vaccination she started feeling of "dry throat." She also noted her heart beat was a little fast. No shortness of breath, no hives or any other signs of reaction. Pt was given diphenhydramine 25 mg orally at 1305. At 1325 Pt reports she is feeling better (she is conversing with friend and laughing). She states she will leave here and f/u with allergist regarding whether or not she should receive 2nd vaccination dose.
51 2021-01-28 mouth numbness Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her a... Read more
Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her and was painful for two days, she could barely move her arm; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing asthma for approximately 25 years ago. There were no concomitant medications. After she took the first dose, on an unknown date, her arm killed her and was painful for two days, she could barely move her arm. She also had numbness in her mouth, face, jaws, and cheeks that lasted about 3 hours. The outcome of the events was unknown.
51 2021-01-28 mouth numbness Patient reported tongue numbness and throat itching sensation within three minutes of vaccine admi... Read more
Patient reported tongue numbness and throat itching sensation within three minutes of vaccine administration. BP 131/87, HR 80, O2 97%. Patient then developed macular rash on bilateral arms and described sensation of generalized warmth about 15 minutes after vaccine administration. presented to vaccine clinic for consult, patient was then transferred to ER via stretcher.
51 2021-01-28 taste disorder, mouth tingling Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain;... Read more
Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD). Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
51 2021-01-31 dry throat, mouth numbness 1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt f... Read more
1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt flush, complained of dryness to throat, drank a glass of water and tolerated Rapid response called; transferred to Ed
51 2021-01-31 vision blurred malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; ... Read more
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
51 2021-02-01 taste impairment Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instruc... Read more
Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instructed to lay down, BP was elevated, continued to rise. Contacted 911, patient transported to hospital, admitted and disharged next day. Symptoms lasted 1 day
51 2021-02-01 eye irritation Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; D... Read more
Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; Day after receiving 2nd dose, patient developed facial congestion, burning eyes, scratchy throat.; This is a spontaneous report from a contactable pharmacist reported a female patient. A 51-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: unknown), via Intramuscular route of administration, on 18Jan2021 03:15 PM (at the age of 51 years old) as a single dose on left arm for COVID-19 immunisation at a workplace clinic. Relevant medical history included thyroid removed 30+ years (onset date unknown). Historical vaccine included fist dose of BNT162B2 (Pfizer Covid-19 vaccine, lot#/exp. date unknown) via Intramuscular route of administration on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021, the patient stated that day after receiving 2nd dose, she developed facial congestion, burning eyes, scratchy throat. She proceeded to get COVID Nasal Swab test on 19Jan2021 with unknown result at time of report. Patient stated workplace did not believe they were adverse reaction to vaccine. The patient received treatment no treatment. The outcome of the events facial congestion, burning eyes, scratchy throat was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
51 2021-02-02 ear pain, pain in jaw On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my n... Read more
On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my neck, jaw, and ear. On Saturday, 1/30, I woke up, and the right side of my face was numb, and my right eye would not blink. I went to ER. When they took my vitals, I had high blood pressure and fever. They did a CT scan of my head and admitted me. I was diagnosed with Bell's Palsy. I was discharged on Sunday, 1/31, with medications: Valacyclovir 1 gram three times a day and Prednisone 20 mg three times a day. I was instructed to followup with a neurologist, immunologist, ophthalmologist, and my primary care physician.
51 2021-02-02 gaze palsy **Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze de... Read more
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
51 2021-02-02 thirst Woke up 1/7/21 at 4:00 am with a temp of 102.0, Nausea, body aches, chills, arm pain, joint pain, ex... Read more
Woke up 1/7/21 at 4:00 am with a temp of 102.0, Nausea, body aches, chills, arm pain, joint pain, extreme thirst and fatigue. Tylenol taken temp continued to be 102 and increased to 102.4. All symptoms lasted until until 1/8/21 5am woke up sweating temp down to 99.8, arm pain, fatigue. 1/9/21 all symptoms resolved.
51 2021-02-03 drooping eyelid She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her f... Read more
She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her face, it has slowly gotten worse and now has a drooping eye, worsening facial numbness and droop.
51 2021-02-03 mouth numbness, mouth tingling Numbness at left side of lip . Numbness almost like novicaine feeling at left cheek up towards lef... Read more
Numbness at left side of lip . Numbness almost like novicaine feeling at left cheek up towards left eye Tingling at back of the tongue
51 2021-02-03 mouth numbness After first vaccine about 25 mins after the shot, the tip of my tongue and lips went numb. I had gen... Read more
After first vaccine about 25 mins after the shot, the tip of my tongue and lips went numb. I had general fatigue the remainder of the day. The day following I was aching, bad headache and pain down my neck, my stomach was upset along with fatigue. These feelings came and went throughout Sunday 10, Monday 11, and Tuesday 12. I felt better on Wednesday Jan 13th. On Sunday January 23rd I started feeling very fatigued, achy and had a fever of 100 F. This lasted through Monday Jan 24
51 2021-02-04 swollen tongue, mouth swelling about 10 minutes after receiving vaccine i got swelling of the tongue, mouth and a little hard to sw... Read more
about 10 minutes after receiving vaccine i got swelling of the tongue, mouth and a little hard to swallow , constriction of throat. i was given an epi pen and taken to Emergency at Medical Center. I was released a couple hours later. I ended up going back to Emergency later on that evening but to Hospital. Tongue started to swell up again and was getting constriction of the throat and hard to swallow. Got released a couple hours later
51 2021-02-04 vision blurred Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle o... Read more
Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle of the night, had increased SOB and chest weakness. Describes as felling "Not well." Drank water. Felt better. Went back to sleep. 2/4: Patient c/o nasal congestion, slight blurred vision, increased SOB/chest weakness, had body aches, slight swelling in neck lymph node (hx of swelling due to abscess). Felt better as day progressed but in afternoon @ 3:30 p.m. while at store with family, had to leave to sit in car due to fatigue and reoccurring SOB. Minor SOB episode throughout the day. Slept well at night. Took Ibuprofen 400 mg PO x1 which improved body ache.
51 2021-02-05 swelling of eyelid, lip swelling Lip swelling, eyelid swelling, are itching. Benadryl oral given. Sent to ER. 2nd day follow-up, n... Read more
Lip swelling, eyelid swelling, are itching. Benadryl oral given. Sent to ER. 2nd day follow-up, no further intervention was given in ER other than benadryl. At home and feeling "99%" better.
51 2021-02-06 loss of smell First shot fine. Just a mild pain in arm day after. With the second shot I noticed lower back pain n... Read more
First shot fine. Just a mild pain in arm day after. With the second shot I noticed lower back pain night of shot started a couple hours after. Had fever and chills start in the night, Thursday. I woke up to awful body and joint aches everywhere the next day, Friday. On Friday I also lost sense of smell. Had nausea, couldn't eat, fever, sweats awful and some chills off and on. Saturday- not much body aches but sweating awful, very tired/drained feeling. Sunday (today)- still sweats and nausea.
51 2021-02-06 bloodshot eyes Induration in axilla of left arm headache fever pain and swelling of left breast pain on both thighs... Read more
Induration in axilla of left arm headache fever pain and swelling of left breast pain on both thighs and knees redness at injection site urticaria and warmth generalized body pain eye redness
51 2021-02-07 ear itchiness, lip itchiness felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine ra... Read more
felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine rash in her bilateral forearm near the wrist; on and off pinpoint itch in different parts of her body; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via intramuscular route of administration on 22Jan2021 at 08:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included Chronic Hep B, borderline DM, HTN, high cholesterol. Concomitant medications included losartan, amlodipine, atorvastatin, metformin, fish oil, and docusate sodium (COLACE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730) on 04Jan2021 at 08:30 am (age: 51 years), intramuscular, in the left arm for COVID-19 immunization; flu vaccine in 2010 and experienced allergies; and Penicillin G and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 22Jan2021 at 08:35, the patient felt warm. At the same time, her lower lip was slightly itchy. She also had pinpoint itch mostly in her scalp left ear and cluster fine rash in her bilateral forearm near the wrist, and four hours on and off pinpoint itch in different parts of her body. The patient was given Zyrtec as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
51 2021-02-07 lacrimation increased Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Mus... Read more
Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Muscle Pain; Kidney Pain; Watery eyes; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscularly in left arm on 29Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, Hypothyroidism, known allergies to pineapple. Concomitant medication included thyroid (ARMOUR THYROID), naltrexone. The patient previously took levofloxacin and experienced allergies, amoxicillin and experienced allergies, levonorgestrel and ethinyl estradiol (reported as LEVONORGESTREL-ETHINYL) and experienced allergies. The patient experienced headache, bodyaches, confusion, nausea, no appetite, fatigue, malaise, loose stools, joint pain, muscle pain, kidney pain, watery eyes, all on 05Jan2021 13:00. No treatment received. No other vaccine in four weeks. No covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab with result of negative on 10Jan2021. The outcome of the events was recovered in Jan2021.
51 2021-02-07 feeling of choking Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety... Read more
Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety). Monitored for 60 minutes and drank some water. Started to feel better. Patient said she experienced this after her first dose, but not until after she left the clinic. She said that time it resolved within 12 hours. Patient said she felt well enough to leave and said she'll seek medical help if symptoms don't resolve or worsen.
51 2021-02-08 mouth numbness, ear discomfort, swollen tongue 1/27/2021 experience sore throat, chills, fever 101.8 F, and body aches. 1/28/2021 still experiencin... Read more
1/27/2021 experience sore throat, chills, fever 101.8 F, and body aches. 1/28/2021 still experiencing symptoms. Was sent to be test for Covid. Results were negative. 1/29/2021 Developed a dry nagging non-productive cough. I would have coughing fits that would last for 30-45 minutes, which would be followed by clear sinus drainage. I began taking Benadryl 50 mg q 4 hrs. with very little relief. 2/2/2021 I was seen at urgent care for this cough. CXR was negative. No signs of infection. I started prednisone 40 mg x 5 days, and Tessalon Perles 200 mg 3 times a day. I was still experiencing the dry cough and by 2/5/2021 had to leave work because the coughing was not letting up. I was now also experiencing my ears and throat itching. I again started taking Benadryl and sudafed q 4 hours. 2/7/2021 I tried to come off the benadryl and experienced ears itching, my throat itching, my lips were going numb and my tongue felt like it was swelling. 2/8/2021 I was seen by my primary care physician. There was no signs of infection. Ears were clear, chest was clear. He told me he felt I was having a reaction to the COVID vaccine, and experiencing a reactory cough as well. He gave me a Steroid injection in the office, prescribed me a steroid inhaler twice a day, and Bromfed cough syrup every 6 hrs prn. 2/9/2021 cough has subsided as well as the itching.
51 2021-02-09 ear discomfort Vomiting about 17 hours after shot; pressure in ears; aches; chills; This is a spontaneous report fr... Read more
Vomiting about 17 hours after shot; pressure in ears; aches; chills; This is a spontaneous report from a contactable other hcp reporting for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on the left arm on 23Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included vertigo from an unknown date and unknown if ongoing, food intolerance to raw eggs, red dye and bag lettuce from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) and paracetamol (TYLENOL). The patient previously had the first dose of the vaccine on 06Jan2021 (lot number: EK5730). On 24Jan2021 09:30 AM, the patient experienced vomiting about 17 hours after shot. Also, pressure in ears and like many others aches and chills. No treatment was received for the events. The outcome of the event was recovering.
51 2021-02-09 eye itchiness itching all over - eyes, arms, legs
51 2021-02-10 vision blurred, eye swelling, pain in jaw, lip blister, toothache 2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch... Read more
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-02-11 taste impairment Local arm pain close to injection site, dizziness, back pain close to elbow to the head, dirrhea, vo... Read more
Local arm pain close to injection site, dizziness, back pain close to elbow to the head, dirrhea, vomiting, headache, burping, bitter taste in mouth, body aches, weakness, farting, tiredness. Still experiencing adverse effects.
51 2021-02-11 sensitivity to light STARTED ON 2/11/2021 WITH HEADACHE ,FEVER ,CHILL,S BODYACHE, HEADACHE, LOSS OF APPETITE, NAUSEA, PAI... Read more
STARTED ON 2/11/2021 WITH HEADACHE ,FEVER ,CHILL,S BODYACHE, HEADACHE, LOSS OF APPETITE, NAUSEA, PAIN AND TIGHTNESS LEFT ARM AND LEFT AXILLA, LEFT CERVICAL PAIN, PHOTOPHOBIA. UNABLE TO GO TO WORK TODAY.
51 2021-02-11 tunnel vision I felt like I had tunnel vision, dizzy, wasn't functioning very well. I had fatigue as well. I went... Read more
I felt like I had tunnel vision, dizzy, wasn't functioning very well. I had fatigue as well. I went to the ED for observation.
51 2021-02-14 eye disorder Acute inflammatory eye disease, vasculitis, iritis The first signs showed up the morning of 02/07/20... Read more
Acute inflammatory eye disease, vasculitis, iritis The first signs showed up the morning of 02/07/2021. I went to the eye doctor on 02/08/2021. Symptoms kept getting worse and I was referred to a retina specialist on 02/10/2021. I go back on Wednesday 02/17/2021. The retina doctor and family doctor have talked and they are recommending that I do not get the second dose at this time because I could be at risk of vision loss.
51 2021-02-14 mouth swelling, swollen tongue, eye swelling Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Other- Anxiety/Panic-Medium
51 2021-02-14 mouth tingling Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left a... Read more
Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left arm, hands and feet. Hives and itching. Received 1st dose of covid vaccine at 1635 today. Developed sxs 2-3 minutes after. Was given bendryl 25 mg po at 1643. Was brought by nurse. Hx of chronic urticaria, takes claritin daily with control. Hx of allergic reaction to bactrim. Has epi pen with her. Nurse brought note from Doctor, to order tryptase lab
51 2021-02-14 swollen tongue, tongue disorder Approximately 20 minutes after the shot was administered my tongue began to feel tingly and thick. ... Read more
Approximately 20 minutes after the shot was administered my tongue began to feel tingly and thick. It made swallowing feel awkward but there was difficulty in breathing. When I got home, about 35-40 minutes after shot was administered I took some Benadryl. About 1 1/2 hours I felt back to normal.
51 2021-02-16 mouth numbness Throat began to feel like it was closing/difficulty swallowing, numbing on left side of tongue and j... Read more
Throat began to feel like it was closing/difficulty swallowing, numbing on left side of tongue and jaw and left side of nose. Bad headache. At 5:53pm still feeling numbness on tongue and roof of mouth, but otherwise symptoms of subsided. Called doctor, Took 2 Benedryl (25 mg capsules).
51 2021-02-17 pain in jaw, ear pain Symptoms have not gone away. I still have (on and off) the back of my left shoulder up my neck into... Read more
Symptoms have not gone away. I still have (on and off) the back of my left shoulder up my neck into my jaw is where it's hurting. This usually comes with a migraine, but I don't have one today. It's just odd because I've never had this before, all the symptoms all at once. I've noticed under my left arm pit on occasions, sometimes when I'm laying at night feel swollen and in my groan as well. I have had some weird symptoms. I do get chills of and on but not at this very moment. My left ear has became hurting where the jaw pain is. I have to have my ears cleaned every so after so not sure if that has to do with my pain going on. I saw the ENT on December 30 and going to see them again on February 24th.
51 2021-02-17 ringing in ears Tinnitus persists
51 2021-02-18 swollen tongue 1245; Scratchy throat, nausea, tongue feels fat, nausea; Dipenhydramaine administered , Epi Pen admi... Read more
1245; Scratchy throat, nausea, tongue feels fat, nausea; Dipenhydramaine administered , Epi Pen administered. Patient alert 1256 - gagging, throat tightness, tongute better, tight throat, nausea; second Epi Pen administered 1258 - EMS arrived, pateint alert and transported to Emergency Department via EMS
51 2021-02-18 swollen tongue Vaccine administered at 10;25am; at 10:32, the individual began experiencing swelling of the throat ... Read more
Vaccine administered at 10;25am; at 10:32, the individual began experiencing swelling of the throat and tongue while seated in the observation area. Vital signs were checked and were withinnormal limits; she remained alert and oriented. A Code White was called; she had already taken Prednisone po from own supply since she has a history of an autoimmune disorder. The Code Team transported the individual to the ED via w/c for further observation.
51 2021-02-19 ear pain Severe chills, fever, muscle aches for 36 hours, joint pain for 72 hours and frequent BM X4 days, ea... Read more
Severe chills, fever, muscle aches for 36 hours, joint pain for 72 hours and frequent BM X4 days, ear pain X 36 hours
51 2021-02-21 ear pain Received her 1st covid vaccine at noon on 2/19/21. Woke later that night in middle of the night wit... Read more
Received her 1st covid vaccine at noon on 2/19/21. Woke later that night in middle of the night with bleeding from right nostril and severe right ear pain
51 2021-02-23 mouth tingling, mouth numbness, taste impairment, swollen tongue Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting are... Read more
Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting area, c/o feeling "whoozy", a metallic taste in mouth and tingling of mouth. A short time later, reports that symptoms are worsening. Walked with stand by assist of two to cot. BP elevated, other VSS. C/o feeling "whoozy", middle tongue feeling swollen, metallic taste in mouth, mouth feeling numb/tingling. Symptoms progressed to rest of body feeling "tingling". Denies dizziness. Symptoms progressing. Denies SOB, itchy throat or throat swelling sensation. Denies any itching of skin. No hives or rash noted. Due to worsening of symptoms, a First Responder was called at 2:01 PM for transport, monitoring and treatment in ED.
51 2021-02-24 mouth numbness, mouth tingling, lip swelling, swollen tongue Swelling of the lips and tongue, numbness and tingling of the mouth, sweating of the lips and mouth.... Read more
Swelling of the lips and tongue, numbness and tingling of the mouth, sweating of the lips and mouth. Patient refused to be seen by EMS
51 2021-02-24 thirst Beginning three days after receiving my second Pfizer COVID-19 dose, I developed intractable nausea ... Read more
Beginning three days after receiving my second Pfizer COVID-19 dose, I developed intractable nausea that lasted for 10 days. That same day, I also developed extreme thirst, which persists today (22 days post-vaccine).
51 2021-02-25 eye itchiness, lip itchiness, mouth tingling, mouth discomfort At the vaccine administration location, patient experienced the following symptoms: tightness in che... Read more
At the vaccine administration location, patient experienced the following symptoms: tightness in chest, tightness in throat, nausea, ithcy tingley lips, burning lips, bumps/gives on inside of lips. Patient given diphenhydramine 25 mg oral solution PO x1. Vitals taken: WNL. Patient denied EMS transport to ER and transported self to ER. Per ED Provider Notes: Patient reports vaccine was given about 1.5 hours prior to arrival. Pt reported sensation of swelling of her arms, left eye itchiness, and itchiness on the inside of her lips. She denied any difficult, no abnormal sensation in her throat, throat swelling or swelling elsewhere in her mouth. Pruritus documented, no rash. Nausea. At the time of the ER provider examining patient. it is reported that patient was not having anaphylaxis but does have a flat appearing raised lesions on side aspect of upper lower lip. Pt treated with IV diphenhydramine, PO Prednisone and IV famotidine along with NS. Patient observed for 2.5 hours and then discharged. No swelling, itching or swelling and time of discharge and reports resolution of symptoms.
51 2021-02-25 mouth tingling, mouth numbness About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient w... Read more
About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient was given oral diphenhydramine 50mg and notified EMS. When EMS arrived about 15 min later, patient initially declined to go to ER for eval. About another 15 min later, patient returned to clinic as face and chin were starting to swell slightly. Re-notifed EMS and the returned and picked up the patient. Patient left in awake condition, no respiratory distress.
51 2021-02-26 taste impairment About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I st... Read more
About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I stared to get a headache and tremors in my hands and arms. After another 5 min I was getting mussel tightness in my face and throte. I started to get dizzy and feel very cold.
51 2021-02-27 eye bleeding 10 days after vaccine I all of a sudden developed extremely high blood pressure of 175/100. Went to ... Read more
10 days after vaccine I all of a sudden developed extremely high blood pressure of 175/100. Went to doctor and he also took blood pressures and still was in the 178-180 range. Never had high blood pressure in my life. Also experienced a broken blood vessel in my eye in between first shot and second shot.
51 2021-02-27 mouth tingling Extreme itching and redness in upper left quadrant (scalp, face, shoulder, arm, into upper thigh) ap... Read more
Extreme itching and redness in upper left quadrant (scalp, face, shoulder, arm, into upper thigh) approximately 12- 15 minutes after injection, dizziness, tingling mouth; ambulance called, taken to hospital, benadryl administered en route and steroids given at hospital
51 2021-02-28 ear discomfort, ear pain ~approximately 30 min after vaccination received a funny feeling in my head not quite like a headach... Read more
~approximately 30 min after vaccination received a funny feeling in my head not quite like a headache and pain around my nose and between my eyes which lasted about 5 minutes followed by ear popping which ceased after about 5 minutes followed by ear pain for about 15 minutes
51 2021-02-28 ear pain Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm, ... Read more
Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm, low grade fever and earache right side only.
51 2021-03-01 lip swelling Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our... Read more
Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our home (approx 2 hr drive) & were on road. My husband is a physician & when we noticed symptoms administered Benadryl, Claritin, & famatodine.
51 2021-03-01 oral mucosal blistering, mouth tingling, lip blister Tingling of my mouth and lips. Blisters in my gum and lips.
51 2021-03-01 mouth tingling Elevated heart rate Elevated blood pressure (214/155) Tightening of throat Mild pressure in tongue ... Read more
Elevated heart rate Elevated blood pressure (214/155) Tightening of throat Mild pressure in tongue Treatment- benadryl; close monitoring for 2 hours by nurses and EMS workers
51 2021-03-01 swollen tongue, lip swelling treatment - benadryl, hydration, rest, monitoring vitals at home
51 2021-03-01 thirst Patient has been experience severe thirst since second vaccine administraiton
51 2021-03-01 vision blurred Within 10 Minutes of receiving my first dose I began to feel dizzy and my vision was somewhat blurry... Read more
Within 10 Minutes of receiving my first dose I began to feel dizzy and my vision was somewhat blurry. I checked my heat rate and it was 160. I motioned for the nurse and the pharmacist who was present monitored me for about an hour. My heart rate did not go below 110 for at least 45 min. I drank water and was allowed to leave once my HR was 88. I was able to drive home and did not have any other symptoms.
51 2021-03-02 taste impairment After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. Howev... Read more
After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. However, that went away within an hour. I had the typical low side effects of localized injection soreness, swelling, redness, warmth feeling and it was red around the injection site. The following two days after vaccination (2/22/21) I experienced the expected low side effects. On the third day after vaccination, I was feeling well again. However, yesterday 3/2/21, I noticed the area where I received the Covid vaccine was red again, with itching, warmth feeling, redness, and a bit of burning sensation. This is only apparent on the injection site. I contacted the CDC today, 3/3/21 and they directed me to you to report this and also to contact my healthcare provider, which I have. The CDC was not able to tell me if it was considered normal to have the localized injection site side effects resurface again a week after receiving the 1st dose vaccine. Therefore, I was advised by the CDC to report it. It is also unclear to me if the reason for the localized injection site side-effects being more prominent because of where the injection was administered. There is a question about it having been administered closer to subcutaneously by the nurse than intramuscular, but I do not know.
51 2021-03-02 ear pain Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever c... Read more
Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever chills. Severe internal ear pain and headache but it's not touched by Tylenol or Ibuprofen
51 2021-03-02 ear itchiness Mild itchiness of the face and neck and ears severely red. Took half of a Benadryl and it resolved ... Read more
Mild itchiness of the face and neck and ears severely red. Took half of a Benadryl and it resolved after a short time. I still have periodic itchiness of face and neck. I take claritin everyday.
51 2021-03-02 swollen tongue Her tongue felt like it was swelling & she said it was getting difficult to swallow. Liquid Diphenh... Read more
Her tongue felt like it was swelling & she said it was getting difficult to swallow. Liquid Diphenhydramine 25 mg was given immediately. About 10 minutes later, another dose was given. About 5 minutes after the 2nd dose of Diphenhydramine was given, she stated her tongue was getting worse & she was having a more difficult time swallowing. Epi 0.3 mg given IM. Within about 3-4 minutes, she stated she was feeling better. Then, about 5 minutes later, she stated her tongue was beginning to swell again. She was immediately taken to the ED for treatment. Steroids were given. Pt was discharged from the hospital. She is feeling much better today (the day after the event).
51 2021-03-02 thirst Patient is a volunteer at a vaccine distribution center. She was able to get a vaccine herself beca... Read more
Patient is a volunteer at a vaccine distribution center. She was able to get a vaccine herself because of this. She reports a persistent vice-like headache that began the day she received her first dose of vaccine that has persisted. Her blood pressure went up with this, so she was started on metoprolol which brought her blood pressure down, but did not affect the headaches. Patient received her 2nd dose of the Pfizer vaccine on 2/27/21 and reports that in addition to the headache she feels fatigued and reports excessive thirst. She is still be worked up for the headaches.
51 2021-03-03 deafness, ringing in ears Ringing in the ear. Hearing loss. Prescribed prednisone Take 40 mg day 1-2, 30 mg on day 3-4, 20 mg ... Read more
Ringing in the ear. Hearing loss. Prescribed prednisone Take 40 mg day 1-2, 30 mg on day 3-4, 20 mg on day 5-6, 10 mg on day 7-8, 5 mg on day 9-10. Prescribed on 1/20/2021. Then on 3/3/2021 prescribed prednisone 20 mg tablets TAKE 1 TABLET 3 TIMES A DAY FOR 7 DAYS, THEN 1 TABLET 2 TIMES A DAY FOR 4 DAYS, THEN 1 TABLET D FOR 4 DAYS, THEN 1/2 TABLET D FOR 4 DAYS. Currently still has hearing loss and ringing in the ear.
51 2021-03-03 mouth numbness Feeling of weakness, numbness around fingers and mouth, nausea.
51 2021-03-03 mouth itchiness half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after),... Read more
half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after), chest tightness, heart racing (3 hours after) - some of this went away after a while - mostly subsided (still having some chest pains and racing heart off and on) - red blotchy face, hands, bit of nausea - 1 day following
51 2021-03-03 sensitivity to light, vision blurred Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular siz... Read more
Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular size. Throbbing in feet and swollen, stiffness can't hardly bend right knee. Made my neuropathy worse. Head aches more, blurry vision, light sensitive, body aches, backache, coughing.
51 2021-03-03 ringing in ears One week and approx. 7 hours after injection, an existing mild tinnitus in the right ear became noti... Read more
One week and approx. 7 hours after injection, an existing mild tinnitus in the right ear became noticeably worse. Three days after that, a bilateral higher frequency buzzing tinnitus (that presents over the head rather than in the ear) appeared. Prior existing tinnitus levels were previously unnoticeable throughout the day (able to successfully ignore and forget about) but now both are noticeable throughout the day and take quite a bit of effort to distract myself from.
51 2021-03-03 tongue discomfort, mouth discomfort, ear pain 20 hours after dose extreme fatigue, chills, achiness, runny nose and earache. 48 hours after dose ... Read more
20 hours after dose extreme fatigue, chills, achiness, runny nose and earache. 48 hours after dose red rash at injection site, extreme fatigue and symptoms previously stated. 72 hours after dose extreme fatigue, swelling and discoloration at injection site with unusual feeling in right arm, mouth, tongue and lip burning. 96 hours after injection until present, extreme fatigue, burning mouth, tongue and lip sensation, unusual feeling in right arm.
51 2021-03-06 taste impairment At about 2:54 after shot at 2:50 I got a headache around my temples didnt last long maybe 5 mins. Ju... Read more
At about 2:54 after shot at 2:50 I got a headache around my temples didnt last long maybe 5 mins. Just felt weird like a heaviness all over my body. About 3:10 I started getting a metal taste in my mouth and throat it was gone by 3:30, but kept coming back through the rest of the day and next morning. By evening 8:45 PM my arm where shot was given started to hurt and bothered me through the night could not lay on it. Next morning my arm was hurting really bad at injection site and was warm to touch. I had some errands to do so I did use the arm sometimes the pain was not as bad other times just my coat touching my arm hurt. Around 4pm I took a tylenol and slept a little not better. Sunday morning March 7 it was still sore not as bad, but after using while doing some chores it is now burning and hurting again at 2pm. I feel nauseous and really dont have a appetite.
51 2021-03-07 ear discomfort Fever from 99.7 as high as 101.1 for 36 hours s/p vaccine - Treated with acetaminophen and ibuprofen... Read more
Fever from 99.7 as high as 101.1 for 36 hours s/p vaccine - Treated with acetaminophen and ibuprofen Clogged ears. - treated with Mucinex
51 2021-03-07 eye itchiness 15 minutes after receiving vaccine, client stated she had symptoms of "hayfever." Eyes itchy, nasal ... Read more
15 minutes after receiving vaccine, client stated she had symptoms of "hayfever." Eyes itchy, nasal congestion, runny nose, headache, sore throat. Denies feeling of throat closing or SOB. Long history of allergies-esp tree nuts . Brought by wheelchair to med exam area: A&O x 3, BP 138/70, Chest: CTA, Cardio: RRR 85 bpm, eyes erythematous, RR 15. Given cold water and kept in med station for an hour. Declined transfer to local ED for further eval/tx. Stated she was improving, symptoms much better. Eyes appeared clear w/out erythema, eupneic, no SOB. States feeling much better. Client stated she was well enough to go home and asked to leave. She then left for home.
51 2021-03-08 inability to speak, mouth tingling Approximately 5 hours after the second shot (EN6205) on March 5, 2021, I experienced full body aches... Read more
Approximately 5 hours after the second shot (EN6205) on March 5, 2021, I experienced full body aches, slight tingling on the tongue, and eventual loss of voice over the subsequent two days. The on duty nurse who had administered the shot, strongly suggest that I drink lots of water and take Tylenol. March 6 and 7, my voice was to a whisper; however, the body aches and tingling of the tongue had subsided. I was extremely exhausted and unable to speak above a whisper on March 8, but did not experience any of the aforementioned side affects. Today, March 9, my voice is back above a whisper, with intermittent hoarseness. I will continue regiments of rest, Tylenol, hot tea with crushed ginger. It is important to note that my breathing had not been affected since having taken the 2nd shot on March 5, 2021.
51 2021-03-08 mouth numbness, mouth tingling Nausea, oral tingling, dizziness, leg/oral numbness. Evaluated by EMS-Transported to Emergency room/... Read more
Nausea, oral tingling, dizziness, leg/oral numbness. Evaluated by EMS-Transported to Emergency room/department or urgent care.
51 2021-03-08 mouth tingling, mouth numbness flushing, lip numbness/tingling, lightheaded, HA. Evaluated by EMS-Cleared
51 2021-03-09 loss of taste, swollen tongue Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with... Read more
Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with being tired then led to extreme exhaustion and lethargy and loss of taste (salty and sweet), but had an appetite and drank a LOT of water, taking Tylenol around 6 pm; slept restless and in pain with fever and feeling both burning up and freezing cold with clammy chills. Couldn't settle. Approximately 3:30 am, had diarrhea until I had nothing in my system and developed uncontrollable shaking. Finally got some sleep after a hot bath. The next day, no appetite, drank little water and kombucha to settle my stomach, exhausted, feverish, napped off and on all day, right arm began hurting tremendously and right side including jaw and tongue felt swollen, took Tylenol in the morning and BC Powder pm before bed. Slept moderately well. Monday, napped off and on but started feeling better with only moderate exhaustion around 6 pm, but right arm was in pain. Tuesday, moderate exhaustion, had to nap for 2 hours mid-day, right side of body including tongue was swollen, arm in pain and entire upper arm muscle felt knotted. Went for a massage and worked out knot quite painfully. Today, moderate to mild exhaustion, upper right arm a bit sore, semi- decent appetite.
51 2021-03-09 dry mouth One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I ... Read more
One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I got in bed at 10pm, all of my muscles began hurting really badly, and I was awake most of the night, feeling sick with nausea, dry mouth, and pain all over. The next day I felt really wrecked, way worse than my usual Fibromyalgia/Anxiety symptoms. My body really hurt all over and I was really fatigued. I felt general malaise all day long and my left arm hurt a lot. That second night I slept better and the next day I was better except my left arm was still sore that day also.
51 2021-03-10 oropharyngeal discomfort Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: PATIENT STATE... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: PATIENT STATED FEELING UNCOMFORTABLE IN THE THROAT AFTER HER 15 MINUTE WAITING PERIOD WAS UP. PATIENT STATED THAT IT WAS MORE OF AN ITCH THAN SWELLING/TIGHTENING OF THROAT. PATIENT REQUESTED BENADRYL TO BE ADMINISTERED. 1 TAB OF 25 MG BENADRYL WAS ADMINISTERED. PATIENT BLOOD PRESSURE WAS ALSO MONITORED. PATIENT WAS KEPT FOR AN ADDITIONAL 30 MINUTES BEFORE LEAVING. FOLLOW UP CALL WAS GIVEN TO PATIENT APPROXIMATELY 40 MINUTES LATER AND PATIENT STATED SHE FELT FINE.
51 2021-03-10 mouth tingling, mouth numbness tongue numb/tingling, "medicine head", HA. Evaluated by EMS-Cleared
51 2021-03-12 taste impairment, mouth numbness Patient complained of headache, metallic taste and numbness on the sides of tongue. She was given 50... Read more
Patient complained of headache, metallic taste and numbness on the sides of tongue. She was given 50mg oral benadryl at 11:55am. No further intervention required. Discharged to home.
51 2021-03-12 mouth tingling Patient received vaccine and1 minute after patient had a warm flushing sensation that she described ... Read more
Patient received vaccine and1 minute after patient had a warm flushing sensation that she described as being similar to getting contrast. She stated that the back of her throat was warm and the tip of her tongue as well, she was remvoed from the cell and brought to the observation area, her blood pressure was 173/87, heart rate 109, pulse ox 98 in the L arm. She was observed and follow up at 0906 was 174/96, pulse 99 and pulse ox 100. She was observed for another minutes and at 0920 in the R arm her blood pressure was 152/ 85 and heart rate 101. She stated that the warm feeling was resolving and that her tongue still felt a little warm. She did have reddened arms as well in her bilateral arms, no other skin changes noted.
51 2021-03-13 taste disorder WITHIN 3 HOURS OF SHOT: LETHARGY, HEAVINESS IN MUSCLES, FUNNY TASTE IN MOUTH, NEXT MORNING (18 HOU... Read more
WITHIN 3 HOURS OF SHOT: LETHARGY, HEAVINESS IN MUSCLES, FUNNY TASTE IN MOUTH, NEXT MORNING (18 HOURS AFTERE SHOT) PAIN/SORENESS AT INJECTION SITE AND IN UPPER ARM, DIGESTIVE DISCOMFORT
51 2021-03-14 loss of smell Healthcare worker tested positive by PCR for Covid-19, >14 days post second covid vaccination. Her... Read more
Healthcare worker tested positive by PCR for Covid-19, >14 days post second covid vaccination. Her husband was positive for covid last week. Her symptoms are cough, headache, congestion and loss of smell.
51 2021-03-14 ear pain, ear discomfort Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 ... Read more
Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 hrs, leg cramps began maybe a couple of days later and still continue over a month later, high fever lasting 3 days
51 2021-03-14 hearing loss, ringing in ears, ear discomfort Within 24 hours ears felt stopped up but some sounds were roaring. Difficulty hearing others talk. ... Read more
Within 24 hours ears felt stopped up but some sounds were roaring. Difficulty hearing others talk. Still having problems but it is improving slowly. This happened after 1st vaccine and lasted for about a week. I just didn?t link it to the vaccine until the experience returned after the second dose.
51 2021-03-14 lip swelling 10-hours after vaccination, I experienced an inability to swallow, tingling sensation in face; lips... Read more
10-hours after vaccination, I experienced an inability to swallow, tingling sensation in face; lips began to feel swollen, chills. Took a Zyrtec and symptoms went away within an hour.
51 2021-03-14 ringing in ears I had tinnitus after the first dose on 2/20/2021 the same day under Lot #EL9267. It had reduced in i... Read more
I had tinnitus after the first dose on 2/20/2021 the same day under Lot #EL9267. It had reduced in intensity over the 3 weeks. Yesterday, after the 2nd dose, the tinnitus got stronger by the late afternoon again. There is no treatment.
51 2021-03-14 vision blurred HARD TO FOCUS VISION, IMPROVING AFTER 5-10 MINS, CHECKED I WITH PARAMEDICS . LEFT BY HERSELF AFTER ... Read more
HARD TO FOCUS VISION, IMPROVING AFTER 5-10 MINS, CHECKED I WITH PARAMEDICS . LEFT BY HERSELF AFTER RECOVERING.
51 2021-03-15 dry mouth Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5... Read more
Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5 -10 minutes resolved . Weakness within 20 minutes and dizziness later that night into next day . Itchy injection site at night .
51 2021-03-15 mouth tingling TINGLING ON THE TIP OF MY TONGUE!!! ITCHY SCALP AND SKIN LEGS AND ARMS STARTED ABOUT HOUR AND HAL... Read more
TINGLING ON THE TIP OF MY TONGUE!!! ITCHY SCALP AND SKIN LEGS AND ARMS STARTED ABOUT HOUR AND HALF AFTER SHOT DRANK WATER IT LASTED 15 TO 20 MINUTES. SOME DAYS STILL ITCHY AND TIRES ALSO EXTREME FATIGUE
51 2021-03-16 lip swelling, swollen tongue, double vision, mouth swelling 1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /mi... Read more
1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /migraines w/ double vision 1/11-1/16: thrush ,open fever blisters lips and mouth,+ swollen mouth, lips, tongue Treated at home w/ Tylenol q4,fluids, benadryal ,salt water mouth rinse. ice pack. Subsided 1/16/2021 . healthy prior to second vaccination
51 2021-03-16 ringing in ears 4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. ... Read more
4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. Ibuprofen and Benadryl 50mg taken. Symptoms resolved. 5 days later, tinnitus in right ear occurs and has been ongoing since then.
51 2021-03-16 ringing in ears Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6... Read more
Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6:30pm I began to feel extremely wired and like my body would jump through my skin. I tried to relax and started feeling sick at the stomach. I went to bed early. 3/12/21 at 6:15am I was awakened with heart racing extremely fast and migraine starting at base of back of head. I could not get my heart to slow down. My husband called 911. Paramedics came and my blood pressure was 163/116 and heart rate 85. 10 minutes later it was 157/84 and heart rate 64. (The day before vaccination my cardiologist recorded my blood pressure at 110/52 and it has always run low. ) I had no energy nor appetite and slept most of the day 3/12/21 through 3/12/14. Still feeling extremely fatigue and ears ringing and can hear heart beating in ears.
51 2021-03-17 lip swelling Patient received her vaccine and had no symptoms in 30 min. post vaccination on 1/29/21. By that aft... Read more
Patient received her vaccine and had no symptoms in 30 min. post vaccination on 1/29/21. By that afternoon, she had generalized hives, malaise, and started wheezing. She developed additional symptoms of lip swelling, edema, lightheaded, dyspnea. She had medical contacts with telemedicine, 2 office visits here with her PCP and a couple phone follow ups with her PCP. She was treated with benadryl, a 10 day prednisone course and a ventolin inhaler. Her symptoms resolved after a week.
51 2021-03-18 swollen tongue, mouth swelling Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 mi... Read more
Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 minutes after vaccination. Received Benadryl, then treated with treated with epinephrine or EpiPen. Transported by EMS to hospital where she received IV famotidine and methylprednisolone sodium succinate.
51 2021-03-18 ringing in ears, deafness Immediate pain right side of neck and hearing loss than ringing in both ears
51 2021-03-18 tunnel vision, mouth numbness Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly eleva... Read more
Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly elevated blood pressure. Tunnel vision. Shaking. 30 minutes after receiving second vaccine for Covid.
51 2021-03-19 taste impairment Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since ... Read more
Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since day 1; brain fog since day 3; PMS like symptoms (cramps, achy feet) only on day 3; itchiness around injection site since day 1; redness and inflammation around injection site (moderate redness, size of adult woman's thumb from day 1 to day 3; increased about 25% in size on day 4 and had returned to previous size with a less red color). Has taken Tylenol when pain was present, removed headache pain on days 1-3 but not on day 4. Used cold compress on day 3 to reduce swelling but did not affect redness/swelling. Has not slept on injection site arm.
51 2021-03-19 eye pain Within 15 min. Headache, eyes hurt (pressure) nose became stuffy, felt like I had a sudden sinus inf... Read more
Within 15 min. Headache, eyes hurt (pressure) nose became stuffy, felt like I had a sudden sinus infection. I became shaky and tingly. My arm was sore and felt heavy. My face became dark red and was hot to the touch. All symptoms still continue now (27 hours later) however my face is not as dark red, just pink. About 10 hours after the vaccine my muscles in my neck and shoulders began to ache. I was very fatigued. My entire body felt week and movement become a chore. Worst symptoms: Through the night I began to experience acid reflux. I have only experienced this a couple of times in my life and very mild. This was severe to the point that I couldn't sleep, my throat burned from the acid. Even drinking water was very painful and it would come back up. I located some Tums and ate 4. This was also a challenge as I couldn't hardly swallow due to the pain. After about 35 min. I began burping which help a little with the ability to keep some water down. Today I feel exhausted, my eyes still hurt, still have the headache and sinus pressure, and continue to have the acid reflux but not as severe as the night and early morning. I haven't tried to eat yet today.
51 2021-03-20 taste disorder, ringing in ears Sudden ringing ears with intense headache and dizziness. Sudden strange taste in mouth with difficul... Read more
Sudden ringing ears with intense headache and dizziness. Sudden strange taste in mouth with difficulty swallowing. Disorientation. Close to passing out. About 3 hours after vaccine I was intensely nauseous.
51 2021-03-20 ringing in ears constant ringing in ears
51 2021-03-21 swollen tongue Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ ap... Read more
Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ approx 11:00am. She was escorted to triage area where she begin to c/o increased itching and tongue swelling. Epi pen and Benadryl was administered. Patient then begin to c/o difficulty swallowing and breathing. She remained alert and oriented to self, time, place and situation. She was taken to Regional per EMT's.
51 2021-03-22 taste impairment No treatment needed. Patient stated she has a metal taste in her mouth. 1310.
51 2021-03-22 lip swelling, swollen tongue, mouth tingling, mouth numbness Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a ... Read more
Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a half hour my lips tongue and throat were swollen. After an hour neck glands were sore and there were a few hives around injection site. Then I took Benadryl and the reaction didn't get any worse but continues into the next day. I have been taking Benadryl every 4 hours.
51 2021-03-22 lip swelling throat scratchy and lips swelled at 2 hours after shot
51 2021-03-22 taste disorder Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, clo... Read more
Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, closing throat, itching and hives, heart palpitations and taste of vaccine after injection and nausea.
51 2021-03-23 taste impairment Metallic taste after shot. Pins/Needles on left side of face - continually near eye, every few hours... Read more
Metallic taste after shot. Pins/Needles on left side of face - continually near eye, every few hours rest of face.
51 2021-03-23 thirst, tongue disorder, dry mouth I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger ... Read more
I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger or heavier) and my mouth was dry. I thought maybe I was just thirsty. Shortly after that, I felt a pressure toward the bottom of my neck, like someone was pushing their thumb on my lower neck. Then, I felt pressure going down my chest. I told the monitor, and she brought the nurses over. The nurses took me to a different location for monitoring. I took some benadryl at about 12:45 pm. At 12:55pm, my throat began to close up, and when I breathed in, it was like a tiny straw was in my throat. The nurses gave me an epinephrine shot and called the ambulance. This event happened on 3/20/2021. On 3/21, I was physically and emotionally drained. I still had a slight pressure going down my chest. On 3/22, I went to work and developed a headache and was nauseous and my stomach was cramping by 10am. I went to the allergist at 3pm. She told me to take non-PEG liquid benadryl and Pepcid AC. On 3/24/2021, I still feel like I have some tightness in my chest (very minimal but still present) and a headache and am continuing to take liquid Benadryl.
51 2021-03-24 mouth tingling, oropharyngeal discomfort Tingling tongue, fullness in back of throat, difficulty swallowing, rapid heart rate
51 2021-03-24 mouth tingling Difficulty breathing - asthma attack was induced 45 minutes later after injection and had to use res... Read more
Difficulty breathing - asthma attack was induced 45 minutes later after injection and had to use rescue inhaler 2X; Tingling sensation of tongue w/i 10 min of injection; Lips felt puffy w/i 10 min of injection; Increased heartbeat - RN measured it at 95 BPM after injection w/i 10 min of injection - normally it is at 66 BPM resting; Bad rash on left arm around injection site after returned home 1 hour later - took orally one Benadryl tablet 25mg Dizziness w/i 15 min of injection - had to lay down at hospital; Felt sick to stomach w/i 15 min of injection - had to lay down at hospital
51 2021-03-24 swollen tongue Approximately 5 minutes post injection, patient reported feeling flush, overheated, and promptly vom... Read more
Approximately 5 minutes post injection, patient reported feeling flush, overheated, and promptly vomited. Patient was observed for s/sx of anaphylaxis. Patient was given 25mg diphenhydramine, temperature checked (temp had elevated ~2 degrees from time of injection), pulse and breathing function. Pt was visibly flushed in the face. Patient was given a cool rag as well. Patient was A&Ox3. Pt did not report any immediate issues of breathing issues, cardiac abnormalities, etc. Injection site was unremarkable. Pt reported feeling a bit better after the medication. About 7 minutes later, patient began to complain of scratchy throat and minor difficulty breathing. Patient does have a history of atopic reactions and has noted this sensation in the past when experiencing allergic reactions. Observed patient tongue and mild signs of angioedema were noted. Patient given second dose of diphenhydramine and water. Epipen was on site. Patient was observed and monitored for 25 minutes further. After approx. 5 more minutes, patient reported feeling better and looked visibly less flushed and the swelling of the tongue had diminished. Approx 5-10 min later patient was walking around, talking normally, and showed no signs of distress or reaction.
51 2021-03-25 taste impairment As soon as shot was given warm sensation throughout body and metal taste in mouth. Felt dizzy for a ... Read more
As soon as shot was given warm sensation throughout body and metal taste in mouth. Felt dizzy for a minute as well
51 2021-03-25 mouth numbness, mouth tingling Pt experienced immediate numbness and tingling in her mouth, No LOC or local site reaction notes.
51 2021-03-25 mouth itchiness I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back ... Read more
I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back of my throat felt numb and had a significant headache. I could not sit up straight due to dizziness. By 11:30 it was hard to talk, my throat felt thick, tight, and like it was getting small. It was difficult to swallow. I was too dizzy to stand up. I would tip over when I stood up. The hospital was called and advised my family to closely observe my symptoms. At 11:20 the pharmacist gave me liquid Benadryl. At 11:30 I took hydroxyzine, prescribed after an adverse reaction to my first covid vaccine and Tylenol. At 12:30 my throat felt less enflamed but sore and scratchy. At this time my whole head was itchy and the headache was not reduced. I had a difficult time walking due to the dizziness.
51 2021-03-25 oropharyngeal discomfort At 1405, patient began c/o headache with a 9/10 pain level. Patient had been waiting approximately ... Read more
At 1405, patient began c/o headache with a 9/10 pain level. Patient had been waiting approximately 30 minutes post-vaccination due to previous reaction to flu vaccine. Vital signs were taken by MSN RN and EMT at 1405 with BP of 179/98, HR 72 and O2 Sat of 95%. Patient also stated that "her throat felt like something was stuck in it like indigestion". Patient also states that she took 1000 mg of Tylenol at 1200 with food prior to vaccination. At approximately 1430, a second set of vital signs were taken with BP 179/89, HR 73, and O2 sat of 95%. Patient was offered and accepted ambulance for further evaluation. Due to increased BP and HA, patient was then transported to Regional Hospital for further evaluation.
51 2021-03-25 mouth tingling, mouth numbness, lip swelling tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from sh... Read more
tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from shoulders down to fingertips that happened simultaneously (one occurence), slight swelling and tingling sensation of lips.
51 2021-03-25 taste disorder body aches, taste of the medicine in my mouth, felt the shot move through my chest and tired from sh... Read more
body aches, taste of the medicine in my mouth, felt the shot move through my chest and tired from shot for over 5days
51 2021-03-26 ringing in ears High pitch - medium intensity constant ringing on both ears
51 2021-03-27 inability to speak Exactly two hours after vaccination, I started to lose my voice and then within 15 minutes of that m... Read more
Exactly two hours after vaccination, I started to lose my voice and then within 15 minutes of that my throat started to tighten/swell. I took another Allegra and the swelling stopped and subsided within an hour. I still am suffering from loss of voice.
51 2021-03-28 inability to speak autoimmune was exacerbated; shortness of breath; chest tightening; Lose of voice/Loss of voice; Fati... Read more
autoimmune was exacerbated; shortness of breath; chest tightening; Lose of voice/Loss of voice; Fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EN6199) injected intramuscularly in left shoulder (left arm) on 09Mar2021 13:30 at age of 51 years old at single dose for COVID-19 immunisation. Medical history included hypertension (HTN), Ehlers-Danlos syndrome (EDS), neurosarcoidosis (diagnosied 1997 with remission since 2002), high cholesterol, depression, gastrooesophageal reflux disease (GERD), osteoarthritis. Allergies to penicillin (no specific manufacturer, lot or expiration) in 1990. Obesity through all her life. No relevant test. Diagnosed allergies, compromised immune status, respiratory illness. There was no family medical history. Patient was not pregnant. There were no additional vaccines administered on same date of the Pfizer Suspect. There were other medications in two weeks. There was not covid prior vaccination. There was no other vaccine in four weeks prior vaccinations. The adverse event patient experienced: lose of voice with shortness of breath with communication and chest tightening, fatigue. This similar to her neurosarcoidosis diagnosied 1997 with remission since 2002. The events started on 10Mar2021 11:30 AM. Received call from consumer regarding the Pfizer COVID vaccine 1st dose. She was losing her voice. She was a pediatric Occupational Therapist. She was eligible on Tuesday for the first dose and went and got it. Her main concern was the symptoms she was having was the same thing that comes out when her autoimmune was exacerbated. She would like to know if it was safe to get next dose. When providing her weight, she said she was not a small girl. There was no prescriber. She was waiting to see if it would disappear before calling Pfizer to report it and it did not. It started yesterday about 24 hours after the vaccine. She received it for prevention and for the population she works with. A lot of her kids she worked with were autoimmune compromised. The majority of her medications she had been on for over two years, so she did not feel they were relevant. No further details provided. No Emergency Room (ER) or physician's office required. She called her physicians' office and they suggested she contact Pfizer. Patient received covid tested post vaccination: nasal Swab/Antigen on 09Feb2021: negative. Outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-03-28 dry throat Customer came into the pharmacy at around 4:30on 03/29/2021 stating that when she went home this mor... Read more
Customer came into the pharmacy at around 4:30on 03/29/2021 stating that when she went home this morning after her shot that her throat was dry. Her breathing was fine, but she had redness around her neck and chest area when she was here at 4:30pm and her breathing was still fine. She went to her provider's office around 4:00pm before coming to the pharmacy and her provider was gone , but the personnel that was left told her to come back in the morning or to seek medical attention if her symptoms got any worse. I instructed her to take some benadryl, but she said that she could not take it. We told her that we could call EMS for her, but she refused saying that she was fine and would take the advice of her
51 2021-03-28 hearing loss, deafness unilateral, ringing in ears lost hearing of the right ear; ear infection; sinus infection; couple of hours later she started hea... Read more
lost hearing of the right ear; ear infection; sinus infection; couple of hours later she started hearing like a buzzing sound, hollow sound; she couldn't hear very well; This is a spontaneous report from a contactable consumer. This consumer reported for a 51-year-old female patient (Reporter's sister-in-law) that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL3247;solution for injection), dose 1 via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Patient's age was 52 years old at the time of vaccination with weight 76.644 kg, height; 154.94 cm. Patient's medical history included diabetes. Patient's concomitant medications included Metformin at 1000 mg for diabetes, Lisinopril at 10 mg for blood pressure, Insulin at 100 units, Atorvastatin at 40 mg (therapy dates unspecified). Reporter stated, "This is regarding my sister-in-law, it's in regards to, I had called few weeks ago and they had told me to call back I need to know who do I speak to as I need to send some paper work. She had a reaction to the Covid injection and I have all the paper work here. They told me that we needed to send also that they are going to try and see how she can get compensated back because she had to go to the hospital, she had to go to the urgent care twice, she had to see specialist and things like that." Reporter stated, "On 29Jan2021 (Later corrected), she got it done at work and couple of hours later she started hearing like a buzzing sound, she end up she couldn't hear very well and then the next day she (word incomprehensible) out of her right ear. It's been like the longest time. Pfizer EL3247." Treatment: Reporter stated, "Well she went to the urgent care twice although she had, one doctor said she had sinus infection the other doctor said she had ear infection. So, she went to a specialist ENT and he said she had none of those infections. He did put her on Prednisone because she lost hearing of the right ear so, he gave her 10 mg of Prednisone, gave 6 tablets 5, 4, 3 like that." She did not take the 2nd vaccine. She had loss of hearing, a buzzing sound, hollow sound, still has loss of hearing in right ear. Reporter was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as 8 am to 8 pm Monday to Sunday as per (EST). Investigation assessment; no. The outcome of events was not recovered for lost hearing of the right ear and for other events were unknown.
51 2021-03-28 mouth numbness Left outside of tongue became slightly numb. Numbness continued to left side of mouth on left lips ... Read more
Left outside of tongue became slightly numb. Numbness continued to left side of mouth on left lips side. Felt like the wearing off of a novicane shot.
51 2021-03-29 eye swelling, lip swelling The day after I received my second dose of Pfizer, I woke up with a swollen face that lasted for 2 d... Read more
The day after I received my second dose of Pfizer, I woke up with a swollen face that lasted for 2 days. My eyes, nose, cheek and lips were swollen. I also had, body aches, chill and a headache. I took Motrin, slept most of the day. The following day/day 2 most of the swelling was gone and my flu symptoms were gone. By day three all of the swelling was gone. I did not go to the doctor.
51 2021-03-29 bloodshot eyes, eye irritation Extremely lethargic in early evening and for 3 days. Headache 3/14, 3/15, 3/16. Nausea 3/15, 3/16, 3... Read more
Extremely lethargic in early evening and for 3 days. Headache 3/14, 3/15, 3/16. Nausea 3/15, 3/16, 3/17. Eyes irritated, red and mild burning 3/17 to present. Wheezing 3/14 to present. Mild cough 3/16 to present. Mild rash on torso from waist to face 3/20 to present.
51 2021-03-29 mouth tingling Patient experiencing tingling lips, lump in throat, and left arm numbness. Reports worsening over w... Read more
Patient experiencing tingling lips, lump in throat, and left arm numbness. Reports worsening over wait period. Provider notified. Escorted to ER.
51 2021-03-30 oropharyngeal discomfort, ear pain Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with... Read more
Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Small hives on bottoms of feet and on hands; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received the first dose of bnt162b2 (formulation: solution for injection), via an unspecified route of administration in right arm on 30Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient's medical history included psoriasis, psoriatic arthritis and lupus, and was allergic to Benzodiazepines. Concomitant medication included guselkumab (TREMFYA). The patient was not pregnant at the time of vaccination. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 03Feb2021, the patient experienced very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding earache and rough throat. Swell occurred 5 days post injection and remained for several days. The patient also experienced small hives on bottoms of feet and on hands (the patient had psoriatic arthritis and lupus, so it was not unexpected). The patient was nervous, so underwent a COVID test on the sixth day (negative). The patient underwent lab tests and procedures on 05Feb2021 which include Qualitative PCR: negative and nasal swab: negative. 11 days out and the patient still have some lymph node swelling, but its nearly gone. The patient did not received treatment for the adverse event. The outcome of the events was recovering. Information on the lot/batch number has been requested.
51 2021-03-30 ringing in ears 2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump o... Read more
2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump on my jaw I looked in the mirror and my left side of my neck was flame red then it spread to the front of my neck then it spread to the right side. It started moving down to my chest. The rash started getting raised hives that looked like they were turning into blisters.. It was horribly itchy but the worst part is it felt like I had been scorched. Luckily I had antihistamines here on hand that eventually thank God turned it around. The next day on Monday I was in almost a comatose sleep like anesthesia I didn't know what day it was. Then on Tuesday my right side of my face went numb and felt like it was drawing down. My speech was slurry I was drooling out of my right side and I was having glitches with my memory. Today I'm still having speech difficulties gait problems and I'm hearing roaring in my ears. This is so terrifying.
51 2021-03-30 toothache, taste impairment Almost immediate onset of neck pain and numbness tingling in hand on the same side of injection. Ab... Read more
Almost immediate onset of neck pain and numbness tingling in hand on the same side of injection. About 30 minutes later face became numb on same side as injection including metallic taste in mouth and sore teeth. Feels like numbing from dentist office. It?s now 4 1/2 hours post injection and numb feeling in face and tingling hand exist.
51 2021-03-31 ear pain High fever lasting hours and not responding to Acetaminophen (102F) Chills Headache Fatigue Lower Ba... Read more
High fever lasting hours and not responding to Acetaminophen (102F) Chills Headache Fatigue Lower Back Pain Periodic severe pain in left ear
51 2021-03-31 eye swelling, lip swelling, tongue discomfort, mouth discomfort swelling of throat feeling, throbbing lips, tongue, gums, and mucus membranes of the nose. I took a ... Read more
swelling of throat feeling, throbbing lips, tongue, gums, and mucus membranes of the nose. I took a dose of Benadryl when it started (about 40 minutes after getting the vaccine) and I took another dose of Benadryl before going to bed that night. I had slightly swollen eyes and lips the next morning, and it subsided thereafter. Question: Can I get the second vaccine? Is there any special protocol I should follow?
51 2021-03-31 hearing loss, eye disorder, eye irritation hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and g... Read more
hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot; Left side of mouth muscle not holding water while brushing teeth; Cannot close left eye/eye wasn't moving; Left eye burning during shower; sick; cannot move that part of your mouth; Sore Arm over Weekend; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Mar2021 08:15 (Lot Number: EN6204) at single dose for covid-19 immunization. Medical history was none. Concomitant medication included diphenhydramine hydrochloride (BENADRYL Tablet). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200) on 19Feb2021 and experienced felt really tired, and received flu shot. The patient experienced bell's palsy on 18Mar2021, sore arm over weekend on an unspecified date in 2021, Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot on 18Mar2021, left side of mouth muscle not holding water while brushing teeth on 18Mar2021, cannot close left eye/eye wasn't moving on 18Mar2021, left eye burning during shower on 18Mar2021, sick in 2021, cannot move that part of your mouth in 2021, hard of hearing on an unspecified date. She felt great over the weekend other than a sore arm. Morning on 18Mar2021 when she woke up her left eye felt weird. When brushing her teeth she noticed the left side of her mouth muscle was not holding water to spit out. Looked in the mirror and noticed when she smiled her left eye wasn't moving. Went to the emergency room and the doctor told her she has Bell's Palsy. Explained that was why she cannot close her left eye. Was given two medications to take; one a steroid and one a antiviral. Left eye has been feeling weird, like when you look away from your cell phone and one eye hasn't dilated or adjusted to the darkness yet. Stated she took a sick day from work today. Mentioned again her left eye burning in the shower and that she has to sleep with an eye patch. She was hard of hearing. Stated she had hearing aids and can currently hear call handler fine. Had a CAT scan and everything at the emergency room this morning. Her grandmother and aunt died from a stroke and she was concerned that she had one. She cannot close her left eye completely. Stated was a weird feeling like when went to the dentist and get the Novocain shot and cannot move that part of your mouth. The doctor told her he thought it will last for 2 weeks. Stated that it could've started overnight but she was uncertain as she was sleeping and didn't notice it until this morning. Mentioned her husband was at the hospital all day yesterday for procedures. After receiving her second dose of the vaccine she thought she didn't feel to bad at all, not tired like with the first one; until she woke up with this today. Stated no for medications but mentions that on 11Mar2021 she had bad allergies and was like a water faucet. She took Children's Benadryl 12.5mg 2 tablets and some eye drops. Stated that it helped. Thought she was allergic to something in the building. Stated was given Prednisone, as she was reading the label she notices she was supposed to take two a day and had only taken 1 this morning. Prednisone is prescribed as 20mg 2 tablets by mouth every day for 7 days. Spelt out name of antiviral medication as IC Valacyclov. Prescribed as 500mg 2 tablets by mouth three times a day. Also has eye drops to keep eye moist. Has eye patch for bedtime. Was instructed to manually close left eye and cover with eye patch at night. Mentioned that she had a flu shot in October no issues voiced. Nephew with Covid, Niece that had Covid. Stated she was not around them. There was no physician office visit reported. The patient underwent lab tests and procedures which included blood sugar: normal, blood pressure: normal, CAT scan: normal on 18Mar2021. There was treatment and emergency room visit except event hard of hearing. The outcome of the events was unknown.
51 2021-03-31 eye floaters Slight headache overnight after 1st dose on 3/8. Adverse reaction after 2nd dose on 3/29 at 3:30 ... Read more
Slight headache overnight after 1st dose on 3/8. Adverse reaction after 2nd dose on 3/29 at 3:30 that afternoon. I started seeing ?floaters? in my right eye only. Floating dark strings, dots, squiggles in my peripheral vision. Took my blood pressure and it was elevated at 168/93. I immediately took an additional 25 mg of losartin and called my eye doctor and was told to come in the next morning for an eye exam. My blood pressure lowered to normal over the next few hours. I felt tired and restless overnight. The next evening 3/30 after my eye dr appt, I developed a very severe headache, first in the front area of my head, then finally on the left side of my head. Overnight the pain in the left side of my head increases and I experienced nausea, body aches and fatigue. The floaters in my right eye remained the same. No floaters or problems with my right eye.
51 2021-04-01 loss of smell Strong headache, fever, coughing, loss of smell
51 2021-04-01 swollen tongue Immediate whole body sensation. Dissasociative feeling at leaving injection booth. Tachycardia start... Read more
Immediate whole body sensation. Dissasociative feeling at leaving injection booth. Tachycardia started immediately when sitting in observation room. Observer noted rash and flushing on chest and face. Medics called. Blood pressure 182/108, heart rate 152, o2 sat 100. Taken to triage area. Had a hard time responding to questions because tongue felt thick. Airway was clear despite edema. I was taken by ambulance to to Medical Center. The paramedics wanted to administer Epi but I was hesitant since I was still able to breathe and I didn?t want to further increase blood pressure. I have a narrative to paste but the Continuation Page is not letting me input text. Please email me.
51 2021-04-01 toothache Headaches, my teeth ached, stomach upset, soreness at injection site, my skin hurt.
51 2021-04-02 double vision, lip swelling, swelling of eyelid 1. Mild allergic response: lip and eyelid swelling, itchy throat, scratchy/itchy feeling 2. 1.5 inch... Read more
1. Mild allergic response: lip and eyelid swelling, itchy throat, scratchy/itchy feeling 2. 1.5 inch diameter bruise at injection site 3. Mild arm pain 4. Intermittent fever?99.1, 99.6, 100.1, 102.1, 99.3 5 Two days after horrible headache with halos and occasional double vision 6. Brain fog and tiredness
51 2021-04-02 ear pain High fever for 18 hours 103 degrees, severe headache, earache, backache, legs felt strange, had hall... Read more
High fever for 18 hours 103 degrees, severe headache, earache, backache, legs felt strange, had hallucinations, nausea, still have pain in injection site and surrounding area after 48 hours.
51 2021-04-02 eye disorder Constant headache since 4 hrs after shot. Had rainbow colors appear for an hour in my eyes evening o... Read more
Constant headache since 4 hrs after shot. Had rainbow colors appear for an hour in my eyes evening of april 2nd. Blood pressure at drs was very low. Dizzy weak feeling. Body aches on April 2nd. Headache as of april 3rd has still not went away.
51 2021-04-02 lip itchiness Per EMS, nearly immediate redness and itching to chest and arms. 25 mg oral Benadryl given, patient ... Read more
Per EMS, nearly immediate redness and itching to chest and arms. 25 mg oral Benadryl given, patient monitored, reported lip itching and throat swelling. 0.3 mg Epi given IM by EMS. She attempted to recover in the parking lot but decided to accept transportation. She was transported to Medical Center. On her first vaccine dose she did not indicate she had any allergic reactions to vaccine. She stated she had "hives" with the first dose of Pfizer but did not report this.
51 2021-04-02 mouth tingling, ear discomfort, mouth numbness, lip itchiness, tongue itchiness Within minutes of receiving vaccination, my tongue began to mildly tingle and itch. Then my lips we... Read more
Within minutes of receiving vaccination, my tongue began to mildly tingle and itch. Then my lips were mildly numb and itchy. The back of my throat had a mild itch. My ears became very red. My tongue 23 hours later still feels mildly sensitive on top.
51 2021-04-03 vision blurred Memory loss, memory issues; Blurred vision; Severe headache down to her neck; still little bit stumb... Read more
Memory loss, memory issues; Blurred vision; Severe headache down to her neck; still little bit stumbling/stumbling like couldnot keep her balance like tripping; Hard to get her words out; very lost and confused; very lost and confused; cognitive issues; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 20Jan2021 (at the age of 51-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "she guess this was the number her doctor told her she needed to call to report side effects from vaccine. She got it on 20Jan2021, first Pfizer vaccine and then two weeks later, she started experiencing memory loss, memory issues, blurred vision and severe headache down to her neck, hard to get her words out, very lost and confused, stumbling like couldnot keep her balance like tripping/ still little bit stumbling, that was after her first vaccine and they sent her to the emergency room, she got an MRI and 'CAT' (not clarified) scan to see as she was having symptoms."Consumer further stated, " she have more information, two weeks after the first dose was when the cognitive issues started and then, a week to the day later, she started feeling herself again maybe 90 percent. Then this afternoon, she got the second vaccine dose and next day she was feeling okay and day and a half later, it all started all over again, headache, back of the head pain, memory loss, blurred vision, all started again. She got an MRI this time and the other day, since then she have severe headache all day, every day, pain down my neck and still little bit stumbling. She went to her neurologist and he said all of her symptoms were symptoms that someone would have with the concussion but she never felt like, she don't have a concussion (hence, concussion not captured as event as consumer was not sure). So, she wanted her to call this number as she said that she believed that memory cognitive issues were all from the vaccine and she guess it was needed to be reported."Outcome of the events were unknow.
51 2021-04-04 taste impairment, loss of taste Complete loss of taste and a permanent metal taste in my mouth
51 2021-04-04 feeling of choking, dry throat 8:45-Vaccinated 9:20- C/O lightheadedness, tingling-throat/dry throat, facial swelling Vital signs w... Read more
8:45-Vaccinated 9:20- C/O lightheadedness, tingling-throat/dry throat, facial swelling Vital signs within normal, O2 sat 98-99 Symptoms improved after given water and observed in recumbent position. 9:50 discharged home.
51 2021-04-04 ringing in ears, ear pain General body aching first day of second dose, then after one week, severe headache and left ear pain... Read more
General body aching first day of second dose, then after one week, severe headache and left ear pain that radiated to left side of the neck and it lasted for 2 weeks. Pain was in tolerable with pain meds( Duexis, Gabapentin) for a week, then intermittent pain with or without pain medications. Primary Dr. prescribed Omnicef for a week, but no ear infection . Then ENT Dr. prescribed another week of antibiotics (Levaquin) and one week of antiviral (Aclovior). Also had ringing of ears. Still have mild - mod pain to the same site and irritation to the left ear. There was no definite diagnosis.
51 2021-04-04 ringing in ears Ringing in my ears, especially my left ear. I had no ringing after my first dose, only after my seco... Read more
Ringing in my ears, especially my left ear. I had no ringing after my first dose, only after my second.
51 2021-04-04 ringing in ears Ringing in ears
51 2021-04-05 loss of taste, loss of smell From Monday night to Friday - Headache, fever, chills, congestion, and fatigue On Monday night only ... Read more
From Monday night to Friday - Headache, fever, chills, congestion, and fatigue On Monday night only - sore throat On Tuesday only - loss of smell and taste Ongoing - Congestion
51 2021-04-05 deafness, taste impairment 2nd dose symptoms: dragging/low energy, chills, upset stomach, onset of sudden constipation, stomach... Read more
2nd dose symptoms: dragging/low energy, chills, upset stomach, onset of sudden constipation, stomach swelling, runny nose, constant taste of a chemical, uncomfortable/not a pain in throat, and sore arm. About 4:00 PM, I felt pains in my chest and I could not hear. My ears felt very hot and then became so dizzy I fell to the ground.
51 2021-04-05 swollen tongue, mouth tingling Tingling lips - with in 5 min Tingling Tongue - with in 5 min Tongue swelling - with in 10-13 min It... Read more
Tingling lips - with in 5 min Tingling Tongue - with in 5 min Tongue swelling - with in 10-13 min Itching - with in 15 min Trouble breathing - with 30 min - EPI administer Headache - with in 7 min Benadryl - 2 pills given before EPI to help but did nothing In ambulance IV Started Hospital IV bag of fluids put on board, Duliad for headache & Zofran.
51 2021-04-05 ringing in ears 6 days after vaccine starting having headache, fever, fatigue, ringing in ears, nausea, rash, and jo... Read more
6 days after vaccine starting having headache, fever, fatigue, ringing in ears, nausea, rash, and joint swelling with pain. Found out that there was exposure to positive person two days after vaccine, March 27th, so was tested at one week after vaccine and was positive. Given prednisone for rash 5 days into course of illness.
51 2021-04-06 mouth tingling 4/2/2021 11pm left hand red swollen 4/3/2021. Extreme fatigue slept 18 hours very exhausted all day ... Read more
4/2/2021 11pm left hand red swollen 4/3/2021. Extreme fatigue slept 18 hours very exhausted all day and night, woke up with face tingling from top of scalp to top of lips across entire area left to right . 4/5/2021. Chills and diarrhea, still fatigued and facial tingling continues 4/6/2021 tingly face continues 4/7/2021 tingly face continues
51 2021-04-06 mouth tingling Initially felt dizzy (3:15pm). Had patient sit down. Lips started tingling. Had patient lay supine... Read more
Initially felt dizzy (3:15pm). Had patient sit down. Lips started tingling. Had patient lay supine with feet elevated (3:30). Patient started having trouble breathing and could not move her lips and face became flush (3:45), called 9-1-1.
51 2021-04-06 mouth tingling Within a few minutes I became extremely dizzy and disoriented a bit, immediately following I had ext... Read more
Within a few minutes I became extremely dizzy and disoriented a bit, immediately following I had extreme difficulty swallowing as if I had a ball in my throat. Nurses recognized and immediately gave me Benadryl. Today I feel a lot of pressure in my head, fatigue, tingling in lips and right hand.
51 2021-04-06 ringing in ears Tinnitus, ringing in ears since second vaccination, possibly since the first.
51 2021-04-06 visual impairment Hot flashes, began within 10min of injection?resolved after 2hours Dizziness, began within 40min of ... Read more
Hot flashes, began within 10min of injection?resolved after 2hours Dizziness, began within 40min of injection?resolved after 3hours Hallucinations, began approx 45min post injection?resolved after 3hours Wild mood swings, laughing then crying, began approx 45min post injection?resolved after 2hours Vision improved, began approximately 12hours post injection?continues, previously -4.25 now approx -2
51 2021-04-07 swollen lips, lip swelling swelling of lips irritation of skin around lips cracking of skin at corners of lips
51 2021-04-07 eye pain Headache. Began with pains at my temple near my eyes, night of the vaccination. Had a headache that ... Read more
Headache. Began with pains at my temple near my eyes, night of the vaccination. Had a headache that night, overnight. Have had a combination of sporadic pains near my temples, and a headache that feels like a band around my head, particularly around both temples. Mostly okay upon waking, pains start after a couple of hours, then actual headache is present from about 1-2 p.m. until I go to sleep. This description applies to second vaccine, administered 3/25/21. For the first vaccine, administered 3/4/21, I had pains by my temples that early evening, then a headache that night until bedtime. I think that headache only lasted one day. I had fatigue for a day following each dose.
51 2021-04-07 lip swelling swelling of lips, irritation of skin around lips, cracking of skin at corners of lips
51 2021-04-07 ringing in ears Ringing in the ears on and off. Getting worse and more constant.
51 2021-04-08 taste impairment Pt reports that she started feeling fussy in the head and her left arm started tingling. Pt also re... Read more
Pt reports that she started feeling fussy in the head and her left arm started tingling. Pt also reported an odd taste in her mouth. Pt reports that she has had a busy morning seeing her chiropractor and having a massage and has not drank any water for hours. Pt was given water to drink and symptoms resolved.
51 2021-04-08 eye pain, eye strain I had eye strain all day April 8, 2021 - the day after I received my first dose of the Pfizer COVID-... Read more
I had eye strain all day April 8, 2021 - the day after I received my first dose of the Pfizer COVID-19 vaccine. My vision wasn't blurry, but my eyes definitely had to work harder to focus and by the end of the day were sore and tired. I'm filing this report on April 9th and the eye strain seems to have diminished considerably. It is almost 5pm and I'm noticing now that my eyes are a bit tired and very slightly sore.
51 2021-04-08 swelling around the eyes I got the shot on Satruday and then that evening, my arm was sore as expected. I had a little someth... Read more
I got the shot on Satruday and then that evening, my arm was sore as expected. I had a little something under my eye. Looked like a little bite. On Sunday, on my face I had what looked like sunburn under each of my eyes and on the side of both of my face. It felt tingly. The redness was there day into Sunday night. I took some Benedryl. On Monday, the red was gone but my eyes were puffy and had some swelling to my face and still had tinglng in my face. I called my PCP and she asked that I come in and see her. On Monday, I had a visit with my PCP, there was stil some swelling around my eyes. She was going to report it and would let me know if I could take DOSE 2. I was advised to not take DOSE 2. It was all better by Wednesday.
51 2021-04-08 swollen tongue 51 year old female patient, with a history of migraines and eczema, presents to ED with complaints o... Read more
51 year old female patient, with a history of migraines and eczema, presents to ED with complaints of an allergic reaction. Approximately ten minutes after receiving her first Pfizer COVID-19 vaccination dose at the Vaccination Clinic (around 4:20 PM), patient developed swelling to her tongue, mild hoarseness of her voice, and very mild shortness of breath. Patient was not given any medications while in the vaccination clinic and was brought into the ED immediately. She only has one known medication allergy to Percocet. Patient has no other associated symptoms including cough, wheezing, chest pain, nausea, vomiting, diarrhea, or rash. She has no other pertinent past medical history. There are no other medical complaints at this time.
51 2021-04-08 thirst Got shot in right arm. Sat in waiting area and within 5 - 7 min felt sick and faint. Dropped to the ... Read more
Got shot in right arm. Sat in waiting area and within 5 - 7 min felt sick and faint. Dropped to the floor and I could not move. I heard people wanting to sit me up to get me in a chair but I could not move on my own. They lifted me and then I went out completely. I remember dreaming and then within seconds, that is what I was told, I could hear them. I then was taken to an area that they checked my pulse, BP, and sugar. Blood pressure, I believe was around 92. I usually run around 120 but can run lower. They called an ambulance because I was unresponsive for a bit while on the floor. I was given IV fluids because of concern with BP. I was aware the rest of the time. I felt nauseous, shaky, cold, thirsty, and very weak. I went to the hospital and they did a CBC and differential as well as a chest xray. All were very good. They also did an EKG which was ok. I started to feel better and the doctor said I could drink and since I felt hungry and had a small protein bar. I was discharged around 12:15p. I continued to feel very weak, some nausea, some diarrhea and a slight headache. I woke in the morning very dizzy and off balance with a sore arm, a little nausea and weak. On 4/8/21 I woke up feeling very weak in my limbs. Headache, sore arm and nausea were gone. By the end of the day the weakness was a bit improved. By 4/9/21 the weakness in my limbs was much better. Still get a little dizzy if I bend over.
51 2021-04-10 taste impairment Immediately after the shot (within 8 minutes) I had a metallic taste in my mouth, followed by a numb... Read more
Immediately after the shot (within 8 minutes) I had a metallic taste in my mouth, followed by a numbness and tingling spreading from my face to my neck and ears. My whole left arm hurt and left side of my body is weak. Two hours later, I have chills, body pains, exhausted, and have a horrible headache. I have taken ibuprofen and Tylenol.
51 2021-04-10 mouth numbness Tingling and numbness from the bottom of my neck to the top of my head on the left side and the top ... Read more
Tingling and numbness from the bottom of my neck to the top of my head on the left side and the top 1/4 of my head on the right side. Numbness in my mouth and on the top of my tongue, but it did not affect my breathing or ability to speak. Swelling and tightness of my left cheek. The numbness/tingling lasted for 2-3 hours. The swelling lasted for about 3 full days. My mother called the Board of Health who said I should lay down. It helped. When I sat up, it started to spread again, so I laid down for about one hour. I later contacted my physician to see if I should get the 2nd shot.
51 2021-04-10 swelling of eyelid I had s these symptoms after both shots:fever, headache, flu symptoms, swelling all over including e... Read more
I had s these symptoms after both shots:fever, headache, flu symptoms, swelling all over including eyelids, joint pain. On 4/11, 11 days after second shot I developed burning/stinging nerve pain throughout body. Went to ER. All tests normal except my abdominal lymph nodes are swollen. Only mild pain relief with morphine. Being referred to a neurologist. Have never experienced this before. Only history of nerve damage is an injury in right foot. In extreme pain with no explanation yet.
51 2021-04-10 ringing in ears Had tinnitus before but it much louder after dose #2. Difficulty falling asleep and unable to distra... Read more
Had tinnitus before but it much louder after dose #2. Difficulty falling asleep and unable to distract myself from the sound as I had been able to previously.
51 2021-04-10 visual impairment Severe headache, vision changes, unable to concentrate or think clearly.
51 2021-04-11 lip swelling, swollen tongue Patient is a 51 year old female who has not completed a 30-minute observation period due to the foll... Read more
Patient is a 51 year old female who has not completed a 30-minute observation period due to the following signs and symptoms of an adverse reaction starting @ 1054: swelling of tongue and lips, body numbness, clammy skin, syncope, shortness of breath, hypertension, and tachycardia (see VS flowsheet for values). Pfizer-BioNTech COVID-19 vaccine # 1 in series administered @ 1035. Action(s) taken: @ 1056 Epinephrine administered and Transferred to higher level of care post RRT @ 1105. Allergy to COVID-19 vaccine documented in Allergies activity: Yes Patient and husband advised to discuss second dose considerations with a clinician and obtain refill for Albuterol and Epinephrine.
51 2021-04-12 eye strain I was brought to the hospital by the ambulance because my throat swelled up.; eyes are tired; My bod... Read more
I was brought to the hospital by the ambulance because my throat swelled up.; eyes are tired; My body is itchy and feel like crap; My body is itchy and feel like crap; she's allergic to the Covid 19 vaccine; I was wheezing within 10 minutes after receiving the first dose of the vaccine.; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8732 and expiry date: 31Jul2021) via an unspecified route of administration in left arm on 29Mar2021 at single dose for covid-19 immunisation. Medical history included Multiple sclerosis (from 1996 to ongoing), 2006-2007, it was because of an MS drug (Interferon (receiving 3 times a week)), it gave her mild cardiomyopathy. She just stopped taking another treatment for multiple sclerosis called Mavenclad. Mavenclad is a chemotherapy drug. She received her first dose in Oct2020, she took Mavenclad for 5 days. Then in Nov2020 she started taking the Mavenclad again for 5 days. She doesn't restart the Mavenclad again until Oct2021. She reports the Mavenclad takes the B and T cells out of her bone marrow. When she has the next dose of Mavenclad, the B and T cells will be depleted again and when the B and T cells come back they are "tricked" so they won't attack her body. Her hair fell out in clumps with the Mavenclad and her throat swelled too. She would really like a haircut to fix her hair. She premedicated prior to receiving the Mavenclad. She reports she was premedicated for 3 days prior and the day she received the Mavenclad, with Benadryl. Within 15 to 20 minutes of taking the Mavenclad she had a reaction. Concomitant medications included vitamin b12 (about a year) for vitamin b12 deficiency and vitamin d (10-15 years) with calcium for Vitamin D deficiency. On 29Mar2021 within 10 minutes after receiving first dose her throat swelled up. The next thing she knows is people are all around her, she's on a gurney and she's going to the hospital in an ambulance. She would say she's allergic to the Covid 19 vaccine. In the emergency department she had to have an IV with all kinds of medications. Yesterday in the emergency department the doctor wanted to give her an epi pen. She told the doctor she didn't want to have the epi pen. In her IV in the emergency department she received Solu-Medrol, Benadryl (as needed), and Famotidine (20mg twice a day 10 days). She was prescribed Prednisone 20mg tablets, take 3 tablets orally every day for 5 days. She also reports she is allergic to egg whites, not deathly allergic. She can eat a hardboiled egg but she has to take Benadryl because her throat will start to close up. She can eat scrambled eggs just fine because the eggs are cooked different. The emergency room was watching her because if she didn't improve, they were going to give her the epinephrine. She started to improve, and she was thankful. She was afraid something else could have happened to her and her husband was in the parking lot and wouldn't have known. She's not sure how many hours she spent in the emergency room. She was not admitted to the hospital; she was discharged from the emergency room. Now she's taking medication for the next 5-10 days. She's not shocked, with her history and her reactions to medications. She didn't really think an allergic reaction was going to happen because the Covid 19 vaccine is not a live vaccine or anything like that. She's not going to look online for allergic reaction information because her eyes are tired. She's been up since 1:30 AM because of all the steroids she's on. On 30Mar2021, her whole body is itchy. She's taking Benadryl and the Benadryl has helped. The itchy feeling is moving on to different parts of her body. She had the swine flu when it came out and it was hellacious. She feels like Covid is much worse and she she believes in science. She knows Covid 19 isn't made up. She's all for the Covid 19 vaccine. Give her the Covid 19 vaccine so she can move on. She reports everyone in her family got the vaccine, and they were all fine besides aches and pains. When probing for specific information regarding the caller's family members, she reports her daughter, who is in nursing school had the Covid 19 vaccine. After her daughter's first Covid 19 vaccine, she had a sore arm that night and she was really tired. The next day her daughter felt a little lightheaded and she felt like she had flu symptoms. She had some body aches. Then under her daughter's armpit where her lymph nodes are were swollen. By the third day her daughter felt better. She was totally fine. She thinks her daughter may have reported her experience online. The outcome of event eyes are tired and I was wheezing within 10 minutes after receiving the first dose of the vaccine was unknown, the outcome of event My body is itchy and feel like crap, My body is itchy and feel like crap and she's allergic to the Covid 19 vaccine was not recovered where the patient recovering from the event I was brought to the hospital by the ambulance because my throat swelled up.
51 2021-04-12 mouth tingling Initially, I had some tingling in the tip of my tongue and some chest tightness. That passed for t... Read more
Initially, I had some tingling in the tip of my tongue and some chest tightness. That passed for the most part and I felt fine until 5pm when I started to feel extremely nauseous, with generalized aching, chills, temp of 99.8, and extreme exhaustion. These symptoms continued through today when I also started having dizziness. Symptoms were treated with motrin and zofran.
51 2021-04-12 ringing in ears About 2 hours after my shot I experienced tinnitus which is still persistent. Sometimes the noise is... Read more
About 2 hours after my shot I experienced tinnitus which is still persistent. Sometimes the noise is louder and sometimes quieter. I am also experiencing a flair up of tissue inflammation, especially in the upper back region. I had an overall achy feeling off and on since the shot at times, but this is very mild.
51 2021-04-12 visual impairment Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general ... Read more
Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general malaise; fatigue; difficulty concentrating; Day 2: General malaise, fatigue; difficulty concentrating; headache; lower back pain Day 3: Fatigue; runny nose, sneezing, cough, aches all over the body; headache; a red, itchy blotch on the right index finger; lower and upper back pain Day 4: Same as above, but vision problems right before bedtime; Day 5: Severe headache, lightheadedness, difficulty talking, numb left side of thCT e face, left hand, left arm, left food. Went to ER and still in the hospital in observation (Day 6)
51 2021-04-13 dry mouth I submitted a report after my first dose of the vaccine , and now this is the report after my 2nd do... Read more
I submitted a report after my first dose of the vaccine , and now this is the report after my 2nd dose of the Pfizer vaccine: I got the 2nd dose at 4:10pm. I did not feel the shot at all this time, but my arm was a bit achy soon after. One hour after the shot my leg muscles hurt and I felt fatigued. Two hours after the shot I felt really tired and really silly, kind of loopy. Three hours after the shot my L arm was hurting more and it hurt to take the band aid off. Then my stomach started feeling upset. I went to bed at 10:30pm and had a very rough sick night. I was awake most of the night, only dozing a few times. I had a fever (101) and chills; nausea and belching; dry mouth; aching and strange pains coming and going; a slight headache; and my L arm was hurting. By 7am I started crying, and I had more physical pain. I got up at 8am feeling so sick with extreme fatigue, headache, and in a lot of pain in body. My Mom had to make my breakfast for me and I took small bites of that oatmeal throughout the day. I couldn't eat very much because my stomach was so upset. I felt hot and cold and got chills often during the day. By 6:45pm the fever returned (100.3) and I felt sicker again with head and tummy hurting; body aching; and nausea. Finally at 8pm I took 2 Tylenol which helped a lot, but then I worried what if that reduced the effectiveness of the vaccine. I went to bed at 9:15pm and fell asleep right away, but woke up many times soaking wet with sweat. The next day I still had trouble with temperature regulation and I felt very tired and headachy and my L arm still hurt. A few days later I got my menstrual cycle about one week early, and it was the strangest period I've ever had. It was a very light flow, I had lots of clots, and along with the small amount of blood, there was lots of clear stretchy mucous like I get at ovulation. After my first vaccine dose I got my period a few days later also, but that time I only had brown spotting for 4 days and no regular blood flow at all, so this time it was slightly more of a period, but it was really not my usual kind of period. Overall, I felt completely whacked and wrecked by the 2nd dose. It was a terrible experience.
51 2021-04-13 mouth tingling Hives on arms and chest. States tongue felt 'unusual' for a brief period of time. Hives resolved wi... Read more
Hives on arms and chest. States tongue felt 'unusual' for a brief period of time. Hives resolved with Benadryl. No swelling of tongue or throat and no difficulty breathing.
51 2021-04-13 sensitivity to light April 6-10 extreme fatigue April 10 to current left arm burning skin sensation sensitive to touch ai... Read more
April 6-10 extreme fatigue April 10 to current left arm burning skin sensation sensitive to touch air and light. Doctor appointment suspected Shingles. Extremely painful
51 2021-04-13 tongue disorder, mouth tingling pt reports difficulty getting a full breath of air, her oxygen saturation is 95% today in clinic. sh... Read more
pt reports difficulty getting a full breath of air, her oxygen saturation is 95% today in clinic. she has diminished breath sounds. no hx of asthma/allergic rhinitis. she reports that her tongue 'feels fat'.
51 2021-04-14 dry mouth client complained of dizziness after receiving 2nd dose of Pfizer Covid Vaccine. Within 2 mins of re... Read more
client complained of dizziness after receiving 2nd dose of Pfizer Covid Vaccine. Within 2 mins of receiving vaccine client informed RN she was feeling dizzy. Client able to transfer by herself from chair to wheelchair. RN pushed chair to observation room where EMT assumed care. PHN joined EMT. Client alert and oriented. Per client feeling warmth, dizzy, dry mouth. Vitals at 1434: blood pressure: 110/80, pulse 86, oxygen 98%. Medical history: diabetes, COPD, bipolar depression, glaucoma, and retinopathy. EMT gave client water. Current medications: latuda, metformin, timolol, travatan, eyedrops, novalog, basaglar, and jenuvia. Per client did not have any reaction to first dose. Client informed we would continue observing for 30 mins. 1439 client stated dizziness was improving. 1443 vitals: blood pressure: 130/80, pulse 85, oxygen 99%. Per client dizziness improving. 1448 vitals: blood pressure: 132/82, pulse 85, oxygen 100%. Client stated feeling warm again and clammy. PHN asked client to lower mask and assess skin color. Face flushed, client denies shortness of breath. Per client warmth feeling worsening, PHN offered Benadryl. Client stated not driving, insurance transport would take her home. 50mg Benadryl given orally at 1454. Vitals: blood pressure 126/80, pulse 83, oxygen 98%. Vitals 1500: blood pressure 124/82, pulse 81, oxygen 100%. Client stated feeling better. Still warm feeling, dizziness improving. 1505 vitals: blood pressure: 122/82, pulse 83, oxygen 98%. Per client more improvement, stated starting to "feel sleepy". 1510 vitals: blood pressure 120/78, pulse 87, oxygen 97%. Per client dizziness resolved, skin color back to normal, no flushing noted. ER precautions given. Transport arrived at 1530, unable to get last set of vitals. Per client feeling much better, client asked to be wheeled to transport car due to tired feeling. PHN and EMT accompanied client to bus. Client able to stand up from chair with no complaints. Able to walk into vehicle by herself with steady gait.
51 2021-04-14 ear pain Sore Arm and Ear Ache. Woke with a very sore throat and very tired
51 2021-04-15 dry eye Patient reports that her symptoms started within 5 minutes of getting the vaccine. Started with fac... Read more
Patient reports that her symptoms started within 5 minutes of getting the vaccine. Started with facial numbing then followed by a bad headache and joint pain all happening within 15 minutes. Facial numbness was her first symptom that started. In the next hour she had chills, scratchy throat, itchy and dry eyes. Slept the rest of the day. The following day she had headaches, chills terrible body aches. 4/12/21 she developed facial swelling under her chin, lymph nodes inflamed/enlarged, chills, body aches, slight headache, cough. Took IB to help with symptoms. She still continues to have side effects today, (4/16/21) which include body aches, fatigue and still "not feeling right."
51 2021-04-15 eye pain Loose BM, pounding headache, body aches, nausea, fatigue, sore arm, chills , eyes hurt-sinus.
51 2021-04-15 pain in jaw, vision blurred, swelling of eyelid, eye twitching, double vision Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccin... Read more
Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccine: severe headache, stiff neck ache, dizziness, nausea, chills, extreme fatigue, feverish but below 100.4, severe muscle aches, loss of taste and smell. Loose bowels at times, slept all the rest of the day and night, drank lots of fluids and electrolytes (low sugar). Felt more weak and dizzy the next day, and when walking felt veering right more, more issues with extended activity. e next dose on 1/22 onwards, and has never gone away fully. R arm pain and raised, tender area at vaccine site contiued to hurt for weeks, even into the next dose on 1/22 onwards, and has never gone away fully. 1/3.2021 woke up 5:30 am sudden onset shortness of breath, deep lung pain in the center of the chest. I felt like my R lung blocked, and started to cough up large amounts of clear mucus, and vomiting mucus due to airway feeling blocked. I did a 4 albuterol puffs to try to open my airway, but I was not wheezing, and did not have any respiratory symptoms or illness at the time before this started. I had been having continued less lung capacity for many months prior due to having been very sick in March 2020 onwards, including loss of sense of smell and taste, shortness of breath, deep lung pain, fever, No wheezing, not sick. Pfizer dose #2 EL9261 1/22/2021 3:50 pm after work. Onset of symptoms by 5:30 pm with headache, dizziness, nausea, extreme fatigue, increased R arm pain at the vaccine site, but it was still hurting at the site from the 1/1/21 shot too, before this dose. Drank fluids and went to bed. Loss of smell and taste returned 1/23/21. Had continued bad headache from 1/22 onwards, with nausea and feeling more dizzy at times, and on 1/26/21 I was at work with increased headache, dizziness and nausea, and went home early from my shift (I am an RN) due to symptoms. Went to bed early, due to continued nausea and headache and dizziness at times. 1/27 continued bad headache, then in the afternoon around 3 pm, GI felt bloated, bad nausea, and then felt shortness of breath around 4 pm and faster heart rate in the upper 80?s lasting for minutes, despite laying down in bed, so I too used my oximeter (I Have photos) and the sats were staying at 88% continuously, and had shortness of breath and return of deep internal mid lung pain, and this lasted for over 10 min. I used a canister of Boost oxygen for 5-6 puffs to try to recover, and the sats raised to 90%. No wheezing. Not sick. I had a bad headache and nausea, and was not feeling good and went to bed. On 1/28/21 I woke up at 5:30 with severe vertigo and dizziness, nausea and a bad headache and could not walk due to the vertigo, and vomited when I was trying to have my head up. I had to crawl to the bathroom on my hands and knees. I called out sick for work due to this and contacted my DR. I was started meclizine 25 mg 3 times a day for vertigo, and was taking Zofran to help. 1/31/21 noted my Re upper eyelid was doing a lot of spastic twitching at times, that would stop and start, but did not think about it much. The vertigo was unrelenting and then I started to have Right arm and hand weakness noted on 2/3/21 and was still very dizzy, nauseated and had a constant headache since I got dose #2 of the COVID vaccine on 1/22. I was using a walking stick for the dizziness to be stable, and also felt weaker on the R side, and drifting to the right when walking .On 2/4/21 I had my first MRI (no contrast, unfortunately) and noticed I could not fully shut my Right eye in the MRI, and by 2/5/21 my face was drooping. I still had the constant headache, nausea and dizziness, and increased R hand, arm and R leg weakness and R hip weakness. I could not lift my R leg up to walk well, cannot grip well with the R hand, and uncoordinated, and cannot walk straight, and am unstable when trying to walk heel to toe, or even stand still with my eyes shut, and have had some double vision with the R eye. I was started on Prednisone and on Klonopin for the vertigo on 2/9 after seeing my neurologist. I took Prednisone for 5 days, from 2/9-2/13 and did not have improvement with the R facial droop or R side weakness and the headaches have persisted, along with some dizziness and nausea. on2/14-15 I had increased shortness of breath and R lung felt like it was not inflating much, and got an xray, and went onto Zithromax for 5 days, which did help my lungs to improve, and I was able to breathe better, and got my Right lung capacity back. I stopped the Klonopin after a week (2/9-2/16), to manage through the symptoms without it, and have been doing physical therapy and. Vestibular therapy. I had another MRI, with contrast on 2/25, after an in-person neurology appointment, and was having some improvement with the vertigo, so I started back to a desk job, not my RN job on 3/4/21, but I was still having the constant headache, nausea, and some dizziness, R face droop, R hand weakness, R leg weakness and walk with a walking stick, and have increased issues with exertion, but have been walking and doing therapies to get stronger.3 I started to have increased R facial droop. EMG done on 3/23 of my R arm. Worse headache, nausea, dizziness at the desk, and fatigue, but R side weakness issues increased, so I started back onto Prednisone on 3/28/21 with 50mg day for 3 days, then 40mg for 3 days, 30mg for 3 days then 230mg for 2 days, but had increasingly bad headache,nausea and increasing R facial droop, and much worse R hand weakness, R arm weakness and pain, and R hip pain and weakness, worse walking, cannot lift my R leg or foot as high as the L, again, and am struggling to walk, and get worse with exertion with R side walking and weakness. I also had shooting pains in my R jaw start on 4/6-7, along with R jaw and face pain and increased numbness, more face droop shooting pains in my R hip, and arm and body pain and a worse headache making it hard to even sleep, and some increased issues with my R eye that I need to have checked. The prednisone last dose was on 4/7, and stopped due to the symptoms I was having, after a video visit with the neurologist. Increased R leg weakness, R weak hip vs left, R foot drag/drop, with increased issues to maintain walking with progressive walking, still using walking stick to try to walk, but now for stability and to keep from drifting, R facial droop increasing and now some R eye blurring 4/9 onwards, that is new.
51 2021-04-16 mouth tingling Approximately 10min after vaccine patient felt tingling in her lips which progresses to tip of tongu... Read more
Approximately 10min after vaccine patient felt tingling in her lips which progresses to tip of tongue 1530 Allegra 60mg given. Patient observed for 30min post dose. Symptoms began subsiding 10 min after receiving Allegra. By end of the 30 min observation, patients reports feeling better back to baseline. Patient advised if symptoms return or would worsen she should go to ER for evaluation.
51 2021-04-17 ringing in ears About 7 hours post injection, I started experiencing general increasing discomfort and almost unbear... Read more
About 7 hours post injection, I started experiencing general increasing discomfort and almost unbearable heat at the injection site. In addition, I started feeling light-headed and had loud ringing in my ears. I was able to move to a chair and sit down, and a family member provided me with a cold pack to place on my arm. Eventually, the ringing in my ears subsided and I no longer felt like I was going to pass out. This episode lasted for about 20 - 30 minutes. I was chilled for the remainder of the evening on 4/17.2021. Today (4/18/2021), I have had periods of light-headedness, but not nearly as severe as yesterday.
51 2021-04-17 ringing in ears Tinnitus began after first dose of COVID Pfizer vaccine. It?s a mild high pitch buzzing in both ears... Read more
Tinnitus began after first dose of COVID Pfizer vaccine. It?s a mild high pitch buzzing in both ears that persists all day. So far it continues and hasn?t abated.
51 2021-04-18 taste impairment, mouth discomfort 43 hours after vaccination, began to experience: metallic taste in mouth, burned feeling lips, flush... Read more
43 hours after vaccination, began to experience: metallic taste in mouth, burned feeling lips, flushed skin on face, chest and neck, slight headache and nausea.
51 2021-04-18 mouth swelling, swollen tongue, eye swelling Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Ton... Read more
Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: leg pain-Mild, Additional Details: pt complained of fatigue, hives over upper half of body starting the day after vaccination and leg/thigh pain starting two days after vaccination
51 2021-04-18 mouth ulceration Pt multiple Painful oral ulcers Associated with low-grade temperature elevation but no true fevers, ... Read more
Pt multiple Painful oral ulcers Associated with low-grade temperature elevation but no true fevers, and associated with several episodes of emesis
51 2021-04-18 ringing in ears Ringing "tinnitus" in one ear. Started off intermittently on the 3rd day after the fist dose of vac... Read more
Ringing "tinnitus" in one ear. Started off intermittently on the 3rd day after the fist dose of vaccine. A week after vaccine first dose it is continuous ringing in one ear.
51 2021-04-18 tongue itchiness, eye itchiness, feeling of choking, mouth tingling Approximately 10 minutes after receiving vaccine the patient's throat felt scratchy, tongue felt itc... Read more
Approximately 10 minutes after receiving vaccine the patient's throat felt scratchy, tongue felt itchy, tingling occurred around lips and throat, and eyes felt itchy. Benadryl 25 mg was given immediately after patient complained of symptoms and after 30 minutes of observation patient felt better and left with her husband. Patient followed up with her allergist and allergist recommended her not to get the second dose. Patient reported she wants to get the second dose, therefore, I recommended she take Benadryl before receiving a second dose of the vaccine if she chooses to do so.
51 2021-04-18 vision blurred Started getting tingling in right thigh followed by tingling in left lower leg & left foot. Severe m... Read more
Started getting tingling in right thigh followed by tingling in left lower leg & left foot. Severe muscle cramps in left calf. Intermittent tingling in both upper arms. This was followed by blurry vision in the left eye & intermittent dizziness.
51 2021-04-19 ear discomfort, deafness, ringing in ears Sever hearing loss and tinnitus. Day after shot clogged ear and fullness, noise. Went to ent hearin... Read more
Sever hearing loss and tinnitus. Day after shot clogged ear and fullness, noise. Went to ent hearing test showed severe hearing loss was put on round of steroids.
51 2021-04-19 ear discomfort Patient called the pharmacy and stated she has had symptoms of clogged ears. It bas been bothering ... Read more
Patient called the pharmacy and stated she has had symptoms of clogged ears. It bas been bothering her even though she has cleaned her ears afterwards. It just happened after getting her vaccine. I recommended to give it another day or two since symptoms will subside usually after 72 hours. If not, she may need to see her provider. Patient understood.
51 2021-04-19 lip swelling Tight chest, cold tight in throat and chest, swollen lips, headache, flared trigeminal neuralgia sym... Read more
Tight chest, cold tight in throat and chest, swollen lips, headache, flared trigeminal neuralgia symptoms
51 2021-04-19 ringing in ears I received the second vaccine at approximately 10:45am on 4/19/21 at pharmacy; later that afternoon ... Read more
I received the second vaccine at approximately 10:45am on 4/19/21 at pharmacy; later that afternoon a very bad migraine started do develop, which I did not take medication for as I want to ensure nothing would interfere with the vaccination doing it's job. The pain of said migraine has traveled to different locations in my head between 4/19 through the morning of 4/21 - from the base of the back of the head and neck area to the top/left of the skull and over left eye area. On 4/20/21 at 10:05am, I developed a very unpleasant ringing in both ears that I am very concerned about as it is exacerbating the migraine and is extremely painful.
51 2021-04-20 loss of taste, swollen tongue Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; c... Read more
Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; chills; tongue swollen; no taste; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (also reported as 52-year-old) female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 51-years-old, administered in Arm Left on 10Mar2021 10:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included asthma and high blood pressure. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced "Bell palsy", pain in arm, pain in neck, headache worsen from center of head to neck, dizzy, nausea, chills, tongue swollen, no taste; all on 19Mar2021 22:30. Description was as follows: "pain in arm, neck, headache, dizzy, nausea, chills and then days later other symptoms, headache worsen from center of head to neck, neck hurting, tongue swollen, no taste, and then woke up with Bell Palsy and was taken to the emergency room". Therapeutic measures were taken as a result of Bell palsy. The outcome of the events was recovering. The events were considered as serious (Disability or permanent damage/ Disabling/Incapacitating). The adverse events resulted in any Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. More information has been requested.
51 2021-04-20 double vision Double-vision due to misalignment of left eye. Examination resulted in a diagnosis of 6th nerve pals... Read more
Double-vision due to misalignment of left eye. Examination resulted in a diagnosis of 6th nerve palsy. Symptoms remain after two weeks, with slight improvement.
51 2021-04-20 eye swelling Experienced severe allergic reaction resulting in anaphylaxis requiring emergency treatment @ ER. S... Read more
Experienced severe allergic reaction resulting in anaphylaxis requiring emergency treatment @ ER. Swelling of face and neck, eyes swollen shut, hives on upper body, difficulty breathing.
51 2021-04-20 mouth numbness Pt informed nurse that her lips felt "numb" directly after receiving vaccine. Pt stated that one wee... Read more
Pt informed nurse that her lips felt "numb" directly after receiving vaccine. Pt stated that one week later she developed pain and numbness toleft side of her face starting from behind her ear, then also started behind her right ear. On 4/4/2021 Pt went to the ER as pain and numbness had not gone away and was dx with Bells Palsy. Pt was started on antibiotics, steroids , and Ibuprofen. On 4/7/2021 Pt went to see PCP at gateway, He informed pt to go home and continue medication regime. Then pt states pain became worse because ibuprofen is no longer working. 4/15/2021 @1755, pt was advised to f/u with PCP tomorrow, or to go to urgent care/ER if symtoms do not improve in the next 24 hours. Pt/Spouse verbalized understanding.
51 2021-04-20 mouth tingling Client c/o tingling of mouth and face. No distress note at the moment. Client able to voice concer... Read more
Client c/o tingling of mouth and face. No distress note at the moment. Client able to voice concerns. Client seen by EMT. No v/s obtained. Client instructed to contact PCP or go to ER if symptom worsen and cleared to go by EMT.
51 2021-04-20 ringing in ears Vaccine did hit me hard the day after, all day Friday, and managed as many naps as possible but keep... Read more
Vaccine did hit me hard the day after, all day Friday, and managed as many naps as possible but keeping G?s routine going. As the night went on, I found it more difficult to stay awake. I experienced something I have not experienced in almost 20 years. I suffered from a few bouts of sleep paralysis in my 20s. It was horrifying to be awake and unable to move a muscle and you can even make a sound. Last Friday, I literally stopped breathing (never happened b4) and woke up paralyzed just for a few moments and when I regained movement, I was gasping for air. I was so scared because it kept happening shortly after falling asleep but I could not stay awake. I am not sure if my fibromyalgia played a part in this or not. I have also been experiencing more shortness of breath since then and the last two days constant ear ringing. It is hard to focus with the high pitch ringing in my ear. I am out of breath with such little movement required.
51 2021-04-21 loss of taste, ear swelling, loss of smell Within two weeks of receiving the first dose of the vaccine I had a fever and I felt terrible. The f... Read more
Within two weeks of receiving the first dose of the vaccine I had a fever and I felt terrible. The fever was around 102 and lasted two days. I had no sense of taste and smell for three days. I tested negative two times during that week. I had a family member who tested positive around the same time as I got the shot. I was prescribed antibiotics at the urgent care because my ear was inflamed. I was fully recovered after one week. I got the second dose with no problems. Lot Number EL9262 I also visited Dr and my blood pressure and heart rate were elevated.
51 2021-04-21 taste impairment c/o pain injection site then entire arm. Also said she had a metallic taste which resolved with drin... Read more
c/o pain injection site then entire arm. Also said she had a metallic taste which resolved with drinking water Observed longer. Continued to have arm pain but no red-ness or swelling. denies an other symptom. Discharged ambulatory.
51 2021-04-22 hearing loss racing heart and high blood pressure lasted for a week. Diarrhea and chills 6 hours. Nausea lasted... Read more
racing heart and high blood pressure lasted for a week. Diarrhea and chills 6 hours. Nausea lasted 4 days. Headache lasted 4 days, severe back pain 1 week. fatigue lasted a month. Cough for a month. Menstrual period felt like I had another miscarriage- severe pain and heavy bleeding for 4 days.
51 2021-04-22 mouth numbness Lip went numb about a day later lasted full time for three days then it happens on and off still bot... Read more
Lip went numb about a day later lasted full time for three days then it happens on and off still both top and bottom lip.
51 2021-04-23 taste impairment Sore arm, swollen lymph nodes under left arm, metallic taste in mouth, 101 degree fever, chills, mus... Read more
Sore arm, swollen lymph nodes under left arm, metallic taste in mouth, 101 degree fever, chills, muscle aches, headache
51 2021-04-23 gaze palsy Hot Flashes/headache Pt observed for 30 mins 2 sets of vitals taken along with 02. all normal pt im... Read more
Hot Flashes/headache Pt observed for 30 mins 2 sets of vitals taken along with 02. all normal pt improved and was discharged home in a stable condition. no medications given
51 2021-04-23 ringing in ears April 10 very fatigued, headache, ?brain fog?. Woke up around 3 am April 11 with horrible high pitch... Read more
April 10 very fatigued, headache, ?brain fog?. Woke up around 3 am April 11 with horrible high pitched ringing in my ears. It does not stop.
51 2021-04-24 loss of smell, loss of taste 1st shot: 3/31/2021- within 5 minutes drenching sweat, rapid heartbeat, dizziness; in the evening b... Read more
1st shot: 3/31/2021- within 5 minutes drenching sweat, rapid heartbeat, dizziness; in the evening body aches 2nd shot: 4/22/2021: fatigue, body aches, chills, fever, headache, loss of taste and smell, weakness
51 2021-04-24 vision blurred, visual impairment, ringing in ears My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so ... Read more
My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so bad I cannot drive; Eyes are blurry; Nausea; Couldn't keep food down; Dizzy; can't get balance; Couldn't sleep for five days; Sore throat; runny nose; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (Lot Number: SJCFR EN 6199) on 24Mar2021 09:00 as single dose, and dose 2 (Lot Number: En6199) on 24Mar2021 (to be confirmed) as single dose, both via an unspecified route of administration, administered in left arm for covid-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID prior vaccination. She has not been tested for COVID after vaccination. On 31Mar2021, the patient reported that her ears were ringing constantly, her eyesight changed, and she couldn't see out of her glasses. Her eyes were blurry, and vision was so bad she cannot drive. She had nausea for a week straight. She also couldn't keep food down. She was dizzy and couldn't get balance. She also couldn't sleep for five days. She also had sore throat, and runny nose for a week. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and has caused disability or permanent damages. Treatment for the events included prednisone and anti-nausea medicine. The outcome of the events was not recovered.
51 2021-04-25 deafness unilateral, ringing in ears Tinnitus in the left ear. Hearing loss in the left ear.
51 2021-04-25 dry mouth, feeling of choking I first had extremely dry mouth within minutes after shot.I felt a slight tightening of my throat bu... Read more
I first had extremely dry mouth within minutes after shot.I felt a slight tightening of my throat but wasn't to concerned to alert staff. 30 minutes after shot and after left facility the whole interior and exterior of nose, sinus cavity and checks went numb. All symptoms subsided within an hour.
51 2021-04-25 taste impairment metallic taste in saliva tongue/lips tingling muscle soreness in the shoulder and neck
51 2021-04-25 eye itchiness EE developed symptoms of rhinorrhea, congestion, and itchy eyes on 4/17/2021 and tested positive for... Read more
EE developed symptoms of rhinorrhea, congestion, and itchy eyes on 4/17/2021 and tested positive for Covid on 4/19/2021.
51 2021-04-25 mouth discomfort Within 15 or 20 minutes of receiving her first dose of the Pfizer Covid vaccine, the patient, felt h... Read more
Within 15 or 20 minutes of receiving her first dose of the Pfizer Covid vaccine, the patient, felt hot and asked for a fan. She started to feel like she was going to faint and said that her mouth felt funny. She was breathing without difficult. The patient eventually had a syncopal episode and then had facial drooping.. When she regained consciousness, she could communicate and answer questions. Breathing remained normal and pulse rate was in the 50s. EMS was called when the patient said that she felt faint. They took her to to the hospital for further treatment.
51 2021-04-25 mouth tingling, feeling of choking patient had throat/tongue/mouth tingling, swelling, throat closing sensation within 15 minutes of ad... Read more
patient had throat/tongue/mouth tingling, swelling, throat closing sensation within 15 minutes of administration of vaccine. She tells me she was administered benadryl, "steroid" and epi-pen and was transported to Hospital ER for observation where she was discharged home with epi-pen prescription.
51 2021-04-25 swollen tongue, lip swelling throat numbness, lip and tongue swelling
51 2021-04-25 swollen tongue PRESENTS 4/26 TO HOSPITAL EMERGENCY DEPARTMENT (ED) 5 DAYS POST VACCINATION WITH TONGUE SWELLING , S... Read more
PRESENTS 4/26 TO HOSPITAL EMERGENCY DEPARTMENT (ED) 5 DAYS POST VACCINATION WITH TONGUE SWELLING , SOB WHILE IN ED HAD CARDIAC ARREST, WAS RESUSCITATED, INTUBATED AND TRANFERRED TO ICU. IS CURRENTLY ON VENTILATOR AND VASOPRESSOR SUPPORT.
51 2021-04-26 ringing in ears Have ringing in my ears that started about a week after my second covid vaccine
51 2021-04-27 hearing loss, ear discomfort, ringing in ears A couple days after my second dose the hearing in my right ear became muffled and I have had a ringi... Read more
A couple days after my second dose the hearing in my right ear became muffled and I have had a ringing in it. It feels as if I have water in my ears.
51 2021-04-27 lip swelling, eye swelling, swollen tongue Facial swelling (eye, tongue, lip), high BP, high HR, shaking, lower O2 (95), monitored for over an ... Read more
Facial swelling (eye, tongue, lip), high BP, high HR, shaking, lower O2 (95), monitored for over an hour while hooked up to BP machine and pulse oximeter, epi was brought out and kept nearby but not administered. Continued for several hours after I got home. Also had severe uterine cramping for about 12 hours even though I am in menopause.
51 2021-04-28 mouth numbness Within 10 minutes of the shot I had a severe headache, numbness in my lips, feet and hands and was w... Read more
Within 10 minutes of the shot I had a severe headache, numbness in my lips, feet and hands and was weak and unable to walk without fear of falling. These symptoms continues for an hour, and while still weak I returned to work. I awoke the next day with a fever, body aches and fatigue that lasted 3 days. I have had 3 more bought s of severe fatigue since the shot and on Monday 4/26/2021 I suffered a seizure bi have no history nor symptomology of seizure activity, and was hospitalized for 2 days.
51 2021-04-28 vision blurred Reaction was immediate Dizzy Blurred vision Nausea Body felt very warm and overheated Heavy feelin... Read more
Reaction was immediate Dizzy Blurred vision Nausea Body felt very warm and overheated Heavy feeling and pressure in chest when breathing Overall uneasy feeling
51 2021-04-29 ringing in ears, dry eye, eye twitching initially while driving home, eye spasms and eye dryness, various sharp pains in leg and right foot,... Read more
initially while driving home, eye spasms and eye dryness, various sharp pains in leg and right foot, a feeling of heightened anxiousness. Following day the typical fatigue, unusual headache, full tunnel feeling in head and ears, off balance feeling, some muscle aches as well as previously mentioned symptoms. this lasted for about 3 days. some mild relief in fatigue and headache but all of a sudden non stop ear ringing (Tinnitus) high pitched EEEEE with occasional low tone whistle sound. fast forward currently no relief in ear ringing and off and on mild pressure headaches, off balance,(some days worse than others) mild fatigue, some isolated off and on muscle aches. slight fainting feeling (occasional), don't feel grounded..... among other things
51 2021-04-29 eye floaters Eye floaters, flashes of light produced a retinal tear
51 2021-05-04 ear swelling, ear itchiness Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swa... Read more
Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative. The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021. Information on the lot/batch number has been requested.
51 2021-05-04 lip swelling Patient began complaining of left upper lip swelling, shortness of breath and tightness of throat 10... Read more
Patient began complaining of left upper lip swelling, shortness of breath and tightness of throat 10 minutes after receiving second dose of Pfizer vaccine. Epinephrine was administered and patient had a significant resolution of symptoms 6 minutes after administration with reduction in swelling and improvement in breathing. 911 was called and patient was transported to emergency department for further monitoring and evaluation.
51 2021-05-09 smell distorsion 2 months ago feeling anxiety and having nightmares - night mares about falling my fear!!- not height... Read more
2 months ago feeling anxiety and having nightmares - night mares about falling my fear!!- not heights but falling -wakes me up every night and recently started having ice pick pains in my left side of my head and smelling odd odors while trying to sleep
51 2021-05-10 taste impairment Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches... Read more
Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; bitter taste; This is a spontaneous report from a contactable consumer(patient). The 51-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Apr2021 14:30 (Batch/Lot number was not reported) as second dose, single for covid-19 immunization. Medical history included hashimoto. Concomitant medication included collagen, peptide powder, multi vitamins. She previously received sulfur based antibiotics. Historical vaccine included first dose of BNT162B2 on 03Apr2021 09:30 AM for COVID-19 immunization and experienced bitter taste in back of throat for half day on date of administration. After second dose, the patient experienced same bitter taste for 24 hours from time of administration. Pulse continued body aches especially in legs making her almost immobile, all on 26Apr2021 06:00 with outcome of recovering. Treatment included alternated taking ibuprofen(ADVIL) and paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID 19, Since the vaccination, the patient had not been tested for COVID 19. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466738 Same patient/drug, similar AEs, different dose
51 2021-05-11 deafness Nerve damage; Dizziness; Lost her hearing in her right ear; This is a spontaneous report from a cont... Read more
Nerve damage; Dizziness; Lost her hearing in her right ear; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0162 and expiry date: Jul2021), via an unspecified route of administration, in Arm Left, on 08Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included thyroid problem and seasonal allergies. The patient did not have any family medical history relevant to events. The patient did not receive any vaccine within 4 weeks prior to vaccination. Concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID- 19 vaccine on 08Apr2021 and one day later on 10Apr2021 when she woke up in the morning, she lost hearing on her right ear. She mentioned her doctor told her she should call. She called her physician, and she did not have any accident or anything outside, she was healthy, she only had the vaccine. It bothers her. She described noise in her ear like a dog barking and her ear feels like a big pressure and every time she heard crying or talking or a loud sound, she could not hear. Her doctor never heard of this with the vaccine. She went to see a primary doctor and her HCP said this was due to allergies and pollen, because it was April and he said that he never heard of a hearing loss for COVID vaccine and prescribed Meclizine. She did not have allergy problems and anything wrong with her sinus or a runny nose, so she decided to go to a professional doctor, ear nose and throat. Then she went to see a ear nose and throat doctor on 15Apr2021 and 21Apr2021, and he said that he heard about a couple of cases with the vaccine and he tested her by performing a hearing test and it was true that the COVID-19 vaccine caused nerve damage. She was deaf in her right ear, her test came back horrible, she could not hear. The patient (withheld) said that this was because of the COVID virus in the vaccine, that destroyed nerves in the right ear and that was why she could not hear. She was currently taking Prednisone 10mg tablets, take 6 tablets for 3 days, and then 5 tablets for 3 days, and then 4 tablets and changes every 3 days. The patient was prescribed with meclizine 25mg tablets to take 3 times a day for dizziness. She did not have the dizziness when she took the pills. The patient also reported that she was healthy before and she usually takes the flu shot every year and this never had happened before. She was COVID-19 positive on 06Feb2021. She had COVID on 14Feb2021. The events did not require a visit to emergency room. The events were resulted in physician office visit. She would like to verify if this has happened to someone else before and if her hearing will return. The COVID-19 vaccine destroyed her health, and second vaccine was scheduled for 03May2021. The patient would like to know if she should get the second dose of the COVID-19 vaccine after presenting side effects from the first dose. The patient got response that she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The patient was referred to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient's healthcare provider knows your health situation and has access to information that can better help inform this decision. Follow up attempts are possible further information is expected
51 2021-05-12 ringing in ears Tinnitus started approximately 4 hours after receiving my first dose of the Pfizer COVID 19 vaccine.... Read more
Tinnitus started approximately 4 hours after receiving my first dose of the Pfizer COVID 19 vaccine. Other symptoms include dizziness, fatigue, difficulty concentrating at times. The tinnitus has been constant. I saw my PCP, an ENT specialist, and an Audiologist. There is no treatment for the tinnitus and it may be permanent.
51 2021-05-14 double vision Immunocompromised; patient is skinny/underweight; having a multiple sclerosis relapse/Multiple Scler... Read more
Immunocompromised; patient is skinny/underweight; having a multiple sclerosis relapse/Multiple Sclerosis flared up after she got the vaccine; double vision that is intermittent and unilateral; had a funny feeling around the lips, tongue, and on the left side of her face; This is a spontaneous combined report from a contactable consumer (patient) via Pfizer. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199) (51 year at the time of vaccination) via an unspecified route of administration in arm left on 15Apr2021 at 10:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included multiple sclerosis from 2000 and ongoing. The patient's concomitant medications were not reported. On 15Apr2021, after the first dose the patient started experiencing double vision and had funny feeling in her lip, tongue and left side of the face (started prior taking the vaccine). The patient said she might be relapsing from multiple sclerosis. The patient was confused whether she should take the second dose of the vaccine. The patient also received IV methylprednisolone (3gm) (to be administered over 2 hours for three days) and taking prednisone for her double vision which comes and goes. Patient stated she had been immunosuppressed due to being on prednisone for 7days. The patient went to the health care professional and the health care professional gave her a steroid and patient stated the steroid was not responding to the double vision. The patient reported that she does not remember having any issues with her eyes subsequent to taking the vaccine which could be coincidental or nothing to do with the vaccine, but she then developed double vision which was getting worse. The patient also reported that she was skinny and underweight. The patient took 3 grams of Solumedrol IV and it did not help her. Therapeutic measures were taken in response to the events and the patient also had to visit emergency room. The outcome of the event's multiple sclerosis relapse, double vision, immunocompromised and skinny/underweight was unknown while for the event funny feeling around the lips, tongue, and on the left side of her face it was reported as not recovered. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-05-14 eye swelling, eye pain Swelling of outer area of both eyes; Left eye worse: sore, tender to touch and feels like a little f... Read more
Swelling of outer area of both eyes; Left eye worse: sore, tender to touch and feels like a little fluid buildup.; Left eye worse: sore, tender to touch and feels like a little fluid buildup.; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old female patient not pregnant patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 11Feb2021 13:00 (Lot Number: EN5318) as single dose (at age of 51-year-old), for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient had no known allergies (NKA) nor food allergies. First dose of bnt162b2 (BNT162B2), was received via an unspecified route of administration, administered in Arm Left on 21Jan2021 13:00 (Lot Number: EL1283) (at age of 51-year-old), for covid-19 immunisation. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient has not been tested for COVID-19 post vaccination. On 12Feb2021 at 16:00 patient experienced swelling of outer area of both eyes. Left eye worse: sore, tender to touch and feels like a little fluid buildup. No treatment was received. Patient had not recovered from the events, at the time of the report.
51 2021-05-18 mouth discomfort, swollen lips, eye swelling, lip swelling, mouth tingling Feeling a little dizzy here and there, so I am worried/ intermittent mild dizziness; Swelling in sof... Read more
Feeling a little dizzy here and there, so I am worried/ intermittent mild dizziness; Swelling in soft palate and uvula/Soft palate tingling then swelling including uvula (area tender from swelling); Having flare up with my rosacea/Redness on rosacea area; Soft palate tingling then swelling including uvula (area tender from swelling); Soft palate tingling then swelling including uvula (area tender from swelling); Soft palate tingling then swelling including uvula (area tender from swelling); Mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); Swelling in my face and throat; Tingling; Swelling in my face and throat; Redness of rosacea really pop-up red and then my lips were just slight little swollen around my nose and around my eyes; Redness of rosacea really pop-up red and then my lips were just slight little swollen around my nose and around my eyes; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old female patient non-pregnant received 1st dose of BNT162B2, (Pfizer covid-19 vaccine Formulation: Solution for injection, Lot number: EN6207) via an unspecified route of administration, administered in arm left on 13Mar2021 09:45 as 1st dose, single for covid-19 immunisation. Medical history included allergy, insulin resistance, food intolerance, yeast, rice, spaghetti squash, hybrid pumpkin, yogurt, asthma, Thyroid and Hypermobility in joints. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) for Allergy; levothyroxine for thyroid; vilazodone hydrochloride (VIIBRYD); phentermine hydrochloride, topiramate (QSYMIA) and allergy Shot. No other vaccine was received in four weeks. Known allergies are Amoxcillin, Bactrim DS, yeast, rice, spaghetti squash, hybrid pumpkin, Betadine alcoolico, Metrogel, yogurt. Other medical history includes Allergies, asthma in remission, adverse reactions to Welbutrin, Contrave, Oxcarzepazine, Victoza. Patient had surgeries. Patient had blood drawn to check calcium level but don't know if that was within the last 2 weeks. On 13Mar2021 patient stated that I had my first Covid vaccination yesterday (13Mar2021) and I did report "Online" (further not clarified, hence captured as initial report) because I did have some swelling in my face and throat and there was sometimes that I was feeling a little dizzy here and there, so what I am worried about is, if I am going to not have the next vaccination because I am scared of the disease too. That's why I called. When paraphrased the concern, consumer stated, Yes and now the swelling that I had was on my soft palate and my uvula. It started tingling and then I did have some swelling there and on my face, I have rosacea and, so was having the flare up with my rosacea anyway, and that made all the areas that I had the redness of rosacea really pop-up red and then my lips were just slightly swollen and it was a little swollen around my nose and around my eyes and the dizziness it was just here and there, it was not anything big but this is a kind of reaction that I have, the thing the soft palate of my throat I have had that before when I had eaten eat something yeast and something like that, so I do not know is the shot may be have yeast so but I have not had that kind of slight swelling there on my face before, that's what I called. When probed for other Medical condition, consumer stated, I actually have allergies, they were pretty bizarre (not clarified) and Allergist calls me his special patient and I have food intolerances, so that's, the things right they are a lot of them. The thing that has calls me the most trouble is yeast. It does not matter if it is baker's yeast or brewer's yeast or yeast extract and I have unusual one like spaghetti squash and hybrid pumpkin, the spaghetti squash was the pumpkin and having that spaghetti squash in the hybrid pumpkin mainly react to it. In response to other medical condition, consumer stated, "There are other medication, I do have some other health conditions, I have Hypermobility in my joints, and I have a lot of "weird" (not clarified) things that I had like surgeries for different thing too but the main, and I am considered insulin resistance and I have had reactive low blood sugar at a time. Shot at 09:45 on 13Mar2021, experienced Soft palate tingling then swelling including uvula (area tender from swelling), mild swelling around nose, eyes and lips (areas feel tight sort of burn), intermittent mild dizziness. Redness on rosacea area. Benadryl -1 at 10:30, 1 at 11am, 2 at 2:41pm experienced headache (pain, pressure) at 01:45, Advil -1 at 07:45 experienced face flushed/hot feeling. Benadryl was self-administered as treatment. No covid prior vaccination and the patient was not tested for covid tested post vaccination. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-05-19 lip swelling Have has 3 severe allergic reactions; Hives; Lip swelling; This is a spontaneous report from a conta... Read more
Have has 3 severe allergic reactions; Hives; Lip swelling; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 04Apr2021 13:00 (Batch/Lot Number: E97533) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Hypertension and "Hashimotos". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included metoprolol, potassium, furosemide (LASIX), famotidine and levothyroxine sodium (LEVOTHYROX); all from unspecified dates and unknown if ongoing, for unspecified indications. Patient's known allergies includes, strawberries, aspirin, zyban, eggs. On 23Apr2021 08:00, the patient had 3 severe allergic reactions; these reactions include hives and lip swelling requiring treatment via injection of epinephrine, decadron, albuterol and pepcid. Due to pandemic isolation, any other possible triggers for reaction have been tested and excluded. the events resulted in Emergency Room/ Physician's Visit. The outcome of event was reported as recovering. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
51 2021-05-21 thirst nearly passed out; the shoulder where she got her injection started hurting really bad; getting hot;... Read more
nearly passed out; the shoulder where she got her injection started hurting really bad; getting hot; sweating; thirsty; Her blood pressure dropped; couldn't breathe; arm hurting really bad; got very weak; turned gray, like an elephant; felt floaty; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at left shoulder (Arm Left) on 19Apr2021 10:00 AM at age of 51 years old (Batch/Lot number was not reported) as 1ST, SINGLE for covid-19 immunisation. The patient's medical history was reported as just told her blood pressure dropped on an unknown date, hooked patient up to a bunch of wires and stomach, monitoring her on a machine. The last couple of time patient had blood drawn, the one last time, she went into shock and passed out. This wasn't quite the same thing with this time. This was maybe 2 years before unspecified date. One time it was pretty bad and patient fell down, get the doctor and hook patient up to all that stuff. Didn't' quite feel the same way as this time. She didn't get hot and sweaty. Patient was not taking any pills. The concomitant medications were not reported. After first dose of the Pfizer covid vaccine. After the injection on 19Apr2021, patient sat for 15 minutes (wait for 15 minutes) and the shoulder where she got her injection started hurting really bad. Arm hurting really bad, walked across the hall and sat in the chair, maybe 2 minutes later. Then started tearing her mask off because she couldn't breathe. Patient started getting hot, sweaty and thirsty. Patient was sweating, started getting hot and thristy and then got really sweaty and super hot. Got really thirsty and was given water. She was trying to grab a bottle of water and she didn't have the strength. She got very weak, turned gray, like an elephant and her blood pressure dropped, and nearly passed out. It lasted maybe 10 or 15 minutes. They called the ambulance. By the time they got there, she was feeling more back within herself and It was pretty much done and was totally better, maybe 90 percent. She just wanted to go home and did not go in the ambulance. She felt floaty but did not pass out. With the first one, she had a reaction and is wondering if she should even take the second one. Therapeutic measures were taken as a result of thirsty included water. Treatment for other event was reported as none, and she was not taking any medication. The event outcome of recovered on 19Apr2021. Information about lot and batch number was requested.
51 2021-05-23 ringing in ears When I received the first dose 4/7/21, I had a burning sensation go up my left arm to my face. My f... Read more
When I received the first dose 4/7/21, I had a burning sensation go up my left arm to my face. My face felt hot and then my chest. I felt scared like I could be having something wrong but I continued on. I then got very tired. The next day I felt achy knees. Two days later I started having buzzing in my ears but didn't realize it could be a side effect. I went to a Urgent Care and was treated for a possible ear infection and given antibiotics. That did not help or cure my condition. The buzzing/ringing is on the same side/left as my injection. On 5/5/21, I went for my second injection and asked if the buzzing/ringing or being on antibiotics was a problem, they said no. The buzzing/ringing increased. I went to my regular Primary Care doctor who didn't see anything wrong. She referred me to an ENT. The ENT ran a hearing test. The hearing test seemed to come back ok but I still have the Tinnitus. The Tinnitus is worse at night and in the morning when everything is very quiet. Some days are worse than others and I have seen no improvement. I also am experiencing hot flashes. They also happened after the first shot and increased after the second. The Tinnitus is very bad at time and I want it to go away. It is like buzzing in my left ear that is always there but sometimes I can tune it out. I think it is important to report this as I have not had anyone tell me it is a possible side effect. If it is than this needs to really be investigated and studied and communicated with people. It is very disturbing as I have never had Tinnitus before. I hope and pray it goes away and there are no other side effects.
51 2021-05-24 loss of taste, mouth numbness Tongue numbness loss of tastes. Chin, cheek and lip lower. Loss of taste right half of all.
51 2021-05-26 mouth tingling LIPS WERE TINGLING. PATIENT GIVEN STEROIDS AND BENADRYL. RECOVERED. ATTEMPTED TO CALL X 4 FOR F/... Read more
LIPS WERE TINGLING. PATIENT GIVEN STEROIDS AND BENADRYL. RECOVERED. ATTEMPTED TO CALL X 4 FOR F/U BUT NO ANSWER WHEN CALLED
51 2021-05-27 eye irritation Muscle tightness and pain, joint pain, headache, nausea, severe back pain, abdominal pain, scratchy ... Read more
Muscle tightness and pain, joint pain, headache, nausea, severe back pain, abdominal pain, scratchy sore throat, emotional, depressed, shortness of breath, severe fatigue, confusion, foggy head, lack of focus, lack of concentration, eye sensitivity, skin sensitivity
51 2021-05-28 oral mucosal blistering, swollen tongue mouth and throat broke out in blisters; mouth and throat broke out in blisters; Tongue is broke out ... Read more
mouth and throat broke out in blisters; mouth and throat broke out in blisters; Tongue is broke out with white sores; tongue is swollen; breathing problems; cough; constantly clearing throat; malaise; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6207), via an unspecified route of administration in left arm on 21Apr2021 10:00 (at the age of 51-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (lot: EP6955) on 31Mar2021 at 10:00 in left arm (at the age of 51-years-old) for COVID-19 immunization. Medical history included asthma, Ehlers Danlos Syndrome, postural orthostatic tachycardia syndrome (POTS), immune disorder, Medium-chain acyl-coenzyme A dehydrogenase deficiency (MCAD), Irritable bowel syndrome (IBS), Chiari-decompressed, anxiety and depression. The patient had no known allergies. The patient's concomitant medications were not reported. The reported adverse events were mouth and throat broke out in blisters; Tongue was broke out with white sores, tongue was swollen, breathing problems, cough, constantly clearing throat and malaise on 24Apr2021. The events resulted doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included prednisone, z pack, valacyclovir hcl, nystatin. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination (post vaccination), patient has been tested for COVID-19 (nasal swab) on 29Apr2021 with result of negative. The outcome of the events was not recovered.
51 2021-05-28 swollen tongue throat and tongue swelling; throat and tongue swelling; This is a spontaneous report from a contacta... Read more
throat and tongue swelling; throat and tongue swelling; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3246) via an unspecified route of administration, administered in left arm on 08Jan2021 at 11:00 (at the age of 51-years age) as single dose for COVID-19 immunization in a hospital. Medical history included hypothyroidism, osteoporosis, and allergies to penicillin, sulfa, nitrofurantoin, levaquin (from an unknown date and unknown if ongoing). Patient received atorvastatin (ATORVASTATIN), levothyroxine sodium (SYNTHROID) and fluticasone (FLUTICASONE) within 2 weeks of vaccination for unspecified indications. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 09Jan2021 at 11:00, the patient experienced throat and tongue swelling. Events resulted in Emergency room/department or urgent care. Patient received treatment with prednisone for the events. On an unspecified date in 2021, events recovered. Follow-up attempts completed. No further information expected.
51 2021-05-28 ringing in ears headache; sweats/hot flashes; sweats/hot flashes; ringing of ears that are still happening 4 days la... Read more
headache; sweats/hot flashes; sweats/hot flashes; ringing of ears that are still happening 4 days later; arm pain from shot but now seems ok; This is a spontaneous report from a contactable consumer. A 51-years-old female patient reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 14:00 (Batch/Lot Number: EN6203) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); omeprazole (PRILOSEC [OMEPRAZOLE]). The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 03Mar2021, the patient experienced headache, sweats/hot flashes, ringing of ears that were still happening 4 days later, arm pain from shot but now seems okay. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
51 2021-05-29 deafness unilateral, permanent deafness Sudden hearing loss in left ear, diagnosed by audiogram and doctor exam; diagnosis: Sudden Sensorine... Read more
Sudden hearing loss in left ear, diagnosed by audiogram and doctor exam; diagnosis: Sudden Sensorineural hearing loss
51 2021-05-29 taste impairment 1st shot just arm soreness and metal taste in mouth 2nd shot subconjuctival hemorrhage 6hrs post inj... Read more
1st shot just arm soreness and metal taste in mouth 2nd shot subconjuctival hemorrhage 6hrs post injection. start of menstral cycle 9hrs post injection
51 2021-05-29 eye irritation Between 24-48 hours began have reactions not expected. Pain in LEFT foot and toes. Severe pain in LE... Read more
Between 24-48 hours began have reactions not expected. Pain in LEFT foot and toes. Severe pain in LEFT hand, fingers, wrist, and forearm. Then pain in BOTH wrists, hands, feet, and then lower back pain. The pain moved from scary levels to dull pain over the 2 weeks post-vaccination. I expect the pain will go away soon. The use of my hands was affected. Walking was affected. It felt like the lymph nodes around my ears, neck, face, eyes, chest, arms, abdomen, legs were all swollen. Can swollen lymph cause carpal tunnel like symptoms? Foot pain? Lower back pain? Began to have allergic like skin reactions 5 days post-vaccination. Burning eyes, itchy skin. Still experiencing itchy skin with red/warm face 13 days post-vaccine. Antihistamine relieves most symptoms. This vaccine does not seem sustainable for me as a yearly vaccine. (I had red palms after the 1st vaccine within hours. I am not sure if this was a reaction to the vaccine. I began taking antihistamine before the 2nd vaccine and did not get red palms. I have no idea if red palms were an early hint that I would be hyper sensitive to the vaccine.)
51 2021-06-01 mouth tingling, mouth numbness The patient received the first dose of covid vaccine at 10 am then went to her car at 10:30 am. Came... Read more
The patient received the first dose of covid vaccine at 10 am then went to her car at 10:30 am. Came back into the monitoring area at 11 am complaining of numbness and tingling around the lips. Patient states 'a general coldness." The patient was given 25 mg of Benedryl. The Benedryl didn't make things better but the symptoms didn't worsen.
51 2021-06-01 swollen tongue Swelling of my tongue and face. Could still breath so didn't go to emergency room. Fully went away a... Read more
Swelling of my tongue and face. Could still breath so didn't go to emergency room. Fully went away after about 4 hours. Left arm could barely lift through the next day. Achy sinuses feeling through the next day.
51 2021-06-03 ear pain swollen lymph node in RT side of the neck; extreme discomfort; producing an earache; sore neck/shoul... Read more
swollen lymph node in RT side of the neck; extreme discomfort; producing an earache; sore neck/shoulder x 3 days which began the day after the injection; sore neck/shoulder x 3 days which began the day after the injection; This is a spontaneous report from a contactable other hcp (patient). A 51-years-old (non-pregnant) female patient received BNT162B2 (BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), dose 1 intramuscularly, administered in Arm Left on 04Mar2021 11:30 (at the age of 51-years-old) as SINGLE DOSE for covid-19 immunization at School or Student Health Clinic. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, migraine, attention deficit hyperactivity disorder, drug hypersensitivity (sulfa allergy) with supplementation therapy from an unknown date. Concomitant medications included pregabalin (LYRICA), naproxen (NAPROXEN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cetirizine hydrochloride (CETRIZINE), vitamin b complex (VIT B COMPLEX), calcium (CALCIUM) tizanidine (TIZANIDINE); quetiapine fumarate (SEROQUEL) was taken for an unknown indication from an unknown start date at an unknown dose and magnesium (MAGNESIUM) taken for supplementation therapy, from unknown start date. The patient had not covid prior vaccination. The patient did not have any other vaccine in the past four weeks. On 05Mar2021 08:00AM, the patient experienced swollen lymph node in RT side of the neck, extreme discomfort, producing an earache and sore neck/shoulder for 3 days which began the day after the injection. The patient did not receive any treatment for events. The patient was not tested for covid post vaccination. The outcome of the events was reported as recovering at the time of report. No follow-up attempts are possible. No further information is expected.
51 2021-06-03 ringing in ears Loud ringing sound inside my right ear; This is a spontaneous report from a contactable consumer, th... Read more
Loud ringing sound inside my right ear; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA165969), via an unspecified route of administration in the right arm on 16Mar2021 at 14:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer treatments completed recently including chemo and radiation. Concomitant medication included minocycline 100mg capsule and (sulfonamide) SULFACETAMID lotion 10% for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products was reported as None. On 16Mar2021 at 20:45, the patient experienced loud ringing sound inside right ear, that started about 6 hours after first dose. The patient did not receive treatment for the reported event. The clinical outcome of the ringing in ears was not recovered. No follow-up attempts are needed. No further information is expected.
51 2021-06-03 visual impairment lightheadedness; headache; vision changes; increased respirations; This is a spontaneous report from... Read more
lightheadedness; headache; vision changes; increased respirations; This is a spontaneous report from a non-contactable healthcare professional. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EN6205, Expiration date was not reported), intramuscularly on an unspecified date (at the age of 51-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included asthma (often triggered by stress and does have albuterol inhaler on hand) from an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced lightheadedness, headache, vision changes and increased respirations. It was reported that during the 15-minute waiting period after the injection, the patient began to experience lightheadedness, headache, vision changes and increased respirations. The patient denied rash, hives, difficulty swallowing, wheezing, throat tightness and hoarseness. The patient has a history of asthma often triggered by stress and does have albuterol inhaler on hand but has not used today. The patient denied frequent use of albuterol inhaler. Treatment included was water and TYLENOL 1000mg. The followup response to treatment was good. The patient's symptoms all resolved prior to discharge. The patient's O2 remained 99-100%, denied difficulties breathing and respirations decreased while she was in the bay. The patient was discharged, stable to go home and for follow up with PCP. The outcome of the events was recovered. No follow-up attempts are possible. No further information expected.
51 2021-06-06 mouth numbness 5 minutes following the shot in my left arm, the left side of my throat, tongue and face (from under... Read more
5 minutes following the shot in my left arm, the left side of my throat, tongue and face (from underneath eye, down to mandible, across from ear to nose) went numb. Feeling was similar to that of being frozen for a dental procedure. It lasted 48 hours. My left hand and foot also went numb and remain mildly numb. Similar to feeling I had when my spinal court tumor was discovered 15 years ago. Post resection, it subsided as pressure on nerves was alleviated. Very scary. I won?t return for a second shot.
51 2021-06-06 vision blurred Initially slight headache, 5hrs later difficulty moving from waist down, 4/18/21 - tingling from wai... Read more
Initially slight headache, 5hrs later difficulty moving from waist down, 4/18/21 - tingling from waist down, went to ER no reflex response in both knees, 4/19/21 tingling in both arms, over a period of six days severe headache, lower body weakness, nausea. When discharged still lower body weakness. Since that time in May experienced 5/2021 complex hemiplegic migraine, lower body weakness waist down. Presently 6/2021 still lower body weakness and severe hemiplegic migraine, blurred vision.
51 2021-06-07 taste impairment Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infec... Read more
Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infection; She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing; arm swollen; Rash; lot of stuffy nose; really bad runny nose; she can't breathe to sleep; ears going plugged; she had a bloody flavor and blood was coming little portion of her coughing; bronchitis symptoms; congestion in one side of my head or in the upper front side, similar like a sinus infection; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in right arm on 17May2021 (Batch/Lot number was not reported) (at age 51 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date at age 51 years old for COVID-19 immunization. The patient reported she had the second shot for the vaccine (confirmed as Pfizer COVID vaccine) on 17May2021 almost at midnight and she had been really sick since Wednesday. She clarified that it was really bad from Monday (17May2021) but on the Tuesday (18May2021) she has her arm swollen and the rash but she thought it was normal and then from the 17May2021 up to the time of report she has been really, really sick, like bronchitis symptoms something like that and she had a lot of stuffy nose and she had congestion in one side of her head or in the upper front side, similar like a sinus infection. She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing, really bad runny nose and she can't breathe to sleep, she had to use (incomplete sentence). The patient's husband stated she got no treatment she did not go to the doctor. They wanted to know if she can take cold medicine because she was up with pneumonia. Outcome of the events was unknown. Information about lot/batch number has been requested.
51 2021-06-07 eye swelling Patient's upper extremities and face swelled up. Eyes were also swollen shut. Injection site on left... Read more
Patient's upper extremities and face swelled up. Eyes were also swollen shut. Injection site on left arm was the size of a half dollar coin.
51 2021-06-08 ear discomfort, ear pain Pt reported she felt dizzy and nausea and had a pain and fullness in left ear. Slight edema under ri... Read more
Pt reported she felt dizzy and nausea and had a pain and fullness in left ear. Slight edema under right eye. Pt had no respiratory difficulties. Pt was went to the emergency department. At the ED pt reported chest pain onset this morning prior to vaccine and feels similar to prior episodes of GERD. Chest pain is described as a pressure sensation. Denies tongue swelling, difficulty swallowing or speaking, rash, abdominal pain, nausea, vomiting. On exam per ED note: no significant facial swelling noted, no tongue swelling. EKG performed 6/9/21 pt in normal sinus rhythm. Chest xray 6/9, impression: Elevation right hemidiaphragm and low lung volumes. no radiographic evidence of acute cardiopulmonary process. Pt did not want to wait in the ER and was angry about the wait time. Pt's breathing was easy and unlabored. Ambulatory out of ED with steady gait. Pt left ED.
51 2021-06-08 ringing in ears I was fatigue and muscle aches and pain in left arm. It lasted for about 2-3 days. The first day abo... Read more
I was fatigue and muscle aches and pain in left arm. It lasted for about 2-3 days. The first day about 4hrs after getting the injection I developed a high ringing noise in my left ear and it is still present to this day. Ten days after getting the vaccine my allergies got really bad and I had to increase my meds it lasted for about three days.
51 2021-06-09 eye floaters, light flashes or floaters in the eye retinal tear; Floaters; flashes of light; dose 1 given 30Mar2021 and dose 2 given 13Apr2021; This is... Read more
retinal tear; Floaters; flashes of light; dose 1 given 30Mar2021 and dose 2 given 13Apr2021; This is a spontaneous report from a contactable consumer (patient). This 51-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine)(Batch/Lot Number: EW0161), dose 2, via an unspecified route of administration, administered in the left arm on 13Apr2021 at 09:00 (at the age of 51-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EP7534), dose 1, via an unspecified route of administration, administered in the left arm on 30Mar2021 at 09:00 as 1ST DOSE, SINGLE for COVID-19 immunization with no adverse effects reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 18:00, the patient experienced floaters, flashes of light and retinal tear. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures taken included an unspecified "laser". Clinical outcome of floaters, flashes of light and retinal tear was recovered with sequelae (reported as recovered with lasting effects). Clinical outcome of inappropriate schedule of vaccine administration was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
51 2021-06-10 mouth numbness, dry mouth dry mouth; tongue felt lazy; trouble swallowing; light headed/Felt faint; Starting tingling; itching... Read more
dry mouth; tongue felt lazy; trouble swallowing; light headed/Felt faint; Starting tingling; itching; Face broke out with a rash; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER, formulation: solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:15 (at the age of 51-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, hypertension, pituitary tumour benign, drug hypersensitivity and food allergy from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. The patient did not have covid prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021, the patient experienced dry mouth and tongue felt lazy for 8-10 minutes, lightheaded/felt faint for 10-12 minutes, itching for 30 minutes, trouble swallowing, tingling and face broke out with a rash. Therapeutic measures were taken as a result of the events. The patient was treated with Benadryl for these allergic reactions. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
51 2021-06-10 swollen tongue Patient states that she is having numbness to face. Feels like tongue is swollen. Reports stiffnes... Read more
Patient states that she is having numbness to face. Feels like tongue is swollen. Reports stiffness to neck. Patient instructed to massage area. Patient reports symptoms no longer persist.
52 2020-12-31 ringing in ears Tinnitus, worse in left ear. Heavy feeling all over. Headache, Tylenol 500mg q6h.
52 2021-01-01 dry eye, eye irritation After receiving the vaccine, my eyes got severely dry to the point I had to use drops. They felt li... Read more
After receiving the vaccine, my eyes got severely dry to the point I had to use drops. They felt like sand was blown in them.
52 2021-01-02 oropharyngeal discomfort About 5 mins after vaccine was received patient started wheezing, felt like her throat was closing. ... Read more
About 5 mins after vaccine was received patient started wheezing, felt like her throat was closing. Difficulty breathing
52 2021-01-02 mouth tingling Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
52 2021-01-03 taste impairment Immediately I had a bitter/metal taste at the end of my throat. It last about 5 hours and and ended... Read more
Immediately I had a bitter/metal taste at the end of my throat. It last about 5 hours and and ended about 2:30-3:30pm. I had a bitter/metal taste when I ate anything or drank water.
52 2021-01-03 mouth numbness 52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial dr... Read more
52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial droop as left lower lip numbess on 31 Dec 2020, which has become more pronounced over the past 2 days. She states she spoke to the nurse hotline right before speaking to me who told her to go to the ED (she was on her way). Denies any extremity weakness, numbness, HA or dizziness. No pain to face or ear. Speech clear on the phone. No recent illness or history of Bell's palsy. NKDA or any prior adverse reactions to immunizations.
52 2021-01-03 mouth tingling Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to b... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered "no" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
52 2021-01-04 feeling of choking Tingling in throat; throat swelling; This is a spontaneous report from a contactable nurse (patient ... Read more
Tingling in throat; throat swelling; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient received first dose of BNT162B2 (lot number: EH9899; expiry date: 31Mar2021), via an unspecified route of administration, on 28Dec2020 10:00 am (left arm), at a single dose, for COVID-19 vaccination. Relevant medical history included hypertension and seasonal allergies. Concomitant medication included levocetirizine dihydrochloride (XYZAL). The patient previously took losartan, sulfa, ultram, morphine, codiene, and lisinopril and experienced allergies. On 28Dec2020, at 10:15 a.m., the patient experienced tingling in throat and throat swelling. The patient received Benadryl as treatment for the events. Outcome of the events was recovering.
52 2021-01-04 drooling within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was m... Read more
within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was monitor there. my blood pressure was noted to be low at 115/41. HR 74. reepat BP was 121/48 which is much lower than my usal BP. i was observed for about 1 hrs. the sx's did not go away but the BP improved a little to 130/64 standing. I went home develop injection site pain, fatigue, headache and the pesistent salivation did not go away. after 1 wk it decreased in frequency but still present today. I can not do my normal activity as this worsen the symptom. and my blood pressure has not normalized. still run in 110's/60's. the headaches and fatigue are becoming a burden.
52 2021-01-04 thirst Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toe... Read more
Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
52 2021-01-04 ringing in ears Woke up at 3:30 am due to ringing in my left ear. Ringing has continued all day.
52 2021-01-05 loss of taste, loss of smell High fever; headache; myalgia ; inbility to smell or taste; fatigue on 22nd; hAD THOSE SYMPTOMS FOR... Read more
High fever; headache; myalgia ; inbility to smell or taste; fatigue on 22nd; hAD THOSE SYMPTOMS FOR ABOUT A WEEK; tested positive for COVID on Dec 26. haven't recovered inablity to smell or taste; fatigue - still have that, too;
52 2021-01-05 loss of taste Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, n... Read more
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
52 2021-01-05 pupils dilated Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated p... Read more
Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.
52 2021-01-05 swollen tongue 10 minutes after administration, back of tongue and soft palate started feeling strange sensation wi... Read more
10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; Other vaccine was received on same date vaccine date 30Dec2020; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EJ1685), intramuscularly on 30Dec2020 at 12:30 PM on Right arm at single dose for COVID-19 immunization in hospital. Other vaccine was received on same date vaccine date 30Dec2020. The patient medical history included known allergies: Shellfish. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications within two weeks of vaccination. The patient experienced 10 minutes after administration on 30Dec2020 at 12:40 PM, back of tongue and soft palate started feeling strange sensation with some swelling. After 30 minutes, the sensation eased up but the swelling stayed the same, not getting any worse. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL). The outcome of the event 'feeling strange sensation' was recovering, outcome of events 'back of tongue and soft palate swelling' was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
52 2021-01-05 taste disorder the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; t... Read more
the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; top of her stomach had a bad burning sensation; Vomiting; she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing; sore throat with a mild cough, like she needed to be clearing her throat; sore throat with a mild cough, like she needed to be clearing her throat; got a chill; food was not tasting right; arm was sore; could not raise her arm; her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on 21Dec2020 on left upper arm at a single dose for COVID-19 prevention. Current medical history included a lung disease called asthma and allergies, diagnosed in her late 20's; Diabetes Type 2, diagnosed about 10 years ago and High Blood pressure, diagnosed when she was in her 30's. Caller also wanted to include that she did have COVID before, she had COVID in Jul2020. Current concomitant medications included salbutamol (ALBUTEROL) at 2 Puffs via inhalation, twice daily for asthma; Unspecified Blood Pressure Medication One pill, once daily by mouth in the morning; Unspecified Nasal Spray 1 spray in each nare, once daily via nasal inhalation; montelukast sodium (SINGULAIR) at 1 pill via oral, once a day for allergies; metformin at 1 pill, daily, by mouth for Diabetes Type 2. The patient stated that her place of employment did not give her the card that has the lot number on it, they said they would give it to her with her second injection. The patient did not know the dose received, just that it was the first in the series. The patient had no other vaccines on the same day as the COVID vaccine. The patient reported that her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds. The patient received the vaccine on 21Dec2020, and as soon as she got the shot, her arm was sore like a flu shot. When she got the shot, she could not raise her arm past her shoulder without pain, but now she can raise her arm again. On Thursday, 24Dec2020, patient got a chill, and later that same night, food was not tasting right. On 25Dec2020, the chill continued, and she had a little bit of a sore throat with a mild cough, like she needed to be clearing her throat. On 26Dec2020 morning, the patient experienced vomiting when she woke up, and the top of her stomach had a bad burning sensation, and she had diarrhea. The patient stated that while she was vomiting, she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing. But the patient stated that she vomited, had diarrhea, and the burning sensation, the whole day on Saturday. The patient stated that on 27Dec2020, it calmed down, and she did not vomit at all. The patient stated that she felt like she needed to vomit, but she did not. The patient states that on Sunday, she still had the chills a little, and the top part of her stomach was still burning. The patient took some Pepto-Bismol and that helped calm down the caller's stomach. The patient stated that she could feel the Pepto-Bismol cooling her stomach off, like it had been hot, and patient stated that the top of her stomach felt swollen and gassy. The patient stated that later Sunday night, things calmed down, but she still has the burning sensation and she did not feel like she needed to vomit anymore. This morning, patient reported that she still has some burning sensation, but now, it is coming and going like labor pains. The patient stated that she did go to the bathroom once this morning and had diarrhea that was like liquid-y water. The patient stated that during all this over the last few days, each and every time that she tried to eat, she couldn't eat much because her stomach would burn more with eating. But yesterday, the patient had some fried fish and stated that the fried fish did not burn as much as the rest of the food she tried eating. The outcome of the events vomiting and the top of her stomach felt swollen and gassy was recovered on 27Dec2020, arm was sore and could not raise her arm was recovered on 26Dec2020, chills, top of her stomach had a bad burning sensation was recovering, Diarrhea/had diarrhea that was like liquid-y water was not recovered and other events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vomiting and Foreign body aspiration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-01-06 eye twitching, mouth tingling, mouth numbness Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was t... Read more
Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was tingling and felt numb. I continued to close up my desk to leave work for the day thinking it would just go away in few minutes. When I got to my vehicle I took two Benadryl capsules and drank a bottle of water and waited nearby the hospital emergency department parking area for 30 - 40 minutes. The numbness had eased and I drove home. Tuesday and today (Wednesday) I have felt very tired and fatigued.
52 2021-01-06 mouth numbness Diarrhea numbness of face/tongue Narrative:
52 2021-01-06 bloodshot eyes, eye swelling, eye itchiness Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon re... Read more
Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon review, patient eyes red and swollen, palms of hands red and sweaty, chest rashy, ears red. Injection site WNL.
52 2021-01-06 ringing in ears constant ringing in ears since vaccine, softer and high pitched, it is constant at a softer level an... Read more
constant ringing in ears since vaccine, softer and high pitched, it is constant at a softer level and then increases to higher and louder. no dizziness, lightheadedness, nausea, visual disturbances, numbness or tingling - it is just the ringing.
52 2021-01-06 vision blurred Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B... Read more
Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B/P dropped to 95/55- She stayed in ER until 11am, No Sxs of breathing issues or SOB. She was NOT admitted, just observed until B/P went up. Vaccine was given in the ED- reason not given.
52 2021-01-07 taste impairment After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mout... Read more
After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mouth. My bones hurt, and my neck hurt really bad. that lasted for three days. I developed chills and a fever, I felt really sick. I had a COVID test and was positive.
52 2021-01-07 eye swelling 12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., i... Read more
12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., itching (Brazo caliente)
52 2021-01-07 feeling of choking, mouth tingling 5 minutes after injection had internal thickening of throat and difficulty swallowing. After a coupl... Read more
5 minutes after injection had internal thickening of throat and difficulty swallowing. After a couple of minutes swallowing improved but throat thickening continued for another approximately 15 minutes. At 50 minutes after the injection had faint tingling around the mouth and mild throat internal throat thickening again. Took 25 mg of Benadryl. No further s/s.
52 2021-01-08 tongue itchiness, ringing in ears, swollen tongue Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was h... Read more
Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was high, dizziness and ringing in the ears
52 2021-01-09 swollen tongue Turned red in upper torso, swelling to tongue and heightened blood pressure.
52 2021-01-10 ear pain Left arm pit pain, left neck pain, intermittent left ear pain. Tolerable mild discomfort. No treat... Read more
Left arm pit pain, left neck pain, intermittent left ear pain. Tolerable mild discomfort. No treatment.
52 2021-01-10 eye pain, swelling of eyelid within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-fill... Read more
within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-filled lesions. Has an appointment with the family physician at 4:40 pm today January 11, 2021
52 2021-01-10 mouth tingling, mouth numbness Employee experienced numbness and tingling of lips and mouth which occurred approximately twenty (20... Read more
Employee experienced numbness and tingling of lips and mouth which occurred approximately twenty (20) minutes after receiving second dose of Pfizer COVID-19 vaccine. Employee was taken to the Emergency Department for treatment. Employee received two (2) doses of Decadron 6 mg by mouth, Benadryl 50 mg by mouth, and Pepcid 40 mg by mouth.
52 2021-01-10 swelling around the eyes 52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin... Read more
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
52 2021-01-10 sensitivity to light Migraine headache began the next morning about 7am and increased as the day progressed including nau... Read more
Migraine headache began the next morning about 7am and increased as the day progressed including nausea and light sensitivity. Waves of nausea and headache continued into the next day. I had not had a migraine in over 2 years prior to this event. Treated with OTC Excedrin at first on Jan 10th, then when that was ineffective took butabital at lunch time and when that was ineffective took Maxalt with phenergan about 5p. The next day on Jan 11th, thought I was better but by 630a nausea returned in waves and headache began building again. Took Maxalt with phenergan about 930a and again at 9p.
52 2021-01-10 ringing in ears Muscle ache and tinnitus. Denies hearing loss
52 2021-01-11 mouth numbness injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness ... Read more
injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness on tong, headache, pain on back of neck, body pain down the back, diarrhea, stomach cramps, very tired, nausea, stomach bloating
52 2021-01-11 mouth numbness Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving ... Read more
Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving home. Took 1 benadryl when I got home and all symptoms subsided approx 30 minutes later.
52 2021-01-11 mouth numbness Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - fir... Read more
Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.
52 2021-01-11 lacrimation increased, eye itchiness, eye swelling Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eye... Read more
Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eyes swelled. Significant scleral edema bilaterally but mostly left eye. Sudden chills and felt freezing in extremities. Face became tingly. Took 50 mg Benadryl, Claritin and rescue inhaler (2 puffs albuterol). Within 1.5 hours felt better and able to rest. Still Itchy but wheezing was better. On 1/12 woke with swollen eyes. Took 25 Benadryl and Claritin. Walked 1 mile and began to wheeze. Took albuterol and rested.
52 2021-01-12 mouth numbness At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Use... Read more
At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Used medication for asthma. Flovent inhaler for 5 times. Used xyzal 5mgs via oral. These medications are used by doctor's orders.
52 2021-01-12 ringing in ears, ear discomfort, deafness I had a mild headache the evening of the shot, I had a headache the next two days that was relieved ... Read more
I had a mild headache the evening of the shot, I had a headache the next two days that was relieved by Advil. I had a very sore arm at the injection site Friday and Saturday after the shot was given. The arm pain was gone Sunday morning. I was very tired on Saturday especially and slept through the morning and early afternoon on and off until about 3:00 pm. On Friday during the day, I noticed my right ear starting to feel unusual and uncomfortable. On Saturday, the ear issue continued, I felt like I had some hearing loss and a constant buzzing and ear fullness feeling. On Sunday, the ear issued continued with the hearing loss, buzzing and fullness and has through today and hasn't stopped. I tried some nasal decongestant on Sunday afternoon, but it didn't have any effect. I made an appointment with the ENT doctor on Monday morning for Tuesday. I had a hearing test on Tuesday and saw the ENT doctor on Wednesday. He prescribed prednisone and ordered an MRI. I will be starting the prednisone later today (Wednesday) when the pharmacy has the prescription ready.
52 2021-01-13 mouth tingling, ear discomfort About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I fel... Read more
About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I felt pain in my temple and I also felt like my ears were clogged. My tonugue was tingling and I had pain across my chest. I had trouble swallowing and taking a deep breath. The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay. When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck. My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl. I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
52 2021-01-14 loss of taste, loss of smell Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of b... Read more
Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of both of my hands with itching and warm redness in them both (I have pictures) Within an hour it began feverish red itching and slight burning on both of The undersides of my forearms. I was advised by the pharmacists on duty in the covid clinic site to use topical Benadryl cream and or take Benadryl by mouth if it worsened. I was told to seek emergency dept help if any signs of breathing issues presented. The next morning the itching was gone the redness subsided and the rash was markedly better but still raised in the tops of my hands. By 1030am on 1/12/21, I could not detect taste or smell at all. I was advised then to report to employee healthline for further instruction. I was told to leave work and proceed to our employee Covid swab testing drive thru facility for Covid testing and remain home for results the following morning on 1/13/21. At approximately 10am 1/13/21 I was confirmed positive for COVID-19 via the swab results. I was told to quarantine and given a return to work date of 1/24/21 as long as my symptoms were resolved. I am currently in home quarantine still suffering no taste or smell, muscle cramps in legs, thighs and back. Fatigue, Loss of appetite, sinus pressure and headache not relieved with medications.
52 2021-01-14 ear pain neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder a... Read more
neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder and over to right ear; left arm sore; neck sore to left shoulder and over to right ear; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number EK4176, Expiry Date: Mar2021, via an unspecified route of administration on 21Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband was calling for his wife that had the second shot. He stated that she was a nurse. He stated that she came home from work with her arm and neck sore. He stated that the neck soreness was causing ear ache. He stated that her fever was 102.9 and stated that they put a cool rag on her head. He stated that she had the shot yesterday and stated that she had her first shot 21Dec2020. They stated that arm sore at 1:00 in morning and stated sore neck at 11:30 this morning. Fever started at 11:30 and was 99.7 and about 15 minutes later was 99.9 and stated that was with having three Aleves. She stated that it is back up to 102.9 and stated that the right ear ache started at 11:00am today. The patient underwent lab tests and procedures which included body temperature: 102.9 on 08Jan2021, 99.7 on 08Jan2021 and 99.9 on 08Jan2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of events was not recovered.
52 2021-01-14 mouth discomfort, mouth tingling Sores on inside of lips, burning tingling lips
52 2021-01-14 pain in jaw, ear pain Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination.... Read more
Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination. Still experiencing as of 1/15/2021. On 1/14/2021 experienced throbbing under ear to jaw bone.
52 2021-01-14 mouth tingling, swollen tongue 1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor ... Read more
1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor as she was anxious prior to receiving vaccine 1444 states sxs are getting worse, still no swelling or SOB noted 1445 States she now feels like tongue is swelling and lump in throat is worse, cough noted. 99.5F, 97% RA, 102HR, 22 Resp, 146/99 BP 1448 Hoarseness in voice noted as associate getting into wheelchair 1449 Turn over care to ED
52 2021-01-14 vision blurred Blurred vision, Generalized body aches. Treatment- Ibuprofen and Tylenol. Outcome: blurred vision re... Read more
Blurred vision, Generalized body aches. Treatment- Ibuprofen and Tylenol. Outcome: blurred vision resolved, no improvement in generalized body aches.
52 2021-01-16 burning mouth syndrome The next morning after I received the vaccine I had multiple kanker sores on my tongue. Around 6 of ... Read more
The next morning after I received the vaccine I had multiple kanker sores on my tongue. Around 6 of them. Seven days later they are no better or worse. I am not sure if it related to the vaccine or not but I have rarely ever had a kanker sore and in the past, if I did it would only be one and would be gone in a few days. This was my second vaccine of the series of the Pfizer-BioNTech COVID-19 Vaccine EUA. My first one was on 12/28/2020. I did not have any sores after the first vaccine.
52 2021-01-16 mouth numbness, mouth tingling I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. Th... Read more
I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. The Np on my unit looked in my throat and noticed my throat was red and swollen. No difficulty with breathing. Oxygen 100 on RA. Benadryl and additional Pepcid taken. Swelling in throat decreased, facial swelling dissipated as well. Lips were tingling for hours and dissipated after additional Benadryl taken.
52 2021-01-17 mouth tingling Sore arm Tingling lips
52 2021-01-17 tongue disorder, mouth tingling Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Ben... Read more
Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Benadryl 1/15 at 9:30pm developed hives on back, stomach, hips and upper thighs,, hands were swollen took 25mg of Benadryl 1/16 at 3am took another 25mg Benadryl hives and itching. 1/16 630am took 25mg Benadryl and Claritin hives and itching improving. 1/16 at 9am all but 2 hives resolved to oatmeal bath and applied hydrocortisone. 1/16 at 630pm felt throat was swelling, voice change, tingling lips and thick tongue took 50 mg of Benadryl went to ER around 730pm. Was given Pepcid and 50mg prednisone in the Emergency Room. 1/16 11pm.Discharged home with prescriptions for prednisone, Benadryl and epi-pen and Pepcid. Continues now with lingering sore throat
52 2021-01-18 deafness After 3 days 1st dose loose hearing then went to ER. They told me ears was clear no fluid given ster... Read more
After 3 days 1st dose loose hearing then went to ER. They told me ears was clear no fluid given steroids' to take. I went Hearing specialist was told by doctor I have 80% right hearing loss.
52 2021-01-18 pain in jaw Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side... Read more
Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included fluticasone propionate (FLONASE), pantoprazole. The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.
52 2021-01-19 tunnel vision Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to... Read more
Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to pick head up off pillow for 2 days. Unable to eat or drink as well.
52 2021-01-20 oropharyngeal discomfort 10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 1... Read more
10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 10min and subsided. 50 min. after vaccine injection: flushed, redness in face, ears, and neck progressing to rash on chest, neck. Lasted for about 10min and subsided. Never progressing into full anaphylaxis reaction. No treatment taken.
52 2021-01-20 swelling of eyelid Pt woke up on day 2 following second vaccine dose and had itchy face, scalp, and swollen lower eyeli... Read more
Pt woke up on day 2 following second vaccine dose and had itchy face, scalp, and swollen lower eyelids.
52 2021-01-20 thirst, dry mouth I received the vaccine on Thursday 1-14-21, on Saturday I started feeling very thirsty and then seve... Read more
I received the vaccine on Thursday 1-14-21, on Saturday I started feeling very thirsty and then severe dry mouth and cold on Sunday and Monday. I just made sure to stay hydrated. On Tuesday I felt better but when I got up on Wednesday morning, I felt dizzy. It progressed into the day and became worse. I had to go home from work and was unable to drive. Today, I feel slightly better but still dizzy if I get up quickly.
52 2021-01-21 ear discomfort, mouth discomfort immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my ... Read more
immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my left arm and into my left jaw. i started to have tingling and loss of sensation to the left side of my face that extended from the left lower eyelid to 4 cm down the left side of jaw, midline to trachea, midline to left nare and radiating to the mid inner left ear canal. I had a burning sensation in the inner left ear canal as well as the left lower lid. Spoke with Dr and was placed on Prednisone 60mg po daily x 10 days with a taper and Valacyclovir 1gm po bid x 10 days. The degree of parenthesis as of 1-22-21 is improved to now encompass from the edge of left nare to the outer canthus of left eye, into the edge of the left ear canal and the edge of the jaw.
52 2021-01-21 visual impairment Once I received the shot and went to my car I noticed I had a rash on my face so I immediately took ... Read more
Once I received the shot and went to my car I noticed I had a rash on my face so I immediately took benadryl. When I woke up the next morning I was extremely dizzy and fell in the shower. It was more than just being dizzy it was like I couldn't see and it was hard to pick myself up. I may have fainted because I didn't recall falling just noticed I was on the shower floor. I thought I had gotten up but then again I was still on the floor. I made it back to bed and slept for a few hours. After that I seemed fine.
52 2021-01-22 mouth tingling, ringing in ears Approximately 45 mins after vaccine, 1620 - NP 169/74, HR 71 - c/o scratchy throat and lightheaded a... Read more
Approximately 45 mins after vaccine, 1620 - NP 169/74, HR 71 - c/o scratchy throat and lightheaded and ringing in ears. 1630 - 179/75 c/o increased tongue heaviness. Code yellow called at 1630. Arrived at 1635 - taken to ED. Patient reports heavy tongue and clearing of throat. No angioedema noted. Patient discharged at 2145.
52 2021-01-22 tongue itchiness Tounge started itching and raw feeling like something scalded it. Same feeling when I have somethin... Read more
Tounge started itching and raw feeling like something scalded it. Same feeling when I have something that has touched something I am allergic too.
52 2021-01-24 ear pain Bilateral ear pain. Treated with a course of Augmentin, Mucinex, Sudafed. No relief. Now on a 12 ... Read more
Bilateral ear pain. Treated with a course of Augmentin, Mucinex, Sudafed. No relief. Now on a 12 day course of Prednisone
52 2021-01-24 lip swelling My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a ... Read more
My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
52 2021-01-24 mouth tingling, feeling of choking fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue... Read more
fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
52 2021-01-24 feeling of choking Systemic: Other- numbness/tingling of face and throat and neck; symptoms lasted 1 day
52 2021-01-24 vision blurred Reported blurry vision, dizziness, and severe headache.
52 2021-01-25 loss of taste, loss of smell Loss of Smell and Taste for about seventy two hours
52 2021-01-25 mouth numbness I received the Covid-19 vaccine at noon today and at 7:30 pm I began having significant bilateral fa... Read more
I received the Covid-19 vaccine at noon today and at 7:30 pm I began having significant bilateral facial numbness, left side greater than right side with lower lip numbness greater than upper lip numbness.
52 2021-01-25 oropharyngeal discomfort Approximately 5-10 minutes after it was administered, I felt a weird sensation in my throat. I could... Read more
Approximately 5-10 minutes after it was administered, I felt a weird sensation in my throat. I could breathe fine, but it felt as if it was swelling and it felt weird to swallow. I didn't want to overreact so I waited a total of 30 minutes and symptoms subsided. My throat still felt weird, but I could breathe so I felt it was fine to leave. Symptoms subsided more once I got home 30 minutes later, but I took Benadryl. Symptoms eased completely and did not return.
52 2021-01-25 swollen tongue Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Pati... Read more
Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Patient took Benadryl 50mg and drank lots of water. Patient states she was severely dehydrated. Patient stated that she "should have probably gone" to the hospital but she did not. She did have an Epipen on her person if needed at the time but decided not to use it.
52 2021-01-26 mouth tingling 12:35pm patient states her tongue and lips are tingling - patient evaluated by provider - 12:40pm 25... Read more
12:35pm patient states her tongue and lips are tingling - patient evaluated by provider - 12:40pm 25mg benadryl given - patient observed 1 on 1 1:25pm patient states she can not swallow - epi pen administered per providers order 1:35pm patient states she is feeling better and symptoms are dissipating
52 2021-01-27 pain in jaw chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind... Read more
chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind12 yr molars); Slept a lot so far; injection arm very sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283), intramuscular on 13Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. The patient medical history was not reported. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]), colecalciferol (D3), estradiol (ESTROGEN), progesterone, "bioidenticle" and multivitamin, reported as "Other medications in two weeks: Multi vitamin, vitamin E, D3, bioidenticle estrogen/progesterone"). The patient previously took iodine, metronidazole (FLAGYL), doxycycline and telithromycin (KETEK) and experienced allergies to all. No other vaccine in four weeks. Facility type vaccine was hospital. The patient received the first dose on 23Dec2020 04:45 PM (lot number: EL0140), intramuscular on the right arm and patient felt slightly light headed. Within 5 minutes right (Rt) hand got red & hot, numb, heat in Rt arm and Rt side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. Patient took benadryl. Next few days was reported as "v fatigued & on p.m. of 24th it hurt to open my mouth (gland by Rt ear felt swollen). I got a line of inflammation in my Rt inside cheek & a tissue mound that has not gone away". On 14Jan2021 (reported as today), the patient experienced chills, dizzy, body aches, fever 99.5, fatigue, joint aches, injection arm very sore (started yesterday on 13Jan2021), jaw hurts more on right (Rt) side (lower behind12 yr molars). Patient took Tylenol and slept a lot so far. No treatment was received (If treatment AE: No) - pending clarification. Outcome of the events was recovering. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination.
52 2021-01-27 mouth tingling Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post ... Read more
Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post vaccine observation. At 0935 provider notified that customer was feeling sweaty with tingling in her tongue. Customer appears mildly flushed, calm. States that she chose to wait a little longer in the observation room because she does not ?feel right.? Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. She reports ?tingling? in the middle of her tongue and is feeling hot and diaphoretic ? different from the same menopausal symptoms that has been experiencing prior to this appointment. BP 120/78, HR 71, O2 95% RA, RR 18. Lungs CTA, RRR. Customer accepts Benadryl 50mg PO @ 0939. No rash, hives noted on exposed skin or at site of injection in left arm. Customer monitored at site. Over the course of the next 40 minutes, she reports feeling better. BP 120/70, HR 78, O2 97% RA, RR 16 @ 1022. She states that her tongue is still a bit tingly but denies feeling other worrisome symptoms she was previously experiencing. She denies feelings of facial/tongue/throat swelling, CP, SOB. Reports slight dizziness that she feels is related to Benadryl. Customer's husband (medical provider) present to drive her home. Customer states she will not be home alone. Customer aware that this provider will notify PCP Team of incident for post vaccine check in. Customer denies questions/concerns at this time. Customer released from site at 1025 ambulating independently with steady gait, no escalation of symptoms reported, no obvious s/sx of distress.
52 2021-01-27 mouth tingling Individual reported tingling in mouth and swelling in throat within fifteen minutes of receiving the... Read more
Individual reported tingling in mouth and swelling in throat within fifteen minutes of receiving the injection. She was given 0.5 mg of epinephrine IM at 6:57 am after having begun her observation period at 6:47. By 7:07 she reported feeling better. Tingling in mouth continued until 7:26 and then she reported it stopped. She left observation at 7:30.
52 2021-01-31 swollen tongue Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest... Read more
Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg IM X3, IV Methylprednisolone 50mg and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.
52 2021-01-31 ringing in ears Rapid HR with ringing in ears, dizzy, high blood pressure, approx., 10 minutes after injection. Sym... Read more
Rapid HR with ringing in ears, dizzy, high blood pressure, approx., 10 minutes after injection. Symptoms went away without intervention at 30 minutes post injection. Became short of breath with elevated heart rate and blood pressure again approx. 45 min. post injection tat worsened when standing, walking or talking, HR 143 BP 229/127 I was sent to the ED to monitor had a EKG, Benadryl, Pepcid, Then I had sinus tachycardia in ED, stayed until approx. 4 hours past injection. Symptoms resolved at time of DC
52 2021-02-01 mouth tingling Patient started tearing up, feeling tingly lips, coughing, and feeling tightness in the chest/shortn... Read more
Patient started tearing up, feeling tingly lips, coughing, and feeling tightness in the chest/shortness of breathe about 10 minutes after receiving her (second) dose of the Pfizer Covid-19 vaccine. She was then sent to the ER where she is given epinephrine IM, benadryl, steroid, PPI, fluid resuscitation, and albuterol/atrovent for her anaphylactic symptoms. She was also given zofran for her coughing and gagging symtoms. About 3 hours later, she had recovered in the ER and was discharged home.
52 2021-02-01 tongue discomfort, mouth discomfort back of her tongue and roof of her mouth felt like they were burning; back of her tongue and roof of... Read more
back of her tongue and roof of her mouth felt like they were burning; back of her tongue and roof of her mouth felt like they were burning; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm on 11Jan2021 10:30 AM at a single dose as COVID vaccine in a hospital. The patient had no medical history. She had no known allergies. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular in the right arm on 21Dec2020 at 11:00 AM as COVID vaccine. It was reported that on 12Jan2021-13Jan2021, the patient noticed the back of her tongue and roof of her mouth felt like they were burning, similar to eating too much pineapple. It was persistent and had not lessened. Treatment was not received for the events. She had no COVID prior to vaccination. She did not have COVID tested post vaccination. The outcome of the events was not recovered.
52 2021-02-03 mouth discomfort Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Mediu... Read more
Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Medium; lasted 1 day
52 2021-02-03 mouth tingling, tongue disorder Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at ... Read more
Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at 3:30 pm consisting of almonds, cranberries and cheese bites and 2 mandarin oranges. Approx 10 minutes after eating I began to cough uncontrollably and had difficulty clearing my throat. Drank water thinking orange juice had gone down wrong. 10 more minutes my bottom lip began tingling, tongue felt thick, chest tightness, light headed. I called clinic who suggested I call for medical emergency because of my previous anaphylaxis. Taken to ED, given epi pen, prednisone, pepcid, monitored and discharged after 2 hours
52 2021-02-03 swollen tongue headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat... Read more
headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin. Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
52 2021-02-03 tongue disorder allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vac... Read more
allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. They evaluatedI started feeling better towards the end of last week. Additional information for Item 18: allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. me for another 15 minutes and they recommended that I be evaluated in the ED. The right arm was noticed to be red. The injection site was painful. I was evaluated by the MD and given medications per their protocol (epi, Benadryl, famotidine, steroid). I was discharged home around 1830 (with a ride) after my throat seemed to be getting better. I was discharged with an Rx for steroids, blockers and and epi pen. Later that night at about 2200, I woke up with my face/scalp itching. I continued feeling achy, intense headache, hot/cold, foggy mind. I called in sick for my shift on 1/19. I returned to work on 1/20 with minor symptoms.I was evaluated by my MD on 1/21 and had minor expiratory wheezes (I have asthma). I seemed to be feeling better until Saturday and then stomach cramping/muscle cramping (noticeable on the right hand/injection side), bad headaches, fatigue have resumed. ; 2/2 I started feeling better towards the end of last week. Still feeling off but able to do my normal routines.
52 2021-02-03 vision blurred With in 20mins of vax had episode where vision were blurred. 8:30pm had another episode of blurred ... Read more
With in 20mins of vax had episode where vision were blurred. 8:30pm had another episode of blurred vision. Lasted 15mins then went to sleep.
52 2021-02-06 bloodshot eyes, eye swelling, eye itchiness, eye pain My eyes and face swelled up and my left eye has been red, itchy, and sore since then.
52 2021-02-07 deafness This was my second dose. Fever as high as 103.4F. Fever lasted 24 hours above 100.0F Chills, Sha... Read more
This was my second dose. Fever as high as 103.4F. Fever lasted 24 hours above 100.0F Chills, Shaking for 4 hours from about 8/9 pm to 12/1am. Nausea, vomiting, bowel pain, inflamed rectum after bowel movement the next day, loss of hearing, dizziness, Trying to sleep and waking up gasping for air about 5 times though out the early morning. Sever Headache which lasted Two and a half days. About 2 pm on 2/5/21 I took some Emetrol for the Nausea, and Tylenol for headache and fever. I took Tylenol again the evening of 2/5/21. On 2/6/21 I Tylenol and then Ibuprofen then Excedrin. On 2/7/21 I took Excedrin once and my headache was finally gone.
52 2021-02-08 mouth numbness lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from... Read more
lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 22Jan2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, morbid obesity, anemia, arthritis, allergic to fish (shell & fin) and all nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but it was reported that the patient took other medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Jan2021, at 16:15 (also reported as after 15 minutes), the patient's lips became numb and the throat started to sound very scratchy and itchy. This resulted in a doctor or other healthcare professional visit. Treatment for the events included the patient taking her own diphenhydramine (BENADRYL), epinephrine (EPIPEN) and albuterol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of lips became numb and the throat started to sound very scratchy and itchy was resolved with sequel on Jan2021. Information on the batch/lot number has been requested.
52 2021-02-09 burning mouth syndrome Pain, weakness, fatigue, abnormal mentation, tongue throbbing, cough, hoarse voice
52 2021-02-09 vision blurred On February 4, 2021, patient woke up at 3 a:m, left eye kept opening and closing, vision was blurry,... Read more
On February 4, 2021, patient woke up at 3 a:m, left eye kept opening and closing, vision was blurry, and left side of face numb by lips and jaw. She took 2 Benadryl and took a nap Thursday afternoon. She went to the ED later and was told it may be Bells' Palsy but was referred to PCP. She is on 5 mg Prednisone but rheumatologist increased dose and put on 5 day regimen. She saw PCP and he told her she had Bell's Palsy and just to follow regiment prescribed by rheumatologist.
52 2021-02-10 toothache injection site pain (current with itching); injection site pain (current with itching); tiredness/fa... Read more
injection site pain (current with itching); injection site pain (current with itching); tiredness/fatigue; tooth pain; joint pain; chills; low-grade fever (100.4); This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELo142), via an unspecified route of administration in right arm on 21Jan2021 09:15 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the workpalce clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included hypothyroidism and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included losartan and levothyroxine sodium (LEVOTHROID). On 22Jan2021, the patient experienced injection site pain (current with itching), three days of tiredness/fatigue, tooth pain, joint pain, chills and low-grade fever (100.4). The patient recovered on unspecified date. No treatment was given to the patient for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.
52 2021-02-11 swollen tongue Slight swelling of back of tongue. Enough to repeatedly clear my throat. Felt like I had phlegm stu... Read more
Slight swelling of back of tongue. Enough to repeatedly clear my throat. Felt like I had phlegm stuck in throat and tried to clear it out. Started about 5 minutes after shot and lasted about 30 minutes
52 2021-02-11 ringing in ears meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; T... Read more
meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease. The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
52 2021-02-12 eye disorder, ear pain On 2/4 it began with severe pain from behind my left ear radiantly upward to the top of my head.I ha... Read more
On 2/4 it began with severe pain from behind my left ear radiantly upward to the top of my head.I have numbness on the left side of my face with mouth distortion (only opens to right side)My left eye does not blink or close.I tape it close nightly per MD.
52 2021-02-12 mouth numbness Numb face, lips, mouth, tongue, flushing, dizziness,
52 2021-02-15 oropharyngeal discomfort Took Benadryl 30 min before vaccine due to allergies. 30 min after vaccine felt lightheaded, headach... Read more
Took Benadryl 30 min before vaccine due to allergies. 30 min after vaccine felt lightheaded, headache. A few hours later was dizzy and had difficulty swallowing and throat was becoming increasingly uncomfortable. Took Benadryl again and headed to hospital. Blood pressure was extremely elevated upon exam. Throat tightness became somewhat improved after Benadryl. Blood pressure improved some after taking BP med. Doctor ruled it allergic reaction to vaccine and sent me home after 5 hours with instructions to take Benadryl every 6 hours as needed.
52 2021-02-16 swollen tongue Patient has recent diagnosis of nut allergies. She denied any adverse reaction with the first vaccin... Read more
Patient has recent diagnosis of nut allergies. She denied any adverse reaction with the first vaccination dose. After receiving the vaccine today, the patient reported feeling like her tongue was swelling. She denied any rash or itchiness. Patient was evaluated by EMT, who placed an IV and gave IV one dose (mg not documented) of epinephrine. She was transferred to the hospital for observation.
52 2021-02-17 toothache chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and i... Read more
chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color, not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none. She then had copious amounts of thin nasal drainage to her left sinus/nostril. Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine. Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning. She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
52 2021-02-18 eye swelling Sensation of bilateral lower eye swelling without obvious signs of swelling. Sensation resolved with... Read more
Sensation of bilateral lower eye swelling without obvious signs of swelling. Sensation resolved without intervention. Resolved the following day, about 10 hours?
52 2021-02-21 lip swelling, eye swelling ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx t... Read more
ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx to take 50 MG of Prevacid to take 1x a day for 5 days. Saturday: 2/20/2021 -- Took 50 mg of prevacid at 9 am and 10 mg of pepcid 4:50 pm. Eyes swelled, lump in throat Went to ER Was admitted for observation at hospital. Received predisone and benedryl through IV 1:30 bottom lip started to swell was given 25 mg of benadryl by mouth Around 7:30 am scalp started to itch - Was given 20 mg of predisone orally Around 9 am rash on face was given 50 mg of benadryl Around 2:30 pm Doctor came into room because my throat felt tight. She looked at it and said "its not too bad." She had the nurse give me benadryl via interveniously Was discharged around 3:30 pm on Sunday, February 21, 2021 Monday: 2/22/2021 Around 1:15 pm felt lump in throat, felt like my neck was swollen, took 25 mg of benadryl. Called Doctor. Took another 25 mg of Benadryl. Still didn't feel right. Went over to Dr office, my asthma and allergy doctor. At Dr office, I was given two injections of medication. (He told me what it was, but I cant recall the names.) He sent me home with the following instructions: zyretc 10 mg am and pm bendryl 25 mg every 4 hours as needed pepcid 20 mg am and pm predisone 20 mg 3x1 day tomorrow take 20 mg of predisone I am to call his office after 1 pm tomorrow 2/23/2021 to give status report on how I am doing
52 2021-02-21 lip swelling States 30-40 minutes post injection face and lips began to swell. Took Benadryl x3 and symptoms reso... Read more
States 30-40 minutes post injection face and lips began to swell. Took Benadryl x3 and symptoms resolved by next morning
52 2021-02-22 tongue disorder Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright ... Read more
Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright red and tongue felt a little thich
52 2021-02-23 loss of smell, loss of taste lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable nurse (p... Read more
lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 04Jan2021 10:45, at single dose, for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), on an unspecified date, at single dose, for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was administered in the hospital. 3 weeks after the 2nd dose, on 27Jan2021 the patient lost taste and smell. Her PCR nasal Covid swab was negative on 27Jan2021. The patient had not recovered from the adverse events. No treatment was received for the adverse events. Information about the lot/batch number has been requested.
52 2021-02-23 dry throat Tiredness, out of breath after a few normal activities. Five days later cold/sinus symptoms started... Read more
Tiredness, out of breath after a few normal activities. Five days later cold/sinus symptoms started with a sore throat, severe dryness of throat, nose, then congestion, runny nose, chills, NEVER a fever. A week later still tire, a little congestion, cough, some white liquid flem.
52 2021-02-23 gaze palsy Chills, fever( highest 101.6), headache, bad body pains
52 2021-02-23 burning mouth syndrome Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swal... Read more
Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
52 2021-02-24 mouth numbness Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all ... Read more
Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all over, pins and needles feeling in my hands, numbness in lips ear cheek , headache neck pain. Tiredness.
52 2021-02-24 bloodshot eyes I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left ar... Read more
I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left arm). I read online that this is a sign of my body fighting the vaccine and it is a good sign. I went to my doctor just to have it checked out and because both of my eyes look like I have pink eye. My doctor isn't sure if my eyes have anything to do with the vaccine but said probably not. She said that I needed to report my mass as it is not one of the most common side effects. I also went to the health department, where I had both shots, and had them look at the mass. They said the same thing about my body fighting the vaccine. My doctor and the health department said that while they have seen the swollen lymph nodes from the shot, they haven't seen such a large mass like mine. Both of them said I needed to report this.
52 2021-02-24 visual impairment Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up ... Read more
Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up her arm; real red spot on wrist; her arms started stinging and itching; Hand and feet were itching off; burning; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283) intramuscular on the left arm on 13Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included acid reflux, antidepressant, normally wears contacts and puts reading glasses on over it. Family medical history of cancer. Concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]) for acid reflux and bupropion hydrochloride (WELLBUTRIN) as antidepressant. The patient went and got her first shot 2 weeks ago. She is a dental assistant. She woke up between 2am-3am on 13Jan2021 and her hands and feet were itching off. They were burning and itching and she did not have any rash. So Thursday, she had to work until 1. Her hands itched and she went home, took Benadryl and put Cortisone cream on hands and feet. She does not have a dose, lot or expiration for either. It would take 2 doses of Benadryl. They just continued to itch until Saturday and she went to a doc in the box and the doctor felt it was a reaction from the vaccine. You could not see anything except red where she scratched it. She gave her some medicine and she just went to pharmacy and the pharmacist said that is just like Benadryl. She started taking it and it immediately helped, but she only gave it to her for 5 days and when she finished, the itching started again. On 27Jan2021, her hands were itching off and she has red streaks going up arms and splotches. She does not have the name. It was like hydro something. She threw bottle away. She does not have a dose, lot or expiration. It improved and stopped when she was taking the medicine and on 26Jan2021, she had a real red spot on wrist, her hands have itched and itched. When her arms started stinging and itching, she pulled her sleeve up and it looks like streaks on her arms and elbows. She has these splotchy red whelps and streaks up her arm. She also noticed she had itching on her torso the day before. She needed to get glasses to see vaccine card. This was required before she took the vaccine, but she did feel like her eyes are worse all of a sudden. She normally wears contacts and puts reading glasses on over it. It has only been in the last few weeks that she has noticed this. Now, her arms were starting to itch again after a dose of Benadryl. She was worried about 2nd shot. She does not want it to get worse and continue. She would like to speak with someone to find out if it would be recommended for her to get second dose or not. No ER or physician's office required: Doctor visit on 16Jan2021 and they prescribed a medication to help with itching and burning for 5 days and it worked and when she stopped taking it, it started back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was at a Clinic for the hospital. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events itching and eyes have gotten worse was not recovered, events burning and pain in arm was unknown and recovering for the other events.
52 2021-02-25 blindness Pt received the Pfizer vaccine (Pfizer Lot#:EN6200, 1st dose) at 1232 on left arm. Pt reported to le... Read more
Pt received the Pfizer vaccine (Pfizer Lot#:EN6200, 1st dose) at 1232 on left arm. Pt reported to lead RN that she got up and felt dizzy. Pt reported not being able to see anything for approximately 5 seconds. Pt stated that she immediately sat down. Pt stated that she has suffered from hypoglycemia in the past. Lead RN gave pt water. Pt was given a piece of candy by one of her friends in the observation area. No vital signs were taken. Pt was kept an extra 15 minutes for observation. Pt immediately started feeling better after eating candy. Lead RN reassessed pt and educated pt on s/sx that would warrant a trip to the ED. Pt stated that she was feeling a lot better. Pt left building after being observed for 30 minutes. Pt walked out of building with a steady gait.
52 2021-02-25 dry mouth Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/2... Read more
Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/21. She reports doing well and better today. She still has a sore arm where the injection site is. No redness or swelling nor fever. She also states that her cotton mouth sensation is gone. She is overall well. Pt is appreciative for the phone call. Denies any other concerns. Progress Notes (Nurse Practitioner) Attempt to reach patient for follow up. No answer. Progress Notes (Nurse Practitioner) Cosign Needed Expand AllCollapse All Date: 2/24/2021 Subjective Pt is a 52 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience chills/shaking "as if my internals are trying to come out.". She also reports of R arm pain "as if someone socked me in the arm" at injection site. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency room area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. PMH: depression/PTSD, recovered alcoholic and pill user x 8 years come this April. Currently on Zoloft, Abilify, Wellbutrin. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, muscle aches (R arm pain where injection site was) and headaches (she developed a headache later while she was in the bay about 15 minutes into her visit. Rates pain at 8/10) Patient denies fever, malaise/fatigue, facial swelling, ear pain, itching in ears, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain She reported about 15 minutes into her visit with me of "Sudden onset of dry mouth.": Previous Reactions: when she was younger, she had an adverse reaction, unable to recall what, to the chicken pox vaccine. She's only been able to get one shot. She's tolerated other vaccines w/o issues. Objective Vitals Vitals: 02/24/21 0907 02/24/21 0926 02/24/21 0943 02/24/21 1000 BP: 135/84 128/71 120/73 101/71 BP Location: Left arm Left arm Patient Position: Sitting Sitting Pulse: 93 82 68 SpO2: 97% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not diaphoretic. Comments: intially appeared fatigued, not as alert. After drinking water, eating a granola bar. She started to come around HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Comments: R arm inspected. Warm, no erythema, swelling nor rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Comments: initially flat/anxious. Pt was able to have normal mood by end of visit. Assessment/Plan Treatment included: water, snacks and ibuprofen for headache Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Doing well after observation. She has a ride. She was able to ambulate out to the front with co-worker. She is aware of precautions to watch for. Advised to place warm compress or ice to R arm. F/up with pcp as needed. Electronically Signed 2/24/2021 12:50 PM
52 2021-02-25 eye swelling, mouth swelling, swollen tongue Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
52 2021-02-25 mouth numbness Numbness in jaw, lips, neck on left side. Tachycardia
52 2021-02-25 vision blurred, swelling around the eyes, bloodshot eyes, lacrimation increased, eye swelling, eye itchiness, eye pain both eyes swollen/ one eye was swollen shut; both eyes watery; Vision is blurry; Eyes were itchy and... Read more
both eyes swollen/ one eye was swollen shut; both eyes watery; Vision is blurry; Eyes were itchy and painful; Eyes got very puffy; Minimal discharge; both eyes itching/Eyes were itchy and painful; both eyes red/Eyes got very puffy and very red; This is a spontaneous report from a contactable consumer. This consumer reported for 2 patients. This is the first of 2 reports. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm at the age of 52 years, on 07Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing breast cancer stage ii , mastectomy from Jun2018 to an unknown date. Concomitant medication included anastrozole (ANASTROZOLE), escitalopram oxalate (LEXAPRO) and atenolol (ATENOLOL). The patient previously took taxol and experienced drug hypersensitivity. The patient stated that this past Sunday (24Jan2021) that her daughter woke up with both eyes swollen, red, watery and itching. It was stated that they took her to the clinic and was told that this was the second one that they had seen like this. It was also stated that they gave her a prescription for eye drops. It was stated that she woke up this morning and one eye was swollen shut and wanted to know what to do or the course of action. It was stated that she was supposed to get her second shot Thursday and wanted to know if she should get her second dose or not. It was also stated that her eyes were swollen and red which were better yesterday and today are worst than they have ever been. It was stated that the left eye is more swollen than the right. It was also stated that she soaked tea bags and put them on her eyes Sunday and stated that she does not know the name of the prescription eye drops. On 17Jan2021, it was reported that the patient's eyes got very puffy and very red. Her eyes were itchy and painful with minimal discharge. Her vision was also blurry. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Jan2021, sars-cov-2 test: negative on 19Jan2021 and sars-cov-2 test: negative on 25Jan2021. Therapeutic measures (Eye drops; Prednisone; Polymixin) were taken as a result of both eyes swollen/ one eye was swollen shut (eye swelling), both eyes red/eyes got very puffy and very red (ocular hyperaemia), both eyes watery (lacrimation increased), both eyes itching/eyes were itchy and painful (eye pruritus), vision is blurry (vision blurred) , eyes were itchy and painful (eye pain), eyes got very puffy (periorbital swelling) and minimal discharge (eye discharge). The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106157 similar report from same reporter
52 2021-02-27 mouth tingling SOB, chest pain, numbness, tingling in mouth, nausea, weak. Cleared by EMS
52 2021-02-28 mouth numbness Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and b... Read more
Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and breathing technique - reaction resolved. Extended monitoring was provided.
52 2021-03-01 eye irritation, taste impairment, mouth tingling Complained of warm feeling after receiving first dose of Pfizer COVID-19 vaccine (lot EN6205, exp 6/... Read more
Complained of warm feeling after receiving first dose of Pfizer COVID-19 vaccine (lot EN6205, exp 6/30/2021). At 1029, EMT was checking in on client since she was in post vaccine waiting area for 30 min observation. EMT noticed flushed face and neck. Per client felt warm sensation and at 1031 stated metallic taste in mouth, feeling clammy with sweaty hands. PHN joined EMTs. First set of vitals: blood pressure 120/80, temperature 101.7 F. Alert and oriented, no shortness of breath, rash, itching, swelling, blurry vision, or tingling noted per client. Per client sulfa, shellfish, and contrast IV dye allergies. Medication client took this morning: Synthroid 75mcg. Clt reported she ate breakfast at 9am consisting of cereal and coffee, client reported a history of Bell's palsy 20 years ago with full recovery. 1034 temp 100.0 F. Assessed for arm drift, no tongue deviation, clt stated no tingling, able to move all extremities. 1042 vitals: blood pressure 120/100, pulse 77, o2 98, temp 99.0 F. Alert and oriented, clammy hands, no shortness of breath, no swelling. PHN offered client Benadryl, client declined. Informed client she would be kept longer for observation and client agreed. At 1047 temp 98.9 F, respiratory rate 24. At 1051 client stated tingling sensation on inner lips, metallic taste, dizziness, and mild burning sensation around eyes and nose area. PHN assessed for swelling in mouth, lips, face. PHN offered Benadryl again and client accepted. Client called husband who was in parking lot, client not driving. At 1054 Benadryl 50mg/ml IM on left deltoid. Vitals 1056: blood pressure 118/90, pulse 70, o2 98. Client informed vitals would be reassessed every 5 minutes. 1101 vitals: 99.1 F temp, blood pressure 118/78, pulse 77, o2 98. Per client dizziness and metallic taste were improving. 1106 vitals: pulse 75, o2 98, respirations 14, EMT unable to obtain blood pressure. Client complained of tingling on left index finder, PHN assessed bilateral grip strength, equal on both sides. 1114 vitals: blood pressure 128/72, pulse 74, o2 99. Per client, improvement of tingling sensation on lips, no metallic taste, no dizziness, no headache. Per client felt Benadryl effects. Vitals 1118: blood pressure 124/82, pulse 76, o2 96. Vitals 1124: blood pressure 128/78, pulse 75, o2 98. Client able to stand, denied dizziness. At 1133 noticed change in speech, slurred. Per client voice was different. called 911 at 1134. Paramedics arrived at 1142 and assumed care. Client transported to Hospital per client's husband request at 1149.
52 2021-03-01 eye discomfort, dry eye, eye itchiness, eye irritation Patient received covid vaccine and experienced flushing immediately post vaccination and about 20 mi... Read more
Patient received covid vaccine and experienced flushing immediately post vaccination and about 20 minutes after vaccination had onset of headache. Felt like a band was wrapping around right side of head, pressure over right eye, and numbness/tingling of right eye noted. No loss of vision noted, no facial drooping noted. Complained of numbness and dryness of right eye continuing at least 30 minutes after vaccination. Noted it started to burn or itch 30 minutes after vaccination.
52 2021-03-01 mouth tingling Within 15 minutes the right side of my face became itchy. My tongue also felt a weird sensation. B... Read more
Within 15 minutes the right side of my face became itchy. My tongue also felt a weird sensation. By 12:30 am that night my chest became itchy and I had red bumps on my chest, then around 2 pm the next day my stomach began to get itchy and red with a red bump.
52 2021-03-01 swollen tongue, mouth numbness Pt reported the sensation of a swollen tongue less than 10 minutes after receiving the vaccine. Exa... Read more
Pt reported the sensation of a swollen tongue less than 10 minutes after receiving the vaccine. Examination of the tongue did confirm this. Epi administered with relief but she then reported numbness of the lips. EMS activated and IM benadryl (difficulty gaining access) administered. Pt transported to NYU. BP noted at 132/87; HR- 99
52 2021-03-01 vision blurred Left Arm - bruising, swelling, redness, itching, hot to the touch. Right arm - rash that includes i... Read more
Left Arm - bruising, swelling, redness, itching, hot to the touch. Right arm - rash that includes itching, red bumps, and warm to touch. I am very tired. My eyes are cloudy.
52 2021-03-02 mouth numbness, ear pain Left sided facial weakness, tongue feels numb on left side, speech just a little off but no left ar... Read more
Left sided facial weakness, tongue feels numb on left side, speech just a little off but no left arm weakness or anything else. Ear pain on the left side and headache. CT Head done on 2/26/21 at ER resulting in no acute intracranial process. Diagnosed with Bell's Palsy and started on 7 days of Valacyclovir HCL 1 gram - 3 times a day and Prednisone 20mg - 3 in the morning for 5 days. Completed course of Prednisone morning of 03/03/2021. Symptoms no better with medications.
52 2021-03-02 oropharyngeal discomfort, lip swelling chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her a... Read more
chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her arms; she had an abnormal feeling in her throat/abnormal feeling in her throat comes and goes, off and on; maybe she is nervous and anxious; maybe she is nervous and anxious; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left deltoid, on 19Dec2020, at single dose, for prevention/COVID-19 immunization, at the hospital. Medical history included allergies and allergies to propylene glycol 3350, polysorbate 20, polysulfate 20. It was reported that the patient had a "quick test" and confirmed she has allergies to propylene glycol and polysulfate 20. Her allergist gave her a list of things to stay away from and said to avoid those ingredients. She stated that COVID-19 vaccine has propylene glycol 3350. She clarified and said her allergist told her to stay away from propylene glycol products. Her allergist told her not to use the COVAX. On 19Dec2021, the patient got her first vaccine shot. Within 3 minutes of getting the vaccine, she had rash on her arms. 3 hours later, she had an abnormal feeling in her throat. She was told to go the emergency room and she was given a quick medicine (unspecified). The patient was unable to clarify what medication she received at the emergency room. On 20Dec2021 (the next day), her lips were swollen, on and off. The patient stated she uses dark shampoo and conditioners and maybe it has PEG in it or maybe she is touching something at the hospital. On 20Dec2020, the patient experienced palpitations. She asked the doctors and nurses about her palpitations and they said maybe she was nervous and anxious since she had a COVID patient in the unit. The patient reported that she thinks palpitation started when she went to pick up over the counter medications on 20Dec2020. On 02Jan2021, the patient experienced chest pain. The outcome of rash and palpitations were recovering; oropharyngeal discomfort, lip swelling, and chest pain were not recovered; and nervousness and anxiety were unknown. Information on the Lot/batch number has been requested.
52 2021-03-02 swelling around the eyes Reaction started on 2.27 mid-morning- she began having a sensation in the back of her neck. Rash beg... Read more
Reaction started on 2.27 mid-morning- she began having a sensation in the back of her neck. Rash began on the nap of neck- swollen bumps. traveled around the front of the neck and then cheeks and eyes. Continued near tear ducks and all-around eye. Both eyes began to swell on 2.28 and she went to the ED for treatment. They gave her a steroid shot and benadryl IM. Discharged home, with no medications, but instructed to take benadryl as needed. She is taking benadryl every 6-8 hours for itching. She is not fully recovered due to itching and continued rash. Follow up appointment with PCP the end of this week begin of next.
52 2021-03-03 gaze palsy About 10 mins after vaccination patient stated she wasn't feeling well. When pharmacist went to chec... Read more
About 10 mins after vaccination patient stated she wasn't feeling well. When pharmacist went to check on the patient she was seizing. 911 was called. Patient's eyes were fluttering and unresponsive, but breathing. Patient came in and out of seizure a few times. 1 full body seizure about 20 to 30 seconds. Patient was laid on the ground on her side till paramedics arrived. She was then taken by ambulance.
52 2021-03-03 mouth numbness An hour after my shot my left check was numb, lower left eye numb, left ear numb and left side of my... Read more
An hour after my shot my left check was numb, lower left eye numb, left ear numb and left side of my tongue is numb. It is still numb as I type this.
52 2021-03-03 lip swelling, mouth tingling Facial hives, lip tingling/swelling
52 2021-03-04 eye swelling Patient rec'd vaccine at 1400. She went to wait her 15 minutes in the car and after about 10 minutes... Read more
Patient rec'd vaccine at 1400. She went to wait her 15 minutes in the car and after about 10 minutes noticed eye sensitivity and headache. When symptoms did not pass after an additional 10 minutes she came back into the office. While waiting when her husband was checking her in, she "passed out." Episode lasted less than 1 minute. She was easily oriented to person, place and time. It was noted that she had some swelling to bilateral eyes. Patient was brought back to room, VS were checked and all were normal. She denied any chest pain, shortness of breath, wheezing, tongue swelling, itching, or tickling sensation to back of the throat. She was able to tolerate sips of water without difficulty. 50mg benadryl IM was given in the left deltoid. Approximately 5 minutes after IM injection patient again "passed out." She was seated at the time and slumped to her right, resting her head on her husband and did not fall from chair. She aroused after approx 2 minutes, and was a/ox4. VS were rechecked and were O2 99% on RA. HR 101, BP 124/88, RR20, temp 98.5/oral. Patient stayed at the clinic for an additional 45 minutes after which her eyesight was reported to be back to normal, her headache had improved and the lower eye edema had resolved. It should be noted that both the patient and the husband were not concerned with her "passing out." She states it happens because of pain and she was fearful of the injections. Patient also states that her neurologist told her that when "she is in too much pain, she will pass out."
52 2021-03-04 eye discomfort Episodes of unilateral facial numbness and tingling. Occurred in 3 separate episodes: First one bein... Read more
Episodes of unilateral facial numbness and tingling. Occurred in 3 separate episodes: First one being 30 minutes after administration of vaccine, 2nd one 8 days later, and 3rd one 10 days later. Each episode lasted about 5-10 minutes. Also reports constant pressure behind both eyes.
52 2021-03-04 swollen tongue At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021... Read more
At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021) and went to EMT observation area. At approximately 1210, patient informed EMT that she was not feeling well. Patient was given the zero gravity chair to sit in. Per EMT, patient c/o fast heart beat. EMT took vitals and assessed patient: BP systolic of 128, HR 88, pupils equally reactive, LOC X4, skin warm, RR of 8. Per EMT, patient was anxious and complaining of discomfort from occipital area of her head and nape. Per EMT, patient was instructed to do deep breathing exercises and patient was given some ice to initiate vagal response. Approximately 15-20 mins later, patient complained that she was not feeling well. At 1235 EMT came over to lead RNs stating that she was having difficulty getting an accurate BP reading due to the lack of having the proper size of BP cuff onsite. RN used personal BP cuff to take patient's vitals. Per RN, At 1238, patient's BP was 170/100, HR 88, RR 12, regular breathing. Per RN, Patient c/o swollen tongue, throat itchiness, and feeling cold, patient's skin showed visible cold urticaria. After assessment, RN instructed RN to call 911. EMT gave report to 911 operator. After the medics were on their way to site, Patient insisted needing to go to the bathroom to urinate, RN and EMT assisted patient to the bathroom. Patient was ambulatory. At 1244 Fire paramedics and AMR arrived. Patient relayed to medics that her tongue is swollen, that she is feeling itchiness in her throat, and that she has a raspy voice. Medics gave patient Benedryl IM in L arm at 1248. Patient refused to be transported to a hospital per Medics recommendation. Patient signed documents declining further medical care. Patient was instructed to call 911 for any difficulty breathing and any throat swelling. Medics and AMR left at 1258. At 1300 niece came from parking lot to assist patient to go to her car to go home.
52 2021-03-06 swollen tongue, mouth numbness After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With i... Read more
After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With in a minute my throat got scratching and had a hard time Swallowing. My Tongue Swelled and my lips felt Numb.A Medic doc was called over to me. I was immediately taken to a tent with other Doctors. The doctor immediately gave me a Epipen in my right upper thigh. With in a few minutes EMS was there they tried to put a IV IN me but was unsuccessful. The EMT gave me a shot of Benadryl in my right arm. EMT rushed me to Emergency room. At the ER they put an IV in and gave me Dexamethasone and Pepcid. I was closely watched and was released after around 5 hours.
52 2021-03-07 eye irritation, swelling of eyelid Patient reported mild fatigue and arm soreness until the following afternoon when her left eye bega... Read more
Patient reported mild fatigue and arm soreness until the following afternoon when her left eye began to burn which progress to the right eye. Later in the evening the left upper eye lid began to swell extending into the lower lid along with right upper lid swelling. She contacted medical through our COVID hotline where I was notified around 9 pm Thursday night ( 03/04/2021). She denied an respiratory or cardiac symptoms and was mostly concerned about the periorbital edema. She did not feel she needed to go to the hospital. She was advised to take Benadryl 50 mg every 6-8 hours and apply cold packs. A follow up call was made by me at 07:30 am on Friday and was instructed to contact her PCP. Later that day she called me indicating she went to Urgent Care and was seen by Dr.
52 2021-03-07 visual impairment, ringing in ears 03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint,... Read more
03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula. BP 131/82, pulse 81, blood sugar 126 ml/dl. When not resolved after approximately 1.5 hours, I proceeded to the hospital Emergency Room. They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours. Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
52 2021-03-08 ear pain I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt q... Read more
I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt quite a bit. My arm started hurting right away. Over the course of the afternoon, I felt achy and tired. I went to bed about 9:30 pm. During the night I suffered nausea, headache (on the left side), bad chills and then sweats. Fever of 102.4. Arm so sore can even sleep on it. By the am, 10:20 am, still massive fatigue, aches, fever (still between 100.9 and 102.4), chills and earache. .
52 2021-03-09 mouth numbness, mouth tingling, eye irritation glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side... Read more
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-03-09 oropharyngeal discomfort patient presented with alot of anxiety about vaccine. Vaccine was administered at 10:50am. We discu... Read more
patient presented with alot of anxiety about vaccine. Vaccine was administered at 10:50am. We discussed vaccine and she was happy to get it. After giving her her dose, she called nurse over to say that she didn't feel well. Patient continued to state that her throat felt weird, she felt like throwing up, it was hard to swallow, and that she was sweaty. She said she had a nervous cough. At 10:20 Am we checked her BP - it was 141/115 and her pulse was 63. She asked for epipen but didn't truly need at the time - said her breathing was fine. At 10:31 Am her pulse was 59 and BP 128/84. She got an ice pack after offering a couple times at 10:31. 911 Was called at 11:05 Am because patient still stated she didn't feel right.
52 2021-03-09 ringing in ears The evening after the vaccination I began to have a constant, high frequency ringing in my ears. I ... Read more
The evening after the vaccination I began to have a constant, high frequency ringing in my ears. I know it's not a big or deadly reaction, but it's nearly a week later and it has not abated. I would not be concerned about it if I thought it was temporary, but it is bothersome and not going away. I have never had any kind of trouble with tinnitus before, but interestingly, my sister has had trouble with it much of her adult life. I do not know if that's important, but the fact is I am a bit worried about the second dose and it being worse or causing it to continue. I hope it did not trigger a long term problem. Still, I am glad to have had it. I have had no other obvious reactions to the vaccine.
52 2021-03-09 visual impairment she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at ... Read more
she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at the injection area; severe back spasms in the thoracic and lumbar; made a different in the vision, it was throbbing; back pain; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL0140), intramuscular on 04Jan2021 at single dose at left arm for covid-19 immunization. Medical history included diabetes (diagnosed six years ago. Her last A1C was 6.1 in Dec2020), chronic edema since her last child was born 26 years ago. Concomitant medications included ongoing furosemide (LASIX), ongoing potassium, ongoing omeprazole (PRILOSEC), ongoing metformin, and paracetamol (TYLENOL). Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose on 04Jan2021 and second dose on 27Jan2021. Caller reported to have experienced back pain 2-3 days after the first dose, and a sharp stabbing back pain with moist cough for almost a month now after the second dose. Caller was diagnosed with COVID-19 in between. With the first vaccine she had headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given diclofenac (VOLTAREN) and cefixime (FLEXERIL). She was taking 1 gram of paracetamol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. Seriousness criteria for back pain, it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor; for event arm pain at the injection area, gripping was not easy and moving her arm was painful. She was left handed. Heat worked better than ice. Ice made things worse; for event headache, made a different in the vision, it was throbbing. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of paracetamol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She had been taking 1000mg paracetamol three times a day and now she was taking it two times a day. She was taking cefixime at bedtime because she can't stay awake when she took it. She can't take it and work. She had missed work because of this. She was taking diclofenac twice a day. Patient didn't have the first bottle of paracetamol she used because she had gone through it. Current bottle of Tylenol was the generic, SunMark Acetaminophen. She had to get her glasses to read the lot number. It was made by (Pharmacy name), Lot number: OLE2349B, expiry: Sep2022. She didn't feel like the medication she took were relevant because she had been taking them for a very long time. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021. She got the results of her PCR test on 13Jan2021. Outcome of event back pain was not recovered, outcome of events headache, arm pain at the injection area and severe back spasms in the thoracic and lumbar was recovered in 2021, and outcome of other events was unknown. Relatedness of drug to reaction(s)/event(s): Events headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar: source of assessment: primary source reporter; Method of assessment: global introspection; Drug result: Related.; Sender's Comments: Event back pain represents an intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-03-10 oropharyngeal discomfort APPROX 15 MIN AFTER TAKING THE VACCINE, ON 03/10/2021- I ATTEMPTED TO DRINK WATER , DIFFICULT TO SWA... Read more
APPROX 15 MIN AFTER TAKING THE VACCINE, ON 03/10/2021- I ATTEMPTED TO DRINK WATER , DIFFICULT TO SWALLOW, BUT ABLE TO SWALLOW, TOOK BENADRYL BY MOUTH 25MG OTC, DIFF SWALLOWING CONTINUES, NO DIFFICULTY BREATHING BUT SWALLOWING DIFFICULT ALMOST LIKE SOMETHING WAS IN THE BACK OF MY THROAT, NOT PAINFUL. APPROX 20 MINUTES AFTER BENADRYL, SYMPTOM IMPROVED. APPROX 1 HOUR LATER IT RESOLVED. TODAY 03/11/2021 , HEADACHE AND BODY ACHES TOLERABLE-NO PROBLEMS SWALLOWING
52 2021-03-10 ringing in ears At 7:00am I had the chills, shaking so bad, could not get warm, vomiting, continued nausea , diarrhe... Read more
At 7:00am I had the chills, shaking so bad, could not get warm, vomiting, continued nausea , diarrhea and headache and continue ribgibg4in my ears into Thursday and
52 2021-03-11 eye swelling My eyes were swollen, rash on face and body, prednisone treatment 20 mg for 12 days and zyrtec
52 2021-03-11 mouth swelling Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. ... Read more
Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. Patient received Epinephrine 0.3 ml of 1 mg/ml solution IM, plus benadryl 50 mg p.o. Patient was transported to ED.
52 2021-03-11 mouth tingling Received first dose of COVID vaccine on 1/23/21. Complicated by itching and tongue pain. No rash o... Read more
Received first dose of COVID vaccine on 1/23/21. Complicated by itching and tongue pain. No rash or tongue swelling. Given dexamethasone and Benadryl. Got second dose of COVID vaccine on 3/4/21 followed 45 minutes later by SOB, lightheadedness and mouth tingling. No rash or tongue swelling. Rx steroid + saline with resolution. ED visit.
52 2021-03-11 swollen tongue Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stat... Read more
Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stated she felt her tongue swelling. There was a noticeable voice change, expiratory wheezing and pallor. BP 122/86, HR 84. At 10:10am, 0.5mL epinephrine was administered intramuscularly in the opposite deltoid, and EMS was called. Patient reported improvement in symptoms. EMS took over care of the patient, and transported her to the local hospital. She was discharged from the emergency room.
52 2021-03-11 ringing in ears 1. TINNITUS (ringing in the ears) - bilateral, persistent: both ears, continuous ringing, high-pitch... Read more
1. TINNITUS (ringing in the ears) - bilateral, persistent: both ears, continuous ringing, high-pitched sound. began intermittently, then progressed to continuous. 2. PERIPHERAL NEUROPATHY (tingle/numbness) - bilateral, hands and feet: began intermittently, then progressed to continuous.
52 2021-03-12 lip itchiness, mouth itchiness, mouth tingling 15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my f... Read more
15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my face was also flushed and the inside of my mouth (mostly roof of my mouth) and lips were itchy/tingly. Then, I took 2 Zyrtec 10 mg. as instructed by my allergist if I had a reaction. Within an hour, the flushing and itchiness were gone. 2 days later - had strange pain, swelling, and warmth in upper left shin below knee. Worried about possible blood clot, I took 2 baby aspirin. Pain and swelling went away. Not sure if related to vaccine but unaware of anything else that could have been different.
52 2021-03-12 tongue disorder 10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse... Read more
10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse and let them know I was having a reaction, and they took me to a bed, I had brought my Benadryl with me and took 5 ml, I became very cold and began to shake, some shortness of breath, tongue became thick feeling, I am not sure of the time schedule, but I also had my Cromolyn and took 5 ml, I was still having problems after an hour and I took 5ml more of Benadryl and cromolyn, after about 2 hours in the covid area I felt good enough to go home
52 2021-03-13 eye pain Headache, chills, nausea, vomiting, aches and pain, severe pain in kidneys, eye pain, weakness, loss... Read more
Headache, chills, nausea, vomiting, aches and pain, severe pain in kidneys, eye pain, weakness, loss of appetite,
52 2021-03-13 lip swelling, mouth tingling Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took ... Read more
Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took took ibuprofen about 27-28 hours later on 2/3/21 due to aches/headache. She developed face/lip swelling and tingling. She was seen by provider via video visit and told she needed to be seen in person. She went to urgent care and was prescribed EpiPen PRN. On 2/22/2021 she was having some back-pain and took ibuprofen. About 1 hour later she developed same response with face swelling/tingling. She does feel her reaction is caused by the ibuprofen but she reports this being a new reaction since the vaccine since she routinely took ibuprofen prior to the vaccine.
52 2021-03-13 ringing in ears Tinnitus. A constant ringing/buzzing in head that has lasted from the initial vaccine. I have not ... Read more
Tinnitus. A constant ringing/buzzing in head that has lasted from the initial vaccine. I have not sought treatment but am convinced it was from the vaccine as the symptom began the same night of administration.
52 2021-03-13 visual impairment This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both va... Read more
This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both vaccines gave me a reaction, and both around the same time the next morning. My reaction to my 1st vaccine included slight fever, aches, and chills. Both doses were administered around 3:30pm and reaction was approximately 10:30-11am the next morning. On this 2nd dose, roughly 40 minutes after waking from sleep, I became mildly nauseas. I sensed I would vomit, so I sat down on the commode with a bucket in front. I started getting the sweats, got very cold, and my arms starting shaking. I started to feel the room spin, saw big black dots, and after banging on the wall to alert my husband something was happening, I fainted and passed out cold. My husband saw me fall face down, and after waking me, I was in a panic, did not know where I was, or how I was on the floor. I passed out a 2nd time, at which point, my husband was able to get me to the car and he took me to the local hospital. I was incoherent on the car ride, moaning, and not knowing what was happening. My eyes remained closed until I was wheeled into the emergency area and they asked me my name. I was taken to a private room, where they hooked up a blood pressure cuff, an oxygenator on my finger, and took several viles of blood. I was then taken to the cat scan room for a brain scan, and several hours later, was given a chest xray. I remained in the room for approx 6 hours, where I was becoming more and more aware of where I was. I had not eaten/drank anything, except a cup of water. I had not used the lavatory. The PA came to me hours later stating all my tests came back negative, and they could not determine what happened, xrays and blood tests were good, and cat scan was good. He said that while they couldn't determine what happened, they would recommend a stay, so they can do more extensive testing. I contacted my husband via cell, told him what they said, and after another 1 1/2 hours, I made the decision to release myself as I was feeling more like myself again, albeit tired. I went home that evening, ate a small dinner, went to bed, and by 12 Noon the next day, I was fine again.
52 2021-03-16 mouth numbness Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both ... Read more
Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both arms and feels itchy all over. Her tongue feels numb, but not swollen. Her voice is hoarse. Her heart was racing initially, but that resolved quickly. She also felt short of breath for a few minutes, but that also resolved prior to her seeking medical care. She has numerous medication allergies and states this feels similar to a reaction she has when she is allergic to a medication.
52 2021-03-16 mouth itchiness Day 1 = Arm pain and body aches Days 2-4 = like a MS flair I have had before + itchy mouth MS flair... Read more
Day 1 = Arm pain and body aches Days 2-4 = like a MS flair I have had before + itchy mouth MS flair - lower right leg hot and tightness and a little weak both legs, but right was more severe Itch mouth got better with Benadryl. I had not issues breathing or swelling. It wasn't bad, just annoying. By day 5, I was back to normal.
52 2021-03-16 mouth tingling Patient monitored for thirty minutes per protocol of having multiple drug allergies. Patient had n... Read more
Patient monitored for thirty minutes per protocol of having multiple drug allergies. Patient had no history of anaphylaxis. Patient left clinic and while in car ( being driven by sister in law) experienced tingling in the roof of her mouth. 50 mg. of Benadryl was administered by mouth per standing orders.
52 2021-03-16 swollen tongue Swelling of tongue and throat
52 2021-03-17 eye itchiness Symptoms: itchy eyes, nose, throat - the same symptoms she reports when she starts to have an allerg... Read more
Symptoms: itchy eyes, nose, throat - the same symptoms she reports when she starts to have an allergy to Shellfish. Time course: started a couple minutes post-vaccination, lasted for only about 10 minutes. Immediately started improving upon administration of Benadryl.
52 2021-03-17 mouth itchiness, mouth tingling itchy mouth, lips tingling & mouth
52 2021-03-17 oropharyngeal discomfort ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper... Read more
ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper chest/throat discomfort. TENT NOTE: PT. COMPLAINED OF TIGHTNESS IN UPPER CHEST AND FEELING FLUSHED. ASSISTED TO GURNEY AND ADULT EMERGENCY CALLED
52 2021-03-17 mouth tingling, mouth numbness started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives ... Read more
started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives and difficulty breathing. EMS administered benadryl, solumedrol, and epinephrine and transferred to ER. She responded to treatment quickly and was discharge from the ER same day.
52 2021-03-17 vision blurred Dizziness, mild headache to right side of head, blurry.
52 2021-03-18 loss of taste, loss of smell 1/31/2021 patient developed chills, cough, loss of taste/smell, nausea, vomiting, sore throat. posi... Read more
1/31/2021 patient developed chills, cough, loss of taste/smell, nausea, vomiting, sore throat. positive for COVID
52 2021-03-18 mouth numbness, mouth tingling patient experienced light headedness and numb or tingling feeling on tongue immediately following va... Read more
patient experienced light headedness and numb or tingling feeling on tongue immediately following vaccination
52 2021-03-18 mouth tingling dizziness and tongue tingling. Evaluated by EMS-Cleared
52 2021-03-18 swollen tongue, ear pain, lip swelling Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; l... Read more
Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation . Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen on 23Feb2021 07:00 with outcome of recovering , fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen on 23Feb2021 07:00 with outcome of recovering , feels like a head cold on 23Feb2021 07:00 with outcome of recovering , earache on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms on 23Feb2021 07:00 with outcome of recovering , sore throat on 23Feb2021 07:00 with outcome of recovering , slight cough on 23Feb2021 07:00 with outcome of recovering. Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use. Follow up information has been requested.
52 2021-03-18 swollen tongue Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue... Read more
Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
52 2021-03-20 double vision SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability t... Read more
SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability to swallow properly, see without double vision, and walk again.
52 2021-03-20 ringing in ears Sporadic Tinnitus (not loud) and sensation of small bubbles in back of throat
52 2021-03-22 eye pain Soreness at injection site, mild fatigue, headache, soreness in eyes
52 2021-03-22 hearing loss, eye pain, bloodshot eyes, eye irritation Earrs: Swollen Eustachian tubes in both ears: distorted hearing, amplified sound, equilibrium off.... Read more
Earrs: Swollen Eustachian tubes in both ears: distorted hearing, amplified sound, equilibrium off. Eyes: both eyes had irritation, then Left eye pain, inflammation and redness on the outer edge of eyeball.
52 2021-03-22 mouth tingling, mouth numbness Within 10 minutes of vaccine administration, pt began to experience tongue "fullness" and lip numbne... Read more
Within 10 minutes of vaccine administration, pt began to experience tongue "fullness" and lip numbness. Progressed to tongue numbness. VSS and lungs clear. Benadryl given with relief of sx's in 20 minutes.
52 2021-03-22 mouth tingling Patient received vaccine at 12:30 pm. Patient started developing redness on face, arm, torso, and ba... Read more
Patient received vaccine at 12:30 pm. Patient started developing redness on face, arm, torso, and back at 12:41 pm and given Benadryl 25 mg x 1 Dose. Patient started developing tingling lips at 12:50 pm and received EpiPen 0.3 mg x 1 dose and EMS was called. Blood pressure at 122/89 at 12:55 pm; 142/87 at 12:58 pm. Patient was taken to hospital for evaluation.
52 2021-03-22 mouth tingling Tingling to tip of tongue and bottom lip.
52 2021-03-22 ringing in ears Sudden onset of both severe HTN and severe tinnitus 36 hours after dose #2. BP taken with regular u... Read more
Sudden onset of both severe HTN and severe tinnitus 36 hours after dose #2. BP taken with regular use cuff and was 210/175 and tinnitus used to wax and wane in past but no problems, and this acute on chronic onset was severe, 24/7, non-stop and interferes primarily with sleep. Very loud non-stop bilateral tinnitus. I treated elevated BP for 2 weeks with Losartan 25 mg qd, then daily BP came back to normal and Losartan stopped. Tinnitus has not changed.
52 2021-03-24 bloodshot eyes, eye irritation, vision blurred Caller experienced fatigue within 2 hrs of rcvding the vaccine on 3/23/2021, and she experienced mil... Read more
Caller experienced fatigue within 2 hrs of rcvding the vaccine on 3/23/2021, and she experienced mild body achiness within 24 hrs of rcvding the vaccine. The fatigue and mild bod yachiness has subsided. Upon waking this morning on 3/24/2021, she have the following symptoms in her left eye: redness, runny, burning sensation and blurry vision.
52 2021-03-24 oropharyngeal discomfort Scratchy throat 10 minutes after injection
52 2021-03-24 swollen tongue Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a re... Read more
Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a reaction to COVID-19 vaccine 5 min. after injection administration flushing face, heavy tongue and light rash and nausea were the symptoms showed up by patient. V/S BP 198/886, P-63, Sat. 99%. Patient transferred to Hospital to get medical care and be under observation.
52 2021-03-25 lip swelling, swollen tongue Later the day of her shot, she reports that her tongue and lips became swollen and she had difficult... Read more
Later the day of her shot, she reports that her tongue and lips became swollen and she had difficulty breathing. She stated that "I felt exactly how I feel when I'm around shellfish." I advised her to see her MD and to not receive the second dose of the vaccine.
52 2021-03-25 mouth tingling, vision blurred, light flashes or floaters in the eye, ear discomfort, mouth numbness Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face l... Read more
Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face lips and tongue 60 minutes after 1st dose. Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves 2 -3weeks after 2 nd dose. Normal CPK, CBC and CMP results. 2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
52 2021-03-25 mouth tingling Immediately after receiving the vaccine I felt A rush in my body and my heart started beating faster... Read more
Immediately after receiving the vaccine I felt A rush in my body and my heart started beating faster and my lips began to tingle. The nurse gave me 25 mg of Benadryl and I also am experiencing itching all over my body.
52 2021-03-25 swollen tongue, burning mouth syndrome, oral mucosal blistering Tongue pain with swelling, blistering & white coating; blisters inside cheeks;slight headache; sore ... Read more
Tongue pain with swelling, blistering & white coating; blisters inside cheeks;slight headache; sore throat; fatigue
52 2021-03-26 swollen lips Vaccine given , symptoms started 1150 am, Itching, rash, lips "like bee stings", chest pressure, thr... Read more
Vaccine given , symptoms started 1150 am, Itching, rash, lips "like bee stings", chest pressure, throat scratchy. 10 minutes after vaccine administered. Benadryl 50mg and Epineprhine pen 0.3ml. Symptoms continued until EMS picked her up at 1231pm
52 2021-03-26 mouth numbness Severe numbness in the left side of face , tongue, mouth ,ear neck, arm and foot.
52 2021-03-26 ringing in ears Constant buzzing in head, tinnitus. Everyday. Loudest when lying down and at night. Doctor said to... Read more
Constant buzzing in head, tinnitus. Everyday. Loudest when lying down and at night. Doctor said to take Flonase and Zyrtec . Has not helped.
52 2021-03-26 tongue itchiness, dry mouth First two days after the vaccine extremely dry mouth. Then progressively increasing rash on right pa... Read more
First two days after the vaccine extremely dry mouth. Then progressively increasing rash on right palm - Itchy and dry to the point of not able to sleep. On some days itchy tongue too. Going to see a doctor on March 30th.
52 2021-03-27 swollen tongue Patient was accompanied by her daughter to translate. Patient marked YES to the question if she had ... Read more
Patient was accompanied by her daughter to translate. Patient marked YES to the question if she had any allergies on her screen form and noted that she has allergic reactions to sulfur. Her daughter verbally told us she also has allergic reactions to shellfish. The daughter also noted that the sulfur allergy is about 10 years old and the shellfish allergy is 2 years. The daughter also stated that patient has carried an EPI pen for about 2 years and had her own pen with her. We took her aside from the other patients and administered the vaccine with PA watching her. Approximately 10 minutes later, patient felt that her throat began to feel constricted and her tongue began to swell. PA assessed her and decided that she should use her EPI pen. We moved her to an adjoining room (for privacy) and the daughter administered the EPI pen as patient stated that she did not know how to use it. The daughter also gave her mother 2 puffs of Ventolin inhaler. PA exam her and she had a slight elevation in her pulse and course rales bilaterally. At this point, PA determined that we should call 911, which I did. The swelling in throat and tongue began to diminish before the paramedics arrived. Paramedics assessed and decided she should be transported to hospital for full evaluation.
52 2021-03-28 taste impairment Within 5 minutes of the injection I developed a metalic/medicinal taste in my mouth. It lasted for a... Read more
Within 5 minutes of the injection I developed a metalic/medicinal taste in my mouth. It lasted for about 3 days. There was a slight medicinal odor to my breath, similar to what I've experinced after having anethesia.
52 2021-03-28 ear pain Started with nausea at 1:30AM on 3/20/2021 and feeling unwell. At 10:00AM ON 3/21/2021 started havin... Read more
Started with nausea at 1:30AM on 3/20/2021 and feeling unwell. At 10:00AM ON 3/21/2021 started having pain in/behind left ear. This continued up to the time when on 3/24/2021 at 6:45AM my left eye was blinking slower than the right eye and the left-side of my mouth showed signs of drooping. I was admitted to the ER for possible stroke due to symptoms I was having but test results showed Bell?s Palsy. Treatment is acyclovir, ketorolac, prednisone and artificial tears ointment
52 2021-03-28 eye swelling Both eyelids are swollen. Left eyelid is more swollen then right.
52 2021-03-28 mouth tingling Woke up in the middle of the night with tingling pins and needles feeling on my tongue. My voice was... Read more
Woke up in the middle of the night with tingling pins and needles feeling on my tongue. My voice was very hoarse and had some nasal congestion. I could breathe but my throat felt a little swollen. I had a similar but much worse reaction to a flu vaccine 10 yrs ago but during that incident my face/lips swelled in addition, so I went to the ER.
52 2021-03-29 mouth numbness Patient experienced numbness in tongue, SOB, and heavy chest following vaccination. Patient given Be... Read more
Patient experienced numbness in tongue, SOB, and heavy chest following vaccination. Patient given Benadryl. Patient vitals taken all within normal limits. Patients symptoms absent after 1 hour from Benadryl taken.
52 2021-03-29 lip itchiness, mouth itchiness, mouth tingling, tongue itchiness Seven minutes after injection, I had itchiness on the roof of my mouth. Then, I also had itchiness o... Read more
Seven minutes after injection, I had itchiness on the roof of my mouth. Then, I also had itchiness on the tip of my tongue. After 45 minutes to 1 hour, I also had itchiness in the back of my throat. From time to time, my heart raced momentarily but then was normal. I never had trouble breathing. Around the one hour mark after vaccination, I took two Zyrtec. Within the next hour, my symptoms went away. Differences between the second dose and my first dose: my face and neck were flushed soon after the first vaccination but not the second. After the first vaccination, my lips were also tingly and itchy but not after the second vaccination. I took two Zyrtec 30 minutes after the first vaccination but tried to wait longer after the second to see if symptoms would resolve on their own. When they progressed to itchiness in the back of my throat, I took the Zyrtec.
52 2021-03-29 mouth tingling, burning mouth syndrome 5 min after dose my heart was racing and it hurt/ felt tight . 10-20 minutes after dose my tongue w... Read more
5 min after dose my heart was racing and it hurt/ felt tight . 10-20 minutes after dose my tongue was tingling /burning feeling also felt swollen. My throat felt tight and it was difficult to swallow. But I could breath okay. I stayed at the location for approximately 45 min -1hr for monitoring. After leaving I had a couple episodes where my chest got tight and I couldn?t catch my breath but after 4 hrs it cleared up. My throat hurt for 3-5 days afterward and I had a hoarse voice. My tongue still hurts, it felt tingly and burnt shortly after 1st dose and turned paper white for 2-1/2 weeks, now (3wks after the dose) it feels like someone ran a razor blade over it and is turning back to its normal pink color. It is starting to feel a little better. Last week (2 weeks after dose #1) I reacted to wall paint, my hands broke out in hives and got itchy, which I?ve never reacted to in the past. They cleared up after washing them and waiting 2-3 hrs. I also have a slight reaction to pasta sauce now, my lips get slightly puffy and hurt while eating it.
52 2021-03-29 swollen tongue Patient reported signs of an allergic reaction during the observation period after receiving the fir... Read more
Patient reported signs of an allergic reaction during the observation period after receiving the first dose of the Pfizer-BioNTech Covid-19 Vaccine. Patient reported uneasiness, tongue swelling, and difficulty breathing. Patient received an Epi-pen and symptoms mildly improved. Patient remained stable until emergency services arrived.
52 2021-03-29 ringing in ears Chills, Temp. 36.4, Headache, Sore Arm and muscles, Arthritic joints, Low Back Pain, Ringing in ears
52 2021-03-30 mouth tingling Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing... Read more
Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
52 2021-03-30 mouth tingling After 1hour / 1 1/2hour from injection start tingling left side of tongue, lip, swelling the throat ... Read more
After 1hour / 1 1/2hour from injection start tingling left side of tongue, lip, swelling the throat After 2hours find a red burning rash under breast/torax.Called health clinic, the Triage nurse directed me to hospital.Went to the Emergency room. Main Hospital Team Dr. Diagnose:allergic reatcion+Yeast infection. 7:28PM gave 3 pills prednisone. Pescription for Prednisone 20mg 3for4days, nyastatin podwder for rush, epinephrine injection in case of anaphylaxis, benadryl as needed.While I was at ER, the tingling/swelling expand my entire body left side. This night I had to remove wedding ring, today the face still swelling/warming+almost same/little bit worsening simptoms
52 2021-03-31 taste impairment Member developed dizziness and metallic taste in mouth about 5-10 minutes after having the vaccine
52 2021-03-31 ear pain Severe headache, ear pain, chills, fever, fatigue, severe muscle aches
52 2021-03-31 mouth tingling left hand was cold in the pinky and into half of her palm; left arm feels a little heavy; prickly fe... Read more
left hand was cold in the pinky and into half of her palm; left arm feels a little heavy; prickly feeling around her right eye; prickly feeling around her right eye and then she started feeling it in her left cheek on her face. She said that it then went to her left arm; prickly feeling in her lips. Then it went to right nostril and then to the roof of her mouth; numbing feeling in her palm and pinky in her left arm/ numbness in her left arm; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 52-years-old, administered in Arm Right on 04Mar2021 17:15 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included, rotator tear, surgery, nerve block, muscle relaxant therapy, sciatica, neuropathy, numb in her leg in her thigh and from the knee down. She had a reaction to muscle relaxers that she was taking for sciatica and stated that it caused her to go numb in her leg in her thigh and from the knee down and it took 3 months for it to go away, but she still has neuropathy in that leg since then. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at the age of 52-years-old, administered in Arm Left on 11Feb2021 (Lot Number: EL9269) as single dose for COVID-19 immunization. Patient is a schoolteacher that was calling about the Covid-19 vaccine and reported that within 10 minutes (04Mar2021) she felt a prickly feeling around her right eye and then she started feeling it in her left cheek on her face. She said that it then went to her left arm and then she got a numbing feeling in her palm and pinky in her left arm. She had no difficulty breathing. The paramedic came and looked at her and asked her to drink the rest of her water. She waited another 30 minutes before leaving and she said that she was fine. She said that when she was leaving she felt the prickly feeling in her lips. Then it went to right nostril and then to the roof of her mouth. She still has the numbness in her left arm, palm, and pinky. She said that she took some Benadryl and it helped. At one point she did have difficulty swallowing and that is what is what prompted her to take the Benadryl. She said that she stopped and got coffee and she felt like her throat was getting hard and she had difficulty swallowing and it lasted about 2 minutes and she took Benadryl to treat it at the time. She said that the Covid-19 Vaccine gave her that same sensation as the muscle relaxer and she did not like that feeling. The numbness and prickly feeling is the same on her left arm. She said that it was on her right arm and hands, but it is not there or on her face anymore. She said that her left hand was cold in the pinky and into half of her palm (unspecified date). She said that her left arm feels a little heavy (unspecified date). She feels like it is heavy and she is trying to wake it up. That left side she had a rotator tear and she had surgery and had a nerve block. She said that it was a couple of years ago. She said that it felt like Deja Vu. Patient wanted to know if this is something that is involving her nerves? She is going to make an appointment with her physician. Therapeutic measures were taken as a result of "prickly feeling around her right eye", "prickly feeling around her right eye and then she started feeling it in her left cheek on her face. She said that it then went to her left arm", "prickly feeling in her lips. Then it went to right nostril and then to the roof of her mouth", "numbing feeling in her palm and pinky in her left arm/ numbness in her left arm", difficulty swallowing. The outcome of the event paraesthesia, hypoaesthesia was not recovered, of dysphagia was recovered on 04Mar2021, while for the other events was unknown. No Prior Vaccinations (within 4 weeks). No Family Medical History Relevant to adverse events. No Relevant Tests.
52 2021-03-31 swollen tongue Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of ... Read more
Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of neck and tongue began to swell Extreme fatigue took over body Mar 29-8pm Rash and itching in following regions: Around collar area/bra line/buttocks/back of thighs/lower back/behind knees/in elbow crease/back of arms Injection site swollen and painful Mar 30-2am Painful abdominal bloating and gas nausea frequent urination chills/arms and feet would not warm up muscle pain joint pain Mar 30 2:30-3:30am vomiting-multiple times and loose stool elimination/turning to diarrhea continued chills and inability to warm up hands and feet complete fatigue Continued muscle pain/joint pain and injection site pain/swelling Mar 30 2:30pm Low grade fever (99.8) all other symptoms remain and limbs begin to warm up Slept from Mar 30th @ 7pm-Mar 31st-7am Mar 31 Woke at 7am and felt much better Injection site on arm still tender, but improving Fever gone/temperature normal (97.5) rash dissipated Joint and muscle pain lingering (reported side effects to Pfizer reporting mid day of Mar 30
52 2021-03-31 ringing in ears, mouth tingling Lightheaded, dizziness, tongue tingling and "feels" inflamed (I am able to swallow. I have had burn... Read more
Lightheaded, dizziness, tongue tingling and "feels" inflamed (I am able to swallow. I have had burning mouth syndrome for the past 3 years due to menopause it seems to be worse since the vaccine), tinnitus (also a preexisting condition but seems worse since vaccine)
52 2021-03-31 visual impairment Presents to virtual urgent care with a complaint of she received her 1st COVID 19 vaccine on Friday,... Read more
Presents to virtual urgent care with a complaint of she received her 1st COVID 19 vaccine on Friday, she states since then, she has felt dizziness, nausea, and feeling a bit disoriented. She had an episode of seeing bright lights, she feels she can't see correctly. She states it feels like she felt when she had west nile virus. She denies any fever or chills, no pain. Advised pt she will need an in person exam and possible some lab work. Patient opted to go to PCP instead of in person urgent care. Referred to eye center and MRI and diagnosed with vaccine related symptom triggered migraine.
52 2021-04-01 eye itchiness, lacrimation increased Adrenaline rush or rapid heart rate sensation (immediate). Stomach upset (within 1/2 hour). Excess... Read more
Adrenaline rush or rapid heart rate sensation (immediate). Stomach upset (within 1/2 hour). Excessive/sudden sneezing (within 1/2 hour, lasting a day or two). Itchy/watery eyes (within 1/2 hour to an hour). Mental/emotional changes within hours (irrational fear).
52 2021-04-01 swollen tongue, lip swelling On 4-1-21 patient returned to get 2nd vaccine an informed our staff of a severe reaction to 1st dose... Read more
On 4-1-21 patient returned to get 2nd vaccine an informed our staff of a severe reaction to 1st dose. After waiting 15 minutes she left to go home. Once on the express way her lips & tongue sterted to swell . She proceded to go home where she took a Benadryl. Our doctor at this clinic advised her to get cleared by her PCP before 2nd dose given.
52 2021-04-01 ringing in ears ears ringing, flushed, itching. Evaluated by EMS-Cleared
52 2021-04-02 pain in jaw 9:30- started body aches, chills, cold hands 11:00-started fever, 100.5, headache, pain in every jo... Read more
9:30- started body aches, chills, cold hands 11:00-started fever, 100.5, headache, pain in every joint, skin painful to touch, especially my legs These events lasted through the next 24 hours Temperature went up to 101.9. Frequent and sudden need for urination, (hourly for about 16 hours) On 3/11/2021 I woke with extreme pain in my jaw joints that lasted about 4 hours. Around 12:00 pm fever, headache and chills subsided. By approximately 4:00 pm all symptoms had stopped.
52 2021-04-02 mouth tingling Low Grade Fever, Body aches, chills, headache, tingling in face and lips
52 2021-04-02 ringing in ears, ear discomfort, deafness unilateral Hearing loss in left ear, pressure in both ears, slight ringing in ears
52 2021-04-02 ringing in ears Increase in tinnitus both ears
52 2021-04-02 vision blurred Rigors at hour 16, lasting approx. 2 hours; hives on day 2, currently ongoing (day 3). NO FEVER. Hea... Read more
Rigors at hour 16, lasting approx. 2 hours; hives on day 2, currently ongoing (day 3). NO FEVER. Headaches, nausea and fatigue throughout. Blurred vision day starting day 2 and ongoing.
52 2021-04-03 smell distorsion, taste impairment While receiving the vaccine, I immediately had a rush of a strong metallic taste in my mouth. I equa... Read more
While receiving the vaccine, I immediately had a rush of a strong metallic taste in my mouth. I equally had a metallic odor in my nose. Within 5 minutes of receiving the vaccine, I experienced flushing and a headache (only on the left side of my head.) My arm at the injection site grew progressively painful (I did not have any redness or bruising at the site.) The headache subsided after approximately 20 minutes; the flushing went away within a couple of hours of receiving the vaccine. Several hours after receiving the vaccine, I developed some minor itching. My arm continued to hurt more at the injection site (I never developed any redness or bruising at the site.) I experienced body aches and general malaise (as I was informed was to be expected.) I continued to have the strong metallic taste in my mouth into the evening and nighttime hours following the vaccine. During the night (approximately 9 hours after receiving the vaccine,) I awoke to an unfamiliar odor, and feeling nauseous. The odor was emitted from my skin. It has been approximately 72 hours since I received the Pfizer COVID vaccine. The skin odor and metallic state have lessened, but are still persistent.
52 2021-04-04 ear discomfort My ears have been bothering me. I describe it as the feeling when you have been swimming underwater.... Read more
My ears have been bothering me. I describe it as the feeling when you have been swimming underwater. It?s as if they are blocked. It gets worse as the day progresses. I have been asking people to repeat themselves quite a bit. At times, It sounds like they are mumbling I hear constant background noise. It?s not loud but it is constant. It is not ringing, it is a faint rumble of sorts. Very hard to explain.
52 2021-04-04 lip swelling I had severe swelling in my lips and was nauseous.
52 2021-04-04 ringing in ears, hearing loss Severe tinnitus: Two days after receiving my first dose of the Pfizer Covid19 vaccine, the pre-exist... Read more
Severe tinnitus: Two days after receiving my first dose of the Pfizer Covid19 vaccine, the pre-existing tinnitus in my left ear, which has been stable and very mild for 35+ years, suddenly spiked to an almost unbearable level. It has remained consistently high ever since. New tinnitus symptoms presented in my right ear at the same time. I also experienced a sudden decline in my hearing acuity. I additionally experienced tingling and muscle weakness in my face, which has since resolved. However the severe tinnitus remains.
52 2021-04-04 ringing in ears Headache - took Aleve; lasted until the next day Tinnitis - lasted until next day
52 2021-04-04 ringing in ears Tinnitus both ears
52 2021-04-05 mouth numbness Numbness in mouth, lips and moving toward back of the throat and up sinuses. headache and fatigue Th... Read more
Numbness in mouth, lips and moving toward back of the throat and up sinuses. headache and fatigue These symptoms were present 4 hours after 2nd Pfizer vaccine- treatment was steroid shot and benadryl tablets these symptoms reappeared 2 weeks after 2nd shot. treating with benadryl tablets and symptoms mildly improving
52 2021-04-05 mouth tingling Patient feeling dizzy. Denies pain, She has a history of anaphylaxis x8 from shellfish. As talking t... Read more
Patient feeling dizzy. Denies pain, She has a history of anaphylaxis x8 from shellfish. As talking to patient, lips began to feel tingly. No SOB, no rash or swelling. Patient refused transport to ED.
52 2021-04-05 swollen tongue, ear pain, eye pain, ear discomfort Vaccine 2 Sore arm quickly Headache Done at 3:11 (could go home) Ear pain then gone Neck pain then ... Read more
Vaccine 2 Sore arm quickly Headache Done at 3:11 (could go home) Ear pain then gone Neck pain then gone Right breast hurts outside side then gone Headache again then gone Headache again 449 97.9 temp Eyes sore 5:25 98 temp 7pm two Tylenol Feeling heavy head and arm and shoulder sore. Little congestion Ears popped Dizzy Went to sleep at 8pm Swollen tongue and throat 10pm Left arm sore forearm Broken toe kinda burns a little Sat was miserable ?kept falling alseep Sunday was a little better but still all the same issues Digestive issues as well? Did not go away until around noon Tuesday the 30th Finally worked and went to gym on Wed but still sore eyes and throat slight soreness. Like having mono. Super crusty eyes each morning and using saline solution since we started distance learning Worked in person TH and F and went to gym Th and Sat. Woke up with super pain in sinuses Sunday Bleb in right eye Sinus pressure that usually indicates an infection? Went to Dr Monday for pressure and eye Bleb and got prednisone and an an allergy eye drop. Sinus pressure is a little less as I started prednisone this morning.
52 2021-04-05 ringing in ears 34 hours post vaccine, my ears started ringing loudly. It is now two days later and they are still ... Read more
34 hours post vaccine, my ears started ringing loudly. It is now two days later and they are still ringing, same level. This has been my only side effect other than a sore arm.
52 2021-04-06 loss of taste, loss of smell She still has are that she still doesn't have her taste and sense of smell back; She still has are t... Read more
She still has are that she still doesn't have her taste and sense of smell back; She still has are that she still doesn't have her taste and sense of smell back; Had a little congestion; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable Nurse (patient) A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3302, Expiration date MAY-2021), via an unspecified route of administration, anatomical location- Left Arm on 18Jan2021 15:20, as single dose for Covid-19 immunization. The patient medical history and concomitant medication were not reported. It was reported that since she got her first dose injected 18Jan2021 at 15:20 and then tested positive 24Jan2021 for COVID-19 with an unknown name rapid test. She says she would like to know if she is supposed to wait or not get the second dose of the vaccine. Also reported that they did start her on new medications when she got sick. She says that her COVID-19 symptoms she still has are that she still doesn't have her taste and sense of smell back. She says for treatment she is taking Vitamins D, C, and Zinc (NDC/LOT/EXP: Unknown). She says that they also started her on Azithromycin (NDC/LOT/EXP: Unknown), a steroid, Decadron 6mg day (NDC/LOT/EXP: Unknown). She says she also was put on a Symbicort inhaler (NDC/LOT/EXP: Unknown), if she had not started these medications, her oxygen saturation was going down, it would have been medically significant if she hadn't taken these medications she would have ended up in the hospital. She says that she has not run a fever, she has had a little congestion, and she cannot taste or smell anything. The outcome of the events was unknown.
52 2021-04-06 pain in jaw At 3:30 pm, pain in left side under ear/jaw area, pins and needles in jaw area starting. By 5:30 pm,... Read more
At 3:30 pm, pain in left side under ear/jaw area, pins and needles in jaw area starting. By 5:30 pm, pins and needles moving between jaw, top of head, left finger tips, and left cheek/sinus area. Took 1 Ibuprofen for neck/arm pain. Laid down at 5:30 pm. Fatigue. Cold enough to get a blanket but no chills. Laid down rest of the evening until bedtime. Woke up many times overnight from arm pain.
52 2021-04-06 ringing in ears extreme tiredness starting a day after the shot continuing thru today. Also, on 4/6, my left ear st... Read more
extreme tiredness starting a day after the shot continuing thru today. Also, on 4/6, my left ear started making a crackling noise. visited doc, but just said to take flonase and tylenol and start my allergy meds.
52 2021-04-07 ear pain Started to feel soreness in arm and throat about an hour after shot. Sore throat got worse overnight... Read more
Started to feel soreness in arm and throat about an hour after shot. Sore throat got worse overnight and worst one I?ve ever had hard times swallowing feels like throat is swollen but still able to breathe. A little stuffy and runny nose and ear soreness on left side. Drank emergen C in water and took a couple throat lozenges. Took a Tylenol for muscle pain last night around 9:30pm
52 2021-04-07 hearing loss, ringing in ears Loud ringing in hears with muffled hearing and nausea began on approximately 2/25 (best estimate). H... Read more
Loud ringing in hears with muffled hearing and nausea began on approximately 2/25 (best estimate). Hearing issues progressed over the next few days to become almost constant and extremely unpleasant. Nausea became severe and turned to uncontrollable vomiting with extreme headache on Monday 2/29 and I went to Urgent care. Treatment improved headache, but did not provide complete relief. Hearing symptoms remained. Returned to Urgent care 3/1. Provided with IV steroids. Headache finally resolved. Hearing issue and mild nausea remained. By the time I obtained my second COVID vaccine (3/11) symptoms had improved by about 50%. However, after receiving second dose, they became worse again. It was then I thought of a possible connection to the vaccine. None of the doctors I had seen had brought it up and it hadn't occurred to me either. Good news for me: It has now been almost a month since my second dose and my symptoms have finally (just in the last few days) improved markedly. I still have hearing issues, mostly now just in the evenings. I am hoping this resolves soon. I am seeing an ENT and having a hearing test next week to see if there has been any damage, etc. Given MRI. Results normal. Referred to Neurologist and ENT.
52 2021-04-07 lip swelling, mouth numbness Numbness of upper lip and lower part of nose. The upper lip was swollen. The numbness lasted for a... Read more
Numbness of upper lip and lower part of nose. The upper lip was swollen. The numbness lasted for approximately 12 hours. The lip was swollen for 3 days.
52 2021-04-07 mouth tingling 30 minuets after receiving vaccine, I was driving home and my lips started tingling, my skin on my f... Read more
30 minuets after receiving vaccine, I was driving home and my lips started tingling, my skin on my face felt tight. This eventually subsided and went away in about an hour.
52 2021-04-07 smell distorsion Day 2 after the first vaccination, I experienced a strange sulphur smell for 48 hours. Day 6 after ... Read more
Day 2 after the first vaccination, I experienced a strange sulphur smell for 48 hours. Day 6 after the first vaccination, I had severe vertigo, dizziness and vomiting which lasted 7 days.
52 2021-04-07 ringing in ears ringing in ears, dizziness, body pain and aches
52 2021-04-08 mouth numbness 20minutes after 1st shot lips & face became numb. Resolved after about 1 hour.
52 2021-04-08 oral mucosal blistering On day 1 injection day, sore arm; day 2 sore body and throat; day 2-3 blisters at the edge of my mou... Read more
On day 1 injection day, sore arm; day 2 sore body and throat; day 2-3 blisters at the edge of my mouth which is very unusual as I don?t get cold sores.
52 2021-04-08 feeling of choking Patient received 2nd dose (booster) of Pfizer with no incident. After being in observation for 10 mi... Read more
Patient received 2nd dose (booster) of Pfizer with no incident. After being in observation for 10 minutes, she became acutely short of breath, red, and complained of her throat tingling. Within 2 minutes patient was impending airway compromise and tachypneic. Patient was given EPI auto-injector (0.3mg) IM. Patient symptoms did not improve. Patient was given a second 0.3mg Epi Auto Injector in opposing thigh. Patient was also administered 50mg Benadryl IV. Ambulance from Fire/Rescue transported patient to St. Joseph hospital. Patient condition improved greatly following second dose of Epi.
52 2021-04-08 swollen tongue Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressu... Read more
Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressure the next two days after I had really bad migraine and high fever of 102.3° with bad fatigue for 4 days.
52 2021-04-08 ringing in ears Confusion, extremely severe ringing in ears, lisping
52 2021-04-09 taste impairment Metallic taste in mouth lasted about 30 min
52 2021-04-09 taste impairment Within 5 minutes after my injection my lips and nose became numb/numbing went up my cheek, forehead;... Read more
Within 5 minutes after my injection my lips and nose became numb/numbing went up my cheek, forehead; Headache; a metallic taste in my mouth; my blood pressure was 180/100; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiration date: unknown), via an unspecified route of administration on 21Feb2021 12:00 on left arm at single dose for COVID-19 immunisation. Medical history included Low Thyroid and allergies to Ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient not diagnosed with COVID-19.Since the vaccination the patient had not been tested for COVID-19. Concomitant medication included Levothyroxine. On 21-Feb-2021 12:00 PM (Within 5 minutes after injection), patient experienced her lips and nose became numb. A nurse brought patient to a doctor where the numbing went up my cheek, forehead, my teeth after almost 5 hours patient was still numb. Patient also had a sight sore throat headache; blood pressure was 180/100 and had a metallic taste in my mouth. Patient visited the physician office but did not received any treatment for events. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.
52 2021-04-09 mouth numbness, mouth tingling my throat began to swell shut; my lips became numb and tingly; my lips became numb and tingly; This ... Read more
my throat began to swell shut; my lips became numb and tingly; my lips became numb and tingly; This is a spontaneous report from a contactable consumer (patient). A 52-year-old (non-pregnant) female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration in right arm on 29Jan2021 10:30 as single dose for COVID-19 immunisation. Patient's medical history included known allergies from sulpha medications and latex. Patient did not receive any other vaccine in four weeks. The concomitant medications of patient included levothyroxine sodium (UNITHROID), lisinopril, nebivolol hydrochloride (BYSTOLIC), furosemide. On 29Jan2021 10:30, the patient experienced my throat began to swell shut, my lips became numb and tingly. There was no covid prior vaccination and no covid tested post vaccination. Event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment. The outcome of event was recovered on an unknown date in 2021.
52 2021-04-09 taste disorder, thirst 4/9 4:25pm: runny nose, headache, stuffy sinuses/pain- went away after 15 minutes 4/9 11:06pm: woke... Read more
4/9 4:25pm: runny nose, headache, stuffy sinuses/pain- went away after 15 minutes 4/9 11:06pm: woke up to speeding heart rate, labored breathing, thumb joint left hand hurts/pain, stomach nausea, racing in stomach, neck itchy, pin prickly hands and legs 4/10 4am: hand joints very stiff, can?t close hands, fingers extremely swollen and painful, injection site - severe pain, thirsty, dehydrated 4/10 7am: neck severely itchy, hands feels like they?re going to explode from pressure- swelling and red with pain, severely dehydrated, coated tongue and disgusting taste in mouth, feel nauseous, multiple head spasms continuing at approximately 15 min intervals, scalp itchy, pain at injection site
52 2021-04-10 swollen tongue About 10 minutes after my vaccine, the nurse asked if I was okay and I said, I'm not sure, I think s... Read more
About 10 minutes after my vaccine, the nurse asked if I was okay and I said, I'm not sure, I think so, and she told me I could go home. I walked to my car and my symptoms became worse, so came back; my symtoms were tightness in chest, difficulty breathing, difficulty swallowing, swollen tongue, cough. The clinic staff called an ER nurse from down the hall and I was wheeled to the ER where I was given treatment of epinephrine, albuterol breathing treatment, prednisone.
52 2021-04-10 ringing in ears Nose bleed, feeling of pulse in lower back, ringing in ears, headache- all occurred simultaneously.
52 2021-04-10 ringing in ears Vertigo off and on yesterday. Loud tinnitus in left ear last night for 3 hours until subsiding. Wo... Read more
Vertigo off and on yesterday. Loud tinnitus in left ear last night for 3 hours until subsiding. Woke me from sleep.
52 2021-04-11 ear discomfort I was tested for Covid in January 2021 and had symptoms for approx. 6 weeks. After approx. 9 hours a... Read more
I was tested for Covid in January 2021 and had symptoms for approx. 6 weeks. After approx. 9 hours after receiving my first Pfizer vaccination shot I took a shower and shortly afterwards started shaking uncontrollably. It was not like shivers from a fever. My entire body shook for approximately 1 1/2 hours laying in bed. It stopped completely then I had a hot/burning sensation on my face and ears for approx an hour. I drifted off to sleep. The next morning I felt muscle soreness and tiredness most likely from the shaking. This is the first time ever having the shakes. I had shivers and chills when I had Covid but this was much worse than shivers. Today is five days after the shot and having this reaction and I am feeling ok. I do not have any serious health conditions. I do have history of high blood pressure, IBS and migraines.
52 2021-04-11 ear swelling, smell distorsion Red triangular raised bump patch (non-itch) of skin from right ear to the middle of the throat. Appe... Read more
Red triangular raised bump patch (non-itch) of skin from right ear to the middle of the throat. Appeared by late afternoon of the day the vaccine was administered. The rash lasted 4 to 5 days, turn brown and skin sloughed off, skin over the area of the throat still feels different now. Also I have been experiencing a change in smell sense. I smell a wood/ash smell numerous time through out the day since receiving the vaccination, I can kind of take it when I smell the ash/wood smell.
52 2021-04-11 lip swelling Lip swelling approx. 15 minutes after vaccination. MD assessed and dosed with Benadryl 25mg. Monitor... Read more
Lip swelling approx. 15 minutes after vaccination. MD assessed and dosed with Benadryl 25mg. Monitored for additional 45 minutes. Pt. stated has not gotten worse.
52 2021-04-11 smell distorsion The second and third days after the March 29 dose, I experienced sinus headaches. I kept the worst ... Read more
The second and third days after the March 29 dose, I experienced sinus headaches. I kept the worst of the pain at bay by taking acetaminophen and ibuprofen. On April 5, I began to feel dizzy, nauseated, very tired and had a severe sinus headache. I also experienced a strong smell of cigarette smoke when no one else could smell it and there were no nearby smokers. The nausea was pretty severe. I felt like vomiting but never did. I did have some diarrhea. This continued at its most severe through April 6. On that date, I called my doctor who recommended I use flonase. I had also started taking Tylenol Severe Sinus. My symptoms improved after starting the meds. My doctor also recommended I get a Covid test. I got the rapid test on April 7. It was negative. By April 9, my symptoms were mostly gone, including the smell of smoke. I also had side effects after the first vaccination on March 8. On March 9 and 10, I had a severe sinus headache. On March 10 and 11, I was very nauseated and vomited twice. I also experienced fatigue for about 5 days.
52 2021-04-11 thirst Extreme dehydration/thirst since the injection. I have been drinking 18 (8 oz each) glasses of wat... Read more
Extreme dehydration/thirst since the injection. I have been drinking 18 (8 oz each) glasses of water a day. As a result, I have had a headache that won't go away.
52 2021-04-12 dry mouth Fatigue, Body aches, Muscle aches, Fever, Back pain, Dry Mouth, Sore Throat
52 2021-04-12 ear pain Ear aches in both ears, still knee joints. Nothing done for the knees. Used ear drops in both ears t... Read more
Ear aches in both ears, still knee joints. Nothing done for the knees. Used ear drops in both ears to try to remove any wax buildup. I usually have to remove wax approximately once per year. There has never been a pain associated with wax build. The pain is still there. Both started ~4/11/2021, between v-safe reporting events.
52 2021-04-12 thirst After vaccine I was told to wait 30 minutes and I started feeling woozy/a mild nausea and broke out ... Read more
After vaccine I was told to wait 30 minutes and I started feeling woozy/a mild nausea and broke out into cold sweats a few minutes later. I got up and told the nurses at Medical Center (site in which I received vaccine) that I felt like I was going to faint. I was instructed to lay down on floor and they put my legs on a pillow. I next recall being blood pressure cuffed and them saying my BP was rather low. I was also very thirsty. I was told I wasn't responding for a few (smelling salts were used) I then was instructed to sit up but my BP was low and I felt dizzy. It was then decided I should be wheeled to the ER for observation. I was in a room where they took my EKG which turned out fine and I was given an IV flush and hydrated. I had blood work done and all was well so I was released a few hours later.
52 2021-04-12 vision blurred Headaches, joint pain, fever , vomiting, Chills, Shortness of breath, muscle pain, vision can't focu... Read more
Headaches, joint pain, fever , vomiting, Chills, Shortness of breath, muscle pain, vision can't focus
52 2021-04-13 ringing in ears Bilateral tinnitus
52 2021-04-13 ringing in ears Tinnitus ongoing
52 2021-04-13 visual impairment C/o dizziness, nausea, warm to touch, visual disturbances feels like "stomach is turning."
52 2021-04-14 mouth numbness, mouth tingling, feeling of choking Employee taken to the ED. 52 y.o. female presenting with numbness and tingling around her throat, t... Read more
Employee taken to the ED. 52 y.o. female presenting with numbness and tingling around her throat, tongue, and lips after receiving the first dose of the Pfizer covid vaccine at approximately 12:15 pm and subsequently was sent to the ED about a half hour later. She stated that after receiving the vaccine, her tongue felt "full" and her lips had some tingling - overall it just felt funny. She received 50 mg of Benadryl - this made the numbness and tingling decrease slightly but it hasn't caused it to completely resolve. She also had a slight headache that started shortly after this. She denied any shortness of breath or rash. She has never had any symptoms like this with a previous vaccine although she has had urticaria with penicillins
52 2021-04-14 lip swelling Swelling of feet, hands,intense itch of hands, major hives, swelling in lips.
52 2021-04-14 mouth tingling, lacrimation increased Injection was at 12 PM. At 12:15 PM I started to feel a furry throat like I had a hairball in my thr... Read more
Injection was at 12 PM. At 12:15 PM I started to feel a furry throat like I had a hairball in my throat and a tickle. Within a minute or so I got a cough, a dry cough with a high pitch. I could not stop coughing. My face felt hot and was flushed, my lips tingly, and I started to sweat a lot. I was short of breath when I tried to talk. The staff on site put an oximeter on and my oxygen was fine but my pulse rate was around 130. My nose was dripping snot and my eyes were running. We walked over to ER which was just around the corner, And sat in the waiting room for about 10 minutes wondering if the cough and symptoms would update. I Peed my pants a little bit. I started to feel very nauseous and little bit scared, even though this has happened to me before. I was brought to a room and soon given a dose of Epi as well as Pepcid (about 1pm) soon after some Zofran. The epi took care of my symptoms within about five minutes. About 90 mins later symptoms came back full on and I was given another dose of Epi at almost 3pm. And agin at 630pm.
52 2021-04-14 ringing in ears Ringing in both of my ears started after my 2nd dose of the vaccine. It is continuous ringing that ... Read more
Ringing in both of my ears started after my 2nd dose of the vaccine. It is continuous ringing that doesn't go away. I have an appointment with an ENT in the next week.
52 2021-04-14 vision blurred, mouth numbness All symptoms last for about 1.5 hours. Lightheaded, foggy vision and weakness in the legs: felt like... Read more
All symptoms last for about 1.5 hours. Lightheaded, foggy vision and weakness in the legs: felt like going to faint.=> washed face and hands with cold water and these feelings disappeared. Then periodic palpitations started, each serious was weaker until they disappeared after about an hour. During the palpitations, felt weakness/ numbness in the low jaw and low lip with difficulties to talk but it lasted only for number of seconds. The last symptom during that 1.5 hour was some warm feeling in the inner part of the leg (thigh and calf) and the outer side of the legs filled just as normal. I di have some tightness in the chest with difficulties to have a deep breath but it was't significant while I was driving home
52 2021-04-15 taste impairment, mouth tingling Around 6 p.m. I started to have tingling and metallic taste in my mouth followed by a headache I too... Read more
Around 6 p.m. I started to have tingling and metallic taste in my mouth followed by a headache I took a hot shower I went to bed I began to have chills and sweating throughout the night I took two Tylenol and continued to have aches and pains throughout the night. When I woke up this morning to brush my teeth I have a black tongue. And a fever of 100.7
52 2021-04-15 thirst Headache, aches, fever, chills, thirst
52 2021-04-15 ringing in ears On the evening of my first vaccine shot, I developed tinnitus. I have had it every day for 3 weeks.
52 2021-04-17 deafness unilateral Approximately 1 week after my vaccination, I began losing hearing in my right ear. Coincidentally t... Read more
Approximately 1 week after my vaccination, I began losing hearing in my right ear. Coincidentally the same side I received my vaccination; This is a spontaneous report received a contactable consumer, the patient. A 52-year-old adult [non-pregnant] female received a single dose (unspecified dose number) of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route in the right arm on 25Mar2021 at 13:30 (at 52-years-old), for COVID-19 immunisation. Relevant medical history included depression. Concomitant medications sans indication, posology and therapy dates included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) and sulfamethoxazole/ trimethoprim (BACTRIM). The patient previously received treatment for an unspecified indication with codeine and experienced a drug allergy. The patient denied any COVID diagnosis prior to the vaccine. The patient reported that on 29Mar2021 she began to lose hearing in her right ear. The patient noted that it was coincidentally the same side that she received the vaccine on. The event did not result in any visit to an emergency room, physician office or hospital. It was unknown if any treatment was received. The outcome of the event began to lose hearing in her right ear was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
52 2021-04-17 ear discomfort hives and rash throughout body and face, labored breathing, fatigued, pressure in head and upper jaw... Read more
hives and rash throughout body and face, labored breathing, fatigued, pressure in head and upper jawline on right side of head/behind ear.
52 2021-04-17 mouth tingling Tingling lips; itching; tight throat; headaches like the headaches I experienced when I had COVID; F... Read more
Tingling lips; itching; tight throat; headaches like the headaches I experienced when I had COVID; Fatigue; injection site warm; This is a spontaneous case received reported from a contactable consumer. A 52-years-old non pregnant female patient received dose 1 of bnt162b2 (BNT162B2, Solution for injection; lot EW6207), via an unspecified route of administration, administered in Left Arm on 25Mar2021 16:45 as single dose for covid-19 immunization. Medical history included PAD (peripheral arterial occlusive disease), Hypertension, COVID-19, Allergies to medications, food, and other products (Sulfa). Concomitant medication included Doxycycline, Cilostazol, Ketogenix, multivitamin. The patient experienced Tingling lips, itching, tight throat, headaches like the headaches I experienced when I had COVID. Fatigue, injection site warm on 25Mar2021 07:30 PM. the patient received Benadryl treatment for allergic reaction symptoms. the patient was diagnosed with COVID-19. The outcome of the events was reported as recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-04-17 ringing in ears The first nite after receiving the shot on April 15 at 10:36 am I had fever, chills and a headache.... Read more
The first nite after receiving the shot on April 15 at 10:36 am I had fever, chills and a headache. Couldn?t sleep all night that night. Had one Tylenol that same night. Didn?t help. The second night I went to sleep and took two 82 mg aspirins for the lingering headache.- it worked slept well. Two days after the vaccine at around 2:30 pm I experienced vertigo- especially laying my head down made the sensation of spinning . I went to sleep to take a nap and try and sleep it off. One hour later I woke up and still had vertigo and also tinnitus- a ringing in my ear. The vertigo has gotten better - still feel it on the third day and still have the ringing in my ear which made sleeping quite difficult on the 3rd night.
52 2021-04-18 eye itchiness, eye irritation, swelling of eyelid, bloodshot eyes Severe itching of my inside my eyes (upper and lower inside lids); bloodshot eyes; swelling of lids ... Read more
Severe itching of my inside my eyes (upper and lower inside lids); bloodshot eyes; swelling of lids themselves. Felt like an allergy. Felt extremely itchy. Also had like a grittiness to my eyes. It was very severe. It lasted for two weeks before I was seen by the doctor. 1/25 - Dr said my eyes were very inflamed. She rolled up my eyelids and said that I had bumps under my eyelids from severe inflammation. I had been using, at home, an OTC allergy eyedrop - Ketotisin Fumerate - that wasn't helping. Dr prescribed a steroid eye drop. They also gave me an Erythromycin ointment for outside of eyes because they said my skin was very dry and affected and she was trying to moisturize it. She described it as a toxic conjunctivitis. The steroid drops did help. I went back for a follow up and it was improved. Subsequent to that, I went back to doctor for an exam for eye glasses and she said there was still a residual of the bumpiness under the eye lids (March 17th). Now I have been experiencing problems with that again that started a week ago today - April 12th. Having a more itchiness (extreme but not quite as severe as the first time) - redness; bloodshot eyes. I tried the OTC med again and it didn't help. I used the Steroid medication again twice and it did help it a bit...I am trying not to use the Steroid medication too much - so just trying to get the symptoms at bay with sparse use of Steroid drops. (Received the 2nd dose - January 20, 2021.)
52 2021-04-18 lip swelling Similar to after first vaccination, I felt quite sick the next day with fever, body aches, fatigue, ... Read more
Similar to after first vaccination, I felt quite sick the next day with fever, body aches, fatigue, etc. I had COVID in March 2020, and it felt similar. I recovered in 24 hours, faster after second vaccine than first. But then Thursday night I developed hives on my inner arms. On Friday morning I woke up and my bottom lip was swollen in one corner. Swelling became worse. I took antihistamine, which seemed to help, and consulted with my doctor. But as the day continued my face became splotchy, my cheeks swelled and warm to touch, and the swelling moved to my upper lip. That evening the swelling became extreme. My doctor put me on prednisone. Next day swelling was reduced. By Sunday morning there was just slight swelling in face. By later Sunday swelling was gone. I also submitted a report after my first vaccination, which included warmth at vaccination site and rash on arm. And two days of feeling like I had COVID again.
52 2021-04-18 mouth tingling, lip swelling Pt first called on 4/13 to report throat and tongue tightness 3 hrs post first Pfizer vaccine. She ... Read more
Pt first called on 4/13 to report throat and tongue tightness 3 hrs post first Pfizer vaccine. She tried Allegra with no response. She then called today to report symptoms that are continuing that she related to the first Pfizer vaccine. She started to experience lip swelling and tinglings as of 4/16. Her PCP instructed her to take Benadryl, and she has had good relief with that. Her throat and tongue tightness have improved since 4/13.
52 2021-04-18 mouth tingling Pfizer-BioNTech COVID-19 vaccine- received a call from client at 1:45 PM, as she was calling to repo... Read more
Pfizer-BioNTech COVID-19 vaccine- received a call from client at 1:45 PM, as she was calling to report something during the night she noticed that her lips had started to tingle. She does not report any other symptoms, but still feels a slight tingling sensation in her lips. 4/19/21 Called client states all symptoms resolved.
52 2021-04-18 vision blurred Pt. develop a reaction to 1st dose of covid-19 vaccine. Symptoms described as having elevated heart... Read more
Pt. develop a reaction to 1st dose of covid-19 vaccine. Symptoms described as having elevated heartrate and headache and blurred vision. Pt. current medications cytomel and levothyroxine, also pt. in remission for cancer with a thyroid of 4/14/21 removal. V/S: 123/71, 73 P. Pt. verbalizes feeling better and recovered . No hospital provided.
52 2021-04-19 eye swelling Fever 100.5 - 102.00 4/16, 4/17, 4/18, Fatigue, body pain, nausea, headache 4/16, 4/17,4/18. Fatigu... Read more
Fever 100.5 - 102.00 4/16, 4/17, 4/18, Fatigue, body pain, nausea, headache 4/16, 4/17,4/18. Fatigue, body pain, nausea, facial / eye swelling, pain when walking in lower back and hamstrings 4/19, 4/20
52 2021-04-20 ringing in ears Increased pain and stiffness of cervical spine about 1 week following 2nd vaccine. Progressed to mu... Read more
Increased pain and stiffness of cervical spine about 1 week following 2nd vaccine. Progressed to muscle spasms and/or contacted muscles, up back of neck, into back of head, causing headaches up the back of head. Tinnitus set in around April 7th, and continues. Nausea started on 4/12/21, and continues
52 2021-04-20 ringing in ears Sore arm and a just a little bit tired after both doses of vaccine. However, after the second dose ... Read more
Sore arm and a just a little bit tired after both doses of vaccine. However, after the second dose the volume of my tinnitus increased that evening and is still at the increased level 1 week later. Contacted ENT office, no treatments available.
52 2021-04-20 ringing in ears Bilateral tinnitus; This is a spontaneous report from a contactable consumer reporting for self. A 5... Read more
Bilateral tinnitus; This is a spontaneous report from a contactable consumer reporting for self. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 01Mar2021 10:30 (Batch/Lot Number: EN6205) at the age of 52 years old as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced bilateral tinnitus on 12Mar2021 19:15. Event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were taken as a result included Hearing test and ENT visit. Outcome of event was not recovered.
52 2021-04-20 tongue disorder, swollen tongue, dry mouth, loss of taste 4/4/2021 - 4/7/2021 - Low fever (99.9 degrees), but oddly only in evening and overnight; severe enou... Read more
4/4/2021 - 4/7/2021 - Low fever (99.9 degrees), but oddly only in evening and overnight; severe enough to disrupt sleep - took Tylenol 4/5/2021 - 4/14/2021 - Two canker sores appear suddenly on my bottom inside lip on the left on 4/5;extremely dry mouth; tongue is swollen and pale; feels like I have cuts on my tongue; constantly drinking water; swollen tender lymph nodes all along the left side of the neck; sores in the back left side of tongue on 4/6. Took Advil intermittently, didn't reduce swelling of either the nodes or tongue, but helped with pain. 4/5/2021 - 4/10/2021 - Fatigue, aches, and chills through these days; took nap in the afternoon on Saturday 4/10 and suddenly felt much better after 4/8/2021 - lost taste for just one day; couldn't taste sweet in the morning and then couldn't taste salty in the afternoon 4/15/2021 - 4/21/2021 - canker sores and "cuts" on tongue reducing over these days; when I look at these sores/cuts on my tongue, I can't really see any cuts or sores...just looks like little bumps or swollen taste buds 4/15/2021 - 4/18/2021 - Lymph nodes on left side of neck still swollen but no longer tender and painful 4/15/2021 - 4/19/2021 - Severe headaches that made me take two Advils every 4-6 hours. Touching hair was sensitive and coughing or sneezing really hurt. 4/19/2021 - 4/20/2021 - Number of swollen lymph nodes slowly reduced in number; not painful. 4/20/2021 - Mostly feel good. No more headaches. Tongue just had two places where it felt like it was cut. Again, can't really see anything wrong when I looked at it. 4/21/2021 - Today I was mostly good. Just only one small swollen lymph node at base of neck on left side (not painful); one "cut" on the tip of my tongue on the left (little painful).
52 2021-04-21 eye strain couldnt move - open eyes headaches fuzzy brain feeling servere joint pain stomach/bathroom system i... Read more
couldnt move - open eyes headaches fuzzy brain feeling servere joint pain stomach/bathroom system issues throat hurt soar very very soar - no relief eyes strained
52 2021-04-21 oropharyngeal discomfort Pt received 2nd Pfizer dose at 1212 32 min after receiving vaccine, Pt complained of feeling somethi... Read more
Pt received 2nd Pfizer dose at 1212 32 min after receiving vaccine, Pt complained of feeling something stuck in her throat and chest pressure denying and chest pain. Pt refused administration of Epinephrine and she self administered her inhaler. Pt vitals at 1239 BP 129/92 P 58 R 16 SAT 99% ED came to transport pt to ED for further evaluation ED administered medications: EPINEPHrine Inj 0.3 mg (ADRENALIN) ? diphenhydrAMINE Inj 25 mg (BENADRYL) ? methylPREDNISolone Sod Succ (PF) Inj 125 mg (SOLU-Medrol PF)
52 2021-04-21 swollen tongue As soon as fluid was injected- a wave of heat flowed thru my blood from head to toe. Then came heart... Read more
As soon as fluid was injected- a wave of heat flowed thru my blood from head to toe. Then came heart palpitations, shortness of breath, sweating, and feeling of faint (NO fainting occured). Feelings in head of disorientation/ disconnect. Sent to observation room to lay down. Provided with water- was able to drink it/ no tongue swelling or throat closing. Monitored by paramedic for 1 hour. Before release, oxygen was 100%/ pulse 74%.
52 2021-04-22 mouth numbness Jaw, lips, mouth area - numb for 45 hours. Pain under right rib for 18 hours. Severe pain in left ... Read more
Jaw, lips, mouth area - numb for 45 hours. Pain under right rib for 18 hours. Severe pain in left arm & hand with a band across my lower back that came on with the arm/hand pain - hand/arm pain lasted 18 hours with the lower back taking 5 days to subside. Severe head to toe itching - no rash found anywhere- took Benadryl evening of the shot and itching was alleviated. Severe headache just at the forehead and up with extreme dizziness - lasted 33 hours. Fatigue lasted 5 days - severe the first 33 hours.
52 2021-04-22 lip swelling Swollen lower lip-starting on the left corner Swollen Left Side Cheek and Jaw White sensitive bumps ... Read more
Swollen lower lip-starting on the left corner Swollen Left Side Cheek and Jaw White sensitive bumps on tongue Getting worse each day. Today is Friday 4/23/2021
52 2021-04-22 swollen tongue, eye swelling, mouth swelling Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of ... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Symptoms began 30min after dose. pt was on way home from vaccine then went to ER for treatment. was given benadryl at hospital then released.
52 2021-04-22 swollen tongue 4:23 PM Pt began to complain of neck stiffness and nausea. She was brought back to exam room and bec... Read more
4:23 PM Pt began to complain of neck stiffness and nausea. She was brought back to exam room and became increasingly lethargic with complaints of chest pressure, numbness in both arms and tongue swelling. She was placed in supine position and 1ml of epinephrine was administered IM in left thigh. She had a visible rash on her left upper arm, chin, neck and ears. One minute after administering Epinephrine the pt reported feeling better. 4:30 PM the redness was improving and the pt was talking 5:00 PM She began to have shaking in her jaw and left hand and arm. This resolved approximately 10 minutes later without intervention and vital signs remained stable, except heart rate increasing into the low 100's. 5:13 1 ml of Dexamethasone 10mg/ml was given IM in right deltoid. Patient was monitored until 6:15pm and released to return home.
52 2021-04-23 ear discomfort, ear pain, ringing in ears One week after the shot, my left ear filled up, extreme pain, was completely clogged, low grade feve... Read more
One week after the shot, my left ear filled up, extreme pain, was completely clogged, low grade fever began (100.2) around that time and I did experience a little dizziness on one day. I had my ear cleaned out at an urgent care, he said my ear was only a little red so it was not an infection but gave me an amoxicillin to take just in case. My tinnitus also increased. It has been a little over 3 weeks since the event began and my fever did break, the ear pain is much less, no more dizziness currently but the Tinnitus is louder than what I had pre-shot. It seems a little better but not back to where it was pre-shot.
52 2021-04-23 pain in jaw All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the e... Read more
All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; vaccine site started being sore; This is a spontaneous report from a contactable consumer/ Non-HCP (patient). This 52-year-old non-pregnant female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in the left arm, on 12Feb2021at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. Patient's medical history included hypothyroidism, irritable bowel syndrome, primary hypertension, seasonal affective depression and flu. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in left arm on 22Jan2021 at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. The patient had no allergies with medications, food or other products. Concomitant medications in two weeks included levothyroxine sodium(thyroxine), sertraline, hyoscyamine and lisinopril. On 12Feb2021, the patient was a little sore that day, but not the next, vaccine site started being sore. On 14Feb2021 patient spent an hour shoveling snow in the morning, but wasn't sore afterwards. On 14Feb2021 (8 plus hours after shoveling snow), the vaccine site started being sore, but the pain was on again/off again. As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm. All of the joints in both arms ached, 600 mg ibuprofen didn't seem to help. On 15Feb2021(Morning), the injection site is a little sore, the joints in her left arm are sore, and, weirdly, her left hip aches. The throbbing pain last night wasn't like any over-used muscle soreness I've ever experienced and the joint aching was also unlike anything I've experienced outside of when I've had the flu. Patient did not receive other vaccines within 4 weeks or prior vaccination. No COVID-19 prior the vaccination and no COVID-19 test was done post vaccination. Patient's treatment medication included ibuprofen. Outcome of the events were recovering. Information on the lot/batch number has been requested.
52 2021-04-23 pain in jaw On April 7 I felt itchy arms which I thought was related to a soap that I was using at a hotel. That... Read more
On April 7 I felt itchy arms which I thought was related to a soap that I was using at a hotel. That day around 3 PM I felt exhausted and had to lie down. The next morning I woke up With a puffy face. The next morning I woke up feeling as if my teeth had punctured my inner cheeks around my job. Friday, 9 April I was still puffy and it was more pronounced on the left side of my face. From there it gradually became more swollen over the next few days before I went to urgent care.
52 2021-04-23 ringing in ears Developed symptoms of tinnitus. Started feeling constant noise in my head and ringing in my ears two... Read more
Developed symptoms of tinnitus. Started feeling constant noise in my head and ringing in my ears two days after getting first shot of Covid-19 vaccine. Decided to submit report after noticing that many people in social media report the same reaction of Tinnitus and Hearing Loss/Impairment after COVID vaccination.
52 2021-04-23 vision blurred, burning mouth syndrome mild flu like symptoms; bloody nose; blood sugars were also elevated; severe pain in her stomach and... Read more
mild flu like symptoms; bloody nose; blood sugars were also elevated; severe pain in her stomach and head; severe pain in her stomach and head; tongue was throbbing and hurt; throat was hoarse; when she was talking she would get out of breath really quickly; producing a lot of phlegm/cough; vaginal mucous; eyes also feels like a film is over them; gums began to hurt; weakness/body felt heavy; total exhaustion; Fatigue; This is a spontaneous report from a contactable consumer or other non-HCP via medical information team. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262) intramuscularly at a dose of 0.3 ml in left arm on 29Jan2021 as single dose for COVID-19 immunization. Patients age at the time of vaccination was 52-years-old. Medical history included type 1 diabetes mellitus, menopause from an unknown date. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, trazodone taken for an unspecified indication. On 30Jan2021, the patient experienced bloody nose; on 31Jan2021, the patient experienced mild flu like symptoms; on an unspecified date the patient experienced blood sugars were also elevated, severe pain in her stomach and head, tongue was throbbing and hurt, throat was hoarse, cough, when she was talking she would get out of breath really quickly (dyspnea), states she slept for several days, producing a lot of phlegm, vaginal mucous, eyes also feels like a film is over them, gums began to hurt, weakness/body felt heavy, fatigue, total exhaustion. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The outcome of the events stomach and head, gums began to hurt, weakness/body felt heavy, fatigue was recovered and total exhaustion was not recovered while for others was unknown. The patient would like to know the timing of the second dose of the Pfizer COVID vaccine if she does not receive it at the recommended 21-day interval. Follow-up (10Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported about the patients height and weight. The patient had a very severe reaction and is still very ill and weak. The patient did have Covid test two days ago and it was negative. No further follow-up attempts are possible, no information is required.
52 2021-04-24 eye disorder severe sinus issues; she is still not feeling good; flu-like symptoms; head is foggy right now, cant... Read more
severe sinus issues; she is still not feeling good; flu-like symptoms; head is foggy right now, cant remember her doctors name; sick/ended up really ill yesterday; vomiting; forgetfulness/cant remember her doctors name; Tired; Sore throat; body aches/body aches and pains; chills without fever; severe diarrhea; nausea; She was not able to eat yesterday as well; she mentioned that she still has a bad lack of energy/stayed in bed all day; burning lungs; severe migraine due to her bad sinuses/migraine headache; severe migraine due to her bad sinuses; crusty eyes; Arm was sore where she got the shot for a few days after the Vaccine; This is a spontaneous report from a contactable consumer reported for herself. This 52-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration in the upper muscle of left arm on 29Mar2021 at single dose for COVID-19 immunization. Medical history included ongoing heavy smoker smoking for at 32 years or more, not drink anymore, agoraphobia started when COVID pandemic came a year ago, pneumonia, anxiety, severe depression, bipolar, panic attacks due to trauma, on disability since her mother passed away 6 years ago. Her family was alcoholic and her dad was an alcoholic, it was just something she did. She went on a 6 year drinking binge over 10 years ago, but she has been sober for 10 years. The patient had pneumonia, anxiety, severe depression, bipolar, panic attacks For years and believed these were related to abuse from years ago. The patient also believed panic attacks was related to her mother passing and her nephew having a car accident in Oct2020. Concomitant medications included gabapentin (NEURONTIN, NDC: 16714033202) from an unspecified date and ongoing for about 32 years for anxiety; lurasidone hydrochloride (LATUDA) from at least 2 months ago and ongoing for depression; vilazodone hydrochloride (VIIBRYD) ongoing for 5 years to help her sleep and for depression and bipolar; clonazepam from an unspecified date and ongoing for anxiety and panic attack, being on it off and on for 32 years for panic attacks and anxiety; valproate semisodium (DEPAKOTE ER, NDC: 16714048502) from an unspecified date and ongoing for about 5 years for bipolar; escitalopram oxalate (LEXAPRO), benzatropine mesilate (BENZOTROPINE), benzatropine mesilate (COGENTIN); clonazepam (KLONOPIN) ongoing for anxiety and panic attack, being on and off for 32 years; a lot of Psychiatric drugs. The patient to change her antidepressant a lot because if being on it for so long it stopped working. The patient had the Pneumonia Vaccine about 1 year ago and flu vaccine about a year ago not at the same time. She reported not having any problems with that. The patient reported tetanus shot years ago and she got a sore arm. The patient had no prior vaccinations (within 4 weeks). The patient mentioned that she received her 1st dose of the Pfizer COVID19 Vaccine on 29Mar2021. She ended up really ill yesterday on 04Apr2021 at 2: 00 am, with body aches and pains, chills without fever, burning lungs, forgetfulness, vomiting, severe migraine due to her bad sinuses, migraine headache which she rarely got, crusty eyes, severe diarrhea and nausea. She was not able to eat yesterday as well on 04Apr2021. As of calling, she mentioned that she still had a bad lack of energy, probably to being sick on 04Apr2021, and a little bit nauseated but not as bad as yesterday on 04Apr2021. The burning lungs, diarrhea, and migraines were gone. She was asking if these were common to appear after this time because the paperwork from her facility stated that most side effects were to be expected with 24 hours. She also mentioned that her boyfriend got his 2nd dose of the Moderna vaccine with no reactions 3 days before she got ill and was asking if she could've gotten it from him. She was COVID-Phobic and took as many precautions as she could. She mentioned that 2 of her friends, experienced side effects on their 2nd dose. She waited the 15 minutes before she left after getting the shot, with no problem. She hoped no one else has to go through this. She was sick yesterday and today, but it was better today than yesterday. The patient was high risk due to heavy smoking, She said that on the 04Apr2021, at 02:00, she woke up with chills with no fever, body aches and pains, a migraine headache which she never got, severe sinus issues, diarrhea, nausea, and stayed in bed all day. She felt bad enough to go the doctor but did not go to the doctor, had really gone out since COVID started but, she did not go due to agoraphobia. From what she had heard from other people the 1st dose did not affect most people, it's the second. She was scared though and did not want to get sick like she did. She wanted to know if it's safe to get the second shot because she didn't want to experience this again. The patient said that she was still not feeling good. At the time of reporting, the patient still felt nauseated and had body aches and her lungs were burning on 04Apr2021 and she was not sure why. She reported these symptoms were not on the sheet she got. They gave her the sheet from the health department. She had heard of reactions within 48 hours and but, it had been week since she got the 1st shot. The patient said that she had bad chills and did not understand how you have chills without a fever. She was not sick like that ever in her life. It was the worst experience. She said that even with the flu bug she was able to function even with throwing up and all of that other stuff. She had never had problems with an immunization before. She wanted to get the second shot. She didn't know how you get a fever with no chills. Caller confirmed her symptoms were flu-like symptoms and are described as the symptoms she gave earlier in the call. She scared of suffocating to death rather than getting the next shot. The patient asked if it was an allergic reaction or a shot reaction she had, she never experienced anything like that. The patient had no problem with the flu like symptoms like the nausea, the vomiting. The only reason she asked was because she was afraid. She had been house bound for about a year and she only went to the physician and psychiatrist. She was able to go to the health department and get the shot because she did not want COVID. The patient reported her head was foggy right now, can't remember her doctors name because she was still sick. This started after getting the shot along with the flu-like stuff. She can't even remember her doctors information because of how bad she felt. She said that she can't believe that she cannot remember the name of her doctor's office, that was how bad she felt. The patient clarified that the fogginess started after she received the vaccine. She reported she had had severe panic attacks for years due to abuse. Even though she was with a good man now she still had panic attacks and the COVID did not help. She tried sleeping as much as possible last night. The flu-like symptoms started at 0200 in the morning, all her symptoms on 04Apr2021. The fogginess, body aches, diarrhea, pain were still here today, but no headache today 05Apr2021. Her chills were keeping her up yesterday, she had never had chills with no fever before. She had no chills today 05Apr2021, they were gone its 70 degrees here, it was bad. Her burning lungs were gone when she woke up this morning she didn't feel it. If it would have gotten worse she would have went to the ER, but she was able to breath. She was able to take her meds again today 05Apr2021. 1st day in years she did not smoke was yesterday on 04Apr2021. The COVID vaccine gave her a sore arm were she got the vaccine but it only lasted a few days after the shot. About an hour after she got the shot, it lasted a few days and was not bad enough for Tylenol of Motrin it was just a slight ache. She did not seek treatment for the flu-like symptoms but, would have went to ER if burning lungs got worse to where she could not breathe. The patient said that she forgot numbers because of the medications she on and also got the shakes. She was not sure which medications are causing it, but she thought she was taking Depakote, Klonopin and Neurontin could be the cause. The shaking was irreversible, she can't even write her name without shaking. The patient stated yesterday she was so sick, she ended up with like her lungs were burning, body ache, she had chills with no fever, mild sore throat, headache won't go away and she was wondering if that's normal. The patient had to get her second Covid shot 17th and she was so scared, she was sick and tired. Outcome of the events 'head is foggy right now, cant remember her doctors name', 'body aches', 'diarrhea', 'body aches/body aches and pains', 'sick/ended up really ill yesterday' was not recovered, of the event 'Arm was sore where she got the shot for a few days after the vaccine' was recovered, of the other events was unknown. No follow up attempts are needed. No further information is expected.
52 2021-04-25 deafness, ringing in ears Ringing in ears, loss of some hearing
52 2021-04-25 taste impairment, smell distorsion 1) within 10 minutes of injection - face above nose became tingly and tight - similar to a botox inj... Read more
1) within 10 minutes of injection - face above nose became tingly and tight - similar to a botox injection - this persisted for the rest of the day 2) Within 10 minutes of injection - dizziness (mild, could still drive) 3) Sore arm at injection site on Day 1 - mild, no redness or swelling 4) Within 1 hour of injection two toes of my left foot became too painful to walk on, but did not hurt when off my feet - lasted until evening, then gone 5)Within 1 hour of injection left leg had muscle aches and cramping 6) Within a few hours had a strange taste in my mouth (like a chemical) - same with smell. Lasted until bedtime - gone next day. Day 2 Mild sore arm at injection site, but remainder of arm 'tingly' Left foot tingly (but toes not hurting) Nose goes completely numb - just the nose. Headache began - mild - alleviated, but not eliminated, with 800 mg IBuprofen Moderate Nausea began with gagging (but not vomiting) Moderate lower back pain - could not move without ibuprofen - ended by nighttime and did not return Dark Urine - cleary dehydrating Dizziness became vertigo by noon second day. Day 3) Arm nearly normal Muscle aches gone Diarrhea began by 10 am Nausea returned - moderate, gagging no vomiting Headache worsened with extreme vertigo by noon Face tightens again - like wearing a tight scuba mask. First temperature - 101.0 800mg Ibuprofen helped overall feeling of illness, but headache not fully eliminated (better but not gone) Sleeping going fine. Day 4 Fine upon waking - no pains Headache and Vertigo return by 10 am, both debilitating Moderate Nausea returns Diarrhea returns Fever less - 100.0 Overall feels like a very bad migraine with nausea and GI trouble, slight fever, and face muscles still intermittently 'tight'.
52 2021-04-25 taste impairment Within 10 minutes of vaccination, client began having a metallic taste in her mouth, then states she... Read more
Within 10 minutes of vaccination, client began having a metallic taste in her mouth, then states she "wasn't feeling right." Client advanced to dizziness and acute onset of fatigue to the point of almost lethargic, started to complain of pain in back, radiating to from of chest and "feeling cold" with shaking all over.
52 2021-04-25 mouth tingling Patient notes a few minutes after receiving vaccination she began to have throat tightness and her t... Read more
Patient notes a few minutes after receiving vaccination she began to have throat tightness and her tongue felt "funny". No sensation of throat closure, SOB or chest discomfort. Patient evaluated and vitals were stable. She was given 50mg Benadryl IM at 2:55p. Patient observed for 1 hour and after this she reports feeling well, no symptoms reported. Vitals were stable. Patient discharged to home and advised to make sure she has someone driver her to have the next vaccination
52 2021-04-25 ringing in ears 2 days after the second dose of my Pfizer Covid-19 Vaccine, I have developed continual ringing in bo... Read more
2 days after the second dose of my Pfizer Covid-19 Vaccine, I have developed continual ringing in both ears which is still continuing at the same volume.
52 2021-04-25 ringing in ears Shortly after COVID vaccine #1 patient developed right sided tinnitus that progressed to bilateral. ... Read more
Shortly after COVID vaccine #1 patient developed right sided tinnitus that progressed to bilateral. Later that evening she developed right facial tingling. The next day she developed right arm, leg and scalp tingling with mild. No change in mental status. 1 week later all symptoms resolved except bilateral tinnitus persists.
52 2021-04-25 tongue itchiness Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after receiving vaccination patient reported tongue an... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after receiving vaccination patient reported tongue and throat itching but able to swallow. Administered diphenhydramine 25 mg. Vital signs: pulse 100 beats per minute, blood pressure 136/78 mmHg, respirtory rate 21 breaths per minute, and pulse oximetry 95% on room air. Patient observed, symptoms improved, and patient discharged to home stable.
52 2021-04-26 eye swelling, lip swelling 4/15/2021 I received the first Pfizer Covid 19 shot. 4/16/021 woke to find red rash at injection sit... Read more
4/15/2021 I received the first Pfizer Covid 19 shot. 4/16/021 woke to find red rash at injection site. 4/16/2021 at 10:30 am, left arm began to itch at injection site. No additional rash detected. At 6:00PM on 4/16/2021 I began to swell just under my left eye. By 10:00 pm both eyes and forehead had become swollen. Took two Bendadryl thinking that would help. By 8:00 am 4/17/2021 both eyes became nearly swollen shut and swelling had moved to upper lip. Went to ER. ER doctor on call prescribed a steroid shot and oral steroids to take starting the next day. Rx was for (3) 20mg prednisone 1x a day for 4 days. Sunday evening 4/18/2021 still had some swelling in face. Monday, minimal swelling in eye lids. I supplemented Cont'd: I also took Benadryl every 5-6 hours around the clock for four days (from 4/17/2021 - 4/20/2021) which seemed to help minimize the swelling. I also had significant flushing (redness) in my face from 4/17/2021 - 4/21/2021. On Wednesday 4/21/2021 I contacted my General Practitioner for a follow up appointment. During that visit, he said that it would not be good for me to get any further Covid 19 shots. I have canceled my appointment for the second shot. At this time, I have not had any additional side effects but, I will be monitoring over the course of the next several months.
52 2021-04-26 mouth tingling Pfizer vaccine. Reactions started the following day. Began with tingling in lips, then tip of tongue... Read more
Pfizer vaccine. Reactions started the following day. Began with tingling in lips, then tip of tongue. Spread to full tongue and then roof of mouth. Lasted 2 days - took Benadryl. Pain under arm started 5 days after vaccine. Large, painful lump under left armpit. Has lasted 2 days - going to primary care doctor next week for care.
52 2021-04-27 lip swelling abrupt onset of abdominal pain that caused her to go home from work. The following morning at 5:30 ... Read more
abrupt onset of abdominal pain that caused her to go home from work. The following morning at 5:30 a she woke up with a swollen face, lips, periorbital region. No swelling of tongue, uvula or pharynx. Urticaria on arms. Resolved without therapy within 8 hours. Advised to NOT take ANY aspirin products and to stop losartan.
52 2021-04-28 loss of smell, loss of taste Cough Fatigue Headache New loss of taste or smell Congestion or running nose
52 2021-04-28 blindness On the 26th I experienced a TIA (mini-stroke) though I have no risk factors. It was one week after ... Read more
On the 26th I experienced a TIA (mini-stroke) though I have no risk factors. It was one week after my second Pfizer shot. I couldn't see out of my R eye, like bright white light--snow blind, then I couldn't decode the words I was trying to read on my computer email. Then I got up and walked around, made a call and on the call was unable to say the word I wanted to say (Aphasia).
52 2021-04-28 deafness unilateral hearing loss in the right ear; This is a spontaneous report from a contactable consumer, the patient... Read more
hearing loss in the right ear; This is a spontaneous report from a contactable consumer, the patient, and a non-contactable consumer, the patient's sister. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 23Mar2021 between 13:00 and 13:30 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history includes ringing in ears, problem with hearing out of the other (left) ear. Concomitant medications were none. There were no additional vaccines administered on the same date, or within 4 weeks of BNT162B2. On 24Mar2021, the patient experienced hearing loss in the right ear and sometime between 19:00 - 20:00, the patient could not hear out of the right ear for a day. The patient never had a problem with this ear. No emergency room or physician's office visit was required. The patient got up the next morning and her hearing was back. The clinical outcome of hearing loss in the right ear and could not hear out of the right ear was resolved on 25Mar2021. Information on the lot/batch number has been requested.
52 2021-04-28 ringing in ears Immediate ( within 1-2 minutes) spike in heart rate and blood pressure, tightness in chest, nausea, ... Read more
Immediate ( within 1-2 minutes) spike in heart rate and blood pressure, tightness in chest, nausea, light headed, shakes. Continued high blood pressure, migraines, ringing in ears continuing on day 6
52 2021-04-28 vision blurred Patient reported having foggy vision.
52 2021-04-29 ear swelling Rash, swelling at injection site , swelling in arm pit , swelling in right ear and throat. Tylenol a... Read more
Rash, swelling at injection site , swelling in arm pit , swelling in right ear and throat. Tylenol and ice
52 2021-04-30 deafness After 24 hours hearing in left ear was diminished and has not resolved.; This is a spontaneous repor... Read more
After 24 hours hearing in left ear was diminished and has not resolved.; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization (Age at vaccination: 52 years). Medical history was reported as none. The patient's concomitant medications were not reported. On 07Apr2021, 08:00, after 24 hours hearing in left ear was diminished and has not resolved. The patient did not received any treatment for the event. Patient was not pregnant The patient did not have COVID prior vaccination. The patient did not test for covid post vaccination. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-05-04 ear pain sore throat; I woke up with a sore throat. I feel it in my ears to; diarrhea; fatigue; aches and pai... Read more
sore throat; I woke up with a sore throat. I feel it in my ears to; diarrhea; fatigue; aches and pains; feels like she has the flu; strep throat; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 29Mar2021 (Batch/Lot Number: 8732) as single dose for COVID-19 immunisation. Medical history included obese, thyroid, fibromyalgia and bell's palsy from 2016 and ongoing. The patient's concomitant medications were not reported. Patient took the first shot on 29Mar2021 and she was due today for the second shot. The caller woke up with a sore throat and it was kind of in the ears feeling on 19Apr2021. The caller almost felt like she had the flu and diarrhea really bad on 19Apr2021. The caller's throat almost feels like strep throat and she has aches and pains on 19Apr2021. Patient felt fatigue. Events onset on 19Apr2021. Outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.
52 2021-05-07 ear pain, hearing loss, ear discomfort, ringing in ears excruciating pain in her ear; left ear completely filled up and got completely full; Hissing and tin... Read more
excruciating pain in her ear; left ear completely filled up and got completely full; Hissing and tinnitus worsened; low grade fever (100.2°F); Couldn't hear; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8734), via an unspecified route of administration, administered in the left arm on 26Mar2021 at 14:45 as a single dose for COVID-19 immunisation. Medical history included labyrinthitis on 2017 to an unspecified date where her left ear became blocked up and had to have her ear cleaned up and experienced severe vertigo and dizziness, swimmers ear in her left ear on an unknown date several years before and afterward just her left ear would get clogged up, low grade tinnitus from 2017 and ongoing. The patient was taking unspecified birth control tablets since 2015 and ongoing for an unknown indication (reported as 'to regulate') which she was off of for a couple of years but had to be put back on because of a pretty intense experience (unspecified). The patient did not have prior vaccinations within 4 weeks from the COVID vaccine. The patient previously got a flu shot on an unknown date, maybe once in the last 10 years and expeirenced flu symptoms. All her other vaccines were when she was a kid. The patient was not a believer of western medicine or vaccinations since medications just poison other things in the body. The patient reported that one week after the first dose of the COVID-19 vaccine, on 02Apr2021, her left ear completely filled up and got completely full. The patient couldn't hear on Apr2021. Her hearing was blocked and she started running a low grade fever (100.2°F) on Apr2021. The patient had excruciating pain in her ear on 02Apr2021 and her ear pain was at a 10 on an unknown date in Apr2021. She added that she has a high pain tolerance and that she is not a baby. She could not get her ear to clear by herself and she could not get her ear to pop in the shower. She went to urgent care, and the provider cleared her ear with a syringe. The urgent care provider cleared the fluid in her ear with the syringe and cleared out ear wax. She thinks that this was an immune response to the Covid-19 vaccine. The patient added that the hissing noise and tinnitus worsened in her head and has been enhanced on 02Apr2021, since she received the first dose of the COVID-19 vaccine. It took another week and a half for her ear pain and fever to resolve. The urgent care provider prescribed her amoxicillin to take. Her pharmacist informed her that if her fever did not stop in 2 days then she did not have an infection and did not need the antibiotics and if she still had a fever after 2 days of taking the amoxicillin, the patient's symptoms were a delayed reaction to the COVID-19 vaccine. She took the amoxicillin and her fever finally broke, her ear pain resolved, but the tinnitus and hissing in her head is louder than it was before she received the first dose of the COVID-19 vaccine. The patient talked to a physician who is at a location administering the Covid-19 vaccine and the physician informed her that she was not crazy and she did not need amoxicillin. The physician stated that he has been seeing and hearing from people getting the COVID-19 vaccine that they are experiencing ear fullness, low grade fever, and ear pain. The patient reported that her concern is getting the second dose of the COVID-19 vaccine. She is concerned that her tinnitus is going to get worse with the second dose of the COVID-19 vaccine. She knows that the vaccine is all new and is for emergency use and she doesn't know what to do. She did want to report what happened to her. She found a support group for those experiencing tinnitus after receiving the COVID-19 vaccine. She was not alone as there are over 1,000 people in the support group. The number of people experiencing tinnitus is relatively low because there have been over 80 million vaccinated. She had her first dose of the COVID-19 vaccine 4 weeks ago, 26Mar2021 and the pharmacist said that the patient could not get the second dose of the COVID-19 vaccine while she was running a fever. The pharmacist informed her that she could hold out on getting the second dose of the COVID-19 vaccine for 6 weeks. She is worried about her ear and the tinnitus and what could potentially happen with the second dose of the COVID-19 vaccine. The people in the support group were saying that the tinnitus is worsening with the second dose of the COVID-19 vaccine. She does not want to live with worsening of the tinnitus, so she needs that answered. For the pain she was experiencing, the patient stated that for her to go buy ibuprofen and risk taking ibuprofen because she knows the side effects for that, she has to be in a lot of pain so she doesn't take anything. She takes natural remedies and for her to go to the pharmacy to get Advil, you have to know she is in a lot of pain. The patient does not have a thermometer so she does not know when her fever started in Apr2021. She stated that it was weird and she felt awful and that she for sure had a low grade fever that whole week. She is still experiencing a small amount of ear pain. The hissing and tinnitus worsened through the whole thing. The patient reported that when her ear filled up and she was having excruciating pain, the hissing got worse. She did not have her hearing tested but once the urgent care provider syringed the fluid from her ear, she felt like her hearing was normal. The patient said she had a hearing test in 2017 that was fine. The physician told her that she was going to have tinnitus, but that the patient would habituate to it and it would get to the point where the tinnitus was not so irritating. She knows that the ear fullness was an immune response. She added that it seems like the COVID-19 vaccine is going for weak areas and triggering a response. The outcome of the events left ear completely filled up and got completely full and couldn't hear was recovered on 06Apr2021 and the event low grade fever was recovered on Apr2021. The event excruciating pain in her ear was recovering the event hissing and tinnitus worsened was not recovered.
52 2021-05-10 tongue itchiness, lip swelling Swollen bottom lip; Red marks under skin/Tiny red spots under skin; Tiny red spots under skin, itchy... Read more
Swollen bottom lip; Red marks under skin/Tiny red spots under skin; Tiny red spots under skin, itchy but no hives; Itchy throat and tongue; Itchy throat and tongue; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 52-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266 and Expiration date was not reported), via an unknown route of administration in right arm on 28Feb2021 at 09:30, as a SINGLE DOSE for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, has the patient not been tested for COVID-19. The patient medical history included high risk asthma and the patient had allergies to erythromycin, amoxicillin and penicillin. The concomitant medication included pantoprazole (patient received within 2 weeks of vaccination). On 28Feb2021 at 10:45 (same day of vaccination), the patient reported tiny red spots under skin, itchy but no hives, swollen bottom lip, itchy throat and tongue. The outcome of the event tiny red spots under skin, itchy but no hives was recovering whereas, for other events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-05-12 mouth ulceration Fatigue; Headache; Oral ulcers; Muscle aches; This is a spontaneous report from a contactable nurse ... Read more
Fatigue; Headache; Oral ulcers; Muscle aches; This is a spontaneous report from a contactable nurse (patient). A 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Lot number: EL0142PF; Expiration date: unknown), via unspecified route in arm left on 06Jan2021 at 10:45 (patient was 52-year-old at the time of vaccination) as a 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history include history: hypothyroid, htn, depression, arthritis, Allergies to medications, food, or other products: TRAMADOL, AMITEZA. The patient received medications within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, has the patient been tested for COVID-19 was unknown. On 07Jan2021, at 7:00, the patient experienced Fatigue, Headache, Oral Ulcers, Muscle Aches. The events are not serious. The patient had not received any treatment for events. The patient received second dose of BNT162B2 on 27Jan2021(Lot number: EL3249) on right arm. The events were recovered on an unspecified date of 2021. Follow-up attempts are completed. No further information is expected.
52 2021-05-12 swollen tongue 4:11 pm tightness and swelling of throat; 4:30 pm anaphylaxis - s/sx swelling of throat and tongue, ... Read more
4:11 pm tightness and swelling of throat; 4:30 pm anaphylaxis - s/sx swelling of throat and tongue, difficulty swallowing, dysphonia, hypertension, low saturation, hoarseness; 4:35pm Tx Epinephrine 0.3 mg IM, ECG, Benadryl 75 mg IV, 5:05pm transport to hospital, ECG, 5:15pm ECG, 5:35 pm famotidine IV, methylprednisolone sodium succinate IV Have had chronic dysphonia since.
52 2021-05-12 vision blurred 20 min after vaccine reports dizziness and blurry vision she had the same thing with the first vacci... Read more
20 min after vaccine reports dizziness and blurry vision she had the same thing with the first vaccine. BP138/78, HR 90, O2 sat 98% respirations/18 /min appears comfortable in cardiac chair c/o being to hot in auditorium. denies SOB no facial swelling lungs clear no hives no CP. reports her lupus is bothering her and her joints. rested for 30 min , remained completely stable all sx resolved with in 5 min . rested in cardiac chair with ice packs felt well upon leaving
52 2021-05-19 thirst, inability to speak Swollen glands in neck and loss of voice, weak, lightheaded, vomiting, chills, body aches, extreme t... Read more
Swollen glands in neck and loss of voice, weak, lightheaded, vomiting, chills, body aches, extreme thirst, constant sleep, heart rate high within 48 hours. At 48 hours, severe breathing issues and small sores on upper arms and chest. Now on day 5, shortness of breath continues, spells of sweating, no sleep for 2 days, and a fluid filled Knoton lower front neck. Had to miss a day and a half of work so far this week
52 2021-05-20 mouth tingling, swollen tongue Approximately 20 minutes after injection, I experienced tingling sensation of tongue with mild swell... Read more
Approximately 20 minutes after injection, I experienced tingling sensation of tongue with mild swelling, pharyngeal pruritis, increased mucus production causing coughing, nasal congestion, and constant throat clearing, globular sensation when swallowing, voice became hoarse. I reported to nurse monitoring patients post injection. Was asked regarding symptoms and told to take medications that I had brought with me. Medications were Pepcid 20 mg, Benadryl 50 mg, Prednisone 10 mg. I was monitored for another 90 minutes. Symptoms began to resolve approximately 30 minutes after taking medications. Full resolution of symptoms occurred approximately 8 hours after taking medications. Followed nurse's instructions and immediately notified PCPs office upon returning home. PCP recommends to not receive 2nd Pfizer vaccine.
52 2021-05-21 thirst PFIZER VACCINE- DOSE 1 -4/30/2021 5/7/2021- SUDDEN ONSET UTI- UNSPECIFIED HEMATURIA- SUGAR IN URINE... Read more
PFIZER VACCINE- DOSE 1 -4/30/2021 5/7/2021- SUDDEN ONSET UTI- UNSPECIFIED HEMATURIA- SUGAR IN URINE LEG CRAMPING/PAIN FATIGUE SEVERE PELVIC PAIN SEVERE BACK PAIN SHORTNESS OF BREATH HEART PALPITATIONS DURATION- STARTING 5/1/2021- CURRENTLY 5/14/2021 SUDDEN ONSET- UTERINE/VAGINAL BLEEDING -PROFUSE!!! DURATION- 5/14/2021- 5/17/2021- PROFUSE/HEAVY 5/18/2021- 5/22/2021 (AS OF THIS SUBMISSON)- LIGHT SPOTTING (NOTE- LAST MENTRUAL CYCLE- 2/2021- DID NOT MENSTRUATE 3/2021 OR 4/2021) DIZZINESS/RACING HEART/LEG PAIN/CHEST PAIN/SHORTNESS OF BREATH/THIRST/EXTREME WEAKNESS AND FATIGUE
52 2021-05-23 swollen tongue, lip swelling Shortly after vaccination, patient complained of tongue and lip swelling, broke out in hives on her ... Read more
Shortly after vaccination, patient complained of tongue and lip swelling, broke out in hives on her chest, and began having trouble breathing. Patient was evaluated by EMS, BP & HR elevated, O2 stats stable. EMS administered 50mg Benadryl without improvement. EMS then administered Epinephrine 0.5mg. Pt also placed on VM with 2.5mg Albuterol. Pt began to improve. EMS administered 125mg Solumedrol and transported pt to ED for further evaluation.
52 2021-05-23 vision blurred Blue Fingers the next day. A few weeks later have tingling in whole body, mostly legs and hands. Blu... Read more
Blue Fingers the next day. A few weeks later have tingling in whole body, mostly legs and hands. Blurred vision. Black and blue marks on in back of lower legs. Veins protruding in hands and continue to be blue.
52 2021-05-24 loss of smell, loss of taste Loss of taste Loss of smell Upper respiratory tract infection, unspecified type Fatigue, unspecif... Read more
Loss of taste Loss of smell Upper respiratory tract infection, unspecified type Fatigue, unspecified type
52 2021-05-24 taste disorder Immediate unusual taste in mouth, followed by headaches, fatigue, fever, breathlessness, weakness, u... Read more
Immediate unusual taste in mouth, followed by headaches, fatigue, fever, breathlessness, weakness, unusual pain. Just found out my heart is enlarged.
52 2021-05-24 ringing in ears, deafness unilateral I developed tinnitus in my left ear that lasted for 3 months. Also sometimes accompanied by a headac... Read more
I developed tinnitus in my left ear that lasted for 3 months. Also sometimes accompanied by a headache at my left temple.
52 2021-05-25 light flashes or floaters in the eye, vision blurred, eye floaters felt pop in right eye; white light flashes; floaters in left eye; blurry vision; This is a spontaneo... Read more
felt pop in right eye; white light flashes; floaters in left eye; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration, administered in arm right on 05May2021 11:15 (Lot Number: EW0982) as 2nd dose, single for covid-19 immunisation. The patient medical history was none. Concomitant medication included metoprolol succinate ER tablet 25 mg. The patient was not pregnant. The patient previously received first dose of BNT162B2 (lot number EW0153) on 07Apr2021, 11:00 AM in Right arm. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. Within 24 hours of receiving vaccine on 06May2021 12:00 PM, the patient felt pop in right eye and experiencing white light flashes and floaters in left eye, blurry vision. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was not recovered.
52 2021-05-25 ringing in ears April 5th 10-15 minutes after dose: tight throat and chest, congested, feeling out of it within 10-... Read more
April 5th 10-15 minutes after dose: tight throat and chest, congested, feeling out of it within 10-15 minutes after dose Later that day: tachycardia, burning sensation throughout body, tingling in nasal passage, arms and legs, lower back pain, lightheaded, joint pain, chills April 6th additional symptoms to above and ongoing at various degrees: migrating shock sensation, cold extremities, swollen lymph nodes, shaking, ear ringing, fatigue, muscle cramping and stiffness, unsteady while sitting and standing, back weakness, periodic cough, nausea
52 2021-05-26 ear pain, oropharyngeal discomfort, dry eye Patient presented to her primary care provider on 2/11/2021 with right ear pain, numbness on right s... Read more
Patient presented to her primary care provider on 2/11/2021 with right ear pain, numbness on right side of face and head, full feeling on right side of throat and right eye dryness. Patient had received 2nd dose of Pfizer COVID19 vaccine on 2/2/2021 and started feeling itchy from head to tow that lasted 24 hours. Was diagnosed with Bell's Palsy at this visit. Patient then presented to the Emergency Dept on 2/13/2021 with shortness of breath.
52 2021-05-26 ear pain, oropharyngeal discomfort, dry eye Patient presented to her primary care provider on 2/11/2021 with right ear pain, numbness on right s... Read more
Patient presented to her primary care provider on 2/11/2021 with right ear pain, numbness on right side of face and head, full feeling on right side of throat and right eye dryness. Patient had received 2nd dose of Pfizer COVID19 vaccine on 2/2/2021 and started feeling itchy from head to tow that lasted 24 hours. Was diagnosed with Bell's Palsy at this visit. She then presented to the Emergency Department on 2/13/2021 with shortness of breath.
52 2021-05-26 ear swelling, ear discomfort, hearing loss swollen lymph nodes in right armpit appeared after about 24 hours from vaccination, the bulge grew t... Read more
swollen lymph nodes in right armpit appeared after about 24 hours from vaccination, the bulge grew the size of chicken egg over th e next 2 days+ fullness/swollen ear canals, both ears. arm pit nodes returned to almost normal condition after 5 days from onset of symptoms, some discomfort remains under armpit but transient (sometime tender nodes are present and other times not). swollen ears remains a problem 2.5 weeks later, partial hearing loss due to swelling. no medical treatments
52 2021-05-27 double vision, blindness, vision blurred couldn't even function; I have been having really bad breathing problem; Loss of appetite; I just go... Read more
couldn't even function; I have been having really bad breathing problem; Loss of appetite; I just got bruised; double vision; couldn't stand; couldn't even focus; her eyes could not focus; could not see to drive, all of sudden my vision was gone away; diarrhea; blurred vision; vertigo; continuous dizziness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 26Apr2021 (at the age of 52 years-old) (Batch/Lot Number: EW0169; Expiration Date: Aug2021) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included syncope Unspecified syncope, migraine Chronic Migraines, concussion history of severe chronic migraines and unspecified syncope due to have a concussion 3 times. The patient received first dose BNT162B2 for COVID-19 immunization on 06Apr2021 at the age of 52 years old. Caller said that since the second dose she has diarrhea that is coming and going, but she has been having it for 2 weeks and is treating it with Imodium AD. She has been having blurred vision, vertigo, and dizziness continuously. She has never had this before. She said that within an hour of getting the second dose, she was taking her dog for a walk and only made it a block before she had to come home because she thought she was going to fall. She states on Mothers Day she felt like she could not get her bearings and states it was "very, very scary." She said that she cant even walk down her staircase or drive her vehicle. Consumer further stated, I have been having a loss of appetite too not feverish or anything and you know I had the shot, I had no reaction there. I just got bruised and I had no hurt or anything. I have been having symptoms. I had several symptoms from Pfizer but the second vaccine I had been having sever symptoms, they haven't gone away. I was vaccinated for second vaccination on second dose was on 26Apr2021. I am pulling it on my screen here because I have a V-safe. I have been having really bad breathing problem. I have brain situation that my neurology check. I have underlying medical conditions. My pulmonologist asked me to get the Pfizer so that's what I did. I had the first dose 06Apr2021, I had the second dose 26Apr2021. Now basically just the second dose, I started having visions problem really bad and dizziness, it's kind of little vertigo. I had severe diarrhea for at least I guess I am still having it little bit. So it was really severe for about a week or so. But I have it, I am having it still couple of days, 3 weeks still, 3 and a half days and week. The vision on modern days I had like double vision and dizziness and I got vertigo, the whole day. So my brother left with my granddaughter. I had to hold on to the banished couldn't stand. I couldn't even focus. I have unspecified think to the give more and I have a severe chronic migraine (Intent: History) since I am 4 years old but I have never had this happened to me until after I took the Pfizer second vaccine. The day that I took the Pfizer second vaccine, I went with my dog outside I only was able to walk a block and a half and then I had to walk back home because I felt dizzy. Now this is about an hour after I took the second vaccine. Also the next day I drove my car to the park, this is about maybe 10 minutes away and I was getting home run around the park and about an hour after that I had going to car and and surrounded and could not even get my barring's. She states the next day she took her dog to the dog park and experienced the same thing so she had to lay down in her car and states she "couldn't even function." She states that when she was driving later, she states her eyes could not focus and she could not see to drive. As she was driving home, all of sudden my vision was gone away, from what happen was is I had to call my son. Then I started to cry because I couldn't able to see. Now this has been continuing since the vaccine. Therapeutic measures were taken as a result of diarrhea. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-05-28 eye itchiness the first day I had a sore arm. the second day I felt ok when I woke up until about 8 pm I was feeli... Read more
the first day I had a sore arm. the second day I felt ok when I woke up until about 8 pm I was feeling dizzy, hard to catch my breathe, and tired. I struggled at work, but made it through my shift. I was pale, dizzy, sweaty. The next day I had itchy eyes and throat. Eyes were red. I went to urgent care and was tested for Covid-19 and was negative. two weeks this continued, chronically tired. my doctor finally put me on steroids ,and after finishing them I was feeling better.
52 2021-05-28 smell distorsion My sense of smell has changed. Everything smells rotten.
52 2021-05-28 ringing in ears, eye pain, dry eye Day after shot, right side facial paralysis Then changed to numb feeling around right eye and ache ... Read more
Day after shot, right side facial paralysis Then changed to numb feeling around right eye and ache behind eye ?Pulling? at right eye Tightness of scalp Ear ringing Tenderness/pain, right side of head Dry eye Nausea (comes and goes)
52 2021-05-30 vision blurred PATIENT DESCRIBED HAVING DIZZINESS, LIGHTHEADEDNESS, BLURRY VISION, AND A DROP IN BP TO 62/32
52 2021-05-31 mouth tingling, thirst First shot was 2/16/21. Also had Pfizer Lot # EN6206 on 3/9/21 I didn't really have any symptoms wi... Read more
First shot was 2/16/21. Also had Pfizer Lot # EN6206 on 3/9/21 I didn't really have any symptoms with the first dose except mild soreness in arm. I had mild dizziness right after the 2nd dose for about 10 minutes and then the next day I had chills, fatigue and aches. But I started having weird symptoms a few weeks after the 2nd dose and I'm not sure if any of all of them are due to the vaccine. First I started having achy knees and some other joints about 2-3 weeks later. It is only a problem once in a while and presents in my left knee, my fingers, wrists, feet and shoulders. Then on May 1st I had a vmild case of what has now become more common and severe. I got tingly feet and became very thirsty. Then on May 23rd I went to the Emergency Room because my feet, hands and mouth/tongue became tingly. After about 20 minutes I became shaky. I was also very thirsty, so thirsty that after about 6 glasses of water I was still thirsty. We thought it was blood sugar issues, but my blood sugar was only slightly elevated and not enough to cause the symptoms I had. I was having fun with my family watching a movie when it started. Then on May 28th it happened again. I went to the school nurse with tingling, dizziness and thirst.
52 2021-05-31 visual impairment she thought she had an ear infection; patient looking at lot number, stated that her eyes are bad; T... Read more
she thought she had an ear infection; patient looking at lot number, stated that her eyes are bad; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 52-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in the left arm high up in the muscle, at age 52 years, on 04Mar2021 18:00 (Batch/Lot Number: EN6205; Expiration Date: 30Jun2021) as 1ST DOSE, SINGLE for COVID-19 immunisation as she did not want to get COVID. Medical history included hypothyroidism and chemical allergies from unspecified dates so she was nervous to get the COVID shot. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations within 4 weeks was none. Patient reported that she received the first dose of the Pfizer COVID-19 vaccine on 04Mar2021 at 18:00, she got the shot in her left arm, high up in the muscle. Then, stated that last Sunday (14Mar2021) she started feeling symptoms and then tested positive last Tuesday on 16Mar2021 for COVID. Symptoms started with stomach, diarrhea thing and it was like wow what is going on, the symptoms are mild as far as COVID goes. She had a fever for a day and a half from an unspecified date. Patient stated she used paracetamol (TYLENOL 500mg) the night she got the vaccine and the morning after (total of 1000 mg) by mouth. The AEs did not require emergency room or physician office visit. Patient stated she made it a year and got the vaccine and then got COVID. Patient stated thank goodness nothing really happened. Patient really didn't think the symptoms, like from watching commercials it lists you can have all this and think you would have everything and she thought she had an ear infection on an unspecified date. When patient was looking at the lot number, she stated her eyes are bad from an unspecified date. She also stated that she can't be the only person that has gone through this, she knows she isn't. Patient stated her friends got the MODERNA vaccine and they didn't say anything and just went and got their 2nd dose and she was just trying to do the right thing here and is not holding for much longer. She wanted to know if she should go back for her second dose scheduled on Thursday (25Mar2021). The outcome of the events was unknown.
52 2021-06-01 ear pain, ringing in ears, deafness had a flu.; vertigo; severe pain.; depression; mental health; Severe pain in my right ear and sudden... Read more
had a flu.; vertigo; severe pain.; depression; mental health; Severe pain in my right ear and sudden loss of hearing in my right ear; Severe pain in my right ear and sudden loss of hearing in my right ear; her ear started ringing; she started to lose sleep.; This is a spontaneous report from a contactable consumer reported for self. This 52-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02May2021 at the age of 52-year-old (Lot number: EW0172) arm left as 2nd dose, single for covid-19 immunisation. Medical history included COPD, asthmatic when was a child. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Apr2021 at the age of 52-year-old (LOT#: EW0158) for covid-19 immunisation. After her 1st dose, she said she had a robust reaction. After the 2nd dose, she said she felt like she had a flu. Then on Tuesday night, 2 days after the 2nd dose (04May2021), her ear started ringing, and her right ear was in pain. She said that her ear was ringing so loudly that she started to lose sleep. She said she had a sudden loss of hearing in right ear that has caused her emotional damage. She was sudden loss of hearing in right ear, along with ringing and severe pain for 13 days now. She said that her ear has become so sensitive ever since she received the vaccine. She also mentioned that she was given Prednisone to treat the symptoms. She also said that her ENT told her that tinnitus can be caused by a previous traumatic injury to the ear and head injury. She said she had neither, so she is sure that this is really from the vaccine. She also said she had vertigo and was in severe pain. She said her daughter saw something on social media about vaccinated people being able to stick magnets to their arms, so she tried it as well. She said she can now also stick a magnet to her left arm from where she received the vaccine, and she wants to know why this is happening. She said she has searched about these symptoms, and said that it was all over google. She stated, "On 04May2021 in the evening, ears started ringing very loudly. started getting a severe pain in right ear and lost hearing on right ear." She went to doctor. She was referred to an ENT. Got a hearing test. The doctor told that what he was seeing is going on with right ear is usually seen, when a person has fluid their ears which the patient did not or if they have a traumatic ear injury which the patient also didn't have and he has given Prednisone (treatment) today, need to go back to another hearing test. Dose of Prednisone, consumer stated, "He got me 60 mg for 3 days. Step down the doses and then for 4 days I have to take 1 pill, then for 3 days I have to take 2 and then step down to half." She added, "Because she was truly deaf, it is kind of a 'depression' because it did kind of ruined part of it, you know quality of my life. She was probably in need of hearing aids, It is very upsetting. She experienced mental health on 18May2021. Lab data included Weight 88.45 kg. Outcome of the events was unknown.
52 2021-06-01 tongue itchiness, swollen tongue Itchy/Scratchy throat at 28-30 minutes after vaccine injection (5:28-5:30 pm). Kept drinking water, ... Read more
Itchy/Scratchy throat at 28-30 minutes after vaccine injection (5:28-5:30 pm). Kept drinking water, throat continued. Itchy tongue. Itchy behind ears and between shoulder blades began at home (5:45-6:00 pm). Roof of mouth itchy and tongue swelling began 1 hour and 15 minutes after injection (6:15 p.m.). Called Primary Care Doctor and they advised to take Benadryl and go to Emergency Room. Took oral Benadryl and called 911 for ambulance assistance. Blood pressure was over 190/110 and itchy/swelling symptoms continued. EMTs administered additional Benadryl by injection into right upper arm and drove me to Emergency Department. Observed for 4+ hours, symptoms subsided with Benadryl and rest. Discharged home. Recommended Benadryl every 6 hours as needed. **Symptoms returned 6/1/2021 at 10 pm home (no foods eaten prior, no Benadryl for one day) - swelling lips, itchy inside ears and back of tongue, scratchy throat. Took Benadryl and rested. Woke 6/2/2021, tongue still a bit swollen.
52 2021-06-02 visual impairment, vision blurred, eye discomfort Left eye became very blurry. Headache and pressure around eyebrow above left eye. Visited eye doc... Read more
Left eye became very blurry. Headache and pressure around eyebrow above left eye. Visited eye doctor after my regular visit 2 months later and vision in left eye drastically changed. Regular doctor also ran blood work and nothing was found. Eye problem started the Sunday following first covid shot that was given in that left arm. This is still causing balance to be off. Another specialist tomorrow.
52 2021-06-03 inability to speak Feels like she is losing her voice; my voice keeps trying to go away; Date of 1st dose of vaccinatio... Read more
Feels like she is losing her voice; my voice keeps trying to go away; Date of 1st dose of vaccination: 24 Mar 2021/received their second dose of the COVID-19 Vaccine on Friday May 28th; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for herself that A 52-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27May2021 13:30 (at the age of 52-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: ER8733 Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 24March 2021first dose single for covid-19 immunisation. Patient medical history included thyroid removed from Jan2012 to an unknown date Consumer stated, I have a thyroid problem, I got my thyroid removed; hypothyroidism Date of diagnosis of hypothyroidism: Consumer stated, It was sometimes in 2011 in September or October and it was removed in Jan of 2012.; Graves' disease and thyroiditis. Concomitant medication included levothyroxine taken for thyroid removed. patient states family medical history was not relevant to adverse event. Patient did not receive any other vaccines prior to the COVID vaccine. On an unspecified date patient experienced Feels like she is losing her voice; my voice keeps trying to go away was reported as worsened. Patient did not receive any medication. The patient underwent lab tests and procedures which included blood cholesterol and thyroid function test with unknown result on an unspecified date. Patient reported that she got a lot of lab test recently because she had been in the hospital. They did drug test, thyroid test they did my cholesterol. It was reported that event was persisting, it's worse than it was yesterday. patient states family medical history was not relevant to adverse event. The outcome of event feels like she is losing her voice; my voice keeps trying to go away was not recovered, while outcome of other event was unknown Information on the lot/batch number has been requested.
52 2021-06-05 mouth numbness Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial a... Read more
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient received shot, waited 15 minutes, felt fine and left store. She called about an hour later (3:05pm) asking about tingling that she was experiencing on the side of her body that got the shot (arm, hand, leg) -I believe it was left side. Also a numbness on her mouth/lips. I advised pt to contact her primary which advised pt to go to urgent care. At urgent care she was seen and her symptoms subsided. I called pt at 8:45pm she stated that she was feeling better, but lip was still numb.
52 2021-06-06 eye twitching 22nd- left eye twitch, 23rd- eye twitch plus cheek numbness, 24th- same with numbness into forehead,... Read more
22nd- left eye twitch, 23rd- eye twitch plus cheek numbness, 24th- same with numbness into forehead, 25th- same with numbness into neck, 26th- same with numbness of left arm (elbow to fingers). ER visit on 26th. Diagnosed as mini stroke.
52 2021-06-06 lacrimation increased, smell distorsion A red spot or bruise with a indent just below the needle hole. This appeared May 9th, a day after th... Read more
A red spot or bruise with a indent just below the needle hole. This appeared May 9th, a day after the 1st shot (EW0183). The spot is still there after a month. Symptoms started May 30th, from the 2nd shot (EW0191). Symptoms include: Severe coughing, chills, running eyes, nasal congestion and sore throat ( which was the first sign of adverse effect), smelling burning odor ( which was one of my symptoms during my COVID-19 infection).
52 2021-06-06 lip swelling Lip swelling with tenderness for a week
52 2021-06-06 swollen tongue, dry mouth, lip itchiness, lip swelling Less than 24hrs after vaccine client started to experience severe dry mouth, lips sticking to her gu... Read more
Less than 24hrs after vaccine client started to experience severe dry mouth, lips sticking to her gums, swollen lips and tongue, bumps/fine rash to chin, cracks to the corners if her lips, peeling, redness, and itching of lips that lasted for for more than 2 weeks despite treatment with Benadryl, and Prednisone.
52 2021-06-07 mouth tingling itchiness body wide; headache; tingling in mouth and face; tingling in mouth and face; swollen face;... Read more
itchiness body wide; headache; tingling in mouth and face; tingling in mouth and face; swollen face; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Mar2021 13:00 (Lot Number: EN6207) (at the age of 52-years-old) as 1st Dose, single dose for covid-19 immunization. Medical history included PFO/ASD (Atrial Septic Defect) , TIA (transient ischaemic attack), asthma, high BP (blood pressure), diabetic and obesity. Patient has known allergies in cinnamon, cloves, allspice, adhesives, mold and pollens. The patient was not pregnant and did not have COVID prior to vaccination. Concomitant medications included BP medication, zolpidem and cholesterol medication. The patient did not receive other vaccine in four weeks. The patient experienced itchiness body wide, headache, tingling in mouth and face and swollen face even after taking 2 BENADRYL on 09Mar2021 at 13:15. The patient was not tested for COVID post vaccination. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
52 2021-06-07 light flashes or floaters in the eye An hour after the vaccine I was driving home and experienced flashing lights in my eyes and then con... Read more
An hour after the vaccine I was driving home and experienced flashing lights in my eyes and then confusion and dizziness. It got worse as the day progressed and I became extremely nauseous and disoriented. I was unable to drive or think straight or work for almost three weeks. The dizziness subsided after a week, but confusion and disorientation (couldn't speak clearly/find words in my head) for weeks after that. I saw my doctor 4 days after vaccination and she did full physical and sent me for MRI and opthamologist to rule out stroke or other eye-related problem. All came back negative. I had a pretty severe case of West Nile Virus in summer of 2005 with the same neurological conditions...not sure if it is at all related.
52 2021-06-07 ringing in ears Noticed tinnitus the day after the first vaccine, which progressively got stronger worse, peaking ap... Read more
Noticed tinnitus the day after the first vaccine, which progressively got stronger worse, peaking approximately day 5. After that, tinnitus became less - but never disappeared. Upon second vaccination, similar timing for increase and decrease. It is now 30 days since the second vaccine shot and tinnitus is still present.
52 2021-06-07 vision blurred Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue... Read more
Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue mark swollen on calfs; Pain in right leg; Black and blue mark swollen on calfs; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) (Batch/Lot Number: 648543) as single dose for covid-19 immunisation. Medical history included hashimotos. Concomitant medications included ergocalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was no pregnancy. The patient was no pregnancy at time of vaccination. Age at vaccination was 52 years. The patient experienced blurred vision, thyroid inflamed, tingling all through out the whole body, blue hands, pain in right leg and black and blue mark swollen on calfs on 15Apr2021. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 1 day. The report was serious with the seriousness criteria of hospitalization. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
52 2021-06-07 visual impairment Waking up around midnight the night after getting the vaccine, I experienced what I found to be pali... Read more
Waking up around midnight the night after getting the vaccine, I experienced what I found to be palinopsia. The light was medium to dim and as I got up and moved around I kept seeing white/silvery lines moving with me. I thought I had a web or string on me. As I tried to brush them off, I realized that they were actually image trails of my hands as I moved them. I would see my hand/arm moving and fading sort of in a stop motion through space. I have never experienced anything like this before. The images were very strong for about 15 minutes and left me dizzy then they faded but never left completely. It has been 4 days since my vaccination and I still have palinopsia usually first thing in the morning, fainter, and lasting only a minute or two. The dizziness is a little better too. I can catch an extra image now and again especially against a dark back ground in low light but don't notice anything else during the day. The only other side effect I had along with this was fatigue and dizziness.
52 2021-06-08 taste impairment 1) Shortly after receiving the vaccine I noted a metallic taste in my mouth. It lasted for 3-4 days ... Read more
1) Shortly after receiving the vaccine I noted a metallic taste in my mouth. It lasted for 3-4 days 2) Within a day or two of receiving the vaccine I noted a sense of heart fluttering/ palpitations 3) I was very tired for 4 days
52 2021-06-09 swelling of eyelid arm is sore at injection area. More concerning I woke up before 5 AM heart was pounding and the left... Read more
arm is sore at injection area. More concerning I woke up before 5 AM heart was pounding and the left side of my face was swollen and my left I was hooded and almost shut, all subsided around 11 AM My lymph nodes in my left arm pit and outside of breast and inside rib cage started tingling swelling about an hour after shot , and left forearms feel tight today. Today is day 2 and left and right lymphnodes are sore in arm pits and joint pain in ankles and elbows,
52 2021-06-09 ringing in ears Skipping beats; heart rate went to 100 or over at rest; Headache; loud ringing ING ears; Dizzy; This... Read more
Skipping beats; heart rate went to 100 or over at rest; Headache; loud ringing ING ears; Dizzy; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0172) via an unspecified route of administration in left arm on 18May2021 12:30 as 1st dose, single dose for COVID-19 immunization. Patient was 52-years-old and was not pregnant at the time of vaccination. Patient medical history included Raynaurds, active TB, Allergic to sulfa, penicillin, tetracycline, erythromycin, experienced drug reaction due to prednisone, alleve (muscle relaxants), allergies to antibiotics, latex and wasp, had shoulder surgery after which used cold medicines, was not getting another, COVID-19 in Nov2020. The concomitant medications included birth control, pseudoephedrine hydrochloride (SUDAFED 12-HOUR). Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 19May2021 at 10:00, patient experienced headache, loud ringing in ears, heart rate went to 100 or over at rest and was skipping beats and was out of rhythm, dizzy. She read studies from country that shows 1 shot for those who had covid is same as having 2 shot. She still was testing that she had antibodies. All she could do was drink water and wait till she metabolized whatever set her system off. She did not want go through that again. Device date was reported as 21May2021. Adverse events did not result in hospitalization. The outcome of the events was resolving.
52 2021-06-10 sensitivity to light, extreme sound sensitivity Migraines; Sensitivity to sound; Higher blood pressure; Sensitivity to light; This is a spontaneous ... Read more
Migraines; Sensitivity to sound; Higher blood pressure; Sensitivity to light; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), first dose on 25Mar2021 08:00 (Lot number: EP7534) and second dose on 15Apr2021 (Lot number: ER8737) both via an unspecified route of administration, administered in right arm as single dose for COVID-19 immunisation. Medical history included RSV (respiratory syncytial virus) autoimmune. No Prior Vaccinations (within 4 weeks). Concomitant medications included ongoing lisinopril (Has been taking for years). It was reported that she was still dealing with migraines and everything else, and light sensitivity. Migraines started the day after the second dose on 16Apr2021, and she had it for 6 days straight. It settled some, enough for her to think straight. It was back again yesterday and was full fledge today. Has had to wear sunglasses ever since. Treatment: Imitrex and some Toradol. She had higher blood pressure in the beginning when she got the first shot in 2021. They gave her another blood pressure medication, stated that the blood pressure was better now. Sensitivity to light it was explained that this was lasting longer than the migraines; she was back in sunglasses due to this in 2021. She also has some sound sensitivity but that was part of the migraines. She has had this going on since the migraines started in Apr2021. Due to migraines patient visited Emergency Room the other month when this first started, in Apr2021. Was not admitted to the hospital. Was on 12 different medications in the previous year. Clarified that she was not on any other medications within 2 weeks prior to the Covid 19 vaccine. The outcome of event migraine was not recovered, blood pressure high was recovering, remaining events were unknown. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-01-03 hearing loss At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minut... Read more
At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minutes later patient reported shortness of breath, not feeling good and not being able to hear properly. Blood pressure was taken immediately at 1.38pm - 189/96mmHg and pulse -88bpm, and again at 1.43pm -180/90mmHg. Emergency services were contacted and came immediately within 3-5mins. After assessing patient they took her to hospital.
53 2021-01-03 lacrimation increased, sensitivity to light I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tende... Read more
I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tenderness at injection site at 3 am (1/1/21) following injection. The nausea had resolved when I woke up, the rash subsided throughout the day as did the chills. The most distressing event began on 1/1/2021 , that being sneezing, runny nose and watery eyes which continued and got much worse over the next two days, despite taking sudafed as often as possible. No other cold or flu symptoms were present and it felt like allergies although I have never had any sort of seasonal allergies. I finally took Zyrtec for it the evening of 1/3/21 and the symptoms stopped. Congestion, light sensitivity remain. I am reluctant to take another dose due to drowsiness side effect. Hoping symptoms will all be gone by tomorrow.
53 2021-01-03 oropharyngeal discomfort Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,... Read more
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
53 2021-01-03 tongue disorder Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongu... Read more
Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongue. Pt given 10mg cetirizine. Pt observed for 30 minutes. Pt states feeling are resolved. Pt released to work.
53 2021-01-04 taste impairment Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 ... Read more
Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 sec; with in 5 minutes of inoculation experienced an odd taste in my mouth; Warm sensation in Left upper arm for at least 15 minutes.; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 at 13:15 (at the age of 53-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included pneumonia, high cholesterol, eczema rashes from perfumes/beauty products/soaps and hand dermatitis all on unknown dates.The patient is allergic to amoxicillin (rash trunk) and experiences seasonal allergies in the eyes/nose/with coughing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 13:20 (reported as "within 5 minutes of inoculation") the patient experienced an odd taste in her mouth, a pounding heart rate felt in her chest that lasted less than 30 seconds (may have been shorter). She stated that she was trying to stay calm. Also, she experienced a warm sensation in the left upper arm for at least 15 minutes as well as a very painful shoulder twenty-four hours later; there was no swelling nor redness noted. Her shoulder was much improved by the third day.The patient did not receive any treatment for the events. The clinical outcomes of heart rate increased, taste peculiar, localized feeling of warmth and shoulder pain were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
53 2021-01-04 pain in jaw, ear pain a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced s... Read more
a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced sharp pain in left ear radiating down to jawline and left shoulder and upper arm. Pain also caused severe headache relieved with high dose Tylenol. Symptoms lasted 24hrs. Headaches became mild lasted thru day of report reaction (1/4).
53 2021-01-04 mouth tingling Tingling lips Sore throat Burning in chest Rash Headache Neck stiffness SOB
53 2021-01-04 mouth tingling feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on th... Read more
feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as "about 5 minutes after shot"), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.
53 2021-01-04 visual impairment, vision blurred blurred vision; little spots on the inside of her eyelids; This is a spontaneous report from a conta... Read more
blurred vision; little spots on the inside of her eyelids; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included eyeglasses wearer (reported as with her glasses). The patient's concomitant medications were not reported. The patient is experiencing symptoms from the COVID-19 vaccine received on 18Dec2020. She began to have blurred vision that night, and it worsened over the following weekend. She saw the eye doctor on 22Dec2020, and they stated her vision had changed even with her glasses. Now she has little spots on the inside of her eyelids that were also noticed on the eye examination in Dec2020. She has already reported these symptoms to the V-safe program. She mentioned that she is not the only nurse in the workplace that has experienced blurry vision. She asked if she should receive the second dose on 08Jan2021. It was still blurry, but it was better than it was a week ago. It still affected her reading and seeing at a distance. It scared her to get the second one because she doesn't want to go blind. She went to the eye doctor for visit on Tuesday. The outcome of the event blurred vision was recovering, while for the other event was unknown. The reporter considered blurred vision as serious due to being medically significant. Information about lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that the reported event vision blurred and eyelid disorder related to the suspect product event most likely due to patient underlying contributory factors
53 2021-01-05 loss of taste, loss of smell loss of her sense of taste and smell; loss of her sense of taste and smell; This is a spontaneous re... Read more
loss of her sense of taste and smell; loss of her sense of taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Since 29Dec2020, the patient had a loss of her sense of taste and smell that was unresolved. The patient wanted to know if this was a known side effect. The patient was not recovered from the events. Information on the batch/lot number has been requested.
53 2021-01-05 loss of taste Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and w... Read more
Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered. Information on lot/batch number has been requested.
53 2021-01-05 lacrimation increased FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 m... Read more
FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 mg po bendaryl. At 4am took and additional 25 mg Benadryl po. and at 1000 took third dose of benadryl po 25 mg. Pt. states that he left eye is watering. Pt. states that she has a little bit of facial swelling still at 1023 am on 1/6/2021.
53 2021-01-05 visual impairment associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of visi... Read more
associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.
53 2021-01-06 swollen tongue Started having tongue swelling about 1 hour after injection, treated myself at home with Benadryl. A... Read more
Started having tongue swelling about 1 hour after injection, treated myself at home with Benadryl. Around midnight increased tongue swelling, throat tightness and shortness of breathe. Went to emergency room and treated with epinephrine, steroids, Benadryl, Pepcid and required a nebulizer (duoneb). Discharged home from ER with prescription s for Prednisone, Pepcid and Benadryl
53 2021-01-07 oropharyngeal discomfort After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Pat... Read more
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97%  At 1642, patient was discharged to family's care and taken home.
53 2021-01-08 eye itchiness, dry throat Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer note... Read more
Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer noted to be frequently rubbing her eyes, initially denies feeling any symptoms. Symptoms of itching eyes persistent followed by customer clearing throat repeatedly. Continues to deny symptoms related to vaccine. States that she has anxiety. Customer noted to be hypotensive at 1226 98/68. Refuses epinepherine, transport to ED for monitoring. Customer accepts Benadryl 50mg PO @ 1227. O2 sat ~94-95%, pulse 79-84. Customer monitored at site, escort and significant other, at chairside. Customer persistent with her request to leave throughout observation, states she is fine. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer does not have resolution with dry throat symptoms but does not wish to remain in observation any longer. Vitals at 1307 consistent with baseline as documented previously in chart. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1315, ambulating independently with steady gait, no obvious s/sx of distress
53 2021-01-08 taste disorder 1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes... Read more
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
53 2021-01-10 lip swelling At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, ... Read more
At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, my left upper lip began swelling. I took a Benadryl as I was already on prednisone. I had no problems during the night except a stuffy nose. On the following morning my face was swollen, more on the left. I took two more Benadryl during the day and on Sunday morning the swelling was gone. I had not other symptoms or complications.
53 2021-01-10 swollen tongue (1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (t... Read more
(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (took tyenol) -Sat am - swollen tongue when I woke up. Took benydril, swelling went down. tongue bled - (brush teeth, scrap tongue) -Sun - semi swollen tongue, rash lower abdomin. R am front area by under arm.
53 2021-01-11 dry mouth, taste impairment Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throug... Read more
Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throughout body but especially extremities. Occurred within the 5-15 min observation period. I did not speak up about it as I was trying to analyze it myself and rationalize the symptoms. It did not cause tachycardia or SOB or intervention but it makes me a little hesitant for the 2nd dose due to my shellfish allergy/sensitivity. The sensation reminded me of the systemic response when receiving a contrast IV dye. I did leave a message at the VAERS 800# to ask if I should submit this form but did not want to delay any longer in case this information is helpful with the feedback/data for others. I understand it is not a true "adverse or sentinel" event but I wanted to report my reaction especially with the shellfish allergy (which I wasn't aware of to be a risk factor until I read more articles about it).
53 2021-01-11 pain in jaw A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ... Read more
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
53 2021-01-11 sensitivity to light Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photo... Read more
Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photophobic), nausea & diarrhea. This occured 4 days after my second COVID-19 vaccine. I had no symptoms prior to this.
53 2021-01-11 ringing in ears Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (histor... Read more
Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (history Rheumatoid Arthritis) began 4 hours later, and she could barely move hands. She had a severe asthma attack (history asthma) 1 hour later. Breathing has been poor since then with many asthma attacks and oxygen level as low as 79%. Still cannot sleep lying down without oxygen level dropping. Seen at Lung Center 12/31/2020 began tapering prednisone dose beginning at 60mg. Didn't tolerate 40mg so was at 60mg through 1/9/2021. Now decreased to 40 mg and is having increased shortness of breath and more breakthrough nebulizers. 1/4/2021 feeling no better. Given dexamethasone and kept on steroids. Returned to working just at home on 1/11/2021. No history of asthma reaction this severe in past other than post- ablation, but duration then was shorter.
53 2021-01-12 ear discomfort 12/27/2020 night head ache, ear popping, off balance, 12/28/2020 period upset and blood pressur... Read more
12/27/2020 night head ache, ear popping, off balance, 12/28/2020 period upset and blood pressure was 180/117 and husband took her to the hospital.
53 2021-01-12 mouth discomfort Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the j... Read more
Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the jaw line to under the chin, malaise, large muscle spasms and cramps, chills and shaking, soreness and swelling at injections site, burning in face and lips, and severe unexplained drop in blood sugar (56) that was very slow to bring back up.
53 2021-01-13 taste impairment Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lig... Read more
Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lightheaded 1st, then headache, feels like someone is pressing down on head and neck- temples and note- feels like a band around head. Pain is 2/10, progessed to 6/10. States muscles are starting to get sore around trapezius region. Stated she had feeling of euphoria initially, BP 128/76, HR 66, 98% RA. Nausea, but no emesis. Metallic taste to mouth- pins and needles when drinking water.
53 2021-01-13 ear swelling Received the first dose of the vaccine on Dec 30, 2020 which was a Wed. By that Sat night I was very... Read more
Received the first dose of the vaccine on Dec 30, 2020 which was a Wed. By that Sat night I was very itchy. On Sunday I had hives on my upper legs, stomach, buttocks and my ears were swollen and purple. went to urgent care 1/2/2021. Gave me prednisone 40mg for 5 days and triamcinolone cream.
53 2021-01-13 sensitivity to light, extreme sound sensitivity Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm ch... Read more
Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm chills, temp 97.8 7:00pm warm shower 7:15pm diarrhea, shortness of breath, sweat dripping down body, dizzy, nauseated 7:45pm cool compresses on head and neck, clams, shortness of breath, still dizzy, weakened began shacking. 7:55pm. Dressed by husband and put in bed. Temperature 90.0 8:00pm 3 blankets on me, gloves on, socks and slippers on and heating pads to ankles and feet, still dizzy and shacking. no circulation to hand or feet. no capillary refill. 8:30pm Called nurse on Call who stayed on the phone with me for 45 minutes, two Advil taken. Trying to eat crackers and hydrate. 8:45pm. feeling blood flowing to hands but not feet. 9:45pm gloves off hands and heavy blanket off, toes still ice cold.10:15pm Up to bathroom with husbands help, no strength. Urinated, no more diarrhea. Stomach still making a lot of noise. Still sensitive to light and sound, feeling to toes, still dizzy.11:30pm Feeling more like myself. Just exhausted. Slept off and on throughout the night and hydrated and up to urinate on my own without assistance. Jan. 14, 2021 , 10:00am- Sitting up in bed. Very tired. Drinking water. 12:00 noon able to eat an egg and avocado sandwich
53 2021-01-14 taste impairment, dry mouth fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in... Read more
fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
53 2021-01-16 loss of taste, loss of smell Was coughing , had chills back pain, fever, Stayed home wed, Thursday. Went back to wk Friday. Sa... Read more
Was coughing , had chills back pain, fever, Stayed home wed, Thursday. Went back to wk Friday. Sat at work she couldn't taste or smelled food. Took covid test, +for covid on 1/2/21. On 1/13/21 had another covid test it was negative. Congestion, h/a cough. Feels better and report back to work 1/18/21.
53 2021-01-16 mouth tingling Mild tingling on upper lip lasting 24 hrs- thought it was a herpes prodrome , took valcyclovir 1000 ... Read more
Mild tingling on upper lip lasting 24 hrs- thought it was a herpes prodrome , took valcyclovir 1000 mg x1. This was unusual because I don?t ever get tingling in upper lip , I only get cold sores occasionally on lower lip, so then I realized after talking with my coworkers, it was probably a vaccine reaction and I shouldn?t have taken the Valcyclovir
53 2021-01-16 swollen tongue, mouth numbness I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower... Read more
I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower leg. Tingling spread to both feet & hands arms lower legs. Slight swelling of tongue/ throat but I could swallow and breathe. It is now 16 hours since I received the vaccine and I?m still experiencing tingling / numbness and slight tongue/ throat swelling. I have decided to take Benadryl to see if it helps.
53 2021-01-16 swollen tongue Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the... Read more
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
53 2021-01-17 ringing in ears Constant ringing in ears
53 2021-01-18 loss of taste, loss of smell She had sniffles and post nasal drip; Got first dose then went to (Entertainment complex name) and c... Read more
She had sniffles and post nasal drip; Got first dose then went to (Entertainment complex name) and contracted COVID/tested positive after getting the 1st dose; Tested positive after getting the 1st dose; She returned home with sniffles, fatigue, and no taste/She had sniffles and post nasal drip; This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program: IBCC (Inbound Call Center for HCPs). A 53-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, exp date not reported), via an unspecified route of administration on 19Dec2020 for given since patient works with COVID patients (COVID-19 immunisation). The patient had no relevant medical history. There were no concomitant medications. Nurse called asking if she can get the 2nd dose of the vaccine 6 days after the 21st day. She tested positive on 05Jan2021 after getting the 1st dose and was still in quarantine. The nurse works at a hospital. She received her first dose of the COVID-19 Vaccine on 19Dec2020, and afterwards donated blood on the same day. She got the vaccine through her place of work. She said when she donated blood on 19Dec2020, her blood was tested for the COVID-19 Virus antibodies, and her blood was negative for the virus antibodies. She lives about 30 mins from work, so she thought she would get both done in the same day. She gave blood right before she got the vaccine. She gave the blood then went and got the Vaccine. She said on 26Dec2020 she went to Entertainment complex as it was her vacation. Her and her family went for 4 days. On 30Dec2020 she returned home with sniffles, fatigue, and no taste. She said she tested positive for the COVID-19 Virus on 05Jan2021. On 30Dec2020 they got back, and on 02Jan2021 she had sniffles and post nasal drip. On 03Jan2021 she did not wanna get out of bed. She was profoundly fatigued. She also lost her smell. She had to go back to work on 07Jan2021, but did not want to go back in unless she was sure she was okay because she works with babies. She had no other symptoms after 03Jan2021, except no smell and no taste. She got tested for COVID and was positive on 05Jan2021 (also reported as 06Jan2021 [pending clarification]). Her and her husband were both positive, but her kids were not. The weird thing was she also on 06Jan2021 got her results back from giving blood and she was negative for COVID on 19Dec2020 prior to getting the vaccine. Caller clarifies that her COVID test was a nasal swab. Patient thought her age may have contributed to her feelings of fatigue. She had indicated she worked in either a hospital NICU or nursery, and that is why she had to quarantine for 14 days. She probably would not have even gotten tested for COVID if she was not a nurse and did not know that losing taste and smell were a sign. She feels fine. She said she was scheduled for her second dose of the COVID-19 Vaccine on 12Jan2021. She said she was now in quarantine for 14 days due to testing positive for the COVID-19 Virus, and her quarantine period ends on 14Jan2021. Since now she is in quarantine, she will miss her second dose which was supposed to be on 12Jan2021. She said she rescheduled her second dose of the COVID-19 Vaccine to 18Jan2021, which was 6 days later than when she was supposed to receive the 2nd COVID-19 Vaccine dose. She asked if getting the dose 6 days late was okay. The events were considered as non-serious by the reporter. The outcome of the events was unknown.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
53 2021-01-18 loss of taste Low-grade fever; severe joint/muscle aches; severe joint/muscle aches; headache; loss of taste; This... Read more
Low-grade fever; severe joint/muscle aches; severe joint/muscle aches; headache; loss of taste; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 18Dec2020 at single dose in right arm for covid-19 immunization. Medical history included hypertension and anxiety. No other vaccine was received in for weeks. Concomitant medications in two weeks included losartan, famotidine, aspirin (acetylsalicylic acid), prazosin, escitalopram. The patient did not have COVID prior vaccination and patient did not underwent COVID tested post vaccination. The patient experienced low-grade fever, severe joint/muscle aches, headache, loss of taste on 19Dec2020 01:00. The patient did not receive any treatments of the events. The outcome of the events was recovered on an unspecified date. Information on Lot/Batch has been requested.
53 2021-01-18 bloodshot eyes Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done... Read more
Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done. received dilaudid and Zofran for pain and nausea. Next day, had pain in bones, feet, knees, back and neck. Also sore throat, red throat, headache, nausea, and diarrhea. Doctor prescribe antibiotics and Norco. Stomach pain returned 12/31.
53 2021-01-18 swollen tongue, burning mouth syndrome right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing,... Read more
right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing, water. approx. 45-50 minutes after I woke with this, I noted a large sore area on the lateral left side of my tongue. Arrived at work 6:30am and noted I was speaking with a "lisp" and tongue was still the same, no changes noted. Very tired, no energy. Reported this to our employee health at 8:00 am when they opened. I then was offered a Claritin by a coworker. approximately 2 hours later the swelling and sore had completely subsided.
53 2021-01-19 vision blurred Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The... Read more
Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The next day on 01/18/2021 at about 1445 started having some itchiness on the face[ cheeks, forehead and around lips] with chills on and off. My face became little puffy and swollen with redness. By the evening, I also ended up with high temperature 100 degree and started having body pain , mainly on the lower back . Took 600 mg Ibuprofen along with Vitamin C 1000 mg and Zinc 1 tablet at night. All my symptoms resolved by 01/19/2021 noon.
53 2021-01-21 mouth numbness, mouth tingling Pt c/o tongue tingling and 'molars' numbness as with first injection in which she reported to after ... Read more
Pt c/o tongue tingling and 'molars' numbness as with first injection in which she reported to after sx started. This injection, sx started earlier. No soa, itching, throat tightness or distress. Pt numbness and tingling resolved and then returned with some throat numbness. Pt remained without distress and after observation period opted to be dismissed and no er visit, called for ride, stated sx almost resolved at time of dismissal, no distress. Dismissal vs- 117/83 bp 79 hr 98% sao2
53 2021-01-21 oropharyngeal discomfort First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chill... Read more
First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chills, and her arm was very sore for a day. Second dose was given 1/15- On 1/19 she had body aches, chills, severe headache, fatigue, abdominal pain, stuffy nose and sore throat. Her arm was very sore for several days, she could not raise her arm. Treatment: took tylenol every 6 hours for 24 hours. on 1/19 and 1/20 she took Dayquil.
53 2021-01-21 oropharyngeal discomfort shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grad... Read more
shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grade fever and chills, digestive issues weight loss body aches.
53 2021-01-21 oropharyngeal discomfort HAD BODY ACHES, SCRATCHY THROAT, HEADACHE AND FEVER OVERNIGHT
53 2021-01-21 feeling of choking Approximately five minutes of receiving the second vaccine broke out in hives everywhere started exp... Read more
Approximately five minutes of receiving the second vaccine broke out in hives everywhere started experiencing throat tingling. Was taken to ER. I am a nurse at hospital Was given Solu-Medrol and Benadryl IV in ER
53 2021-01-23 taste impairment Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started... Read more
Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started a prickly tingle about 5 minutes and lasted about 3 hours, mild left palm and arm started a prickly tingle about 10 minutes after injection and lasted 1 hour, started feeling light headed about 10 minutes after and lasted about 1 hour with no blacking out, warm flush feeling started about 5 minutes after the injection and lasted for 32 hours (did not take temperature), my chest felt very heavy and breathing was a little diminished which lasted about 20 minutes. The following morning I felt some nausea with mild dizziness that lasted about 4 hours.
53 2021-01-23 ringing in ears I woke up at around 0430 the morning following vaccination with dose two feeling feverish (alternati... Read more
I woke up at around 0430 the morning following vaccination with dose two feeling feverish (alternating chills and sweating - did not take temp), global muscle and joint aches and pains, abdominal pain, a feeling of exhaustion, pounding headache, and ringing in my ears. While most symptoms resolved with a dose of acetaminophen followed a few hours later with a dose of ibuprofen by 1600 the same day, the tiredness and abdominal pain lingered for four days, and the ringing in the ears is remaining persistent. The ringing has not yet ceased (today is day five post vaccination).
53 2021-01-24 loss of smell, loss of taste Near complete loss of taste and smell.; Near complete loss of taste and smell.; This is a spontaneou... Read more
Near complete loss of taste and smell.; Near complete loss of taste and smell.; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration at left arm on 08Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included anxiety and depression, both from an unknown date and unknown if ongoing. The patient's concomitant medication included lamotrigine, fluoxetine, rheum rhaponticum root (ESTROVERA) and gabapentin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at right arm on 22Dec2020 at 10:00 at single dose for COVID-19 immunization. On 11Jan2021 at 14:30, the patient experienced near complete loss of taste and smell. The patient underwent lab tests and procedure which included SARS-COV-2 antibody test (Nasal swab): negative on 11Jan2021. The patient outcome of the events was not recovered.
53 2021-01-24 bloodshot eyes I called facility to check on everyone and see how they felt, and pt stated that her eyes looked ver... Read more
I called facility to check on everyone and see how they felt, and pt stated that her eyes looked very very red. She me a pic which I shared with. She has a burning sanitation and she bought over the counter eye drops.
53 2021-01-24 mouth tingling my first covid vaccine caused tingly lips; This is a spontaneous report from a contactable Health Pr... Read more
my first covid vaccine caused tingly lips; This is a spontaneous report from a contactable Health Professional reporting for herself. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided, expiry date unknown) via an unspecified route of administration in the left arm at single dose on 23Dec2020 at 15:30 for COVID-19 immunization. The patient had allergy to codeine. Concomitant medications included metformin, atorvastatin, vortioxetine hydrobromide (TRINTELLIX), insulin glargine/lixisenatide (SOLIQUA). The patient reported that her first dose of the vaccine caused tingly lips. Onset date and outcome of the event were not reported. Information about lot/batch number has been requested.
53 2021-01-24 light flashes or floaters in the eye became dizzy, clammy diaphoretic and nauseated at the end of her 15 minutes. This was her second do... Read more
became dizzy, clammy diaphoretic and nauseated at the end of her 15 minutes. This was her second dose and had no problems with the first COVID vaccine dose. Continued nausea with lightheadness and started to see visual spots when lifting head. Benadryl 25 mg 1 tab given by mouth at 1258 pm. At 1345 pm attempted to have her stand at stretcher and she continued seeing spots, dizzy. At 1406 transported to the ED for evaluation. She was seen, evaluated and released to home from the ED.
53 2021-01-25 taste impairment within 15 minutes of receiving my injection, I experienced a strong metallic taste in my mouth that ... Read more
within 15 minutes of receiving my injection, I experienced a strong metallic taste in my mouth that lasted constantly for a week after my injection. I am still occasionally experiencing an intermittent metallic taste, that dissipates quickly,. I am scheduled for my second injection this evening.
53 2021-01-25 eye swelling Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches.... Read more
Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches. Right eye is swollen. I took allergy eye medicine , a 24 hour tablet of Allegra, and put Cortizone 10 on my legs below the knees. As of 1/26/2021 - the medicine has stopped the itching, but eye is still slightly swollen.
53 2021-01-25 oropharyngeal discomfort, mouth tingling Patient was given Pfizer Covid 19 vaccine, after administration she reported having burning to her t... Read more
Patient was given Pfizer Covid 19 vaccine, after administration she reported having burning to her throat, tingling of lips and tightness on her throat. Dr. was immediately called. Orders for Benadryl 100 mg IM was given and medication was administered on right gluteus. Vital signs were taken and recorded on chart. Patient was monitored and verbalized improvement within 5 minutes of adminstration. Patient was monitored for another 30 minutes. Patient stated that she was feeling better.
53 2021-01-25 mouth tingling, taste impairment At 1:50 pm in post vaccine observation, patient reported metallic taste in mouth and warm flushing s... Read more
At 1:50 pm in post vaccine observation, patient reported metallic taste in mouth and warm flushing sensation from head to toe and tingling in lops. Vital signs taken at 1:50pm 158/92, pulse 71, resp 20, 1:55pm: 138/64, pulse 62, 2:05pm: 112/70, pulse 60, 2:15pm: 110/72, pulse 59, 2:28pm: 130/70, pulse 60, 2:40pm: 128/74 pulse 60, resp. 18. O2 sat remained 96-99% on room air. After 45 minutes patient reported feeling better and left with family member. Instructed to self monitor and to contact MD or report to ER if symptoms return or worsen. Patient verbalized understanding. Patient received Pfizer BioNTech Covid 19 vaccine EUA.
53 2021-01-26 ear swelling Systemic: left ear swelling at 40 minutes; symptoms lasted 1 day
53 2021-01-26 mouth tingling dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side ... Read more
dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side numbness on my face limping leaning to the left side when walking tingling on my gums and teeth
53 2021-01-26 swelling of eyelid On 01/25/21, 53 yo F received the Pfizer BTN162b COVID-19 vaccine. ~2-3 hours after the injection, p... Read more
On 01/25/21, 53 yo F received the Pfizer BTN162b COVID-19 vaccine. ~2-3 hours after the injection, pt developed swelling of eyelids, lightheadedness and nasal congestion. Pt reported similar symptoms related to seasonal allergies which she also experiences at this time of year. Pt self-medicated with fexofenadine (Allegra). Pt notified primary care provider. Pt denied any shortness of breath, difficulty swallowing or rash. Pt was advised to take diphenhydramine 50 mg. In no improvement in swelling, pt was advised to go to urgent care.
53 2021-01-27 loss of taste, loss of smell 12/28 received COVID-19 vaccine left deltoid. This was complicated with momentary (about 30 sec) l... Read more
12/28 received COVID-19 vaccine left deltoid. This was complicated with momentary (about 30 sec) lightheaded and some pruritis, although patient continued with work (rounding on service). Self treated with tylenol. She noted two spots on her left arm (pictures emailed to me), self-treated with motrin. 12/29 in the arm she believed the spots on her left wrist were more pronounced, with new spots on her forearm. Round maculopapular back left of spine 12/19 in am. Self treated with claritin. Called the reaction line and evaluated by Dr. on Thursday as all symptoms progressed. Simmered down over the weekend. Last claritin or any antihistamine was 6 days ago. Had COVID with positive PCR in April 2019. Still with positive antibodies, measured repeatedly as part of participation in program. Persistent loss of taste and smell. No history of known miralex exposure. Has not had a colonoscopy before. Minimal use of personal care products/lotions. Received annual flu vaccine without complications. Never history of anaphylaxis. Allergic reaction to COVID19 vaccine with diffuse cutaneous symptoms; not classical IgE mediated reaction No evidence of clear anaphylaxis to COVID-19 vaccine (or any other injectable). Patient received their second dose of vaccine on 1/19 - 30 minutes of monitoring instead of 15 minutes.
53 2021-01-27 swollen tongue reports she received the 2nd dose of Covid vaccine on 1/27 at 1430 and started having fever 100.8-1... Read more
reports she received the 2nd dose of Covid vaccine on 1/27 at 1430 and started having fever 100.8-100.9 and HA, swollen tongue, around 1/27 2100.
53 2021-01-27 ringing in ears Bilateral Tinnitus
53 2021-01-28 loss of taste, loss of smell she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tigh... Read more
she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
53 2021-01-28 blindness lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is ... Read more
lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications. On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills. As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.
53 2021-01-28 dry throat 1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a s... Read more
1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a steriod shot (methylPREDISolone (Medrol (pak)) and I was given famotidine (Pepcid pill). A prescription was called into my pharmacy (famotidine and methylPREDNISolone)
53 2021-01-28 eye discomfort, vision blurred Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed bl... Read more
Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed blurry vison; 1/25/21 - had an e-visit ; 1/26/21 - evaluated by her PCP referred to ophthalmologist; 1/27/21 - evaluated by ophthalmologist and referred to retina specialist as she had pressure behind her eye; 1/29/21 - retina specialist used laser to decrease pressure behind her eye.
53 2021-01-28 tongue disorder FEVER, "THICK TONGUE", LOWER BODY ACHES
53 2021-01-30 lip swelling developed swollen upper lip 15 minutes after receiving COVID-19 vaccine
53 2021-01-31 lacrimation increased Extreme chills fevers Sneezing Runny nose watery eyes Fatigue Body aches . Extreme chills And fatigu... Read more
Extreme chills fevers Sneezing Runny nose watery eyes Fatigue Body aches . Extreme chills And fatigue started 34 hours after shot . Sneezing started 48 hours after the shot Runny nose watery eyes And body aches Started 56 hours .
53 2021-01-31 thirst not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she wa... Read more
not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she was going to pass out; Fever; Nausea; tingling on her face; This is a spontaneous report from a contactable consumer (patient). A 53 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date Apr2021) via Intramuscular on 14Jan2021 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history heart murmur and high blood pressure diagnosed about 10 years ago. The concomitant medications was reported as none. Patient was still not feeling good. She said that she had side effects that started on Saturday 16Jan2021. Caller clarified that she had fever, nausea, and tingling on her face. Fever was noticed it on Saturday 16Jan2021 and gone by about 2am on Sunday 17Jan2021. Patient stated that she was feeling real thirsty. Nausea was still there and this morning, patient felt like she was going to pass out. She stated that she had weakness. She stated that she is trying to make an appointment to see her doctor. She stated that the nausea is persisting, but the nausea comes and goes. She stated that yesterday she felt ok, but this morning, she felt nauseated and like she was going to pass out. Patient said that the tingling stopped around 17Jan2021 02:00 along with the fever. Patient stated that she is drinking Gatorade and eating crackers and is staying stay hydrated. She stated that she is at work, but she feels weak. She stated that she had chills and she hurt like someone had hit her. She noticed these symptoms on Saturday 16Jan2021 and stated that this was ongoing and they come and go. The outcome of fever and tingling on her face was recovered on 17Jan2021 02:00. The outcome of not feeling good and feeling real thirsty was unknown. The outcome of other events was not recovered.
53 2021-02-01 lip swelling, mouth discomfort Employee reported that she began dry, burning lips and neck which started day after covid vaccine ad... Read more
Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest. Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving. Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day. Did not have to seek emergency treatment but did miss 1 day of scheduled work. Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
53 2021-02-01 pain in jaw Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Seve... Read more
Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Severe.
53 2021-02-02 ear itchiness 23 minutes following administration of vaccine began feeling nauseous, clammy, warm. Evaluated patie... Read more
23 minutes following administration of vaccine began feeling nauseous, clammy, warm. Evaluated patient BP 98/62 RA, wnl per pt. P 77, RR 16, O2sat 95-97%. During evaluation pt stated felt slightly itchy throat and itching in her ears. Pt given Claritin 10 mg po at 12:19 pm and remained under observation by RN. Pt began feeling better, sipping water. P 88-91, RR 16, O2sat 98%. Reviewed pt status with MD. Pt allowed to leave at 12:35 pm.
53 2021-02-02 mouth numbness, mouth tingling Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spont... Read more
Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness due to temporal relationship. However, the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-02-02 mouth tingling Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in che... Read more
Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in cheeks, throat tightness and lethargy
53 2021-02-02 visual impairment On 1/28/21, I experienced a temporary blind spot in my left eye, which lasted for about 30-45 minute... Read more
On 1/28/21, I experienced a temporary blind spot in my left eye, which lasted for about 30-45 minutes. When the vision was restored, I had a frontal headache.
53 2021-02-03 eye swelling, eye pain, bloodshot eyes, sensitivity to light, dry mouth Piercing eye pain; Swollen/red left eye; Swollen/red left eye; Extreme photophobia; Body wide muscle... Read more
Piercing eye pain; Swollen/red left eye; Swollen/red left eye; Extreme photophobia; Body wide muscle pain; Fatigue; Increased dry mouth; GI upset; Nasal congestion; Wheezing; Shortness of breath; This is a spontaneous report from a contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9262,), via an unspecified route of administration in left arm on 21Jan2021 at 16:45 as a single dose, for COVID-19 vaccination. The most recent COVID-19 vaccine was administered at a Workplace clinic. Medical history included rheumatoid arthritis dry eye, hypertension, anxiety and asthma. Concomitant medication included lisinopril (LISINOPRIL), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), iron (IRON), oxymetazoline hydrochloride (CLARITIN ALLERGIC), montelukast sodium (SINGULAIR). No other vaccines were given within 4 weeks. . Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number:PFR-20364-01; in the right arm on 29Dec2020, at 09:00. On 22Jan2021 at 05:00, the patient woke the day after at 5AM with piercing eye pain along with swollen/red left eye. extreme photophobia. body wide muscle pain. fatigue. increased dry mouth. GI upset. nasal congestion. Wheezing. Shortness of breath. No treatment was received given for the events. The clinical outcome of piercing eye pain along with swollen/red left eye. extreme photophobia. body wide muscle pain. fatigue. increased dry mouth. GI upset. nasal congestion. Wheezing. Shortness of breath was recovering. Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No Allergies to medications, food, or other products:no Vaccine Facility information available. Ethnicity information is available. Race information is available.
53 2021-02-03 mouth numbness DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDE... Read more
DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDED HERE) NUMB LIPS AND TONGUE THROAT HOARSE LEFT ARM ACHE
53 2021-02-04 eye twitching 1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple o... Read more
1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple of days muscle aches all over, bone pain, fatigue, 1/18 First Covid Test 1 Negative Continued symptoms 1/21 Went to PCP Covid rapid and Covid lab both negative Labs drawn all within normal limits Symptoms continued including occasional leg cramps, random muscle twitching, sharp needle like pain in foot, feeling shaky, waking to numbness hands
53 2021-02-04 taste impairment Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevate... Read more
Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevated 160/90; no other issues.Monitored; hot resolving, metal taste resolving
53 2021-02-04 lip itchiness, tongue itchiness Headache 3-5/10 for DAYS 1-5 Itchiness of the face, scalp and right hand DAYS 1-5 Itchiness of lips... Read more
Headache 3-5/10 for DAYS 1-5 Itchiness of the face, scalp and right hand DAYS 1-5 Itchiness of lips and tongue DAY 1 and DAY 5 Bilateral Hip and Knee pain DAYS 1 and DAYS 3-5 Flank Pain DAYS 3-5
53 2021-02-07 lip swelling, eye itchiness, eye swelling SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 ... Read more
SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 AND BECAME WORSE LATER THAT MORNING. EXTREME TIREDNESS. TOOK BENADRYL TO RELIEVE THE ITCHING AND SWELLING.
53 2021-02-07 ringing in ears, pain in jaw, ear pain Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for va... Read more
Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for vaccines, but did not this time due to recommendation of not doing so with this vaccine. One hour post vaccination, developed cognitive changes- deer in the headlight, unable to think/process information, lasting 4-5 hours. Later that evening, extreme fatigue. Resting respirations labored >20/min lasted most of the night along with chills with no fever x 3days. Dizziness with LOUD ringing in R ear started around 1-2am and lasted one week. Pain in joints/muscles of jaw. Next day both ears were hurting inside (eardrum, middle ear) x1week. HR elevated up to 135 bpm walking to bathroom x 2 days post vaccination. Felt sick/wiped out post vaccine for 3-4 days with no energy with muscle aches/stiffness.
53 2021-02-08 dry throat her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel... Read more
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
53 2021-02-09 ringing in ears Tinnitus beginning one day (1/20) after administration of second dose of COVID-19 vaccine.
53 2021-02-10 taste impairment After 30 minutes receiving the 1st dose of covid-19 vaccine, patient reported metallic taste. The h... Read more
After 30 minutes receiving the 1st dose of covid-19 vaccine, patient reported metallic taste. The heart rate was 83 bpm. The blood pressure was fluctuate from 125 to 150 / 70 to 83. After 15 minutes taking 2 tablets of Benadryl 25 mg, the metallic taste went away. Patient was back to work as usual.
53 2021-02-11 feeling of choking, mouth tingling throat and tongue tingling, HA
53 2021-02-12 loss of smell 1) Dried blood in upper nostrils for 5-7 days noticeable 12/24/2020 2)Loss of smell from 12/24/202... Read more
1) Dried blood in upper nostrils for 5-7 days noticeable 12/24/2020 2)Loss of smell from 12/24/2020 ongoing since then with mild congestion 3)Local effects- swelling and mild pain at the site of injection for 24 hours after 2nd vaccine on 1/11/2021 4)Fatigue for 24 hours after 2nd vaccine on 1/11/2021 5)3 short episodes of dizziness since 2nd vaccine on 1/11/2021
53 2021-02-14 dry mouth, dry eye Initially, soreness around injection site. Backaches. Then the next few days, I realized, I was havi... Read more
Initially, soreness around injection site. Backaches. Then the next few days, I realized, I was having a flare up of sjogrens. Dry mouth and dry eyes were worse. Dry cough, chest discomfort was the most difficult to deal with and GERD issues got worse
53 2021-02-14 mouth tingling Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak... Read more
Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak. Patient was taken to Clinic for evaluation at onset of symptoms, approx 12 minutes after distributing vaccine. At Clinic, patient states her symptoms have improved. She states she thinks she got a little anxious and feels comfortable driving home at this time. Patient denies oral/throat/tongue/lip edema. No headache, vision changes, difficulty swallowing, difficulty handling oral secretions, chest pain, palpitations, shortness of breath, nausea/vomiting. No pruritus. Patient is siting comfortably in the chair and drinking water without difficulty. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss the second dose of the covid vaccine. Patient agreed to the plan. Patient ambulated out of clinic without difficulty. 1/1/21: Pt received 2nd dose of vaccine. Experienced some dizziness and slightly high BP. Both symptoms resolved within 30 minutes and patient was discharged home.
53 2021-02-14 mouth tingling Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was giv... Read more
Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was given Benadryl 50mg IM. Within 15 seconds she reported not feeling well. Then she started seizing for about 30 seconds. Initial BP 148/88 and pulse ox 98. After 5 mins BP of 125/77 and pulse ox 99%. Patient regained consciousness, was A&O x3 but felt weak/tired. She was transported to the hospital.
53 2021-02-16 mouth tingling, mouth numbness Numbness and tingling around mouth. Benadryl 25mg given at 1054am v/s at 1058am 145/82 p 74 r18 96%... Read more
Numbness and tingling around mouth. Benadryl 25mg given at 1054am v/s at 1058am 145/82 p 74 r18 96% v/s 131/71 68 16 97% numbness and tingling resolved at 1122am
53 2021-02-18 thirst 7 days of serious nausea and severe heartburn Unable to eat or drink until day 7 Still have heartbu... Read more
7 days of serious nausea and severe heartburn Unable to eat or drink until day 7 Still have heartburn on day 7
53 2021-02-22 visual impairment, eye irritation Foggy vision and irritation in the eye for 5 hours.
53 2021-02-23 dry mouth, mouth tingling Patient complained of flushing, tingling tongue, dry mouth.
53 2021-02-24 thirst Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, ch... Read more
Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.
53 2021-02-26 pain in jaw Numbing on left side of the face, unable to close left eye all the way no control on left side of th... Read more
Numbing on left side of the face, unable to close left eye all the way no control on left side of the lips; sharp pain on neck and jaw
53 2021-02-27 eye swelling Left eye very swollen
53 2021-02-27 tongue disorder Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: sk... Read more
Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: skin flushed/got hot, hands got numb and tingly, back of and sides of my tongue got thick- felt like it was swelling, got more difficult to breathe, heartbeat started racing, felt light-headed. I sat up in the edge of my seat and almost called for help, however the symptoms subsided within 2-3 minutes and then I was fine. Had a lingering, very minor headache and no other symptoms. I didn't tell anybody and came home and took 1 benadryl just to be safe.
53 2021-02-28 eye swelling Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers in... Read more
Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization in a workplace clinic. Medical history included hypothyroidism, idiopathic thrombocytopenic purpura (ITP), and previously administered dermal fillers in Jun2020. The patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine, tamoxifen, and vitamin D. The patient also received her first dose of BNT162B2 (lot number: EJ1685, unknown expiration) for COVID-19 immunization in right arm on 29Dec2020. The patient experienced swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness on 21Jan2021. The patient received steroids and antihistamines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the events on unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.
53 2021-02-28 feeling of choking, mouth tingling, mouth numbness Pt received first dose of Pfizer vaccine and was sitting in the observation area for about 5 minutes... Read more
Pt received first dose of Pfizer vaccine and was sitting in the observation area for about 5 minutes when she alerted staff that she was feeling numbness and tingling to lips that was moving up face and down to throat. Pt stated that she also had slight difficulty breathing which was relived when she took off her mask. She stated that she has allergies to papaya and cantaloupe and this reaction was similar. Pt was given 50mg Benadryl and stated that she was feeling much better about 15 minutes later. Vital signs WNL. Pt d/c home with instructions on when to seek medical care.
53 2021-03-01 mouth tingling Patient reported feeling tingling in the tongue and around her mouth for approximately three hours a... Read more
Patient reported feeling tingling in the tongue and around her mouth for approximately three hours after receiving the COVID vaccine then subsided without any further intervention.
53 2021-03-01 ringing in ears Significant ringing in the ears
53 2021-03-02 eye pain Body aches, fatigue, mild headache, eyes hurt. Feel feverish but have no fever
53 2021-03-03 double vision I started to feel severe lethargy and fatigue. My eyes flared, double vision up with my usual autoim... Read more
I started to feel severe lethargy and fatigue. My eyes flared, double vision up with my usual autoimmune attack. I could not get out of bed for five days. Chills and back pain, joint swelling. It felt like a really flare up of my autoimmune condition. I also had similar problems with the first dose but not as bad. I was midway between my bi-weekly Cosentyx.
53 2021-03-04 oropharyngeal discomfort Within a few minutes of getting the injection my face began tingling. A few minutes after that the ... Read more
Within a few minutes of getting the injection my face began tingling. A few minutes after that the tingling turned into a burning feeling. My cheeks were slightly flushed but felt like I had a bad sunburn. At the same time my throat felt thick. I could talk and breathe but it definitely felt like it had swelled inside my throat. I also felt shaky. My hands were not shaky but I felt shaky on the inside. I didn't report this to the people working the vaccine clinic (but in retrospect I should have) The thick throat feeling resolved within one hour and the face burning feeling was gone by the next morning. Then I just had the typical sore arm, a few body aches and nothing else. Note: never a vaccine reaction but I had an anaphylactic reaction requiring treatment when receiving a 2nd dose of chemotherapy
53 2021-03-06 eye swelling Within 10 minutes my face and head was tingling and went numb. Eyes felt swollen/numb. This lasted ... Read more
Within 10 minutes my face and head was tingling and went numb. Eyes felt swollen/numb. This lasted for 4 hours. Both hands also were numb even longer. EMT's on site checked my vital signs. My blood pressure and oxygen were OK so they said I could drive home when I felt ready.
53 2021-03-07 lip swelling Symptoms: throat swelling, lips swelling, face turned red, racing heart and blood pressure, feeling... Read more
Symptoms: throat swelling, lips swelling, face turned red, racing heart and blood pressure, feeling faint. This happened 10 minutes after shot was given. Benadryl shot was given in arm and didn't help and then epipen was administered. Then taken to ER and given Decadron and Pepcid. Was monitored for 4 hours and sent home.
53 2021-03-08 ear discomfort My head felt heavy; it felt like my head was surrounded by water. Lots of pressure around my ears. ... Read more
My head felt heavy; it felt like my head was surrounded by water. Lots of pressure around my ears. My mind was very foggy; I could not think clearly. It was hard to concentrate and focus. It felt like I was extremely groggy but not sleepy. My think pattern was very slow. My appetite decreased; I felt nauseous a couple of times. No fever. I took 2 Tylenol tablets (regular dose), and laid down to rest for several hours. The longer the day went, the more severe the symptoms become. I took another 2 Tylenol tablets at bedtime, and went to bed earlier. During the day I drank lots of fluids, and ate light food.
53 2021-03-08 lip swelling, eye swelling, eye pain, mouth numbness Received vaccine on 3/4. Noticed swelling under right on 3/5 in the afternoon. Minimal under left... Read more
Received vaccine on 3/4. Noticed swelling under right on 3/5 in the afternoon. Minimal under left eye. Right eye more painful. On Monday 3/8 noticed swelling to right side of upper lip lasting through Tuesday 3/9. Described as painful, numb, and tingling. Stated she felt short of breath until morning of 3/9 with chills. At time of report right upper lip swollen but pt. says has decreased. Took Zyrtec, and Advil for relief. Pt. received fillers for under both eyes and lip on June 6, 2020. Swelling occurred where injection of filler was placed.
53 2021-03-08 mouth tingling Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively wors... Read more
Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively worse, trouble clearing throat, had epi and IM benadryl and sent by EMS to hospital, SOB, wheezing, EC- epi, Decadron, admitted and then intubated and had epi infusion.
53 2021-03-08 swollen tongue, mouth tingling Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protoc... Read more
Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protocol for observation of serious adverse reaction to vaccine. At 1325, pt. reported feeling well and left the clinic. After returning to her private vehicle from vaccine clinic, pt. states that she noticed her face was flushed and her tongue "felt funny." At 1337, the pt. returned to the front entrance of hospital reporting that she thought she may be having a reaction to the vaccine. Pt. was immediately taken to the ED for evaluation. According to the patient, she was given 50 mg IV Benadryl and observed for a short time. Her symptoms of tongue swelling, itchiness with no hives, mild numbness/tingling in extremities bilat., tingling at top of head all resolved. Pt. was then discharged to home with a prescription for Prednisone and instructed to return to ED with any new/worsening symptoms. Pt. also instructed to f/u with PCP regarding advice for admin. regarding second dose of Covid-19 vaccine.
53 2021-03-08 thirst Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hou... Read more
Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hours later notice marked abdominal/gut tightness and bloating. Very fatigued. Swelling in extremities and moderate joint pain. Increased thirst. Next morning had sharp pleuritic type of chest pain increased with inspiration lasting about 20 min. Moderate/severe fatigue. Abd tightness, bloating, and fatigue continued for the next 48 hours and persisted but is milder today on 3/9. Continued fatigue. And the expected headache.
53 2021-03-09 ringing in ears Left ear buzzing followed by dizziness , headaches
53 2021-03-10 eye swelling My eye started swelling 48 hours after event. Continues to swell until closed. Saw an NP on 3.09.21 ... Read more
My eye started swelling 48 hours after event. Continues to swell until closed. Saw an NP on 3.09.21 - suggested Benedryl and cold compresses.
53 2021-03-10 mouth tingling tingling month and tongue. Evaluated by EMS-Cleared
53 2021-03-10 mouth tingling feels flushed, lips tingling, reports feeling throat closing. Evaluated by EMS-Cleared
53 2021-03-12 lacrimation increased Woke up the morning at 7:30 after the 2nd vaccine yester at 1:30 and had a deep bruise on left eye ... Read more
Woke up the morning at 7:30 after the 2nd vaccine yester at 1:30 and had a deep bruise on left eye lid only. No puffiness, slightly sore to the touch, eye is a bit watery, vision is currently unaffected.
53 2021-03-14 loss of smell, taste disorder Headache, Myalgia, UrticariaPruritus, NauseaVomiting, Tachycardia, Reports had R knee pain (prior ... Read more
Headache, Myalgia, UrticariaPruritus, NauseaVomiting, Tachycardia, Reports had R knee pain (prior injury there) and took tylenol, naproxen and tramadol for symptoms which were intermittent for the next 10 days. Narrative: Employee directed to go to ED and declined. Employee is a physician. Employee took 2nd Pfizer Vaccine, EL1042 on 1/13/2021 and experienced L shoulder injection site pain, headache, body aches. Fever up to 101F. Tx with tylenol, Reports in bed all day. Missed work on 1/14/2021 and 1/15/2021. 1/15/2021 got up and severe burning all over body. Smell decreased and change in taste. Reports increased teeth sensitivity to cold, citrus tastes. Feeling more weak and fatigue. Neurologist diagnosed with Small fiber neuropathy R/ T Covid vaccine administration on 3/3/2021.
53 2021-03-14 eye swelling Patient states she developed left eye swelling on the morning of 03/15/21. States she does not thin... Read more
Patient states she developed left eye swelling on the morning of 03/15/21. States she does not think its allergies since she took a claritin and it did not help her.
53 2021-03-14 mouth tingling Patient felt mouth tingling with 1st dose & red scattered rash next day. After second dose next day... Read more
Patient felt mouth tingling with 1st dose & red scattered rash next day. After second dose next day symptoms of body aches/joint pain, severe headache, neck back pain, fever 101. Heart palpitations.
53 2021-03-14 thirst, oropharyngeal discomfort Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like s... Read more
Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like something in my throat and it's still there, my arm was hurting, that night I was able to sleep, Friday it started getting more sore, Saturday I noticed I could not sit because my butt cheeks were hurting, then I started feeling leg and hand cramps on my left side, Then Sunday my arm, leg, back, spinal cord everything was hurting and I was extremely thirsty and I couldn't lay down, sit or even walk. I have not been feeling good at all. Also, I have lupus
53 2021-03-14 vision blurred Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment ... Read more
Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment required. Headache within 2 hours. Very distracting although not severe. Prevented sleeping. Took 1x advil 200mg. Resolved. Foggy head within 4 hours. Trouble focusing eyes and thoughts while having a conversation with neighbor. Resolved at 48 hours. Tiredness within 6 hours. Resolved at 54 hours. Chills but no fever starting at ~27 hours from shot and lasting 4 hours. Resolved.
53 2021-03-15 dry mouth, taste impairment, thirst Severe nausea after first shot 3 days after 1st Vaccination ~ dizziness, weakness, exhaustion, heada... Read more
Severe nausea after first shot 3 days after 1st Vaccination ~ dizziness, weakness, exhaustion, headaches, using albuterol inhaler in the morning for shortness of breath, bad taste in the mouth and stomach described as the taste of burnt rubber and smell and taste of ignited /lit matches, excessive thirst and dry mouth that has prevented me doing normal activities ~ general malaise and feeling unwell
53 2021-03-15 dry mouth, swollen tongue, dry throat Feeling of impending doom Throat tightening Tongue swelling Increased heart rate Increase in blood ... Read more
Feeling of impending doom Throat tightening Tongue swelling Increased heart rate Increase in blood pressure Dry mouth and throat Dizziness
53 2021-03-15 eye itchiness Client was vaccinated with her second dose of Pfizer @1030 and while waiting the recommended observa... Read more
Client was vaccinated with her second dose of Pfizer @1030 and while waiting the recommended observation time, she felt her eyes itching @1045. Client continued to self monitor as she has HX of these exact symptoms to other triggers and the notified medical staff @1130. No s/sx resp distress, no SOB, Client took 25mg of Benadryl in which she brought herself and felt her symptom diminish by 1200. Client advised by paramedic and nurse to seek further medical evaluation if symptom re-occurs.
53 2021-03-15 mouth tingling Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in ... Read more
Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in two days
53 2021-03-15 mouth tingling Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye w... Read more
Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye with radiating pain in head and swelling of neck and throat. Numbness subsided within 24 hours followed by pain and sensitivities on entire left side for the next 24 hours. Swelling in throat continued for the next 24 hours following vaccine peaking the next day 36 hours after vaccine. Significant trouble swallowing liquids including salvia. Choking on solid foods the day following vaccine. Lips tingling continued for 48 hours after vaccine and subsided at end second day 3/12. Throat and esophagus swelling continues to this day - 6 days after vaccine with only slight improvement in swelling. Swallowing is still difficult as of 6 days following 1st vaccine. Spoke with EMT at vaccine site who recommended Benadryl. Benadryl started within 1.5 hours of vaccine administration. Contacted allergist who recommended 2-3 x dose of antihistamines for swelling. A dose of 3x was done for 4 days and decreased to 2x dose of antihistamines on Monday and continue at that level at time of report today.
53 2021-03-16 loss of taste, loss of smell Received 1st dose of Pfizer COVID vaccine on 1/6/2021. On 1/11/2021 developed body aches, loss of ... Read more
Received 1st dose of Pfizer COVID vaccine on 1/6/2021. On 1/11/2021 developed body aches, loss of taste/smell, rhinorrhea, and pharyngitis. Positive COVID test.
53 2021-03-16 vision blurred nausea, headache, diarrhea, general feeling of being unwell. Most concerning to me is the affect on ... Read more
nausea, headache, diarrhea, general feeling of being unwell. Most concerning to me is the affect on my left eye and eyes in general and headache. My left eye is wandering, like a "lazy" eye. It is as if my eye floats, and when this happens I am not able to focus. With the eye is also a frontal area headache and i get an uneasy feeling in my body just prior to this happening. My reaction started around 5 hours after the vaccine shot. It is now four days later and my symptoms are less but still present around my eyes and headache.
53 2021-03-17 taste impairment Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chil... Read more
Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chills; funny taste; dizziness; itchy feelings; tired; discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202, expiry date not reported), via an unspecified route of administration administered in arm right on 26Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and known allergies: arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hallucinating, lot of pain all over her body, chills, funny taste, discomfort, dizziness and feel like her body is having a allergic reaction and itchy feelings and tired on 27Feb2021 01:00. The patient did not recover from the events.
53 2021-03-17 eye swelling, eye pain, vision blurred My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face a... Read more
My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face and neck itchy.
53 2021-03-17 mouth tingling, mouth numbness Patient complained of numbness/tingling to lips after receiving vaccine. Was monitored for 30 minute... Read more
Patient complained of numbness/tingling to lips after receiving vaccine. Was monitored for 30 minutes by provider and symptoms resolved.
53 2021-03-17 swelling of eyelid, eye itchiness, feeling of choking About four hours after receiving dose 2 of pfizer vaccine, I began sneezing, had a tickle in my thro... Read more
About four hours after receiving dose 2 of pfizer vaccine, I began sneezing, had a tickle in my throat and terribly itchy eyes. Then my eyes and throat swelled up so much that I couldn't open my right eye.
53 2021-03-18 eye pain received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minute... Read more
received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minutes. Symptoms increased and continued through out the night, childs and sweats , overall feeling of weakness. Mentally slow processing, feeling foggy. Symptoms Cleared on Monday evening around 9pm. New symptoms on March 19th swollen glands roof of my mouth, neck, underarms. Painful, brain fog, exhaustion, chills and sweats, stuffy nose, headache.
53 2021-03-20 taste impairment At 35 minutes post shot, I started experiencing lower abdominal cramping. This occurred when I was d... Read more
At 35 minutes post shot, I started experiencing lower abdominal cramping. This occurred when I was driving home and continued for an hour or 2 after shot. For about 24 hours, I had very intermittent cramping. For a couple of hours after shot, I had a metallic taste in my mouth. I also had some stiffness in my right hand and wrist appear after a few hours that was gone when I woke up the next day. I had 1 episode of loose stools the next morning. For 5 days after I felt off especially in the morning, with some slight dizziness, and something similar to restless leg syndrome which I have had some years ago. (at night.) I took my blood pressure and it was low. It remained low in the morning for 5 days.
53 2021-03-20 eye pain Head ache, muscle aches, eyes were aching, chills, sweats, exhausted, tired, low grade temperature 1... Read more
Head ache, muscle aches, eyes were aching, chills, sweats, exhausted, tired, low grade temperature 100.4
53 2021-03-21 dry eye Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms ... Read more
Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms right side of face since 03/07/21. Swelling is transient symptom. Cluster headaches are transient symptoms. Bells palsy symptoms have not resolved. Treatment from PCP is steroid prescription started 03/20/21.
53 2021-03-21 dry mouth, dry eye 1/9/21 after 2nd dose on 1/7/21 I had a moderately severe headache and severe fatigue. By 1/10/21 A... Read more
1/9/21 after 2nd dose on 1/7/21 I had a moderately severe headache and severe fatigue. By 1/10/21 AM I was fine. 3/1/21 I developed moderately severe dry mouth and dry eyes that haven't resolved.
53 2021-03-21 thirst Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Inj... Read more
Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
53 2021-03-22 loss of smell, loss of taste Patient vaccinated 1/3/2021. On 1/11/2021 developed headache, chills, cough, aches, nausea, loss of... Read more
Patient vaccinated 1/3/2021. On 1/11/2021 developed headache, chills, cough, aches, nausea, loss of taste/smell, and rhinorrhea. Tested positive for COVID.
53 2021-03-22 ear pain Extreme headache; pain in both ears; fever; chills; nausea; This is a spontaneous report from a cont... Read more
Extreme headache; pain in both ears; fever; chills; nausea; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 16Feb2021 at 16:00 (at the age of 53-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included psoriasis. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on 26Jan2021 at 16:00 in the right arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included an unspecified low dose blood pressure medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 at 07:00, the patient experienced extreme headache, pain in both ears, fever, chills and nausea. The patient did not receive any treatment for the events. The clinical outcomes of the events headache, pain in both ears, fever, chills and nausea were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
53 2021-03-22 swollen tongue FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREAT... Read more
FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREATHE. OVER THE NEXT 48 HOURS MY OTHER AREAS WHERE I HAD BEEN BITTEN BY FIRE ANTS AND A HORNET STING BEGAN TO SWELL AGAIN AND MORE BENADRYL AND PEPCID
53 2021-03-23 eye pain, eye discomfort Continuous right side headache starting February 14, 2021. Right side headache, scalp burning & sens... Read more
Continuous right side headache starting February 14, 2021. Right side headache, scalp burning & sensitivity, orbit pain, right temple pain, pain at base of skull, forehead pain & sensitivity. right eye discomfort
53 2021-03-23 mouth numbness, mouth tingling facial and tongue numbness with tingling
53 2021-03-24 mouth numbness staff member was asked by writer if she had any anaphylactic reaction to any previous vaccines in th... Read more
staff member was asked by writer if she had any anaphylactic reaction to any previous vaccines in the past and she stated NO but was nauseated and felt funky from the flu shot. covid vaccine given at 1523 and approx. 3 -4 minutes after in the observation area she started stating that she felt numbness in her mouth and felt funky. she also was a little tachy and shaky of her upper extremities. we followed standard protocol for infusion reaction and gave 1 dose of epinephrine stat and activated emergency response system. she started to feel better but was nauseous. EMS arrived and no other doses of epinephrine administered. EMS transferred to ER.
53 2021-03-24 mouth itchiness, mouth tingling Patient received COVID-19 Pfizer vaccine today. She has a hx of allergies and was being monitored fo... Read more
Patient received COVID-19 Pfizer vaccine today. She has a hx of allergies and was being monitored for 30 minutes. She alerted staff after approx 25 min that she was feeling unwell. Reported that she developed generalized headache, ear fullness and tingling in the upper lip soon after receiving vaccine. Denied symptoms of anaphylaxis. She was brought into the triage area. She appeared well, in no distress, no evidence of angioedema or hives. VS were taken: BP 114/70, HR 87 bpm, SpO2 97%. She was given zyrtec 10 mg PO once. After approx 10 minutes she reported that she was experiencing new mild itching in the roof of her mouth and back of throat. She was then given benadryl 25 mg PO once. VS taken again: BP 112/74, HR 86 BPM, SpO2 98%. Continued to appear well. There was no observed difficulty breathing. No hives or evidence of angioedema. After approx 10-15 minutes she reported significant improvement of symptoms. She reported resolution of headache, ear fullness, tingling of the upper lip, and 90% resolution of itching of roof of mouth and back of throat. She denied feelings of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness. She was monitored for an additional 30 minutes after reporting feeling improved. During that time she reported resolution of symptoms. She continued to appear well. Prior to leaving she was counseled that should she develop any recurrent tingling in the lip, itching in the throat/mouth, feeling of swelling of tongue or lips, tightness in throat, difficulty breathing, hoarseness, dyspnea, wheezing, CP, chest tightness, abd pain, N/V, dizziness, lightheadedness she should seek urgent medical attention. Her daughter is waiting outside and will escort her home. Encouraged her to call with questions or concerns. She verbalized understanding of and agreement with plan
53 2021-03-24 mouth tingling 15 min after shot tingling of upper lip and tongue. similar to symptoms with iodine allergy. ems cal... Read more
15 min after shot tingling of upper lip and tongue. similar to symptoms with iodine allergy. ems called
53 2021-03-24 feeling of choking, mouth numbness Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 ... Read more
Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 - HR 75 1643 Epi 0.3 via pen Right thigh Feeling shaking Medical emergency called 1645 Benadryl IM right arm. Feeling flushed ED clinical staff here and transferred in own electric wh/chair. Husband with patient Allergy to CT Contrast - completely swollen shut
53 2021-03-25 swollen lips 4:15 pm Presented self after vaccination w/ c/o sl. H/A and lips feeling funny. Lips observed w/ no... Read more
4:15 pm Presented self after vaccination w/ c/o sl. H/A and lips feeling funny. Lips observed w/ no swelling. B/P 97/61, HR 86, O2 sat 99%, T 97 deg. Stated lots of stress. 4:30 pm Stated feeling much better. 4:40 pm Left observation.
53 2021-03-25 mouth numbness, swollen tongue Pt complained numbness/swelling in tongue. I gave her 2 diphenhydramine 25 mg immediately. Observed... Read more
Pt complained numbness/swelling in tongue. I gave her 2 diphenhydramine 25 mg immediately. Observed her for total of up to 24 minutes. All this time she was not having and chocking/closing of throat. She could talk fine and awake and alert, pt's husband was with her. I called her PCP and informed them about having this reaction and got EpiPen RX for her and dispensed her to take it home. I walked through with her on how to use it and instructed to call 911 if any emergency situation and any time she feels she cant breath. She was in the pharmacy under observation for about an hour and then she left with her husband with EpiPen to go home. I called her again around 4:30 pm to check on her. She was feeling ok
53 2021-03-25 bloodshot eyes, vision blurred Pfizer-BioNTech COVID-19 Vaccine EUA was administered at 1 pm. Within 10 minutes or less, my vision ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA was administered at 1 pm. Within 10 minutes or less, my vision blurred and the store darkened and felt like it was closing in. I felt dizzy and nausea. I sat down away from people and let someone know. I got a pink in my eyes and some parts of my body. I waited about 45 minutes and my vision cleared and the dizziness faded considerably. The nausea remained and some pinkness remained. Slight headache off and on for two days. Had minor discomfort for two days.
53 2021-03-25 swollen tongue, mouth tingling, feeling of choking Shortly after vaccination. Patient complained of tingling in mouth, throat and lips, and tongue swe... Read more
Shortly after vaccination. Patient complained of tingling in mouth, throat and lips, and tongue swelling. Patient was evaluated by EMS. IM Benadryl and nebulizer given by EMS. Patient was transported by EMS to Emergency Room for further assessment.
53 2021-03-25 ringing in ears Tinnitus
53 2021-03-26 ear pain Chills, fever, extreme muscular pain all over enter body, extreme fatigue, migraine, stabbing pain i... Read more
Chills, fever, extreme muscular pain all over enter body, extreme fatigue, migraine, stabbing pain in inner ears. Most severe symptoms persisted for 2 days and began to subside on day 3. Fatigue remained for an additional 2 days for a total of 5 days.
53 2021-03-26 eye swelling, bloodshot eyes Left eye swollen and very red in morning. Left side of neck very stiff and painful Injection was i... Read more
Left eye swollen and very red in morning. Left side of neck very stiff and painful Injection was in left arm
53 2021-03-26 eye swelling 03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face ... Read more
03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face especially around my eyes and slight swelling of my eyes, weakness.
53 2021-03-26 thirst, dry mouth Sore arms, extreme fatigue, hunger, dry mouth/thirst. Symptoms persisted for about 2 to 3 days.
53 2021-03-27 mouth tingling Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, she expe... Read more
Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: tingling on L scalp, L Face, L tongue, L arm and L hand. She gave this information to observation nurse after 15 minutes of waiting after getting vaccinated. Pt informed this nurse that she had a migraine before coming in to get vaccinated and the symptoms that were presenting to patient (tingling) usually accompanied her migraines. Pt was taken to an area to be assessed by paramedics. Pt was able to swallow water without difficulty. Per Paramedics, pt is okay to be discharged home. Pt states her tingling in her tongue has gone away but she still has tingling in her L scalp, L hand, L arm. Pt is alert and oriented at discharge and notified to call 911 if symptoms worsened. Pt verbalized understanding of instructions and husband was driving her home today. Pt stated she would take a benadryl at home after being offered benadryl at vaccination site. VS: 140/76, 64hr, 100%02. 123/67, 58hr, 100%02 Assessment : Time of assessment 1548. Alert and oriented. Actions taken: Vitals sign taken VAERS form completed Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 15 minutes. Discharged home. Instructed to follow up with PCP for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.
53 2021-03-28 vision blurred Patient reported dizziness, itching, blurred vision and nausea 15 minutes after receiving COVID19 va... Read more
Patient reported dizziness, itching, blurred vision and nausea 15 minutes after receiving COVID19 vaccination
53 2021-03-29 deafness Patient with previously stable autoimmune inner ear disease noticed L > R hearing loss after 1st dos... Read more
Patient with previously stable autoimmune inner ear disease noticed L > R hearing loss after 1st dose of vaccine. Undergoing intertympanic steroid injections.
53 2021-03-29 swollen tongue Swollen tongue, numbness in the back of throat
53 2021-03-30 lip swelling, mouth tingling Approximately 25min after vaccination, my throat became itchy and my lips were tingly and slightly s... Read more
Approximately 25min after vaccination, my throat became itchy and my lips were tingly and slightly swollen. This lasted for hours even after taking Alavert
53 2021-03-30 swelling of eyelid, eye swelling 10:days after first vaccine eyes were swollen. Saw eye doctor, he did not know direct cause. Exact... Read more
10:days after first vaccine eyes were swollen. Saw eye doctor, he did not know direct cause. Exactly 1 week after 2 nd vaccine eyes were significantly more swollen. Primarily, upper lid and under eye Right eye on both occasions was significantly worse but both I pacted
53 2021-03-31 taste impairment Strong Metallic Taste in Mouth lasting about 2 days with a painful sore throat
53 2021-03-31 mouth tingling SOB, numbness, tingling lips. Evaluated by EMS-Transported to Emergency room/department or urgent ca... Read more
SOB, numbness, tingling lips. Evaluated by EMS-Transported to Emergency room/department or urgent care.
53 2021-03-31 thirst, dry mouth, tongue disorder Minor change - cotton mouth at some point in every day since starting 1 hour after vaccination, incl... Read more
Minor change - cotton mouth at some point in every day since starting 1 hour after vaccination, including slight difference of tongue feeling thicker as in slightly thirsty and dry. MAJOR CHANGE - 12 hours after vaccination, like a faucet turning on menstrual cycle break-through heavier somewhat clotted bleeding starting 4 days early which NEVER happens - convinced is due to the vaccine. Flow for 12 hours then stopped for 12 hours, going on since but now into the regular week. Want to know why. VERY CONCERNED about girls such as 13-year olds and what the vaccine might do to their female bodies and ability to have children and to have normal cycles.
53 2021-03-31 ringing in ears Ringing in ears; tinnitus
53 2021-04-01 dry throat extreme neck stiffness, soreness on complete neck - all the way around and inflamed glands - hurts t... Read more
extreme neck stiffness, soreness on complete neck - all the way around and inflamed glands - hurts to turn or tilt head - sore to touch and affecting swallowing and voice - raspiness and cracking - dryness of throat
53 2021-04-01 eye swelling, mouth numbness Numbness on the roof of my mouth, near my throat. Hot flashes, sweating, high blood pressure, the fe... Read more
Numbness on the roof of my mouth, near my throat. Hot flashes, sweating, high blood pressure, the feeling of passing out, super hot throughout my body. Numbness in left cheek and upper lip. Swelling in left cheek and left eye. Dizzy.
53 2021-04-01 lip swelling Approximately 4 to 4 1/2 hours after vaccine notice cheeks getting red, feeling flushed. Got more a... Read more
Approximately 4 to 4 1/2 hours after vaccine notice cheeks getting red, feeling flushed. Got more and more warm to touch. No fever. Gradually moved to high on cheekbone. Took Tylenol and went to bed for night. At 24 hours after vaccine still continued redness, a bit of swelling under eyes and high on cheekbone. took tylonol. At 5;30pm took Benedryl. At 8:00pm noticed and felt swelling in bottom lip. Went to ER. Now 48 hours after Vaccine and two 60 mg. of Prednisone still very red, hot flushed cheeks. No more swollen lip. Taking Pepecid, Zyretc, and Benedryl. Presciption is to taper down on Prednisone 2X60, 2X50 and so on.
53 2021-04-01 mouth tingling pt vaccinated at 1106, was at observation area pst vaccination then 19 mins post injection c/o tingl... Read more
pt vaccinated at 1106, was at observation area pst vaccination then 19 mins post injection c/o tingling on lips/cheeks, halds felt funny the had chest tightness, MD, RNs responded , vital signs stable. Discharged AMA at 1142 AM, stable.
53 2021-04-02 dry mouth, mouth discomfort About 5 hours after vaccination, I started feeling very tired that I had to tell my employer that I ... Read more
About 5 hours after vaccination, I started feeling very tired that I had to tell my employer that I wouldn't be able to continue working much longer. I work from home at a computer. After 6 hours after vaccination (4 pm), I was so exhausted that my mouth muscles were too weak to be able to speak strongly. My muscles were too relaxed that I needed to lie down at this point. Inside my mouth, near my lips, there was a warming sensation (no pain). I've never experienced that before. It didn't last long. After about 6.5 hours after vaccination as I was in bed, I felt a little pain in my right thigh for an unknown reason. For a few seconds I felt a little nauseated so I kept a kidney dish near my head in bed. I slept in a deep sleep for at least 2 straight hours. I woke up groggy and with a very dry mouth. I usually drink a lot of water in my typical day, but after my vaccine I do not recall being unusually thirsty. I may have inadvertently dehydrated myself. That night after my vaccination I had a very dry mouth while sleeping. When I woke up each time, I would drink a little water. That carried over to the 2nd night after my vaccination, despite drinking a lot of water that day. Meanwhile, I had not had any alcohol, coffee, nor any caffeine during this entire time.
53 2021-04-02 eye itchiness, bloodshot eyes, eye swelling swollen, red, itchy eyes. Rash on back of neck appeared on day 2 after injection. Rash spread to upp... Read more
swollen, red, itchy eyes. Rash on back of neck appeared on day 2 after injection. Rash spread to upper chest, arms and hands by third day. 4/3 purchased over the counter Benedryl to counter act allergic reaction. Also too Tylenol 3/31, 4/1 and morning of 4/2
53 2021-04-02 oropharyngeal discomfort 58 y/o female, s/p 1st vaccine. C/o hotness to throat and intermittent right hand numbness. Speech ... Read more
58 y/o female, s/p 1st vaccine. C/o hotness to throat and intermittent right hand numbness. Speech clear, drinking water, a/o x4; medic 71 on scene, care assumed. Pt signed out AMA. Symptoms resolved.
53 2021-04-02 ringing in ears, ear discomfort DAY 1 POST-VACCINATION (4/1): NOTICED RINGING IN BOTH EARS WHEN I WOKE UP IN THE MORNING. ACCOMPAN... Read more
DAY 1 POST-VACCINATION (4/1): NOTICED RINGING IN BOTH EARS WHEN I WOKE UP IN THE MORNING. ACCOMPANIED BY SINUS CONGESTION ALL DAY (NOSE, EARS). FEELS LIKE WHEN YOU HAVE WATER IN YOUR EARS AND YOU WANT TO HOLD YOUR NOSE TO TRY AND BLOW IT OUT. DAY 2 POST-VACCINATION (4/2): EXPERIENCED MILDER RINGING IN BOTH EARS MORNING TO EVENING. NO SINUS CONGESTION. RINGING SHIFTED PREDOMINANTLY TO LEFT EAR. BY END OF DAY. PERSISTED AT BED TIME. DAY 3 POST-VACCINATION (4/3): WOKE UP TO HIGHER INTENSITY RINGING IN LEFT EAR. INTENSITY INCREASED MID-MORNING AND SHIFTED TO LEFT EAR. NO SINUS CONGESTION, BUT LEFT EAR WHERE RINGING HAS INTENSIFIED FEELS LIKE IT IS PLUGGED UP LIKE WHEN YOU HAVE WATER IN YOUR EAR AND WANT TO HOLD YOUR NOSE TO TRY AND BLOW IT OUT.
53 2021-04-02 ringing in ears, eye swelling, swelling around the eyes PUFFY/SWOLLEN AND IRRITATED EYES; SWOLLEN FACE; SNEEZING, CONGESTION, DIZZY, LETHARGY TINITUS.
53 2021-04-03 lip swelling About 10 mins. after my shot, I got a headache. They gave me a lollipop and I felt better. Told me t... Read more
About 10 mins. after my shot, I got a headache. They gave me a lollipop and I felt better. Told me to take one Advil and to hydrate with Pedialyte and water. Waited another 15-20 mins. and left. Went to pick up Pedialyte and started to drive to work. Started itching all over- head, face, nose, neck, arms, hands, stomach, legs and feet. My lips felt swollen or chapped. Looked in the mirror and saw a little bit of a rash on my forehead, temples and left jawline. Drove to the pharmacist and she said it was a reaction, not a side affect. Told me to take Benadryl and if I didn't feel better to go to the hospital. Took an Advil, Benadryl and drank Pedialyte-- felt better. Took the Benadryl and Pedialyte all day Thursday and Friday. Saturday only Pedialyte. Today, Sunday, I am itchy again. Feels like something is biting me and have a few welts or pimple like bumps. Will start taking Benadryl now.
53 2021-04-03 eye discomfort Day of vaccine I got a bad headache. I suffer migraines and it was not a migraine, it was my whole h... Read more
Day of vaccine I got a bad headache. I suffer migraines and it was not a migraine, it was my whole head. I had nausea and vomiting that evening and the next day. Headache persisted the next day also. Got chills. Knees hurt. On 3rd day, was better. then got congestion in nose and eyes, similar to allergic reaction to when I?m near a cat. Lasted two days. Knee still hurts and have been flushing for two weeks.
53 2021-04-04 ringing in ears Increased tinnitus symptoms on day 3 following 2nd vaccine dose. Humming in ears is much louder.
53 2021-04-04 ringing in ears Headache, tinnitus, pressure in my chest. Since the day I received the vaccine
53 2021-04-04 vision blurred After my first dose Pfizer vaccine, I felt light headed and developed slight pain to the left side o... Read more
After my first dose Pfizer vaccine, I felt light headed and developed slight pain to the left side of my neck. I had slight headaches and felt fatigued. For several days I had headaches and the left side of my neck was sore and I felt very fatigued. I also had an episode of shortness of breath with dizziness. I went to play top golf with my kids and after playing I felt very fatigued, tired and this went on for about one week. I missed three days of work. I also then developed a migraine headaches to the point that i vomited profusely. I took headache medication which temporarily relieved my pain. I also started to have blurry vision, vertigo and I spent two days in bed. I had no fever. Of and on, I keep getting SOB upon light exertion. On the past Wednesday and Thursday I experienced dizziness and I had to stay in bed because I felt sick to my stomach and I continue with the pain to the my left side of my neck. I still have not gotten my second dose Pfizer vaccine.
53 2021-04-05 eye discomfort A bit of soreness below the site of injection. Discomfort in right eye disturbing sleep which star... Read more
A bit of soreness below the site of injection. Discomfort in right eye disturbing sleep which started around midnight and lasted until the next morning around 10am
53 2021-04-05 mouth tingling At 45 minutes approx after the vaccine was given in my right arm, my lips and the area of my face ar... Read more
At 45 minutes approx after the vaccine was given in my right arm, my lips and the area of my face around my mouth were tingling and felt "rubbery". More specifically its as though a 2 inch wide circle around my mouth and my lips were affected. My tongue and throat were no affected at all. There was no constriction of breathing. There was no swelling or nothing discernable. This sensation stayed with me for about 1 hour. I want to note that the fist shot had slighter but similar symptoms. For the first shot I felt a much more mild version of what happened for the second shot.
53 2021-04-06 swollen tongue Patient came for second dose of covid vaccine. Shortly after receiving the vaccine. Patient reporte... Read more
Patient came for second dose of covid vaccine. Shortly after receiving the vaccine. Patient reported of having tingling of hands and swelling of tongue. Pharmacist gave patient a dose of 0.3mg EpiPen injection and call 911. Patient was alert and able to talk. Patient went with paramedics to the hospital to get checked out.
53 2021-04-07 ear discomfort IT KICKED MY ALLERGIES INTO OVERDRIVE. STARTED OUT WITH RUNNY NOSE WENT INTO STUFFY HEAD .THEN IT PL... Read more
IT KICKED MY ALLERGIES INTO OVERDRIVE. STARTED OUT WITH RUNNY NOSE WENT INTO STUFFY HEAD .THEN IT PLUGGED UP MY SINSUS AND MY EARS. THIS WAS OVER A THREE WEEK PERIOD.
53 2021-04-07 eye irritation High fever 102.2 Chills, body aches, total body pain and weakness headache burning eyes pain in arm ... Read more
High fever 102.2 Chills, body aches, total body pain and weakness headache burning eyes pain in arm at site of injection with numbness and tingling down arm post vaccination
53 2021-04-07 mouth tingling, swelling around the eyes Tuesday 6 go the first Pfizer Covid vaccine at the race track. In the past I have had angioedema and... Read more
Tuesday 6 go the first Pfizer Covid vaccine at the race track. In the past I have had angioedema and breathing issues but never severe enough to warrant going to hospital with several injections and from over the counter meds and prescription meds. So I was wary but decided to risk a jab. Straight up got tingling tongue and lips but after 15 min was just dizzy and roughly the same feeling. I am a slow up taker and excreter though. By the time I got home, about 20 min after the 15 min wait my neck on the injection side and swelled so much I no longer had a jaw and my eyes and cheeks were pretty puffy. Then the breathing issue started. I called the gp who said Tylenol, benedryl. Usually have them made because I have problems with additives but i don?t have any right now. So I used two ea kids chewable which allow me to have a dosage that works for me as I am sensitive to larger doses which can cause pvcs. Things were better but not good enough so took Zyrtec 10 ml/24 hr. If I had not had a similar experience with other injections this would have completely freaked me out. Thank goodness my quick treatment worked well enough that I felt confident worse was unlikely to happen, though the gp and allergist both wanted me to go to the er. Yesterday I did a repeat of Tylenol and benedryl in the morning and Zyrtec in the afternoon at two pm then Tylenol and benedryl again in the evening as I still had angioedema and felt tight in breathing. Repeat benedryl and Tylenol today but no Zyrtec as felt good enough to ride stationary bike a very slow Five miles. As to fever and other typical symptoms it has been hard to tell what is reaction and what is simply the vaccine doing its job. I did not take my temperature but have felt hot no general malaise. I recognize my symptoms are unusual but felt you should have them.
53 2021-04-07 mouth tingling Patient reported feeling anxious, having trouble breathing, and like her tongue was tingling approxi... Read more
Patient reported feeling anxious, having trouble breathing, and like her tongue was tingling approximately 30 minutes after receiving her vaccine. We called paramedics, they determined that she did not need to be transported to the hospital. Patient stayed another 30 minutes and felt fine.
53 2021-04-07 vision blurred Pt went to stand up right after receiving the vaccine and immediately passed out on the floor. Upon ... Read more
Pt went to stand up right after receiving the vaccine and immediately passed out on the floor. Upon examining the pt, pt stated she was dizzy after receiving the vaccine and we thought she just stood up too fast. Observed pt for several minutes, pt vomited shortly after and remained dizzy and sweaty. After about 30 minutes, pt stated she felt better and wanted to go on to work. While walking down the hallway to leave, pt passed out again. Contacted 911, pt had blurred vision, dizziness, slurred speech. Ambulance arrived, BP and HR were normal, but pt couldn't stand up unassisted. Pt was taken to the ER by ambulance.
53 2021-04-08 permanent deafness Sudden Sensorineural hearing loss, profound left ear
53 2021-04-08 eye itchiness Hives from scalp to bottom of feet, eyes itched nonstop for hours. Took (2) antihistamine tablets, ... Read more
Hives from scalp to bottom of feet, eyes itched nonstop for hours. Took (2) antihistamine tablets, Eyes still itched the next day until noon.
53 2021-04-08 extreme sound sensitivity Got vaccine on 4/7 at 10-10:30 am approximately By 1 pm I was sleepy and woke up at 3 By 4-5 pm I h... Read more
Got vaccine on 4/7 at 10-10:30 am approximately By 1 pm I was sleepy and woke up at 3 By 4-5 pm I had chills, body ache, no fever, nausea, heart palpitations, feeling that my blood is on fire, mild sore arm By 6-8 pm I was vomiting a lot and also going to the bathroom loose no diarrhea All night I felt sick and had raising thoughts in my mind. I have sensitivity to noises as well. On 4/8 I woke up very sick. Kept throwing up water and liquids. Couldn?t eat. By 1 pm I have thrown up some more The raising thoughts and things in my mind bother me 3 pm my veins in the back of my knees are hurting I have the feeling that I can feel my kidneys, liver, intestines Took Tylenol 9 pm and still feeling sick 4/9 still nauseous and with a pounding headache Took Tylenol By 8 pm I?m feeling a bit better
53 2021-04-08 swollen tongue PATIENT C/O SWELING OF HER TONGUE AND MILD ITCHING.
53 2021-04-08 ringing in ears Consistent ringing in ears since 2 days after vaccine
53 2021-04-08 ringing in ears Ringing in ears. Started to notice 2 days after. Constant hissing sound, like crickets. At first I t... Read more
Ringing in ears. Started to notice 2 days after. Constant hissing sound, like crickets. At first I thought it was due to Spring noise but then noticed it was constant and even at night when trying to sleep. VERY WORRIED and not sure if I should get the 2nd shot!!!!!!
53 2021-04-08 visual impairment site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm com... Read more
site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm completely without pain. I'm a nurse, so doing my own physical therapy. BUT, main issue has been daily headaches. I've had more headaches in the last 3 months since vaccine, then I have had in my entire life. no treatment except Tylenol or ibuprofen. Although, the other day I had a severe headache, with visual disturbance, vertigo with dizziness and nausea. Was treated at local ER for possibly stroke. MRI showed no issues. I am now diagnosed with migraines.
53 2021-04-09 pain in jaw, toothache 12 hours after vaccine, started with headache and dizziness, pain in knee , the tooth pain and jaw p... Read more
12 hours after vaccine, started with headache and dizziness, pain in knee , the tooth pain and jaw pain. few hours later sharp pain in bones, fever and chills added around 18 hours post vaccine, around 20 hours after vaccine I had a pulse of 118 feeling palpitation, flue like muscle achiness and weakness hit at night. I took Tylenol for it. the next day the lymph node in my arm pit same side vaccination (left) was swollen painful , and tender to touch. 2 days later I had runny nose with headaches.
53 2021-04-10 lip swelling It took a couple of days but my lips swelled. I monitored my self and the swelling started going do... Read more
It took a couple of days but my lips swelled. I monitored my self and the swelling started going down the next day on its own.
53 2021-04-10 swollen tongue Patient c/o tongue swelling 10 minutes after 2nd vaccine. No difficulty breath or throat swelling. ... Read more
Patient c/o tongue swelling 10 minutes after 2nd vaccine. No difficulty breath or throat swelling. Did not appear in acute distressed. Assessed by EMS, BP 126/80, P 95. Given 75mg of liquid Benedryl. Declined transport. Patient not driving, being driven by spouse. Pt stated that tongue swelling improved 30 minutes after Benedryl administration.
53 2021-04-10 taste disorder My taste changed. Now when I eat anything that has chocolate, peanut butter, bread, anything breade... Read more
My taste changed. Now when I eat anything that has chocolate, peanut butter, bread, anything breaded or fried, I get an awful taste in my mouth. I describe it like you are eating a wet, burnt house. I had Covid 19 the last week of December 2020 and lost my taste and smell. I could taste sweet, sour, bitter, and salty foods, but I could not taste any flavors. After the vaccination, my taste changed. I had heard on the news that the vaccine, for some people, had reversed some of the long term symptoms, so I thought that maybe my taste and smell were returning and this was just temporary. I was wrong. I still am experiencing the awful tastes described above.
53 2021-04-11 eye twitching starting 30-45 minutes after injection, my right eye started twitching. By evening, I had mild flu ... Read more
starting 30-45 minutes after injection, my right eye started twitching. By evening, I had mild flu symptoms and a sore arm that lasted for 24 hrs. One week later, my eye is still twitching numerous times daily and I am getting off and on headaches.
53 2021-04-11 dry eye Red, tender area on left neck. Erythematous lesion on left side of neck with vertical ?ripples,? dry... Read more
Red, tender area on left neck. Erythematous lesion on left side of neck with vertical ?ripples,? dry spot on left side of upper lip, eyes and eyebrow itching
53 2021-04-11 swollen tongue With in 10 min of getting the vaccine my throat felt was closing and I had difficulty breathing and... Read more
With in 10 min of getting the vaccine my throat felt was closing and I had difficulty breathing and tongue swelling diaphoresis in and out of consciousness Ent gave me 1st Epi-pen in right arm called EMS gave me diphenhygramine 50 mg and 2nd Epi-pen and IV albuterol nebulizer treatment and oxygen I think they worked on me for 20 minutes then I went to the hospital and was treated there with meds in IV know I have to carry a Epi-Pen with me at all times
53 2021-04-11 ringing in ears High pitched ringing in the ears started the evening of the first shot on 2-10-21. I still got the ... Read more
High pitched ringing in the ears started the evening of the first shot on 2-10-21. I still got the second shot on 3-4-21 because immunity was important. The ringing in my ears is still ongoing. I visited a ear nose and throat doctor and my hearing is fine with no blockages. No explanation except the ringing started the day of the shot.
53 2021-04-12 double vision Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/... Read more
Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/was very pale and noted shaking. EMT took BP which was high (I'm typically on lower end of average). Observed me for 45 minutes as BP came down to normal range and asked if wanted to go to hospital. Declined as had appointment later that day with my electrophysiologist at Hospital. As day went on, became increasingly tired and had bouts of uncontrollable shaking. Thought it would wear off so just went home to rest. On 3/31/21, BP was high again, tremors were getting worse, had leg weakness, double vision, brain fog, dropping things, loose stools, felt off. Went to Hospital and was admitted for 3 days. Neurloigst, Dr., said it was due to Covid vacccine and NOT to get the second shot, and the hospital internist agreed (MRI of brain and cervical spine showed no new lesions). Wanted todo heart procedure but they are not my private cardio group so checked myself out and went to Hospital the next day (admitted 4/3-4/5/21)
53 2021-04-12 ringing in ears Tinnitus within minutes of receiving the vaccine. I received the 2nd vaccine today, but I am still e... Read more
Tinnitus within minutes of receiving the vaccine. I received the 2nd vaccine today, but I am still experiencing the tinnitus from the first injection.
53 2021-04-12 ringing in ears Loud buzzing in left ear and fullness in right ear - Tinnitus - started one week after vaccine. Some... Read more
Loud buzzing in left ear and fullness in right ear - Tinnitus - started one week after vaccine. Some nausea and dizziness.
53 2021-04-12 ringing in ears Bilateral tinnitus
53 2021-04-12 vision blurred Client received the 1st dose of COVID vaccine by Pfizer lot #EW0161 and expiration 4/14/2021 at 10:5... Read more
Client received the 1st dose of COVID vaccine by Pfizer lot #EW0161 and expiration 4/14/2021 at 10:58AM. At 11:30AM client reported to EMT that she felt shaky and anxious. Nurse responded and found client sitting upright and talking to EMT. Client has a history of high blood pressure and diabetes and had COVID during Christmas. Client is taking Lisinopril and bulsgar. Client reports no history of anxiety. Provided client with water and repeated sets of vitals. Client alert and oriented x 4. At 11:30 am the first set of vitals were taken: Blood pressure: 120/70, Pulse: 88, Oxygen 95%. At 11:40 am vital signs were: Oxygen 96%, pulse86 and blood pressure: 115/70. Client reports she had a tightness in her chest at 11am but states it rapidly went away. client reports no headache or chest pain at this time. Client reports she has constant dizziness and blurred vision due to her diabetes. Client reports she sees her provider every three months. Provide client with emergency precautions. At 11:49am last set of vitals taken blood pressure: 115/70, oxygen: 95%, pulse:88 and client reports symptoms resolved and does not want to wait. At 11:50am client left facility with a steady gait.
53 2021-04-13 taste impairment Dizziness, severe HA, chest pain, back pain, swollen lymph nodes, stomach ache, metallic taste in mo... Read more
Dizziness, severe HA, chest pain, back pain, swollen lymph nodes, stomach ache, metallic taste in mouth. Fatigue
53 2021-04-14 vision blurred Dizziness, nausea, blurry vision. 114/70, HR 60, 99%. Exit time 1:25pm.
53 2021-04-15 eye twitching Muscle contractions mainly back Eye spasms
53 2021-04-15 eye swelling Reports face/neck rash beginning 2 days after 2nd Pfizer vaccine, different from her psoriasis rash.... Read more
Reports face/neck rash beginning 2 days after 2nd Pfizer vaccine, different from her psoriasis rash. She felt very itchy, with redness of head/neck area with swelling of face and eyes; worst day was 7 days after the 2nd shot. Saw her rheumatologist 2-3 days after shot and received a steroid shot, Pred-pak and is using topical calamine lotion. States rash is improving but still present. Face is now "splotchy" and eyes only swollen in AM.
53 2021-04-15 mouth numbness, taste impairment Dizziness after 10 minutes lasting a few minutes, on the way home after 30 minutes wait experienced ... Read more
Dizziness after 10 minutes lasting a few minutes, on the way home after 30 minutes wait experienced lips became numb, dizziness, diarrhea and metal taste. A few days later on 7/10 nose and roof of mouth became numb and didn?t feel well. On 7/14 experience numbness in face and roof of mouth, dizziness and head ache
53 2021-04-15 mouth tingling 1710 on 1/18 received the second Pfizer COVID-19 vaccination. 1740 developed chest tightness, wheezi... Read more
1710 on 1/18 received the second Pfizer COVID-19 vaccination. 1740 developed chest tightness, wheezing, throat tightening, tongue tingling, lip tingling
53 2021-04-17 ringing in ears unusual sensation of sharp tinny sound when she was talking/ hear someone talking nonstop causing he... Read more
unusual sensation of sharp tinny sound when she was talking/ hear someone talking nonstop causing her irritation; Tinnitus like symptoms; mild headache; mild sinus irritation; This is a spontaneous report received from a contactable consumer(patient). A 53-year-old female patient(not pregnant) received BNT162B2, dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 02:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was none. Concomitant medication included estradiol, progesterone (BIJUVA) taken for hormone replacement therapy. There was no covid prior vaccination, no covid tested post vaccination, no known allergies. Patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 15:00, She experienced tinnitus like symptoms, unusual sensation of sharp tinny sound when she was talking. First time was in a restaurant and she could hear someone talking nonstop causing her irritation and onset of a mild headache. She was also feeling mild sinus irritation. There was no treatment. Outcome of events was not recovered. Information on the lot/batch number has been requested.
53 2021-04-18 eye movement disorder, double vision At 6:45am on March 16, I felt my right eye cross inward. I experienced double vision for approximat... Read more
At 6:45am on March 16, I felt my right eye cross inward. I experienced double vision for approximately 5-8 minutes. I checked my blood pressure, which was 158/89. After about 10 minutes, my vision returned to normal. I immediately went to the emergency department and was admitted. I was diagnosed with a TIA.
53 2021-04-18 mouth tingling reported upper lip tingling & anxiety due to vaccinator asking and telling her about news / social m... Read more
reported upper lip tingling & anxiety due to vaccinator asking and telling her about news / social media describing adverse events / deaths . R/T Covid vaccines & relaying he/she didn't get & won't get vaccinated. no other S/S; lip is not swollen; TX- support emotionally & issue taken to Medical Dr.
53 2021-04-19 mouth numbness, mouth tingling Patient complains of dizziness and was brought to medical tent. Offered water and rest , elevated le... Read more
Patient complains of dizziness and was brought to medical tent. Offered water and rest , elevated legs. Pt then c/o of numbness and tingling to left side of face. Benadryl 25mg was given @ 11:53AM. PT was stable and symptoms continued to progressively increase. More numbness, tingling extending to entire face, lips, and neck. Able to speak in full sentences, lips appear slightly edematous. Given a second dose of Benadryl. VS stable. Pt left with EMS at 12:15
53 2021-04-19 ringing in ears, eye pain, burning mouth syndrome She got the vaccine, within the first night she woke up around 9:00 to 10:00 as she felt more fatigu... Read more
She got the vaccine, within the first night she woke up around 9:00 to 10:00 as she felt more fatigued. She had pulsing ringing (already has tinnitus), really loud ringing. Her skin was really hot (sunburn hot), tongue was sore, her eyes hurt (tissue burning sensation) feeling. Heft left arm was extremely painful, but went away. The headache all through the front, part of her forehead, eyes, head, and took 2 Tylenol. About 3 days after that her right wrist started hurting, throbbing pain. She has never had any joint pains. She has been taking Turmeric, the right wrist is still hurting. She did have body aches, throat, and all symptoms, felt like she had a flue/cold. She is completely dizzy, disoriented and not able to use her phone. She is not able to regain her balance at this point. The lingering effects are she cannot read, she always feels like she has been lost in space. The pain is improving, but is still present. When she looks down the dizziness is a lot worse. She has pushed back the 2nd vaccine. She has called her doctor and reported this who told her to call us. She took Claritin and it stopped a lot of the symptoms.
53 2021-04-20 inability to speak Starting the Friday following the immunization (2 days after), patient started running a fever of 10... Read more
Starting the Friday following the immunization (2 days after), patient started running a fever of 100-102 consistently even while taking Tylenol. This continued for 4 days and even still on Monday when she called to report it. She also developed a sore throat and lost her voice temporarily on Sunday.
53 2021-04-20 taste impairment Metallic taste in mouth with difficulty of swallowing
53 2021-04-20 feeling of choking Patient reported itchiness and tingling in throat and lower extremities as well as hoarseness of voi... Read more
Patient reported itchiness and tingling in throat and lower extremities as well as hoarseness of voice. Reports that when she had an anaphylaxis reaction to shellfish it started the same way and progressed to occluded airway. Vitals were within normal limits and 911 was called for transport Hospital ED. Symptoms reported around 11:05, EMS arrived around 11:30 and patient transported around 11:40.
53 2021-04-20 ringing in ears After being vaccinated with the second dose, within 1 day, my left ear started ringing.
53 2021-04-21 loss of smell received 2nd Pfizer dose on 2/3/21. Tested positive for COVID 19 by PCR on 4/7/21 w/ symptoms of co... Read more
received 2nd Pfizer dose on 2/3/21. Tested positive for COVID 19 by PCR on 4/7/21 w/ symptoms of cough, anosmia, sore throat.
53 2021-04-21 swollen tongue tongue swelling, throat closing - required emergency department visit
53 2021-04-22 vision blurred 53-year-old female patient presents emergency department with complaint of left-sided facial numbnes... Read more
53-year-old female patient presents emergency department with complaint of left-sided facial numbness and left arm numbness. Patient states that around bedtime last night at 2100 patient was watching television with her husband when she developed a headache and noted some left blurred vision. She states she also developed left facial swelling with mild redness and some sore in her mouth. She woke up at 0600 this morning with new symptoms of left face and left arm numbness. She reports the facial swelling, redness, and sores, as well as left eye blurred vision have improved some. The symptoms have not interferred with her ADL or prevent her from functioning. She denies history of stroke, HTN, TIA. She reports that she received her second Pfizer COVID-19 vaccination on 2/9/21 and developed the above mentioned symptoms within about 24 hours. hief complaint numbness left side of her face, blurry vision on left eye, numbness left arm, blisters on hard palate after Covid vaccine administration-symptoms improving, still have some numbness left side of her face Muscle strength equal on the right and left, no mouth droop, normal speech Assessment and plan Acute left facial and left arm paresthesias Left eye blurry vision Headache Covid 19 vaccine administration 3 days ago Questionable TIA History of ocular migraine Palpitation Neurochecks MRI of the brain Check TSH, iron studies, B12, folic acid level, magnesium, echocardiogram MRI - normal CT angio - normal echo - normal symptoms rapidly improved after 1 day in the hospital other than some lingering mild blurry vision. pt was discharged after 1 night in the hospital
53 2021-04-24 dry mouth Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mout... Read more
Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination. On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering. Information about Lot/Batch number is requested.
53 2021-04-24 taste impairment Heavy metallic taste x 1 week Low grade fever x 2 weeks Migraines x 2 weeks Sore throat x 2 weeks ... Read more
Heavy metallic taste x 1 week Low grade fever x 2 weeks Migraines x 2 weeks Sore throat x 2 weeks Bruise at injection site (vaccine administration was painless)
53 2021-04-24 eye irritation 16 hours after receiving my 2nd Covid 19 vac shot, I woke up and my body felt like it was on fire, m... Read more
16 hours after receiving my 2nd Covid 19 vac shot, I woke up and my body felt like it was on fire, my eyes were burning and had a bad headache. I took 2 Advils and tried to fall back to sleep. Six hours later my fever and headache returned along with the chills and body aches. I took 2 more Advil and waited an hour and the headache went away. It took about a day and a half before before the side affects subsided.
53 2021-04-24 smell distorsion, taste disorder diverticulitis; Dizziness; nausea; general unwell; affected my sense of taste; After losing part of ... Read more
diverticulitis; Dizziness; nausea; general unwell; affected my sense of taste; After losing part of her sense of smell since Mar2020, it came back really strong; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 31Mar2021 16:00 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included diverticulitis, abscess in back at the moment of the vaccination, and losing part of her sense of smell from Mar2020. There were no concomitant medications, and vaccines in four weeks. The patient experienced dizziness, nausea and generally unwell. Two days after receiving the vaccine, on 02Apr2021 15:00, patient was in the ER with diverticulitis. She had to take Ciprofloxacin and metronidazole. After losing part of her sense of smell since Mar2020, it came back really strong. It affected her sense of taste and all food taste bad now. It was like pregnancy sickness. Her sense of smell came in an estrange manner. The events were experienced on 02Apr2021 15:00. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
53 2021-04-24 thirst Patient had some difficulty with the 1st dose of this vaccine at a different location. She was very... Read more
Patient had some difficulty with the 1st dose of this vaccine at a different location. She was very nervous(highly anxious) about receiving the 2nd dose. She had a fair amount of pain on injection and on administering the vaccine. Quite unusual for 0.3ml dose. While waiting in area, she became very hot, thirsty, her husband got her some water, she was becoming very pale, I was clearing a spot in immunization room for her to lay down and elevate her legs to help with that, before I could get the location prepared, her husband noticed she was about to pass out. At that point she did pass out for a very short time, I prepared and administered a dose of 0.3mg EpiPen in the left outer thigh. I did this at approximately 01:33pm. All the events occurred very rapidly, she responded to the epi pen as far as her consiousness was concerned, then we called "911"! While waiting for the paramedics she began vomiting and continued that until they arrived and after they arrived. They administered a dose of andansetron and fluids IV. They then took her to the hospital for further treatment and observation,
53 2021-04-24 ringing in ears 2 weeks after first shot started having terrible night sweats. The next morning I woke with vertigo ... Read more
2 weeks after first shot started having terrible night sweats. The next morning I woke with vertigo so bad I could hardly walk. Actually fell off the toilet reaching for paper. Also started noticing a ringing in my ears. Vertigo, dizziness and nausea lasted 5 days. As the vertigo finally subsided the tinnitus has gotten louder and louder. I have put off my second shot as I'm afraid it will make it worse.
53 2021-04-24 vision blurred Hazy/blurry vision began approximately 12 hours after vaccination and lasted for about 2-3 days.
53 2021-04-25 eye swelling 6 hours after the second vaccine I experience typical symptoms of fever, fatigue and muscle aches. T... Read more
6 hours after the second vaccine I experience typical symptoms of fever, fatigue and muscle aches. Then 6 hours later I woke up with a swollen face, swollen eyes, welts, and hives. It burned and itched. I called the EMT and a doctor said I was not having an anaphylactic shock, but some sort of allergic reaction. He gave me a cortisone bill and proscribed an antihistamine. I took 50 mg. of cortisone for two days with 10mg. of an antihistamine. It subsided a bit, but at night, I swelled up again. Today I went to the doctor and got a cortisone infusion.
53 2021-04-25 visual impairment Severe body aches, entire body. My scalp hurt, my ribs, everything. This started 13 hours after inje... Read more
Severe body aches, entire body. My scalp hurt, my ribs, everything. This started 13 hours after injection. Fever, chills, unable to walk or stand, exhaustion but unable to sleep. My vision also seems to be impaired. I'm not seeing as well as I should be. Random heart palpitations. Sore arm at injection site, red and warm to the touch.
53 2021-04-26 taste impairment Patient describes development of metallic taste and headache after vaccine administration . No othe... Read more
Patient describes development of metallic taste and headache after vaccine administration . No other symptoms reported . No dizziness , sob, difficulty ambulating / standing noted . Patient sent home with ER precautions and told to follow-up with PCM.
53 2021-04-26 mouth tingling, mouth numbness pt. complain of tingling and numbness of the lip. She also c/o of light headache. Symptom was reso... Read more
pt. complain of tingling and numbness of the lip. She also c/o of light headache. Symptom was resolved and pt. went home after light comfort measures.
53 2021-04-26 swollen tongue Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadnes... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: Patient felt faint within 5 min of administration, room was spinning and she felt as if she was going to pass out. Back of tongue swelled up. patient was given 2 tablets of benadryl and felt better after drive home. Symptoms stopped around evening
53 2021-04-26 swollen tongue Pt. C/O thick tongue and throat scratchiness same as when she took Penicillin. Pt give Benedryl, IM... Read more
Pt. C/O thick tongue and throat scratchiness same as when she took Penicillin. Pt give Benedryl, IM and within 5 min stated feeling better, no more sx reported
53 2021-04-26 swollen tongue This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her... Read more
This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 11Apr2021 09:15 (Lot Number: EP7533; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 53 years). Medical history included asthma, Blood pressure high, acid reflux , allergies: Sulfa, Lactose intolerant and allergies: Latex. The patient's concomitant medications were not reported. The patient had a historical vaccine of Flu shot (INFLUENZA) on an unspecified date for immunisation and experienced bad side effects. The patient previously took bactrim, minocycline, doxycycline, ciprofloxacin, Moxifloxacin, demerol, avelox, nitrofurantoin, naprosyn, motrin, perocet, tramadol and aleve and experienced allergies. The patient experienced anaphylaxis on 11Apr2021. It was also reported that she had an appointment for COVID Vaccine at 9:15AM. Received COVID Vaccine and was told to wait for 30 minutes. Within 10 minutes her chest starting getting tight with difficulty of breathing. Her throat was closing up, and she was light headed. She explained this to the administrator who asked if caller could get up to see the paramedic. As caller tried to stand up, she almost passed out. Had to sit there for a second and the second time was able to get up and made it in to the room. Was going in and out of consciousness. Had to stab her with an Epi Pen. She couldn't breathe. Her throat was closing up. Her tongue was swollen. She was in and out of consciousness. First Epi Pen didn't work. An IV was put in and was given something through it. She was jabbed with a second Epi Pen. Was still in and out of consciousness but she was starting to come back. Was given oxygen and a nebulizer. She does have asthma. Ambulance was called. Was told she was worked on for 20 minutes. When ambulance arrived she was able to get up and get on the cart. She was taken to the hospital. Was given medicine through her IV. Had to be kept at hospital because she had two Epi Pens and medication at the vaccine facility. Hospital wanted to make sure when the Epi Pens wore off she didn't go back into anaphylaxis. Was kept in ER for over four hours. Was given IV fluids. Her oxygen, heart rate, and blood pressure dropped at vaccination facility. Oxygen was 81. Blood pressure was 94. At hospital, her levels started to get better. Once she was given the second Epi Pen and whatever else she was given, the medication started to work and she had come through. At the hospital, someone came in and did bloodwork for research to see why this happened. Was prescribed Epi Pens by the doctor in the hospital and was advised to carry Epi Pens with her at all times. If she has another anaphylaxis, was advised to jab herself with Epi Pen and call right away. Was told her tongue was swelling. Attempted to obtain the outcome of the anaphylaxis. At the hospital, she was so out of breath walking to the bathroom. Was told at hospital now she is having side effects from the COVID Vaccine including the tiredness and headache she is experiences. Was told to take Tylenol and Benadryl, lay down and rest, and to make sure she drinks so she does not get dehydrated. Today, she feels nauseous, lightheaded and tired with a little headache. She feels better from yesterday. Is getting better and is having a little chills maybe an hour ago. She checked her temperature and does not have a temperature, but her insides feel warm . The patient was hospitalized for the event anaphylaxis on an unspecified date. Therapeutic measures were taken as a result of was going in and out of consciousness. Events for anaphylaxis, consciousness fluctuating, chest discomfort. dyspnea, throat tightness, presyncope and swollen tongue occurred on 11Apr2021 while the remaining events occurred on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: dropped and 94, blood work: unknown results, heart rate: dropped, oxygen saturation: 81 and dropped on an unspecified date. Therapeutic measures were taken as a result of all the events. Outcome of the events was unknown.
53 2021-04-26 thirst Thirsty - last the rest of the day Craving for salty food - that last until I ate something salty (p... Read more
Thirsty - last the rest of the day Craving for salty food - that last until I ate something salty (parmesan cheese) Pain at the injection site - last 24 hrs
53 2021-04-26 ringing in ears patient is reporting that the next morning after receiving her vaccine that she is experiencing seve... Read more
patient is reporting that the next morning after receiving her vaccine that she is experiencing severe dizziness, severe ringing in both ears, and that she can barely stand up. She said when she does try to walk that she only makes it a few step and then needs to hold on to something--she is very weak. This has been going on for 3 days now.
53 2021-04-27 ringing in ears First experienced lightheadedness and numbness in my arm and leg. This progressed to ringing in ears... Read more
First experienced lightheadedness and numbness in my arm and leg. This progressed to ringing in ears and severe imbalance. I have had continuing problems with lightheadedness, movement sensation and dizziness. I have also been very fatigued.
53 2021-04-28 loss of taste, loss of smell Began with rash, severe body aches, loss of smell and taste, brain fog, unsteadiness, nausea, diarrh... Read more
Began with rash, severe body aches, loss of smell and taste, brain fog, unsteadiness, nausea, diarrhea that eventually led to dehydration and finally colitis that resulted in ER visit for fluids; sent home; next day, passed out at home, back to ER and was admitted for the colitis.
53 2021-04-28 swollen tongue, lip swelling 1815: Fifteen minutes after injection given the patient felt, "hot, shaky, ears itching, swollen lip... Read more
1815: Fifteen minutes after injection given the patient felt, "hot, shaky, ears itching, swollen lips, itchy all over." She was given 100mg total of Benadryl. Patient AOx3 1830: Continues with increased heart rate, complaining of swollen tongue. Patient's personal Epi pen given and EMS called. Patient AOx3 1845: EMS arrived 1855: EMS departed for Emergency Room.
53 2021-04-28 visual impairment Left Thalamic Infarction, headache and visual changes noted about April 12th
53 2021-04-29 loss of taste, loss of smell Cough Shortness of Breath Headache Nasal and Chest Congestion Loss of Taste and Smell
53 2021-04-29 deafness, ear discomfort, ear pain Feeling of left ear congestion early in the morning today. Afternoon a loud whistle like sound and ... Read more
Feeling of left ear congestion early in the morning today. Afternoon a loud whistle like sound and unable to hear lasting approx. 40 seconds. It now feels like I am getting a possible ear ache... different though almost feels like my inner left ear has been scratched or cut open? Not throbbing like an ear ache.
53 2021-04-29 taste impairment Pt here for 2nd dose of Pfizer vaccine. Pt after injection in post observation and c/o metallic tast... Read more
Pt here for 2nd dose of Pfizer vaccine. Pt after injection in post observation and c/o metallic taste in her mouth and progressed to dizziness and nausea. Pt reports she has not eaten today. Pt given juice and it was tolerated well. AID call to evaluate Pt. Pt reports hx of anxiety with giving blood. Pt stands up per medics request. Pt reports feeling better. Pt cleared to drive home by medics. Medic event lasted approx 30 min. VS per medics 1230 BP 138/palp HR 98 O2 sat 100% on RA VS per medics 1240 BP 129/84 HR 80 O2 sat 100% on RA
53 2021-04-29 eye irritation, tongue disorder, eye strain c/o eyes feeling tired and burning. left side of face felt "tight" and tongue felt thick. BP 188/91,... Read more
c/o eyes feeling tired and burning. left side of face felt "tight" and tongue felt thick. BP 188/91, HR 88,R 16, O2 sat 97. Known borderline HBP. Administered Benadryl 50 mg. 1107 BP 177/90, HR 82, R 16, O2 Sat 98. States feels much better. No more tightness in face and eyes better. No feeling of tongue thickness. Swallows well. No c/o rash, itching and none noted.
53 2021-04-30 taste impairment Metallic taste; sore arm; This is a spontaneous report from a contactable consumer (patient). This 5... Read more
Metallic taste; sore arm; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EP7533) on 12Apr2021 05:45 PM in right arm at single dose for COVID-19 immunization. Medical history included epilepsy, bradycardia, hypothyroidism, trigeminal neuralgia, allergies to sulfa. Patient was not pregnant, not pregnant at the time of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. Concomitant medications within 2 weeks of vaccination included levothyroxine sodium (LEVOTHROID) and acetylsalicylic acid (ASPIRINE).The patient previously received levetiracetam (KEPPRA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced metallic taste and sore arm on 12Apr2021. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-05-03 deafness unilateral Sudden hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient)... Read more
Sudden hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 13:30 (Lot Number: EN6198) at a single dose, and the second dose via an unspecified route of administration in left arm on 19Mar2021 13:30 (Lot Number: EN6199) at a single dose for covid-19 immunization at the age of 53 years old. Medical history included hypertension and known allergies to sulfa, both from an unknown date and unknown if ongoing. The patient did not have covid prior vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included irbesartan taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden hearing loss in right ear on 10Apr2021 12:00. The event resulted in doctor or other healthcare professional office/clinic visit, and cased disability or permanent damage. The patient underwent lab tests and procedures which included covid-19 virus test (nasal swab): negative on 14Apr2021. Therapeutic measures were taken as a result of sudden hearing loss in right ear included steroid injection series into eardrum. The outcome of the event was not recovered.
53 2021-05-03 tunnel vision, visual impairment I was sitting at my work computer and I experienced a vertigo sensation which lasted for 10 min. Ne... Read more
I was sitting at my work computer and I experienced a vertigo sensation which lasted for 10 min. Next, I had tunnel vision with a bright light where I couldn't read the words on my computer screen. This lasted for about 20 min. Next, I saw Kaleidoscopic vision on the sides of both of my eyes. This lasted for 1/2 hour more. It then turned into a headache. I have NEVER had anything like this in my life and went to the emergency room. They did a CT scan and found no abnormal findings. My blood pressure and all labs were normal. They stated it was "probably" a migraine with aura. It happened again 2 days later and again yesterday. I have an appointment to see my GP on 5/6/21. Again, this is not normal and has never happened before in my life.
53 2021-05-04 deafness, ringing in ears, ear discomfort, deafness unilateral, permanent deafness I had my Covid Pfizer vaccine on 4/30 in the morning and only felt a mildly sore arm that evening. I... Read more
I had my Covid Pfizer vaccine on 4/30 in the morning and only felt a mildly sore arm that evening. I woke up the next morning to very stuffed ears, high pitched ringing in my ears...It was difficult to hear over the loud tone in my head/ears., My hearing declined Throughout the day by night time I have no hearing left in my right ear. I went to see my ENT specialist on Monday, 5/1/2021. I had a full audiology work up and meeting with my ENT. The exam so that I had 100% hearing loss in my right ear. I am having an MRI on Weds 5/12 and meeting again with my ENT on 5/18. I was put on a high dose of steroids, Prednisone, for the next 2 weeks. trying to get back some hearing.
53 2021-05-07 blindness Loss of vision in left eye.; This is a spontaneous report from a contactable consumer. A 53-year-ol... Read more
Loss of vision in left eye.; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration, administered in right arm on 13Apr2021, at 10:00 as single dose for covid-19 immunisation. Medical history included Lupus, Hashimotos, chronic obstructive pulmonary disease, asthma, non- alcoholic fatty liver disease, and allergy from unknown dates. The patient experienced loss of vision in left eye on 13Apr2021, at 10:00. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent other tests and magnetic resonance imaging in Apr2021 with unknown results. Therapeutic measures were taken as result of the event. No COVID prior to vaccination was noted. No COVID test was performed post vaccination. The outcome of loss of vision in left eye was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
53 2021-05-09 eye movement disorder Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Light... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild, Additional Details: Notified by another vaccinated person waiting that pts "eyes were rolling to the back of their head". RPh went over and pt was having difficulty speaking, difficulty breathing. Husband translated that she was saying she could not breathe. RPh instructed staff to call 911, grab epinephrine, grab pulse ox and BP cuff. Epipen was NOT administered although box was open and dose was taken out (EMS can confirm this as well). EMS arrived on scene when pts BP was 130/105, pulse 103, O2 sat 92.
53 2021-05-11 ear discomfort i have a crinking sounds in my left ear. It is not constant but rather comes and goes throughout th... Read more
i have a crinking sounds in my left ear. It is not constant but rather comes and goes throughout the day. When I am at the sink, or in the shower with the water running, the noise seems to be reverberating in my ear very loudly. The noises started day 2 (4/30/21) after the 2nd dose (4/28/21) and have been occurring on and off every day since. It's been 15 days after the 2nd dose and i am still hearing the noises. Only yesterday did they seem to lessen a bit.
53 2021-05-11 eye swelling, swollen tongue, bloodshot eyes, mouth swelling Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of... Read more
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: PATIENT COMPLAINT ABOUT SWELLING AND REDNESS ON EYE AND FACE; PATIENT WAS CONTACTED 4HRS LATER AND WAS BETTER AFTER TAKING BENADRYL. SHE DECIDES TO SEE HER PCP AFTER
53 2021-05-11 swelling around the eyes shortness of breath, swelling under eyes
53 2021-05-13 sensitivity to light Patient presented on 5/12/21 to Hospital ED with severe headache, photophobia, neck stiffness that ... Read more
Patient presented on 5/12/21 to Hospital ED with severe headache, photophobia, neck stiffness that began on 5/10/21. Lumbar puncture done and confirmed meningitis with Varicella Zoster Virus isolated from CSF. Patient remains hospitalized at this time receiving two weeks of IV Acyclovir treatment. Infectious Disease physician consulted and felt that there could be a correlation to her recent COVID vaccination and a reactivation of VZV.
53 2021-05-17 ringing in ears Tinnitus, Pain/Stiffness in Shoulder
53 2021-05-19 ear pain, eye irritation pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F... Read more
pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F; a very strong headache; sore throat; The arm is very hot and swelling; The arm is very hot and swelling; pain in the back, neck and everything; pain in the back, neck and everything; shortness of breath; My eyes are so hot and burning; earache; she is not feeling very well; she had a really sore arm in the area of the shot; her head is foggy this morning and all day; This is a spontaneous report from a contactable consumer. A 54-year-old female patient (Age at time of vaccination 54 years) received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 04May2021 at 16:00 (Batch/Lot Number: EW0176) as SINGLE DOSE for covid-19 immunization. Medical history included back injury, neck injury, Knee Surgeries, 2 Bulging Discs, Heel Spurs and Sciatic all on the left ongoing since 2010 and Covid-19 on 29Mar2020. The patient's concomitant medications were not reported. The patient experienced pneumonia, i've been very very sick, body ache, chills, nausea, so tired/very exhausted, fever 99.3f, a very strong headache, sore throat, the arm is very hot and swelling, pain in the back, neck and everything, shortness of breath, my eyes are so hot and burning, earache, she is not feeling very well, she had a really sore arm in the area of the shot and her head is foggy this morning and all day all on 05May2021. Consumer reported "Since this morning I've been very very sick. I'm sick. I have body ache, chills, nausea, so tired, fever 99.3F, a very strong headache, sore throat. The arm is very hot and swelling. I had Tylenol this morning nothing is working. The body ache is so horrible, pain in the back, neck and everything. I had covid on march 29 last year, I had pneumonia. I have lingering issues, body ache and pain, I still get very tired, shortness of breath; I feel like it's coming back after getting the vaccine. My eyes are so hot and burning, you know the sensation when you have a fever. Commented how she felt like she was getting covid again after getting the vaccine. Yesterday, 04MAY2021, she was vaccinated with the Pfizer Covid Vaccine. States it was her first dose and she is having a lot of side effects. Her temperature is 99.2, she has body aches, earache, headache, a little bit of shortness of breath, very tired, very exhausted and she is not feeling very well. She is wondering if this is a normal reaction for the first vaccine? States it feels like when she had Covid. Clarifies at she was fine last night other than she had a really sore arm in the area of the shot and it is really hot, like if she has a fever in the area. States at 9:30-10:00 a.m. this morning she started having a headache, chills, and nausea. She took a hot shower, and had some tea and took Tylenol. It is progressing worse and worse. States she has body aches and fever getting warmer and warmer, and her throat feels a little bit sore. States all of them are getting worse. She is staying home and laying down not trying to do a lot, drinking water and staying hydrated. States she spoke to a friend and she said she is not supposed to get these side effects with first one. Her body aches are horrible, it feels like when she got the virus, all the aches and pains. Her head is foggy this morning and all day, and she has issues with pain all over, so much body aches. States she is reporting her side effects and she read the side effects but it seems like when she had Covid last March and she is still going through a lot of issues with it, the pain Covid left her with. States she did a Covid test, and she had antibodies, but this feels like the virus again. States she has the same symptoms as when she got the virus. Treatment: Took 2 Tylenol and nothing seems to help. UPC and Expiration: Unknown Lot: 110856. Caller states the UPC and Expiration got erased because she has had it for awhile. Tylenol Rapid Release 500mg.Caller states she took a hot shower, and had some tea. Caller states she is staying home and laying down not trying to do a lot, drinking water and staying hydrated. The outcome of the event pneumonia was unknown. Outcome of all the other events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-05-19 mouth numbness Brain fog, Right face numbness. Right arm injection site pain, charly horse and still with pain with... Read more
Brain fog, Right face numbness. Right arm injection site pain, charly horse and still with pain with movement now. Right arm numbness down to right leg numbness at times. Left side cheek, throat numb feeling. Tongue feels numb and down thoracic spine.
53 2021-05-19 tongue discomfort, loss of taste, mouth discomfort, swollen tongue mouth and tongue started feeling like she ate or drank something way too hot felt burning; mouth and... Read more
mouth and tongue started feeling like she ate or drank something way too hot felt burning; mouth and tongue started feeling like she ate or drank something way too hot felt burning; tongue was swollen; tongue was swollen and really red; tongue was swollen and really red making it difficult to speak; can't taste plus eating was difficult; can't taste plus eating was difficult; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 16:30 (Lot Number: EW0167) as 1st dose, single for covid-19 immunization, administered at the hospital. Medical history included rheumatoid arthritis. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took Xarelto and experienced allergies: adverse reaction to Xarelto. On 01May2021 at 17:00, patient's mouth and tongue started feeling like she ate or drank something way too hot felt burning, have it another day or two and getting worse; her tongue was swollen and really red making it difficult to speak the swelling and redness was nearly an inch and can't taste plus eating was difficult because it feels like she burnt her mouth and very uncomfortable. The patient didn't have any of these symptoms before the vaccine and initially not worried as both of her daughters are nurses and has heard of it but nothing to this extreme. The patient was advised to contact her doctor on 07May2021 or if worse, urgent care. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
53 2021-05-21 ear discomfort, ringing in ears, deafness Blood sugar increased; no hearing in my right ear at all; ears were both stuffy; heavy pressure and ... Read more
Blood sugar increased; no hearing in my right ear at all; ears were both stuffy; heavy pressure and could hear a loud tone in my head/ears; noise got worse and more intense as well as higher pitched/a loud tone going through my head, tinnitus; severe loud high pitched screeching noise that gave her a terrible headache; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Apr2021 11:30 (Batch/Lot Number: EW 171) as 1st dose, single for COVID-19 immunisation. Medical history included fibromyalgia, osteoarthritis (mildly), allergy: latex and Sulfa. Concomitant medication included furosemide (LASIX [FUROSEMIDE]) taken for an unspecified indication, start and stop date were not reported. Patient woke up the morning after vaccine (01May2021 07:00) and immediately noticed ears were both stuffy and it was difficult to hear. Patient had heavy pressure and could hear a loud tone in head/ears that was consistent and never stopped. Throughout the day the noise got worse and more intense as well as higher pitched. By that evening (01May2021 19:00) patient realized she had no hearing in right ear at all. Only severe loud high pitched screeching noise that gave her a terrible headache. She saw her ENT (ear, nose, throat) on Monday AM (03May2021) and they did audiology test and confirmed 100% loss of hearing in right ear! Severe tinnitus at deafening pitch and 24/7 nonstop, no silence ever since Saturday 01May2021. The Dr. prescribed her 60 mg prednisone over 7 days then taper down over 2nd week. Patient had MRI of brain on 12May2021 and follow up appoint on 18May2021. She met with her primary care doctor on 05May2021 to discuss all and she did a great deal of bloodwork and all normal. Investigation on unknown date included blood sugar increased. The events of ears were both stuffy and it was difficult to hear/ heavy pressure and could hear a loud tone in head/ears/ noise got worse and more intense as well as higher pitched/a loud tone going through head, tinnitus and no hearing in right ear at all were resulted in Physician Office Visit and received treatment included prednisone and were reported as serious with seriousness criteria: disability. Outcome of blood sugar increased was unknown. Outcome of other events was not resolved.
53 2021-05-23 loss of taste, ear pain Bell?s Palsy- right side of face paralyzed with severe ear pain and loss of taste. Doctor prescribe... Read more
Bell?s Palsy- right side of face paralyzed with severe ear pain and loss of taste. Doctor prescribed Prednisone 10 mg and Valacyclovir 1g
53 2021-05-23 eye strain 05/21 intermittent breathing issues - full breath hard to take and caused a cough. happened once ... Read more
05/21 intermittent breathing issues - full breath hard to take and caused a cough. happened once every few hours lasted through 05/23 05/22 started feeling warm - low grade temp 98.9 around 4pm only lasted about 4 hours 05/22 body aches around 6pm - lasted until 05/23 am 05/23 fatigue - could not fully wake up. even when up eyes were heavy and felt like closing. 05/24 nausea in the morning. included vomitting. brief dizziness when went back to bed 05/22 - 05/23 diarrhea 05/22 - present. injection site sore / upper arm hurts 05/24 - midday - muscular pain around midsection - hurts when taking deep breath or twisting 05/22 - 05/23 chills 05/21 - 05/24 just not feeling good
53 2021-05-24 mouth discomfort Patient called PCP office on May5th, 2021 stated that 30-45minutes after receiving the vaccine on th... Read more
Patient called PCP office on May5th, 2021 stated that 30-45minutes after receiving the vaccine on the 4/30 2021 that her mouth, tongue and gum, root of mouth was dark red and felt like she had burned her mouth, she was advised to go to the nearest Emergency room, but refused to have gone for treatment. Patient went to see PCP on May 10th, no medication was ordered.
53 2021-05-24 oropharyngeal discomfort Patient checked in to Immunization for Pfizer Covid Vaccine Dose #1 (LOT EW0183 EXP 08/21) at 1254 t... Read more
Patient checked in to Immunization for Pfizer Covid Vaccine Dose #1 (LOT EW0183 EXP 08/21) at 1254 then sent to observation area. shortly after receiving the dose of Pfizer covid vaccine, patient complaint of itchiness. Observer went to notify Nurse. Nurse noted patient was also having trouble talking and difficulty swallowing and breathing. EPIpen was immediately administered to Right Thigh (0FM500 exp May 22) at 1325. Patient states she has history of Anaphylaxis with Influenza vaccine and a "list" of medications. Patient stated immediately after receiving the COVID vaccine, when itchiness began she self medicated with 25mg of Benadryl PO when she alerted the Observer of the itchiness. Code was called at 1331 and transported to ED for further treatment and evaluation. Nurse from Immunizations went with Code team member to transport patient to ED when 2nd Epipen (0FM407 EXP FEB22) was administered with direction of MD in elevator after patient began having tightness in chest and grabbing throat.
53 2021-05-24 feeling of choking following morning started with allergy symptoms around 8 with rash on face, mostly right side. Follo... Read more
following morning started with allergy symptoms around 8 with rash on face, mostly right side. Followed by rash turning into hives, then a red rash and itching starting at top of head, going through neck. Tingling and tightening in throat. From the start to throat tightening, around 45 minutes - 1 hour. Took 100 mg of Benadryl when rash turned to hives. Called doctor immediately. Put on Prednisone, famotidine, Benadryl and Zyrtec for a 7 day course.
53 2021-05-25 hearing loss I have noticed a decrease in hearing acuity. I find myself asking people to repeat things because I ... Read more
I have noticed a decrease in hearing acuity. I find myself asking people to repeat things because I didn't hear it clearly.; This is a spontaneous report received from a contactable health care professional. A 53-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248) via intramuscular route of administration on the left arm on 20Jan2021 at 12:00 as single dose for COVID-19 vaccination and the patient also received first dose of BNT162B2 (BNT162B2); Lot/batch no: (EL1284) via intramuscular route of administration on the left arm on 31Dec2020 at 11:00 as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications included bupropion for an unknown indication since an unspecified date and is unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not allergic to medication, food, or other products. On an unknown date in Feb2021, the patient had noticed a decrease in hearing acuity and she find herself asking people to repeat things because she did not hear it clearly . It was unknown whether the patient received therapeutic measures for the event. The clinical outcome of the event decreased hearing was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
53 2021-05-25 swelling of eyelid, pain in jaw Left arm sore; swollen at the edges of the lid with secretions; red at the edges of the lid; Left ey... Read more
Left arm sore; swollen at the edges of the lid with secretions; red at the edges of the lid; Left eyelid began to get sore; shoulder were very sore; Pain in jaw near my earlobe when chewing; This is a spontaneous report from a non-contactable Non-Health Care Professional (Consumer or other HCP). A 53-years-old non-pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6208) as a single dose on an unspecified route administered in left arm on 12Mar2021 at 8:00am (at the age of 53-year-old) for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Patient past drug includes penicillin allergy. The patient lab test was not reported. On 12Mar2021, patient experienced left arm sore, shoulder very sore and on the same day patient experienced left eyelid began to get sore, red and swollen at the edges of the lid with secretions for four days and also had pain in jaw near earlobe while chewing. Therapeutic measures were not taken for any events. The clinical outcome of the events was reported as recovering. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Also, the patient was not tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
53 2021-05-25 ringing in ears pt says she became very disoriented and dizzy. She had to put her hand out to catch herself while s... Read more
pt says she became very disoriented and dizzy. She had to put her hand out to catch herself while she was sitting. She kept getting these random episodes of dizziness. She went to her PCP on 1/18/21. She was told she had water behind her but she told him her ears were fine. She was given antibiotic and steroid. On 1/21/21 she started feeling a fullness with in her ear and began having tinnitus. It started with the right ear but eventually moved to both ears. On 1/25/21 she went back to her PCP and she was given another Medrol pack which did not help. She was still having episodes of a high pitch sound and humming noise like a machine. She went to ENT on 3/16/21. They did a hearing test and she was sent for a VNG test. VNG was abnormal. No DX was given. She returned to ENT on 4/5/21 and was told she needed to try the epley maneuver. Pts last visit was on 4/16/21 but does not seem to think this procedure helped any since she is still having symptoms. Now on 5/26/21 she is still having episodes of dizziness but feels like they are less frequent.
53 2021-05-26 oropharyngeal discomfort 5/25/2021: Patient checked in to Immunization for Pfizer Covid Vaccine Dose #1 (LOT EW0183 EXP 08/21... Read more
5/25/2021: Patient checked in to Immunization for Pfizer Covid Vaccine Dose #1 (LOT EW0183 EXP 08/21) at 1254 then sent to observation area after vaccine administration. Shortly after receiving the dose of Pfizer covid vaccine, patient had complaint of itchiness. Observer went to notify Nurse. Nurse noted patient began to have trouble talking and difficulty swallowing and breathing. EPIpen was immediately administered to Right Thigh (0FM500 exp May 22) at 1325. Patient states she has history of Anaphylaxis with Influenza vaccine and a "list" of medications. Patient then stated that immediately after receiving the COVID vaccine, when itchiness began she self-medicated with 25mg of Benadryl PO when she alerted the Observer of the itchiness. Code was called at 1331 and transported to ED for further treatment and evaluation (via wheelchair as awake, alert and oriented). Nurse from Immunizations went with Code team member to transport patient to ED when 2nd Epipen (0FM407 EXP FEB22) was administered with direction of MD in elevator after patient began having tightness in chest and grabbing throat. Patient care transferred to ED. Code cleared at 1348. 5/26/21: Follow up: This 53 yo stated within 5 min after yesterdays vaccination she was itching all over and felt hot and skin bumpy (rash). She took a benadryl and told staff and they gave her total of 2 epi pens due to c/o hoarse thick feeling in throat, SOB, chest tightness, (states this reaction was much faster than past reactions to other medications). Today she is doing well, no further itching, redness, tight throat, no SOB/CP and reports no fevers, HA, arthralgia, muscle aches or site irritation post vaccination. She is continuing the 3 medications given on discharge (steroid, 2 antihistamines) and is drinking lots of water to flush her system. She has family in the house with her.
53 2021-05-26 swelling of eyelid, eye strain Light headache; Felt left eye is tiring; Injection site sore; Short period of tinkling in left side ... Read more
Light headache; Felt left eye is tiring; Injection site sore; Short period of tinkling in left side of the brain; eye lid is heavy; This is a spontaneous report from a non-contactable consumer or other non hcp. A 53-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in arm left on 23Feb2021 09:00 as 1st dose, single dose for covid-19 immunisation. The patient's age at vaccination was 53 years. The patient was not pregnant. The patient's medical history and concomitant medications were not reported. On 23Feb2021 15:00, the patient experienced injection site sore, light headache, short period of tinkling in left side of the brain, feel left eye is tiring, eye lid is heavy. Vaccine facility type was other. The patient did not have any other vaccine in four weeks. No covid test was done post vaccination. The patient did not have any known allergies and other medical history. Therapeutic measures were taken as a result of injection site sore, light headache and short period of tinkling in left side of the brain with Tylenol. The outcome of the events was recovered on an unspecified date 2021. No follow-up attempts are possible. No further information is expected.
53 2021-05-27 eye bleeding a burst blood vessel in my eye; injection site pain; low grade fever; fatigue; body pain; This is a ... Read more
a burst blood vessel in my eye; injection site pain; low grade fever; fatigue; body pain; This is a spontaneous report from a contactable consumer (patient). A adult female patient (age at vaccination 53-years-old) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06May2021 17:00 (Batch/Lot Number: EW0176) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Known Allergies: Seasonal allergies. The patient has no covid prior vaccination and not covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at the time of vaccination. The patient was vaccinated at Pharmacy/drug store. Concomitant medication included drospirenone, estradiol (ANGELIQ); cetirizine (CETIRIZINE) and; fluticasone (FLUTICASONE, reported as 50), all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6204) first dose on 15Apr2021 13:45 PM at the arm left for covid-19 immunization. It was reported that on "Saturday afternoon, about 48 hours (08May2021, 05:00 PM) after the shot, I noticed a burst blood vessel in my eye, which is atypical for me. I had not been coughing or vomiting, had only experienced low-grade fever, fatigue, body pain, and injection site pain since receiving the second shot." The outcome of the events was recovering. No treatment was initiated. Events were considered serious by the reporter. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-05-27 mouth numbness, mouth tingling After 1st dose, had tingling and numbness on face, lips, tongue and all through right arm/hand/fing... Read more
After 1st dose, had tingling and numbness on face, lips, tongue and all through right arm/hand/fingers; tingling on lips and tongue lasted for about 24-26 hours; throat tightness about 7 hours; face/cheeks were flushed, hot/warm, and slightly swollen; hand, arm, and lips still have occasional periods of tingling/numbness through current date
53 2021-05-28 loss of taste Patient was diagnosed with covid after being fully vaccinated. Currently has symptoms of runny nose ... Read more
Patient was diagnosed with covid after being fully vaccinated. Currently has symptoms of runny nose and loss of taste.FYI_ item number 22 should have been left blank.
53 2021-05-28 lip swelling left side of cheek close to left bottom lip swollen; lips swelled; This is a spontaneous report from... Read more
left side of cheek close to left bottom lip swollen; lips swelled; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 53-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included allergies: Benzoyl peroxide. The patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 at 04:00 PM (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced lips swelled at 4:00 am on 09May2021, she went to urgent care, took a corticosteroid shot, was put on steroids for a week; finished on 15May2021. On 17May2021, the patient woke up with her left side of her cheek close to her left bottom lip swollen. She was at the hospital now. This case was provided as non-serious by reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The adverse event resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment (steroid shot and medication) received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in May2021.
53 2021-05-31 swollen tongue Swelling of tongue and face near right lower lip.
53 2021-06-01 ear discomfort, eye floaters pain all up the arm/As time passed the pain progressed up her arm. She couldn't straighten arm at al... Read more
pain all up the arm/As time passed the pain progressed up her arm. She couldn't straighten arm at all/When she lifts her arm up, it is still sore/her right arm wrist also has pain; now she also has pain in her right wrist/pain has started to increase in her left arm wrist/her right arm wrist also has pain; swelling at the injection site; left shoulder inoculation site edema/edema is minimal; left ear was burning; left eye had floater; left hand and wrist were double the size of right hand/it was so swollen it was a bite/because of the swelling. She couldn't even bend her knuckles at all; swelling in the right wrist/wrist doubled the size of right hand/it was so swollen it was a bite; entire arm where the vaccine was given was red and swollen/swelling in her left arm has increased; entire arm where the vaccine was given was red and swollen.; arm was warm; she has cried; intramuscular pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0182), intramuscular at the age of 53-year-old administered in arm left on 06May2021 10:40 at single dose for covid-19 immunisation. Medical history included chronic anemia, pulmonary embolism in both lungs (doesn't remember the years but she had 4 or 5 of them/maybe between 2016 and 2019), didn't have a bladder from Apr2020 (cystoscopy performed in Apr 2020), dehiscence of wounds, gastric bypass from Jul2007, two major blood clots in right arm from 2019 (because of infiltrated IV. One was 7mm and one was 8mm. A piece broke off of one of them within 24 hours and went into right lung), Smoker, allergy to antibiotics, slightly topical itch reaction to Morphine, cat scratch infection, had a reaction to IVP dye for kidney scan where her eyes started swelling. Concomitant medication included gabapentin (NEURONTIN) taken for left knee nerve pain from Mar2021 and ongoing. The patient previously took Doxycycline and experienced anaphylactic reaction, morphine and experienced slightly topical itch reaction. She received her first Pfizer COVID19 Vaccine on 06May2021 which was a Thursday. Everything was fine. Shot was in left arm. Wednesday, last week, which was six days later she woke up with her entire left hand and wrist doubled the size of right hand on 12May2021. A friend of hers is her in home nurse because caller has underlying health issues. They thought because it was so swollen it was a bite. Caller did Benadryl and RICE treatment. As the day progressed, she had pain all up the arm on 17May2021. She had an appointment with physical therapy. They said to get to the hospital. Her nurse met her for lunch and caller's arm was warm in May2021 and her nurse said to get to the ER. They wanted to rule out a blood clot. They didn't want to admit her, but she had severe issue with her arm that day. She was given pain medication, Benadryl, and had CT scan to rule out blood clot in ER. She couldn't move her neck to the left. She was there 8 hours. While there, her left ear was burning (on 12May2021) to the point it felt someone was ripping it off. In her left eye she had floater on 12May2021, like black fuzzy lines. Everything was on the left side. She didn't hit anything in the time between receiving the injection and 6 days later. She had not done nothing out of her normal routine. It is too much of a coincidence that this is the only thing she has had in the left arm. For 2 or 3 days since last Wednesday the entire arm where the vaccine was given was red and swollen in May2021. She didn't have an immediate side effect, but 6 days later she had a great amount of side effects. She can't say it is the vaccine. She has had a flu shot every year and pneumonia shot every 5 years with no side effect. She is anaphylactic or resistant to every oral antibiotic. Even with IV antibiotics there are only certain ones that can be use, but she has to be pretreated with 50mg of IV Benadryl. She was on Doxycycline all last summer oral and IV. After 4 weeks on it she was sent home with a temp medline for IV infusion. Within 3 hours of her giving herself the next dose she had an anaphylactic reaction. Her body does not immediately react to any side effects or adverse reaction. It can be days out and it hits all of a sudden. On last Wednesday she woke up around 7AM. She felt like it woke her up because of the swelling. She couldn't even bend her knuckles at all. As time passed the pain progressed up her arm. She couldn't straighten arm at all. Everything was on that Wednesday and on the left side. She had full range of motion on the right side. The hospital said it was intramuscular and she read that could possibly be side effect. This was her first dose. Left hand and wrist were double the size of right hand: It resolved. She noticed it around 7AM as the day progressed the swelling went down a little bit. That is when the arm started hurting and the swelling would come back. The swelling wasn't as significant as it was first thing in the morning. She has pictures she can provide if needed. Pain all up the arm: the pain has resolved except for the top of the arm where she received the vaccine. When she lifts her arm up, it is still sore. It wasn't sore the first 2 to 3 days or immediately following the inoculation. It is still very mildly sore. They also did an ultrasound when in the ER. At home she takes, not for this issue, Gabapentin 3 times a day. It was just filled and is in the pharmacy vial and she doesn't have NDC, lot, and expiry. Caller clarified that it is Neurontin 300mg not Gabapentin. She has been on Neurontin since Mar2021. She takes it for left knee nerve pain. For the pain meds she was given in the ER and the Benadryl she doesn't have NDC, lot, or expiry. The hospital administered 100mg of Benadryl. When they did the CT scan they did it with contrast. 40 years ago she had a reaction to IVP dye for kidney scan where her eyes started swelling. Anytime she has contrast solution she is always treated with 50mg of IV Benadryl. She has a slightly topical itch reaction to Morphine. In the ER, they gave her 40mg of IM morphine because they couldn't get a line going. She basically has no veins. They gave her 50mg of Benadryl subcutaneously in the inner area. Then before the CT with contrast, they gave her another 50mg of Benadryl. What she took at home was off brand. It is called Banophen Diphenhydramine HCI 25mg antihistamine. She took one when the reaction happened. The manufacturer is Major. NDC: 09045551-59. When providing NDC caller states, "Come on eyes." Lot number: P121325. Expiry: Aug 2022. Caller just found a sugar cookie from Panera Bread to eat. She was in (withheld) in mid October to late October. Unfortunately when she was down there with her best friend her cat scratched her and caller ended up in the hospital because of cat scratch infection. Even though they were very cautious and following all the CDC guidelines and wearing mask when she came home for 5 days she had many COVID symptoms. She went for a rapid test and it came up negative. She has been tested 15 times since last year because she has had so many surgeries. The reason she got the vaccine was with her underlying health conditions she doesn't want to die. What is interesting is her husband and son both after she felt ill coming home had the same symptoms she did. She is scheduled to get her next dose 27May2021. Is that normal to be scheduled 3 weeks apart? Her greatest concern is her nurse provider is not familiar with her. Her GI doctor and orthopedic surgeon said she should be ok. She wants to receive both as recommended. Her concern with the second vaccine is if the side effects that she experienced could be dramatically worse or result in a horrible outcome. When she spoke to the physician and the nurses and the medical care team they said there are no studies or reports where the vaccine is causing blood clots and what she was experiencing was not associated with the vaccine. When she looked up the vaccine, it said that intramuscular issues could be a rare side effects. Her thought was that it wasn't reported that it hasn't happened. Could intramuscular issues be a rare side effect? Caller clarified that she does not have the Doxycycline or any other antibiotics that she is resistant to or had reaction with to provide NDC, lot, and expiry. The last time she had it was when she had the temp medline put in. She had the reaction and spoke to the infectious disease doctor only in hospital. She threw all the vials and all the bags away. She torn up the lot numbers. The actual bottles she soaked them and then flushed the labels down the toilet. She has chronic anemia. It has been brought to her attention lately that she has critically low iron saturation. Low saturation should be 18 and her iron saturation level was a three. She had the blood test on the same day of the vaccine on 06May2021. On the 7th she had iron infusion. The vaccine was given at 10:40AM. The blood work was drawn at 02:40PM. The iron infusion was at 9:30AM on 07May2021. She received one unit. Adds she previously reported she had gotten the Pfizer COVID 19 vaccine and six days later she had severe side effects. States she was encouraged by her health care professional to go to the ER to rule out a blood clot which she did and the result was negative. Adds when she had the first dose of the vaccine 06May2021, intramuscular in the left shoulder; she had no side effects or anything. Six days later her left hand was swollen to double the size of the right had. She took a 25mg Benadryl that did nothing, which she previously reported. Adds at lunch yesterday she spoke to a friend who is an in home care nurse who has taken care of her before because of her other medical problems; and she encouraged the caller to do RICE treatment; rest, ice, compression and elevation for her wrists. This friend saw the hand at lunch and noticed that the caller was unable to straighten the left elbow and arm; she had great pain in the left elbow and from the hand up the arm. All of these events were previously reported. Caller mentions she is in so much pain and her symptoms are getting worse. New events reported today include the pain has started to increase in her left arm wrist; swelling in her left arm has increased. Caller mentions the physical therapist saw the edema especially on the left shoulder at the vaccination (inoculation) site on 17May2021 and said there is still swelling and she had not noticed this before. Caller clarifies later that day around 1700PM 17May2021, the caller attended a physical therapy treatment and the therapist noticed swelling at the injection site on 17May2021 which was not previously reported. Adds as the day went on yesterday, her right arm wrist also has pain; since yesterday through last night and today it has been at a 10. Adds she has cried in May2021. Mentions she feels she has limited use of her fingers that she noticed yesterday when she had the wrist pain; even picking up things or trying to chop chicken, she can't; she doesn't think she mentioned particularly the left wrist yesterday. Her main concern today is that the pain in her left wrist has increased and now she also has pain in her right wrist on 17May2021. Caller adds she put muscle rubs on; and ice. Her pain in her wrists has not responded to the Gabapentin. She applied three different topical solutions with no improvement in her pain: Generic muscle rub from store; Natureplex Ultra Strength muscle rub; NDC 67324002-01; Jul2022;Topical 5% pure lidocaine cream; Lot 20G13C1; Jul2022; OTC from the pharmacy, no box. Voltaren Gel; Dec2019; lot WN791; unable to locate NDC due to pain in her wrist. Adds the swelling on both wrists is minimal but the pain is incredible; excruciating. Just the edema is minimal; she has kept ice on it on and off; 20 minutes on and off. Adds she has never had pain like this before. Caller mention she did speak with doctor yesterday. Adds she was greatly upset when they told her after she had explained all of her symptoms, that intramuscular joint pain had been detected in May2021. The events results in Emergency Room Visit. The patient underwent lab tests included blood test: unknown results on 06May2021, Iron saturation: low (Low saturation should be 18 and her iron saturation level was a three) on unknown date, CT scan (to rule out blood clot): unknown results, ultrasound: Unknown results, COVID test: negative. The outcome of event left ear was burning and left eye had floater was recovered on 12May2021, the outcome of event Swelling of wrists, Vaccination site oedema and Wrist pain was not recovered and other events was unknown.
53 2021-06-01 eye irritation, ear pain, eye pain, eye discomfort Right ear pain, shooting/stabbing, around 8:40 pm May 31. Woke from sleep around 4 am June 1, severe... Read more
Right ear pain, shooting/stabbing, around 8:40 pm May 31. Woke from sleep around 4 am June 1, severe pain right ear. Walked around 5:20 am, pain outside and top of left foot. Right side ear pain continued through morning, as did foot pain. Foot pain eased around 10 am. Scalp on right side hurt too much to brush hair. Eye pain/discomfort started before noon. Felt like bruise and burning, especially bottom lid and inside half of eye. Went to ER around 2. Ear pain had lessened, only jolts of pain, certain facial expressions exacerbated pain. Eye discomfort more prominent. Scalp most painful right side, rear half.
53 2021-06-01 swelling of eyelid Caller experienced swelling of the eyelid after receiving the second dose of the vaccine; swollen ly... Read more
Caller experienced swelling of the eyelid after receiving the second dose of the vaccine; swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21May2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) for covid-19 immunization. On 21May2021, the patient experienced swelling of the eyelid after receiving the second dose of the vaccine and also experienced swollen lymph nodes and has been using cold compresses and tea bags to remedy the swelling. Patient also mentioned that she had the photos of the AE she experienced take last Wednesday (19May2021) and yesterday (21May2021). Overall safety summary included in clinical studies, adverse reactions in participants 16 years of age and older included injection site swelling (10.5%). Clinical trials experience solicited local and systemic adverse reactions across both age groups, 18 through 55 years of age and 56 years and older, mean duration of swelling 2.3 days (range 1 to 34 days). No information found for swelling specifically in the eyelid area. Referred to HCP. The events were considered as non-serious. The outcome of events was unknown. Follow up attempts are needed. Further information has been requested.
53 2021-06-01 ringing in ears Tinnitus; no treatment. Still experiencing tinnitus at the time of reporting (06.02.2021)
53 2021-06-02 eye twitching, tongue disorder, eye swelling, vision blurred Hemiplegic migraine; Forgetful; Peeing more often; Heavy tongue; Slurred speech; Aura; Bleary vision... Read more
Hemiplegic migraine; Forgetful; Peeing more often; Heavy tongue; Slurred speech; Aura; Bleary vision; Left eye twitching on and of; black and blue eye; Hands shaky; swollen black and blue eyes; Depth perception problem on right side; Headache; Fatigue and very tired; This is a spontaneous report from a contactable patient. A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: unknown) via unspecified route of administration on 04Mar2021 at 10:30 am (at the age of 53- years) as a single dose for COVID-19 immunisation. The patient's medical history included asthma, seasonal allergy, Transient Ischemic Attack (TIA) in 2014 and migraine. The concomitant medication includes erenumab aooe (AIMOVIG) for migraine from unknown dates. Patient previously took botulinum toxin type A (BOTOX) for migraine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Mar2021 at 08:00 am, the patient experienced fatigue for 1-3 days, headache, until she had gone to urgent care. The patient also reports swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful, depth perception problem on right side and heavy tongue, hands shaky, aura, peeing more often (sometimes she had to sit longer) and hemiplegic migraine. It was also reported that, the events migraines and headache she had after the vaccine was intolerable. At the time of report the events of mild headache and blurred vision was ongoing. The adverse events resulted into healthcare professional office/clinic visit and emergency room/department. Therapeutic measures for the reported adverse events included treatment with metoclopramide, methylprednisolone and "nr" from unknown dates. The clinical outcome of the events of fatigue, headache, swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful and heavy tongue, hands shaky, aura, peeing more often and hemiplegic migraine was reported as recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Updated reporter details (reporter name, for correspondence contact in slide#2, Health care professional leave blank; Protect confidentially and Correspondence contact was checked). Patient details added (Patient's first name and age/units). For concomitant drug "amogiv" was considered as typo and coded as Aimovig. Concomitant therapy leave blank since the concomitant drug was coded via WHO drug in product tab already. Deleted duplicate reported Indication of BNT162B2. Lot# UNKNOWN was removed from dosage regimens tab. Best doctor/Health care professional information such as phone number and email were added in vaccine administration tab. Treatment received was ticked as Yes for events. Physician Office Visit and Emergency room visit were checked. "Depth perception problem on right side" was added as AE.
53 2021-06-03 lip blister Lip blistering; General malaise; This is a spontaneous report from a contactable nurse. A 53-year-ol... Read more
Lip blistering; General malaise; This is a spontaneous report from a contactable nurse. A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in left arm on 06Jan2021 at 09:15 (at the age of 53-year-old) (Lot Number: Ek9231) as 1st dose, single dose for covid-19 immunisation. Medical history included hypothyroid, migraines, latex and sulfa allergy. Concomitant medications included armor and BCP (taken as other medications in two weeks). The patient did not receive any other vaccines within four weeks. Prior and post to the vaccination patient not tested to covid. The patient previously took Cipro and experienced allergy. On 28Jan2021, the patient experienced general malaise. On unspecified date, the patient experienced lip blistering. Treatment was not received for the events. Outcome of the event general malaise was recovering while unknown for rest of the event. Follow-up attempts are completed. No further information is expected.
53 2021-06-03 visual impairment Vision changed can not see well with glasses on. If I remove my glasses my vision is better.; This i... Read more
Vision changed can not see well with glasses on. If I remove my glasses my vision is better.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unknown route of administration in the right arm (at the age of 53-year-old), as a single dose on 18Mar2021 at 07:30 for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to codeine. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021 at 11:00, the patient vision had changed, could not see well with glasses on and the vision was better if glasses removed. The patient cleaned and checked glasses. No therapeutic measures were taken for the event. The clinical outcome of the event was reported as not recovered. Information about lot number cannot be obtained. No further information is expected.
53 2021-06-04 eye swelling face and head went numb and were tingling; face and head went numb and were tingling; Eyes felt swol... Read more
face and head went numb and were tingling; face and head went numb and were tingling; Eyes felt swollen/numb; Eyes felt swollen/numb; Left arm and both hands were numb even longer; This is a spontaneous report from a non-contactable female consumer. A 53-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205, Expiration date: unknown), via unspecified route, administered in left arm on 04Mar2021 (at the age of 53-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history include heart- mitral valve prolapse, pre ventricular contractions, and concomitant medications were not reported. The patient had history of Prilosec induced drug hypersensitivity, cephalexin induced drug hypersensitivity and sulpha drug allergies. The patient was not tested positive for covid-19 prior to vaccination. On 04Mar2021, 02:15 pm, 15 minutes after the vaccination, the patient experienced face and head numbness and were tingling. Eyes felt swollen/numb. This lasted 4 hours. Left arm and both hands were numb even longer. The reporter assessed all events as non-serious. The outcome of the events was recovered on mar2021. No follow-up attempts possible. No further information expected.
53 2021-06-06 extreme sound sensitivity I developed extreme sensitivity to sound first, then sycope, then vertigo (urgent care visit 3/22/21... Read more
I developed extreme sensitivity to sound first, then sycope, then vertigo (urgent care visit 3/22/21) then swollen lymph nodes affecting my swallowing and causing pressure on my heart from axilla, sub scapular and nodes near throat such that my heart started to feel the pressure so I went to the ER. Internist there suggested immediate breast diagnostics.
53 2021-06-07 ringing in ears, vision blurred Within a few days of second shot, my ears started ringing constantly. Mostly the left ear. After 4 ... Read more
Within a few days of second shot, my ears started ringing constantly. Mostly the left ear. After 4 weeks, I have noticed a bit of trouble focusing my eyes. I am not sure if it is related to the tinnitus or just an issue of my monovision contacts.
53 2021-06-08 swollen tongue throat started to hurt like it was swollen; It felt more muscular.; a couple episodes of trouble swa... Read more
throat started to hurt like it was swollen; It felt more muscular.; a couple episodes of trouble swallowing.; it felt like the very back of my tongue was also swollen.; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer (patient) reported that who received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: En6198 and expiry date was unknown) via an unspecified route of administration on 04-MAR-2021 19:00 as a single dose for COVID-19 immunisation. Medical history was Psoriatic arthritis, osteoarthritis, fibromyalgia, asthma, allergic to Several Antibiotics, deet. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08-MAR-2021 17:00 her throat started to hurt like it was swollen. Did not have a sore(irritated) throat. It felt more muscular. She had a couple episodes of trouble swallowing. Tuesday night it felt like the very back of my tongue was also swollen. This problem was not constant. She have episodes of it happening. No treatment was received due to events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
53 2021-06-09 thirst, oropharyngeal discomfort a warm and thirsty throat; a warm and thirsty throat; dizziness; nausea; pain around spleen; tiredne... Read more
a warm and thirsty throat; a warm and thirsty throat; dizziness; nausea; pain around spleen; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EN6206) via an unspecified route of administration administered in Arm Left on 10Mar2021 09:30 (at the age of 53-years-old) as single dose for covid-19 immunization. The patient's medical history included thyroid cancer, chronic back pain, thoracic carcinoid and known allergy to green vegetables and some type of MRI or CT Contrast. The patient's concomitant medications included levothyroxine at 100 mg. On 10Mar2021 at 09:45, after been vaccinated patient started having a warm and thirsty throat. Within next hour, started feeling severe dizziness, nausea and pain around spleen. Next, the patient started feeling tiredness and weakness. The patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
53 2021-06-10 loss of taste Headache; body aches; tired; loss of taste; This is a spontaneous report from a contactable consumer... Read more
Headache; body aches; tired; loss of taste; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 09Mar2021 14:30 (Batch/Lot number was not reported) (at the age of 53 years-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included thyroid, migraine, allergy, acid reflux. However, the patient also reported that her other medical history was "none". The patient was not pregnant. The patient did not have Covid prior to vaccination. The patient had no known allergies. Concomitant medications included medications for thyroid, migraine, allergy, acid reflux and an inhaler. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 16Feb2021 at 02:30 PM (at the age of 53-years-old) for Covid-19 immunisation. The patient did not receive other vaccines in four weeks. The patient experienced headache, body aches, tired, loss of taste/lost sense of taste. All started 20 hrs after on 10Mar2021 at 10:30 AM. Loss of taste was still here 4 days later. No treatment was received for the events. The patient was not tested for Covid post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
53 2021-06-10 lip swelling lymph nodes in her legs were swollen; lymph nodes in her legs were painful; severe gluten allergy; s... Read more
lymph nodes in her legs were swollen; lymph nodes in her legs were painful; severe gluten allergy; staff tried 5 to 6 times in both arms trying to get blood; difficulty breathing/couldn't breathe; a herpes outbreak on her buttocks/herpes simplex outbreak/7 quarter size areas on her left butt and down her left leg; a rash completely covering her hands, head and ears; hand were itching/head was itching/ears were itching; loses 3-4 lbs after each episode and has lost a total of 12 pounds; an upset stomach; four other allergy attacks/ allergic reaction during a barbeque; urticaria/ a rash from the bottom of her breasts to her nose; lip swelling; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727; Expiration Date: 31Jul2021), via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 53-year-old) as single dose for COVID-19 immunization. The patient provided the following for her medical history described: As a teenager, she was very allergic to everything- foods, vegetables, apples, tomatoes, avocado, raw almonds and pollen: Her throat would swell, and her face would swell up but would take cortisone and it would be good the next day. After her pregnancies, her allergies subsided and were well managed for 15 years. In the past, she was taking RECTODELT for her allergies to food and normally it would help with that. It worked quick, within 15 minutes. She also has ongoing herpes simplex and sometimes it's on her butt. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity, start and stop date were not reported; dexamethasone (manufacturer unknown) taken for malaise; naproxen (manufacturer unknown) taken for pain; naproxen sodium (ALEVE) taken for an unspecified indication. The patient previously received Flu vaccination in Aug2020. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205; Expiration Date: 30Jun2021), via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 53-year-old) as single dose for COVID-19 immunization. The patient reported that she received her second Covid-19 vaccine on 20Mar2021, and she didn't have a reaction right away. On 04May2021 she had an allergic reaction completely different than what she's used to. She explained that she had a BBQ (barbeque) and she ate vegetables and had half a glass of rose wine, and she went to bed around 11:00PM on 04May2021. On 04May2021 at night she woke up in the middle of the night with difficulty breathing, an upset stomach, and a rash completely covering her hands, head and ears. On 04May2021, she took some cortisone, RECTODELT, a 100mg prednisone suppository, but it didn't help. She has a doctor friend who had given her some medications. Her doctor friend had given her an antihistamine liquid, CELESTAMINE N 30ml, and a cortisone liquid, SENISTIO 20ml, and those two medications combined helped her symptoms. The next day it was better. On 06May2021 she couldn't breathe so her doctor friend told her to go to the emergency department (ED) so she went to the emergency room on 06May2021 in the middle of the night. She also did have an outbreak when she went to the emergency room. She had it so very bad. She had about 7 quarter size areas on her left butt and down her left leg and the lymph nodes in her legs were swollen and painful. The emergency room checked her blood pressure and it was fine, they checked her oxygen level and that was fine, they did an EKG and that was ok, and they did blood work and that was ok too. In the emergency department, she did have an IV and they gave her Cortisone in her IV. She had the IV in her right arm and when she received the Cortisone her arm was getting warm and then she felt flushed through her whole body. It was really strange, and she was super scared. Also while she was in the emergency room, the emergency room staff tried 5 to 6 times in both arms trying to get blood and he tried to go in her lower arm and she finally asked that someone else try to get blood. They discharged her and told her to follow up with her primary care physician (PCP) and an allergy doctor. Since 04May2021, she has had four other allergy attacks. She loses 3-4 lbs after each episode and has lost a total of 12 pounds. She reported she saw her primary care doctor on 18May2021 and received a prescription for steroids for a herpes outbreak on her buttocks and went down her legs. During her doctor visit on 18May2021, she had allergy testing done: She is allergic to almost everything, and she can only eat chicken and rice because she now has a severe gluten allergy. She was told to take 2 Allegra per day for 10 days and was given 1mg dexamethasone to take if she feels really bad. When she saw her family doctor, her doctor asked her if she had been in a fight because her arms looked so bad from all the needle sticks trying to get blood. It was very painful. She doesn't think the allergic reaction was related to the emergency room staff not being able to get blood from her. And she does drink a lot so she doesn't get dehydrated. She had some allergy tests and those came back that she's allergic to almost everything. The doctor also prescribed Valacyclovir HCl 1gm tablet for the herpes simplex. Her doctor told her to take it for another week and then stop taking it and then start again if she has another outbreak. The Acyclovir she was taking wasn't working. It was Acyclovir 800mg in a pharmacy bottle (Discard by date: 14Aug2021). Her gynecologist gave her Naproxen to take for pain. She does a lot of yoga and when her joints are hurting she takes Aleve. She did take Aleve on the day of her first Covid 19 vaccine and she drank a lot of water and a lot of Gatorade. The patient reported that the itchy head, hands, and ears happened 3 or 4 more times. She's thinking this could be related to the Covid-19 vaccine, that the Covid-19 vaccine triggered her allergies. This past Monday/Tuesday (May2021) she had her most recent allergic attack (she is not sure if it was from eating potato chips or just taking one Allegra that day), she had difficulty breathing, lip swelling, urticaria/ a rash from the bottom of her breasts to her nose. She had an EpiPen nearby and she took an 100mg suppository of prednisone. Her doctor told her to take 2 Allegras everyday indefinitely. She is feeling better today and was able to go to a yoga class- but still has the rash. She saw her PCP yesterday (25May2021) and got a prescription for valacyclovir, she is to take it for 7 days and then start again if it flares up again. She is getting an inhaler today for if she has difficulty breathing again due to an allergic reaction. Her doctor thinks this may all be caused by a histamine intolerance from the shot, her other HCPs do not believe its vaccine related. Her doctor also said that it could be due to a bad mosquito bite that she got two weeks before her first allergic reaction or due to a teeth whitening procedure that she had issues that she also received before the allergic reactions started. The clinical outcome of the events " urticaria/ a rash from the bottom of her breasts to her nose" was not resolved, and the outcome of the events, difficulty breathing/couldn't breathe, "a herpes outbreak on her buttocks/herpes simplex outbreak/7 quarter size areas on her left butt and down her left leg", "four other allergy attacks/ allergic reaction during a barbeque", an upset stomach, "a rash completely covering her hands, head and ears", loses 3-4 lbs after each episode and has lost a total of 12 pounds, lip swelling, hand were itching/head was itching/ears were itching, lymph nodes in her legs were swollen, lymph nodes in her legs were painful, severe gluten allergy and "staff tried 5 to 6 times in both arms trying to get blood" were unknown.
53 2021-06-10 mouth tingling, taste disorder Her face drooping on one side/when brushing teeth water dribbled out of side of her mouth/ Bell's pa... Read more
Her face drooping on one side/when brushing teeth water dribbled out of side of her mouth/ Bell's palsy; Her jaw locked up, when / she could not open her mouth wide enough to eat; Her tongue felt like it was burnt and her food tasted funny; Her tongue felt like it was burnt and her food tasted funny; Her neck hurt; This is a spontaneous report from a contactable consumer (Patient herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 (at 53-years age) as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26May2021 a week after the vaccination patient experienced her tongue felt like burnt and her food tasted funny, and face still felt funny, her neck hurt. On 29May2021 her jaw locked up, when brushing teeth water dribbled out of side of her mouth, she could not open her mouth wide enough to eat. On next day 30May2021 her son noticed that patient's face drooping on one side called 911. She thought she was having a stroke but at the hospital said she had Bell's Palsy. The doctor at the hospital stated it was one of the side effects of the shot. The patient started to take 60mg of Cymbalta and .37mg of Synthroid daily as a treatment to event. The outcome of the events was unknown.
54 2020-12-31 thirst Fevers, muscle, joint aches, fatigue, "crawling skin"extreme thirst X6 days as of this form
54 2021-01-02 mouth tingling Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, a... Read more
Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, arms, legs, lips, face, mouth. Started Friday morning January 1st 2021. I went to the ER on Friday January 1st 2021 and was given Prednisone. I'm still having symptoms today Sunday January 3rd 2021.
54 2021-01-03 eye swelling 48 hours later bilateral eyes swollen. Saw dr. in office and treated with steroid cream and allergy... Read more
48 hours later bilateral eyes swollen. Saw dr. in office and treated with steroid cream and allergy meds resolved without difficulties
54 2021-01-04 eye itchiness Itchy eyes and hives on most of body that started 2 hours after injection. I took 50mg of Benadryl ... Read more
Itchy eyes and hives on most of body that started 2 hours after injection. I took 50mg of Benadryl and that put me to sleep. When I woke the hives were gone but I still itches another day. I took Claritin which did not help. When I got home from work I took 25mg of Benadryl which took care of symptoms. Eyes have been itchy off and on still.
54 2021-01-04 lip swelling, swelling of eyelid About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, ... Read more
About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, itchy throat, upper and lower eyelid swelling, lip swelling, difficult swallowing. Selt-treated with prednisone 40mg, fexofenadine 1 tablet, famotidine 40mg, albuterol breathing treatment. Felt better, but then 6-8 hours later, felt chest tightness again that did not resolve with breathing treatment. Went to the Hospital Emergency Department. No epinephrine was administered. But received IV corticosteroids, diphenhydramine and famotidine, and was discharged with 6 days of oral corticosteroids
54 2021-01-04 bloodshot eyes Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sp... Read more
Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sputum. No fever, has had body aches, lethargy, malaise, fatigue, bloodshot eyes and diarrhea, loss of appetite.
54 2021-01-05 loss of smell, loss of taste positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); ... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); night sweats; Soreness at injection site; slight temp 99.5 degrees/her temperature was 101 degrees Fahrenheit/it was 102.5 degrees Fahrenheit/99 degrees Fahrenheit and then 98 degrees Fahrenheit; Tiredness she related to giving blood; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular on 19Dec2020 15:45 on left deltoid at a single dose for prevention as frontline health worker at hospital (COVID-19 immunisation). The patient donated blood on 18th and no antibodies were present then. The patient was a former smoker and quit 2 or 3 years ago. Patient diagnosed Osteoporosis in 2015, benign heart arrhythmia in 2005. The patient took 70 mg alendronate sodium (FOSAMAX) once weekly and just a regular OTC daily multivitamin. Caller reported she was having the covid vaccine on 19Dec2020 and began having fever, night sweats, loss of taste and smell and then tested positive for covid. The patient received the Pfizer COVID 19 vaccine through work on 19Dec2020. She received it at 3:45 pm and should have taken temperature before, but she was afebrile the day before because she donated blood. At 7pm, she had slight temp 99.5 degrees Fahrenheit and by 10:30, her temperature was 101 degrees Fahrenheit and she still felt fine. She was surprised that it was that. She woke up at 2:30 am on 20Dec2020 and took her temperature and it was 102.5 degrees Fahrenheit. She took 2 Tylenol and went back to bed and felt fine. By morning it was 99 degrees Fahrenheit and then 98 degrees Fahrenheit a little later. She has been afebrile since then. She was a little tired because she gave blood and though it was related. She does not know if it was a side effect or not. It was not significant tiredness and was just not having energy in the evening of 19Dec2020. She also had soreness at injection site that night after 22:00 and the next day. It did not bother her until she woke up in the middle of night, and she noticed her left arm was sore. She received the vaccine at 3:45pm and started with low grade fever at 6:30 pm, earlier stated at 7:00 pm. There was no prescriber. She tested for COVID (PCR) on Saturday, 26Dec2020 at 14:50and it came back positive 28Dec2020 18:45. At 10pm on 19Dec2020, her temperature was 101 degrees Fahrenheit. If she had not been monitoring her temperature, she would not have known. She has been Afebrile since morning of 20Dec2020. Tiredness she related to giving blood and the holidays. She was a little stressed about the holidays and running around. It was very mild. Soreness at injection site was during the night after 10pm when she went to bed. On Wednesday, 23Dec2020, she woke up congested, sniffly, sneezy, with a runny nose. This persisted through Wednesday night. Her sense of taste was off. She had no problem with that on Tuesday. She had some horrible smell at work she recalled, so she knew her sense of smell was fine. On Thursday, 24Dec2020, she had no sense of taste or smell. She could not smell a pine candle. She was congested on Thursday and called employee health on 24Dec2020. This both improved and persisted. She is still congested but it has improved. She has never had a complete loss of sense of taste or smell before. Mild cough started yesterday morning. On the night of 20Dec2020, and 21Dec2020, she developed night sweats. She had not had any night sweats before this since menopause and she woke up really wet. The patient was not hospitalized and not admitted to an Intensive Care Unit. NO ER or physician's office required. She did not know if she was exposed on the day of the vaccine or if a couple of days later if the fever is from the vaccine. She stated what are the chances she goes 10 months and is super careful and then gets the vaccine and test positive. The patient did not display clinical signs at rest indicative of sever systemic illness. The patient did not require supplemental oxygen nor receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID- 19. No initiation of new medication or other treatment or procedure. Not any preexisting diseases worsen during the SARS-CoV2 infection. She would like to know if there is a chance of false positive for this. It would just be her luck to be 10 months and not getting it. She has not gone anywhere without her N95 and then gets the vaccine and gets COVD. She wears mask and face shield at work always. She also wanted to know if she should get the second dose. The outcome of the event slight temperature was recovered on 20Dec2020 and the other event was recovering.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
54 2021-01-05 lip swelling 20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swel... Read more
20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.
54 2021-01-05 taste disorder About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme he... Read more
About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme heat or hot flash, shaking, almost hyperventilating but was able to control breathing. Episode lasted 10 mins Immediately with vaccine I noted an antiseptic taste in my mouth and this continues.
54 2021-01-05 visual impairment One week after the vaccine I was find until....I got out of my car after driving and started stagger... Read more
One week after the vaccine I was find until....I got out of my car after driving and started staggering and could not function. Severe dizziness, heavy headedness , nausea and vomiting and a horrible headache. My husband had to physically muscle me back to my car. He wanted to take me to the ER and I would not let him because of the waiting room is full of COVID positive patients. I threw up along the way home and multiple times to the point I had drive heaves. I am a Registered Nurse and felt the symptoms I were experiencing were Vertigo. I had one bout with Vertigo in 2015 and it was extreme. I had Meclizine on hand and and took one tablet and slept. The severity of this was so bad I could not walk unassisted or sit up without falling over. After 6 hours of sleeping I got up, dizziness continued, and vision a little off. I still do not feel 100% I have had a headache since. It never dawned on me this could be from the vaccine I had taken a week before.
54 2021-01-06 mouth numbness her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le... Read more
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-01-06 mouth tingling Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took ... Read more
Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took personal albuterol inhaler and waited in car 50 minutes Reported to employee health office Sent to ED for SOB, wheezy, tingling in tongue per MD note. (arrived 0958) Nebulizer administered. Chext X-ray negative for acute disease. ED MD states: Asthma exacerbation Left 1143
54 2021-01-07 eye irritation Warm neck and face. Burning sensation in eyes.
54 2021-01-07 mouth pain, pain in jaw COVID 19 vaccine received 12/23/20 left deltoid. She has been experiencing left jaw/TMJ joint pain s... Read more
COVID 19 vaccine received 12/23/20 left deltoid. She has been experiencing left jaw/TMJ joint pain since Sunday 1/3/20 worse in the morning,. patient describes it as a dullness on the left side of face. Denies any trauma to area. No hx of TMJ. Denies any facial droop, or dry eye, no weakness. She tried NSAIDs with no improvement, however pain with opening her mouth.
54 2021-01-10 oropharyngeal discomfort Patient complained of dizziness and feeling of something in her throat. She felt the need to clear h... Read more
Patient complained of dizziness and feeling of something in her throat. She felt the need to clear her throat.
54 2021-01-10 pain in jaw Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she descri... Read more
Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she described arm pain that radiated up to her left jaw and chest. At this time we recommended she be escorted to the Emergency Department for assessment. This was completed and she was later released home without any longstanding concerns.
54 2021-01-10 vision blurred Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, pa... Read more
Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, patient starts seeing a cloud-like blurry vision, intermittently, during the day.
54 2021-01-11 swelling around the eyes pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma an... Read more
pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma and had some mild sob day before vaccine
54 2021-01-12 inability to speak I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was ... Read more
I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was worse, the chest tightness was worse and definately had a cough. I self isolated over christmas. My ribs were sore from the coughing. I was screened for FLU & COVID on the 28th before I could return to work. I was treated for bronchitis. I was given cough syrup and an antibiotic.
54 2021-01-12 swelling around the eyes Patient noted periorbital swelling about 1 hr after the vaccine and was sent to ED. She had some mi... Read more
Patient noted periorbital swelling about 1 hr after the vaccine and was sent to ED. She had some mild asthma symptoms earlier in the day (before vaccination) and these did not worsen after the vaccination. She did not have throat tightness, chest pain, dizziness, rash, itching. She has hx asthma, GERD. She has allergy to sulfa and cipro (Rash) and Prozac (psychosis). In ED, patient was given IV benadryl and famotidine and discharged with Rx methylprednisolone and epipen.
54 2021-01-13 loss of taste TEMP LOSS SENSE OF TASTE BODY ACHES, MUSCLE CRAMPS, FATIGUE SEVERE HEADACHE DIZZINESS LIGHT HEADED
54 2021-01-13 taste impairment Metallic taste for about 1 1/2 hrs immediately following the injection. It did go away.; This is a ... Read more
Metallic taste for about 1 1/2 hrs immediately following the injection. It did go away.; This is a spontaneous report from a contactable other healthcare professional. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on her left arm on 31Dec2020 at 10:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had allergies to medications, food and other products; all unspecified. Prior to vaccination, the patient was not diagnosed with COVID-19. No vaccines received within 4 weeks prior to COVID vaccine. Concomitant medication included levothyroxine sodium (SYNTHROID) which was received within 2 weeks of vaccination. The patient experienced metallic taste for about 1 1/2 hrs (hours) immediately following the injection on 31Dec2020 at 10:45. It did go away. The patient did not receive treatment for the adverse event. Outcome of the event was recovered on unspecified date.
54 2021-01-14 eye twitching Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as... Read more
Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as if my upper lid gets stuck, lasting only a few seconds, not painful and doesn't affect my vision). It occurs intermittently throughout the day and began approx. 2 hours after receiving the injection.
54 2021-01-14 taste impairment, eye bleeding Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hour... Read more
Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hours. Mysugar climbed to 250 by dinner time. By bed tme my sugar was 300. I did not eat dinner. I had no appectite. I increased my insulin and metformin dose. I had chills and fevery thru the night and the next day. High fever 101. I treated this with tylenol and showers. I was really sleepy all day. I had little to eat and still my sugar was 300 most of the day. on Jan 6. I woke up and had a hemmorrhage in my right eye. I called my retinol specialist and and received an injection of Eylea on Jan 7, 2021
54 2021-01-14 eye bleeding, taste impairment Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose... Read more
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose was 89 in the morning. by 1400 hours my glucose was 250. By bed time it was 300. I did not eat dinner and adjusted my insulin and took an extra 500mg metformin. I had chills and fever through the night and all the next day. Fever 99 to 101. Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also. I woke up on Jan. 6, 2021 with a hemorrhage in my right eye. I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021., He asked that I report this advers reaction.
54 2021-01-14 eye pain, bloodshot eyes Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea.... Read more
Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea. This started 8 hours after injection and lasted for 24 hours. Extreme exhaustion followed the next 24 hours. Severely blood shot eyes developed during first 24 hours and remains still after 78 hours. Still having brain fog after 78 hours.
54 2021-01-14 eye swelling 1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen,... Read more
1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen, headache and chills by afternoon mouth and right eye was drooping. Was prescribed RX prednisone on 1/15/2021. Current symptom (1/15/2021) is mouth drooping, other swelling and eye drooping resolved. Reports has occurred twice before. About 7 years ago with unknown etiology, lasted for about 6 months, Occurred again about 5 years ago with unknown etiology and lasted about one month.
54 2021-01-14 vision blurred convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints wer... Read more
convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation. Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.
54 2021-01-15 mouth tingling At approximately 20 min following dose administration noted left neck pain subsequently developed pe... Read more
At approximately 20 min following dose administration noted left neck pain subsequently developed perioral paresthesia, chest tightness. No stridor, drooling, wheezing or nausea/vomiting. Vitals were stable. Patient states that she took Claritin prior to her vaccination. No medications since symptoms started. States symptoms have improved in all told lasted approximately 30 min.
54 2021-01-19 dry throat Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of b... Read more
Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of breath chocking sensation and dry throat. Worried about her breathing, she went to the emergency department, blood pressure taken- 183/103. She was given IV fluids and recommended follow up with PCP.
54 2021-01-20 feeling of choking, mouth tingling Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identifie... Read more
Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identified herself to staff. She stated that she usually takes Benadryl when she has these symptoms. She had an elevated blood pressure at the time (BP= 180s/110s. She proceed to take 50mg Benadryl. Approximately 20 minute later, she developed coughing and continued tingling of her perioral area and that the tingling was extending to her nose and forehead. At which time, she said that she would use her Epipen at such a time. She self administered an Adult Epipen. Approximately 10 minutes, her symptoms improved. She continued to cough and have elevated BP. She was transported via EMS to the nearest ER in stable condition.
54 2021-01-21 taste impairment Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection s... Read more
Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection site; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKQ231), via an unspecified route of administration at the left arm on 11Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 11Jan2021, patient experienced metallic taste in mouth, which was reported as worsened and sore arm at injection site. On 12Jan2021within about an hour after vaccination, the patient experienced lowgrade fever that was slowly going up, headache, stomach ache, & body ache. The patient has not recovered from the events.; Sender's Comments: Based on the time association, the reported events are possibly related to suspect BNT162B2 administration in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-01-21 oropharyngeal discomfort, mouth numbness It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food ... Read more
It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food (never found out what the allergen was). About 20 minutes after receiving the vaccine, my throat felt strange, my sinuses started getting congested, my ears started plugging. I felt dizzy when walking. I spent extra time at the clinic under observation. About 40 minutes after receiving the vaccine, I suddenly felt like I was being sucked into a vacuum and thought I was going to pass out. I alerted the nurses, who checked my vital signs and put me on O2. My heart rate was normal, my BP was high, my O2 sat was 100%. After about 5 minutes I started to feel normal, they removed the O2. They continued to observe me for another 15 minutes, until I felt better. As I drove home (about 1 hour 10 min after receiving the vaccine), my face and lips became numb. I continued driving home and the numbness resolved in about 10-15 minutes. I notified my doctor of the event and she advised me not to get the second dose and to report the event.
54 2021-01-21 mouth tingling, pain in jaw Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk... Read more
Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk (like a spasm). There was no twitch the a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body) . I also had bilateral jaw pain (not sure if its was because I was in so much pain in the legs that I was clenching my teeth) I also had slight numbness on by left face and by the evening I had redness on my left cheek but it went away. My face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw.
54 2021-01-24 mouth numbness, mouth tingling Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg ... Read more
Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg before bed last night and then took 10 mg Zyrtec before getting the shot. She states about 15 mins after administration she began to have numbness and tingling of her hands, forearms, lower legs, neck, face and lips. She came to ER was monitored for a few hours, about 3 hours post administration while in ER her voice became more hoarse and she noticed edema under her eyes bilaterally. Pt was given 25 mg IV bindery and remained under observation for another 1.5 before being DC. She maintained airway the entire time, VSS and AOX4;
54 2021-01-25 tongue disorder Within 3 minutes of receiving the vaccine, felt that tongue was "getting fat"
54 2021-01-25 vision blurred Reported tightness in throat, headache, fever,body aches, and blurry vision.
54 2021-01-26 tongue disorder, dry throat "THICK TONGUE"/"THROAT DRY" INCREASED PULSE 90-100 BPM
54 2021-01-27 loss of taste, loss of smell losing taste and smell for two days; losing taste and smell for two days; This is a spontaneous repo... Read more
losing taste and smell for two days; losing taste and smell for two days; This is a spontaneous report from a contactable pharmacist. A 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on her left arm on 19Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included known allergy to Sulfa. The patient's concomitant medications were not reported. The reaction with the first dose was losing taste and smell for two days (unknown date). The reaction with the 2nd dose was three nights of very vivid nightmares to the point of waking up with panics with worm head. This is not usual and happened the night of the vaccination (11Jan2021) and subsequent two nights. The patient did not receive treatment for the events. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
54 2021-01-27 lip swelling Lip and facial swelling on the left side of my face. Took 50 of benadryl which took several hours to... Read more
Lip and facial swelling on the left side of my face. Took 50 of benadryl which took several hours to work. Was placed on 3 days of prednisone to decrease the swelling. Prednisone did decrease the swelling. Spoke with my primary doctor on the phone as it was after hours by the time I called him who prescribed the prednisone.
54 2021-01-27 mouth ulceration The patient reported numbness, tingling, and heaviness in vaccinated arm which travelled up neck, to... Read more
The patient reported numbness, tingling, and heaviness in vaccinated arm which travelled up neck, to eyelid and side of face. This prompted a visit to urgent care and urgent care sent the patient to the ED for stroke rule-out. The ED did not believe patient was experiencing a stroke and administered 10 mg of IM decadron. The patient's symptoms resided overnight but the next day developed red bumps all over upper palate of mouth. The patient went to her PCP which did not test for strep at this time. The red bumps developed into ulcers with white heads and the patient went back to the PCP which performed a rapid strep test which was negative. The PCP was concerned for mono due to lymph node swelling. The patient's palate has improved slightly but they still feel fatigued.
54 2021-01-27 vision blurred Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable ... Read more
Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3246, expiry: unknown), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included lupus SLE and known allergies with Stadyl. Concomitant medications included ascorbic acid (ESTER-C [ASCORBIC ACID]) and prednisone. The patient had no other vaccine in four weeks. The patient experienced severe migraine, blurred vision, dizziness and nausea on 12Jan2021 at 14:00. The patient was tested for Covid prior to vaccination but was not tested post vaccination. The events were not treated. The outcome of the events was recovering.
54 2021-01-29 mouth tingling 20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing... Read more
20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing. Did not progress, waxed and waned. Had more flushing later, took benedryl. Went to Urgent care, advised benedryl to continue, but did not feel there was any cause for concern. Day after injection, mild flushing at times, and diffuse mild itching including scalp, face, particularly borders, and general arms, legs, torso. No rash, hives, and itching not aggressive, just mild. Persisted for about a week. Feel anxiety may have played role. Continued with benedryl. Had telehealth visits with PCP and with allergist. Resumed taking zyrtec daily with additional dose in pm- symptoms resolved. Not felt to be "serious" reaction by either MD, feel it is ok to have 2nd dose.
54 2021-01-31 dry throat body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; ... Read more
body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.
54 2021-01-31 visual impairment I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with... Read more
I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with my RIGHT eye. I had a sore left arm and headache, which I attributed to the vaccine. By 12/27/20, I called the emergency number at my primary ophthalmologist as was seen. They thought I had a posterior vitreous detachment and asked me to see my primary eye doctor in a week. By 12/30/20 I could not see to work and called the eye doctor and they decided I should see my retinal specialist who deals with problems with my left eye. He could see nothing to explain my decreased acuity and told me to keep my follow up at the other office. I saw a Dr on 1/4/21, who takes care of my left eye cataract and glaucoma. He called in an associate. My vision had further declined and they thought I had ocular neuritis. I couldn't see the big E on the eye chart at all at my worst. I was scheduled for an MRI of the head, which showed ocular neuritis in my right eye. Dr assumed care and I started IV steroids on 1/13 for 3 days, followed by oral prednisone taper. I also was referred to a neurologist to rule out MS. I saw Dr. 1/28/21. After the steroids, my vision improved, but I still can't work or drive. Neurologist does not think I have MS and is ruling out NMO but doesn't think I have that either.
54 2021-02-01 mouth tingling, taste impairment Metallic taste in mouth started approximately 1 hour after receiving vaccine and still reporting met... Read more
Metallic taste in mouth started approximately 1 hour after receiving vaccine and still reporting metallic taste. Tingling on tongue started after receiving vaccine and went away after a few days.
54 2021-02-01 ringing in ears Tinnitus; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-... Read more
Tinnitus; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=PFZ39), via an unspecified route of administration in left arm on 14Jan2021 19:00 at first single dose for covid-19 immunisation. Medical history included obesity, depression, hypothyroidism. Other medications the patient received within 2 weeks of vaccination included: levothyroxine sodium (SYNTHROID), bupropion hydrochloride (WELLBUTRIN) and vitamin supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took demerol and experienced drug hypersensitivity. The patient experienced tinnitus on 14Jan2021 20:00 with outcome of not recovered. Since about an hour after receiving the vaccine, the patient's ears had been ringing. She had never experienced this before. It's noticeable but did not interfere with daily activities. Event was considered as non-serious. No treatment was received for the adverse event. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
54 2021-02-02 lip swelling swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre... Read more
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
54 2021-02-02 visual impairment Impaired right eye vision. 01/29/2021- Retina Specialist diagnosed: Hemiretinal Vein Occlusion Rig... Read more
Impaired right eye vision. 01/29/2021- Retina Specialist diagnosed: Hemiretinal Vein Occlusion Right Eye. Will begin treatment for ocular injections in the next week
54 2021-02-03 mouth tingling 10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after i... Read more
10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
54 2021-02-03 smell distorsion Typical headaches; muscle aches; nausea; distorted sense of smell (rancid smell and altered smells) ... Read more
Typical headaches; muscle aches; nausea; distorted sense of smell (rancid smell and altered smells) and sense of taste severely diminished at 24 hours after initial dose of vaccine.; distorted sense of smell (rancid smell and altered smells) and sense of taste severely diminished at 24 hours after initial dose of vaccine.; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in the right arm on 22Jan2021 12:15 at single dose for COVID-19 immunisation. Medical history included elevated blood pressure and allergy to raw walnuts and pecans. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included biotin (BIOTIN), vitamin d nos (VITAMIN D NOS), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), fexofenadine, hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ), cetirizine. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 15:00, the patient experienced typical headaches, muscle aches, nausea, distorted sense of smell (rancid smell and altered smells) and sense of taste severely diminished at 24 hours after initial dose of vaccine. No treatment was received for the adverse events. Clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.
54 2021-02-04 dry mouth, mouth tingling, mouth numbness, feeling of choking PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING ... Read more
PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING IN MOUTH AND THROAT. PATIENT BEGAN TO FEEL DIZZY AND WAS PLACED INTO TRENDLENBERG POSITION FOR 20 MINUTES, AFTER WHICH SHE RETRUNED TO HIGH FOWLERS POSITION. SHE CONTINUED TO COMPLAIN OF NUMBNESS AND TINGLING IN MOUTH AND THROAT AND PATIENT REQUESTED EMS BE CALLED. PATIENT WAS NEVER IN ANY APPARENT RESPIRATORY DISTRESS, HR STRONG AND REGULAR, INITAL BLOOD PRESSURE MILDLY ELEVATED, SUBSEQUENT ONES WERE WNL.
54 2021-02-05 eye pain, pain in jaw High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy ... Read more
High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy and nauseous
54 2021-02-05 lip swelling Woke up approximately around 1:30 a.m. with chills. Got up to get ready for work and felt slightly a... Read more
Woke up approximately around 1:30 a.m. with chills. Got up to get ready for work and felt slightly achy so I took my temp and it read 100.6. I ate a piece of toast and took one 500 mg tablet of a Tylenol and went to work but was sent home due to the fever after getting home my aches kept getting worse I developed a headache and my temp fluctuated all day between 99 3 and got as high as 101.7 bye the afternoon. When I went to bed around 10 p.m. my temp had dropped to 99 but my upper lip felt puffy and was slightly swollen. When I got up the next morning at approximately 6 a.m. my upper lip was still swollen and my right cheekbone very was very tender to the touch. Upon submitting this report it is approximately 1:15 Eastern Standard Time and my lips are mostly back to normal but around my mouth is very tender and to my right cheek bone is still very tender to the touch. Other than that headaches are gone fever is gone and I overall feel pretty good.
54 2021-02-05 feeling of choking Rec'd Vaccine and at 2:38 associate C/O burning/tingling in throat. Advised to take Benadryl but dec... Read more
Rec'd Vaccine and at 2:38 associate C/O burning/tingling in throat. Advised to take Benadryl but declined.
54 2021-02-06 mouth numbness Numbness of lips, mouth, chin, upper area of neck
54 2021-02-07 pain in jaw both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles ... Read more
both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles so tight that I was unable to walk/ just a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body); like a spasm; bilateral jaw pain; slight numbness on by left face; face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw; redness on my left cheek; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 21Jan2021 09:15 at a single dose for COVID-19 immunization. Medical history included shellfish allergy. Concomitant medications included received within 2 weeks of vaccination but were not reported. The patient previously took codeine and experienced allergy. On 21Jan2021 11:30, both of her legs seized. The muscles so tight that she was unable to walk (like a spasm). There was no twitch just a muscular contraction that left her unable to walk properly (the left side seem to be the tightest side of by body). The patient also had bilateral jaw pain (not sure if it was because she was in so much pain in the legs that she was clenching my teeth). She also had slight numbness on by left face and by the evening she had redness on her left cheek but it went away. Her face still had a bit of muscle sensitivity (tingling sensation) near the mouth and jaw. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Events were reported as non-serious. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-02-09 mouth numbness Adverse effect: numbness on the right side of body, facial numbness, oral mycosis numbness Treatmen... Read more
Adverse effect: numbness on the right side of body, facial numbness, oral mycosis numbness Treatment: Benadryl Outcome: Recovered in 2 hours
54 2021-02-09 tongue itchiness, taste impairment Immediately post vaccine patient complained of metallic taste in mouth, itchy tongue, diaphoresis an... Read more
Immediately post vaccine patient complained of metallic taste in mouth, itchy tongue, diaphoresis and shortness of breath. On VS Heart rate and blood pressure were elevated O2 sat was WNL. Patient w as placed in a supine position and VS were repeated after 15 min and she felt better and VS were now WNL
54 2021-02-11 gaze palsy, sensitivity to light, eye pain headache, sensitive to light, eyes hurt, fatigue, body aches( felt like i was punched in various pla... Read more
headache, sensitive to light, eyes hurt, fatigue, body aches( felt like i was punched in various place on my body, mild dizziness(foggy feeling), left arm swelling and pain at injection site, stomach pain(mild nausea and achy empty feeling)
54 2021-02-12 taste impairment, dry mouth, tongue disorder, lip swelling metallic taste in mouth; thick/heavy feeling of tongue; feeling of "fat lip" First noticed approxi... Read more
metallic taste in mouth; thick/heavy feeling of tongue; feeling of "fat lip" First noticed approximately 90 minutes post injection. Took Benadryl (1 capsule). Metallic taste faded to dry mouth and other symptoms lessened throughout evening (over course of 3-4 hours). Woke up next morning and all symptoms were resolved.
54 2021-02-12 eye itchiness COVID PSYSR Vaccine observation area 1622 - 20 min after injection c/o itching inside of left ear ... Read more
COVID PSYSR Vaccine observation area 1622 - 20 min after injection c/o itching inside of left ear / left face and left eye VS 150/102 HR 79 O2sat 97% Doctor notified 1628 sx increasing - Benadryl 25mg PO given 1640 sx decreasing VS 157/91 HR 65 1650 face and ear itching resolved.... eye still feel heavy 1700 - feeling well. Left observation area
54 2021-02-12 lip swelling Th 11 Feb: initially flushed face within 15 min of shot; chest pressure and shortness of breath with... Read more
Th 11 Feb: initially flushed face within 15 min of shot; chest pressure and shortness of breath within 30 min-1 hr; took benedryl 3 hrs later before bed but woke up next morning (12 Feb) with similar symptoms; symptoms are continuing into 13 Feb with added swollen lip - tool L-lysine and 5mg levozyterizine antihistimine;
54 2021-02-15 mouth tingling c/o sob, CP, throat tightness, tongue tingling minutes after administration of vaccine. Vitals were... Read more
c/o sob, CP, throat tightness, tongue tingling minutes after administration of vaccine. Vitals were within normal limits. Alert and oriented. Given IM benadryl and Epi. Transported to ED.
54 2021-02-17 swollen tongue Patient experienced dizziness after 1st dose of covid vaccine, BP was 153/68 and reported feeling an... Read more
Patient experienced dizziness after 1st dose of covid vaccine, BP was 153/68 and reported feeling anxious. Was taken to ED due to complaints of tongue and throat swelling wit some shortness of breath. No rash, abdominal pain, vomiting, or diarrhea. In the ED patient received diphenhydramine 50mg IV, epinephrine 0.3mg IM, famotidine 20mg IV, methylprednisolone 125mg IV, and 1000mL of normal saline. Discharged home with an EpiPen and 5mg prednisone daily for 5 days.
54 2021-02-17 ringing in ears Big echo on right ear; Very tired; Discomfort on right arm injection site; This is a spontaneous rep... Read more
Big echo on right ear; Very tired; Discomfort on right arm injection site; This is a spontaneous report from a contactable nurse report for self. This 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, Expiry Date: Apr2021) Intramuscular injected in right deltoid on 24Jan2021 12:00 at single dose for COVID-19 immunization. Patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Diabetes surgically induced in 2013. None prior vaccinations within 4 weeks. She takes flu vaccine each year and never has any problems. None vaccines administered on the same date with BNT162B2. There were no concomitant medications. Patient got the first vaccine on 24Jan2021 and was fine. The next day on 25Jan2021 patient experienced discomfort on right arm injection site, and at 18:00, she was very tired, she wanted to just go to bed and not get up. On 26Jan2021 18:00, she started having a big echo in her right ear, the nurse considered "Big echo on right ear" was medically significant. She could hear herself talking to herself. Since then, she has a difference in her ears. She heard people from a distance if she closes right ear. Right now, it echo's so bad. She did not have a problem with her ear before the vaccine. The ear has improved but persisted. Some noises are intolerable and some are ok. She is going for second dose in 3 weeks. Workplace clinic visit on 28Jan2021. They looked at her ear and had no medical intervention. Events outcome was recovering. Relatedness of vaccine to all events reported "related".; Sender's Comments: By close temporal relationship and absence of factors which may provide an alternative cause the events reported as tinnitus, vaccination site discomfort and fatigue, may be attributed to suspect product BNT162b2; the event vaccination site discomfort is consistent with the known toxicity profile of the suspect product. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-02-21 mouth numbness Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Mov... Read more
Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Moved to tip of nose; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number Em9809), via an unspecified route of administration at single dose in the left arm on 04Feb2021 11:30 for covid-19 immunisation. Medical history included pituitary tumour. The patient had not been tested for COVID-19 prior and post the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included famotidine, paracetamol (TYLENOL), cabergoline, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). On 04Feb2021 12:15, the patient experienced numbness in chin, then lip area. Moved to tip of nose and then several hours later, left eyelid and area between my eyes was completely numb. No treatment required. The outcome of the events was recovered.
54 2021-02-22 eye swelling Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied dif... Read more
Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied difficulty breathing. Benadryl 25mg IM administered and transferred to Emergency Room for further treatment.
54 2021-02-22 swollen tongue, mouth tingling Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin... Read more
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
54 2021-02-22 tongue discomfort, mouth discomfort burning tonge, oral mucosa burning few hours after vaccine dose #1, much milder after vaccine dose ... Read more
burning tonge, oral mucosa burning few hours after vaccine dose #1, much milder after vaccine dose #2
54 2021-02-24 gaze palsy COVID-19 Vaccine Pt received vaccine 1/7/2021 and discharged to home. Pt endorsed one day of nausea... Read more
COVID-19 Vaccine Pt received vaccine 1/7/2021 and discharged to home. Pt endorsed one day of nausea, headache, fatigue, and chills following vaccination. On Monday 1/11/21, pt woke up to a large, red, discolored, warm, grapefruit-sized lump on her arm at site of injection. PA at clinic she worked with was curbsided, who said it might be cellulitis. Pt called her PCP who issued prescription for cephalexin 500 mg cap PO TID x 10 days on 1/11/2021. After 2 days of therapy, pt reports lump is still red, discolored, and grapefruit-sized, but is no longer warm. 2/2/21: Pt received 2nd dose of COVID vaccine without issue.
54 2021-02-24 visual impairment, dry mouth Progress Notes by Family Medicine Nurse Practitioner COVID VACCINE CLINIC 2/19/2021 Patient is ... Read more
Progress Notes by Family Medicine Nurse Practitioner COVID VACCINE CLINIC 2/19/2021 Patient is a 54 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience mouth dryness. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes seasonal allergies (took zyrtec this am as routinely scheduled), htn, hld. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/19/21 1533 02/19/21 1536 02/19/21 1541 02/19/21 1600 BP: (!) 157/91 (!) 164/91 (!) 158/92 (!) 149/87 BP Location: Right arm Pulse: 88 SpO2: 99% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Pt stable and doing well. Pt agreeable to monitor symptoms. Aware of when to seek emergent care. Follow up with pcp otherwise. Pt given ride with one of her co-workers. Pt ambulatory out of the facility. Electronically Signed 2/19/2021 3:41 PM
54 2021-02-25 lacrimation increased Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes aft... Read more
Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes after the shot, the right side of my face felt numb and tingly (Felt like when novocaine is wearing off.) Continued for 48 hours and worsened with slight drooping when smiling. Clearing my throat a lot and my right eye keeps tearing up. The doctor confirmed it was "Bell's Palsy" this morning and I have been put on Prednisone.
54 2021-02-26 visual impairment, mouth numbness Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vis... Read more
Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vision in left eye , chest pain in center of chest and walking imbalance
54 2021-02-28 mouth numbness Pfizer-BioNTech COVID-19 Vaccine EUA: During observation, vaccine recipient complained of lip numbne... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: During observation, vaccine recipient complained of lip numbness. She was monitored by EMS. No further intervention.
54 2021-02-28 mouth tingling Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and i... Read more
Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment. Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm. By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
54 2021-03-01 eye itchiness, lip swelling Post vaccination and while in recovery experienced itchy eyes, proceeded by swelling of upper lip, i... Read more
Post vaccination and while in recovery experienced itchy eyes, proceeded by swelling of upper lip, itchy throat and coughing. Remained alert and oriented to person, place and time. Rapid Response Team called, vaccine recipient transported to Emergency Room. Release to home post recovery.
54 2021-03-02 ear swelling, swollen tongue Rash, hives, swelling face, mouth tongue, nose, ears, eyes. Beet red face. Blood pressure normally... Read more
Rash, hives, swelling face, mouth tongue, nose, ears, eyes. Beet red face. Blood pressure normally low 110/70 but went from 166/86 at 1333 HR 80 02 100%, then BP 163/88 at 1404 HR 74 02 100%, then at 1409 HR 68 BP 175/110 RR24 O2 100% 1405 - 911 called took benadryll at 1330 (25 mg) then again 1349 took 2nd dose of benadryll 25 mg liquid capsules. PT has adverse reactions to epinephrine. 1412 tongue swelling. by 330 pm patient went home prepared to go to ER if anything changed. She walked around in cool air and had hives move around her body. Not shot in upper right arm. It was tasted during injection. Then after the shot reactions kicked in at 20 minutes moving up the right side primarily same as shot side. Arms, chest, and face flush off and on. Swelling moved around.
54 2021-03-02 smell distorsion Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells... Read more
Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells; motion; tired; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: T23248), intramuscular in the left arm on 29Jan2021 at 10:00 AM as a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. The patient did not have COVID prior to vaccination, had no other vaccine in four weeks and was not pregnant at the time of vaccination. Concomitant medications included multivitamins, ibuprofen, and paracetamol (TYLENOL). The patient received the first dose of BNT162B2 on 10Jan2021. On 29Jan2021 at 07:00 PM, the patient experienced uncontrollable chills, stabbing pain all over, headaches, body shakes, nausea, sensitivity to smells, "motion", and tired. The patient was not COVID tested after vaccination. The patient received no treatment for the events. Outcome of the events was recovering.
54 2021-03-02 swollen tongue her tongue swelled/started to have tongue swelling; This is a spontaneous report from a contactable ... Read more
her tongue swelled/started to have tongue swelling; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 54-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1203, expiration date: unknown), via an unspecified route of administration from 26Jan2021 to 26Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient has no medical history. Concomitant medications were not reported. On 26Jan2021, after the administration of the vaccine her tongue swelled and started to have tongue swelling. Therapeutic measures were taken as a result of her tongue swelled/started to have tongue swelling which included Benadryl. The outcome of the event was recovered on an unspecified date.
54 2021-03-03 mouth numbness, mouth tingling 54 y.o. female a past medical history as documented below presenting to the ED for evaluation of pos... Read more
54 y.o. female a past medical history as documented below presenting to the ED for evaluation of possible allergic reaction. She received her 1st COVID-19 vaccine just prior to arrival. Seconds after receiving the vaccine she developed numbness/tingling to the roof of her mouth and her tongue and was advised to come to the ED for further evaluation. She denies swelling of the face, throat, lips or tongue, cough, shortness of breath or difficulty breathing. No headache, visual changes, weakness, extremity numbness/paresthesias. Symptoms improving upon arrival to the ED. Treated with PO diphenhydramine, observed ~ 2 hours and released without incident.
54 2021-03-03 mouth numbness The left side of my face and tongue got numb / tingly. It began to lessen after about an hour and co... Read more
The left side of my face and tongue got numb / tingly. It began to lessen after about an hour and continues to lessen as the day goes on. It is believed that my body may have just responded quickly. I was monitored for a few extra minutes, and then released.
54 2021-03-03 mouth numbness lips numb, chest pressure, flushing, nausea. Evaluated by EMS-Cleared
54 2021-03-04 eye disorder, mouth tingling No adverse reactions other then pain in the injection site and being tired then last night 48 hours ... Read more
No adverse reactions other then pain in the injection site and being tired then last night 48 hours later my eye was twitching. Today it 72 hours later eye twitching again and then this afternoon my bottom lip began to tingle. Called the Urgent care they said come in and I did and the said it is bells palsy and gave me steroids and another drug to take
54 2021-03-05 swollen tongue 5 minutes after vaccine, patient began to feel like her throat was tightening/ closing and that it ... Read more
5 minutes after vaccine, patient began to feel like her throat was tightening/ closing and that it was difficult to swallow. She also reported feeling like her tongue was swelling mildly. She felt mild itching but denied rash, chest pain, or difficulty breathing. Also denied nausea, vomiting, abdominal pain. She received 50 mg of IM Benadryl and was observed until an ambulance arrived to transfer her to an emergency department. She felt better after the Benadryl. Reports a history of similar reaction to eating berries.
54 2021-03-08 mouth numbness Numbness of lips and throat commencing approximately one hour after receiving vaccine. Patient self-... Read more
Numbness of lips and throat commencing approximately one hour after receiving vaccine. Patient self-treated with benadryl and symptoms resolved after about 2 hours.
54 2021-03-08 ringing in ears Chills, mild fever (99.5F) and very loud Tinnitus Fever only lasted 6 hours but tinnitus continues
54 2021-03-09 mouth numbness 15 minutes after receiving the vaccine, my tongue, lips, inside of mouth (roof) and cheeks became nu... Read more
15 minutes after receiving the vaccine, my tongue, lips, inside of mouth (roof) and cheeks became numb. I administered benadryl 30 minutes after receiving the vaccine. The symptoms came and went throughout the next 4 hours. I administered a second dose of benadryl 4 hours after the vaccine and that seemed to reduce the symptoms greatly. My temperature was slightly elevated during this 4 hour period, as well. I took tylenol and that was effective. I had no further symptoms overnight or today. My concerns were about whether or not I should get second vaccine.
54 2021-03-09 mouth pain Brief, intermittent sharp pain on R side of mouth; This is a spontaneous report from a non-contactab... Read more
Brief, intermittent sharp pain on R side of mouth; This is a spontaneous report from a non-contactable consumer. This 54-year-old female consumer (patient) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK5730/expiration date: unknown), via unknown route of administration, on 06Jan2021 as a single dose for COVID-19 immunization at a hospital. Relevant medical history included Hypertension, allergic rhinitis. Relevant concomitant medications included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID), HCTZ, magnesium oxide (MAG OXIDE), multivitamins. The patient was not diagnosed with COVID-19 prior to the vaccination or if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date in Jan2021 about a week after vaccine injection, the patient experienced brief, intermittent sharp pain on R side of mouth, lasted 2 days. The outcome of the event was recovered. The patient did not receive any treatment for the event. It was not known that since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
54 2021-03-09 mouth tingling difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This... Read more
difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL 3246/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 at 08:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: not provided), via an unspecified route of administration, on 26Dec2020 at 10:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included exercised induced asthma, and psoriatic eczema. The patient had known allergies to penicillin, fentanyl, and levofloxacin (LEVAQUIN). Concomitant medication included levothyroxine sodium (SYNTHROID) and atorvastatin (LIPITOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 at 08:15, the patient experienced difficulty inhaling, cough, hives, itching, tongue and lips tingling. The events resulted in an emergency room visit. The patient received treatment for these events which included treatment epi: IV fluids, IV benadryl, Pepcid, Solumedrol then IM. The outcome of the events difficulty inhaling, cough, hives, itching, tongue and lips tingling was recovered with lasting effects (sequel) on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
54 2021-03-10 mouth tingling Tachycardia, tingling in mouth, evaluated by medics, cleared.
54 2021-03-10 swollen tongue scratchy throat and tongue. Tongue feels swollen
54 2021-03-11 taste impairment, tongue discomfort At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning... Read more
At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning for few minutes. The Doctor in place informed that it was a normal reaction. Everything was going well until I went to sleep. I woke up in panic due to not being able to breath. I felt like my brain, face, eyes, and nose were swelling. My chest was compressed. Then I remembered I didn't take any medication; therefore, I took two Advil. After and hour, I noticed that by sitting or walking , I began to feel better. I went back to sleep in a seated position around 4:30. Not sure if I want to take the 2nd dose. I'm frighten. Have an appointment with my Doctor on March 22nd.
54 2021-03-11 eye irritation, eye itchiness Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cou... Read more
Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cough, shortness of breath, traveling leg pain, development of ear infection, dizziness
54 2021-03-11 mouth numbness Around 5:55 I felt a numbing at the top of my leg while seated while waiting my 15 minute wait time.... Read more
Around 5:55 I felt a numbing at the top of my leg while seated while waiting my 15 minute wait time. The numbing continued down the right side of my right leg. I didn't think much of it because I thought it was the way I was sitting. I didn't report it to anybody at that time. I got in my car and my three right toes started to numb. Then I felt it down my arm and the right three fingers. About 15 minutes later my jaw muscle, then up to my temple and across the fatty area of the eyebrow went numb. Several minutes later I noticed my nostril and right side of my tongue numb. It felt like my tongue and face were swollen but when looking in the mirror they were not and there was no drooping when I smiled and raised my eyebrows. It was a similar feeling that I have had when a shot has almost worn off from a dental procedure. The feeling and the movement is there but still tingly. The arm, leg, and toe numbness went away 2-3 hours later on the same day of the shot. I had no numbness on the left side. Two days later I still have the same numbness on my right two fingers, tongue, jaw, eyebrow area, and nostril.
54 2021-03-11 mouth tingling Tingling in mouth started Wednesday (3/10) and hives and little trouble breathing. Patient took Bena... Read more
Tingling in mouth started Wednesday (3/10) and hives and little trouble breathing. Patient took Benadryl and Inhaler. THursday patient still using Benadryl and used Prednisone. Saw MD Friday 3/12. Getting better now.
54 2021-03-11 mouth tingling tingling in tongue and lips, rash on neck, certizine given 10mg
54 2021-03-14 permanent deafness, ringing in ears, ear discomfort, deafness On that day I woke up with hearing loss in my right ear, feeling of fullness and pulsatile tinnitus.... Read more
On that day I woke up with hearing loss in my right ear, feeling of fullness and pulsatile tinnitus. I was seen by my Primary doctors office and given Amoxicillen for days with a Medrol dose pak. After 5 days this did not improve and was seen by ENT. Audiology testing was done and I was diagnosed with Sudden Sensorineural Hearing Loss of my right ear of moderate degree. MRI testing was done on 3/12/2021 and revealed no reason for these symptoms. Prednisone 30 mg was taken for 7 days tapering to 20 mg for 3 days and then to 10 mg for 3 days. Follow up is on April 6 to ENT. Hearing may not return and pulsatile tinnitus may remain.
54 2021-03-14 lip swelling, swollen tongue Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, troubl... Read more
Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, trouble swallowing, difficulty breathing, confusion, chills, difficulty speaking.
54 2021-03-14 mouth tingling Throat & chest tightening, tongue tingling, coughing, trouble breathing - immediately after receivin... Read more
Throat & chest tightening, tongue tingling, coughing, trouble breathing - immediately after receiving vaccine. Pt has extensive medical hx and hx of severe allergic reactions, carries epi pen with her. Epi (given asap after start of symptoms) and Benadryl given here prior to transfer to ED- Medical Emergency Team immediately called at onset of symptoms and transferred to ER with them.
54 2021-03-15 pain in jaw slight rash on arm and legs, sore throat, nausea, severe chills, severe headache, jaw ache, tirednes... Read more
slight rash on arm and legs, sore throat, nausea, severe chills, severe headache, jaw ache, tiredness,
54 2021-03-15 mouth tingling My lips started to tingle (same reaction as cobalt allergy before my lips swell). I asked if I coul... Read more
My lips started to tingle (same reaction as cobalt allergy before my lips swell). I asked if I could take benadryl (which I brought with me). The person watching us texted someone and they came in and looked at me, asked me what was happening, took my blood pressure and said to take 2 benadryl. I told the nurse I only take one benedryl when this happens. She said take 2 benadryl. I did take 2 benadryl 12 minutes after my vaccine. My blood pressure went up. They called an ambulance and I went to the Hospital. My blood pressure was 176/105 at 11:50 am. While I was in the ER, I took a selfie and noticed that I had a rash. No one mentioned that earlier so I am guessing that is why they had me take 2 benadryl. At the ER I was put on an IV - NS .09% 1000ML at 12:27 pm. Then at 13:04 I was given Pepcid 40 MG/NS 250 ML IV at 500 ml/hr intravenous. At 1:12 pm my blood pressure was 138/96 and at 2:31 pm it was 135/70. My rash went away then. Up until last week I have been taking benadryl and/or pepcid everyday since the vaccine. I would still get a rash. I have not had the rash for about 5 days.
54 2021-03-16 mouth itchiness Patient's reaction(s) noted during COVID vaccine observation period: 0754, patient complaints of fe... Read more
Patient's reaction(s) noted during COVID vaccine observation period: 0754, patient complaints of feeling itchy and reddness at injection site, runny nose. No hives noted. 0754: 126/67, 98% O2, 77 HR 0805: 118/66, 98% O2, 75 HR; still c/o itchiness and redness at injection site, post-nasal drip 0820: Pt stated that she is feeling itchy in mouth and is having thicker post-nasal drip. Code Medic called and at bedside within a minute. Taken via wheelchair to ED and pt remained awake and alert. Patient reports previous anaphylactic reaction after receiving the flu shot. Discharged home from ED 1000
54 2021-03-17 mouth tingling Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My li... Read more
Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My lips were tingling and my arms and legs felt suddenly so tired. They monitored me in the reaction tent for 45 minutes until I could sit up and walk. By the time I got home I had a burning rash on my neck and my voice was suddenly hoarse as if I was sick. Just rested and symptoms slowly subsided over the day. I must be hypersensitive to something because this is the third time I have had a reaction like this. The others were with the fly shot. Folks took good care of me.
54 2021-03-17 swollen tongue c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty ... Read more
c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty swallowing saliva by report. No resp difficulty. Resp 16/min - nlabored SPO2 98%, HR 101, BP 160/85. 12:30pm Epi 0.3mg given R. thigh via auto injector by anaphylactic type reaction. All transport to closest ER.
54 2021-03-17 swollen tongue She got the Pfizer vaccine at the medical center at 2:15pm. and her tongue started swelling around... Read more
She got the Pfizer vaccine at the medical center at 2:15pm. and her tongue started swelling around 6pm. It got large enough that she felt that she may soon have difficulties swallowing. After the sides of her tongue started swelling , she took two Benadryl and the swelling gradually went down. Of note, she took two aspirin around 4:30pm and ate grapes and pumpkin seeds before the reaction. Denies shortness of breath, swelling of the lips or eyelids, rash, or any other symptoms.
54 2021-03-18 mouth pain Large boil/nose formed inside right roof of mouth very painful and full of puss. The dentist could ... Read more
Large boil/nose formed inside right roof of mouth very painful and full of puss. The dentist could only drain 1/2 of it. I do have pictures if needed.
54 2021-03-18 tongue discomfort Itchy throat, eyelid edema, burning sensation on the tongue, headache (10/10), neck pain (10/10).
54 2021-03-19 lip swelling, mouth tingling History of histamine poisoning related to tuna. She states she is aware when to go to the ER. Sympto... Read more
History of histamine poisoning related to tuna. She states she is aware when to go to the ER. Symptoms are lower lip swelling, tingling of mouth. Refuses transfer to hospital.
54 2021-03-19 mouth tingling Tongue tingling sensation. BP 154/93 (pulse 96), O2 sat 98%. F/U BP 135/83 (pulse 87). Patient felt ... Read more
Tongue tingling sensation. BP 154/93 (pulse 96), O2 sat 98%. F/U BP 135/83 (pulse 87). Patient felt like her reaction was more anxiety related.
54 2021-03-20 eye swelling At around 7pm, the symptoms started first with diarrhea. 10-20 minutes later, she started sneezing a... Read more
At around 7pm, the symptoms started first with diarrhea. 10-20 minutes later, she started sneezing a lot. She took a Claritin, then took a shower. In the shower, she began feeling itchy everywhere, especially in the face. She developed hives around the body (3-4 small patches on underarm, legs). There was also a hive patch on her left eyelid, which started as a small bump, but worsened while she was in the shower. It grew bigger, taking up half of her eyelid. She came out of the shower 10-15 minutes after she began sneezing. 20 minutes after that, her body hives subsided but the eye hive worsened further. The hive took up her entire left eyelid and the eye was swollen nearly shut. Before going to bed (9:30pm), she took a Benadryl. The eye was still swollen in the morning but less so than the night before. Now, 24 hrs after the symptoms began, the eye hive has almost entirely subsided. She feels less severe symptoms now, like fatigue and scalp tenderness.
54 2021-03-21 pain in jaw, mouth tingling When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left ... Read more
When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left side of my face was swollen around the cheek. I have a little soreness around the jaw. My left are was sore to the touch and slight stiff where I cannot raise my arm all the way. I took 2 Benadryl tablets.
54 2021-03-21 swollen tongue, mouth tingling Patient reported having trouble breathing, tongue swelling, tingling sensation on lips. States havin... Read more
Patient reported having trouble breathing, tongue swelling, tingling sensation on lips. States having this same reaction last time she used her prescribed epi pen . Administered epi pen at 12:55. Symptoms subsided after injection given in right thigh. Paramedics called and took her to nearest hospital for further evaluation.
54 2021-03-21 swollen tongue Patient returned to vaccination POD after developing tongue swelling within one hour of vaccine admi... Read more
Patient returned to vaccination POD after developing tongue swelling within one hour of vaccine administration Patient took her own Benadryl with resolution of symptoms.
54 2021-03-22 loss of taste, loss of smell Received dose 1 of Pfizer COVID-19 vaccine on 12/24/2020. On 12/27/2020 patient developed chills, ... Read more
Received dose 1 of Pfizer COVID-19 vaccine on 12/24/2020. On 12/27/2020 patient developed chills, body aches, cough, loss of taste/smell, and congestion
54 2021-03-22 ear pain, eye pain, ringing in ears The night of the injection I had a headache and chills no fever. In the morning my headache was a m... Read more
The night of the injection I had a headache and chills no fever. In the morning my headache was a migraine no energy and a rash on forehead. My evening my head was on fire and blister formed on rash. My ear was ringing and hurt It was painful to swallow. Went to ER and was Dx with shingles was prescribed valtrex 1gram q8 hours and lotramin lotion
54 2021-03-22 vision blurred After receiving my second dose, i started to feel very sick, by the second day after the vaccination... Read more
After receiving my second dose, i started to feel very sick, by the second day after the vaccination, I had a severe headache, my eyes couldn't focus i was nauseous and i was vomiting, sever upper body pains, it was the worst headache I have ever had in my life, my husband took me to the emergency room yesterday and i was there all day, I had a neurological exam, blood work and chest x-ray, everything came back negative, i was told my the attending physician that it was the side effects of the second dose of the Pfizer Vaccine. I was given Motrin 600mg and Metoclopramide via intravenous, several hours later, i was feeling a bit better and i was released from the hospital by 4:30pm.
54 2021-03-23 taste impairment Metallic taste and L shoulder pain
54 2021-03-23 swollen tongue EMS narrative: NARRATIVE RESPONDED TOFE FIELD FOR A 54 YEAR OLD FEMALE HAVING ALLERGIC REACTION. AR... Read more
EMS narrative: NARRATIVE RESPONDED TOFE FIELD FOR A 54 YEAR OLD FEMALE HAVING ALLERGIC REACTION. ARRIVED ON SCENE TO FIND PT SITTING UPWRITE ON A BED. PT IS ALERT AND ORIENTED. PT DOES NOT APPEAR TO BE IN DISTRESS. STAFF MEDIC CLAIMS THE PT RECEIVED HER FIRST VACCINATION AND BEGAN TO HAVE A REACTION. PT STATES HER TONGUE BEGAN TO SWELL UP AND HAD DIFFICULTY BREATHING. STAFF STATES THEY GAVE THE PT BENADRYL AND SOLU-MEDROL. PT HAS ALREADY IMPROVED WITH THE MEDICATIONS. PT STATES SHE FEELS MUCH BETTER AND HAS NO SHORTNESS OF BREATH. PT SHOWS NO SIGNS OF ALLERGIC REACTION. PT WANTS TO BE TRANSPORTED. PT WAS ABLE TO STAND AND SIT ON THE COT WHERE ALL STRAPS AND RAILS WERE APPLIED. PT WAS BROUGHT TO THE AMBULANCE WHERE VITALS WERE ASSESSED AND MONITORED. PT WAS TRANSPORTED WITHOUT INCIDENT.T PT WAS BROUGHT INTO THE FACILITY WHERE CARE WAS TRANSFERRED TO RN.
54 2021-03-24 lip itchiness, bloodshot eyes severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; ha... Read more
severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; hair loss; headaches; Anaphylaxis; hives; itching breathing, lips, throat impacted; itching breathing, lips, throat impacted; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 23Feb2021 at 01:00 PM (at age of 54-year-old) as SINGLE DOSE for covid-19 immunisation, Lot Number: EN6198. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 03Feb2021 in Left arm for COVID-19 immunisation, Lot number: EL8982. Medical history was not reported. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 23Feb2021 within 20 mins patient experienced anaphylaxis, hives, itching breathing, lips, throat impacted. On 23Feb2021 at 02:00 PM (also reported as over next week) patient experienced severe fatigued; red eyes; fever; darkened skin in face; subsequent results, Itchy scalp and subsequent hair; seeing hair loss continuing and fatigue, headaches ongoing thus far. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatments received included Anaphylaxis medicine, intravenous (Iv) administration; prescript. Patient had not recovered from the events, at the time of the report.
54 2021-03-24 pain in jaw Within a couple of hours post shot I started getting a headache and had some stiffness and pain in m... Read more
Within a couple of hours post shot I started getting a headache and had some stiffness and pain in my head and jaw. When I woke up the next morning (18 hrs post shot) I was running a fever (highest documented was 100.4), body aches (felt like I had been hit by a truck), pounding headache and chills (couldn't get warm despite several blankets). This continued all day (hours 18-34 post shot). Fever broke around hour 34 and at hour 42 post shot all symtpoms have resolved.
54 2021-03-24 mouth tingling Feeling "light" and tingling in hands and lips
54 2021-03-25 ear pain Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for... Read more
Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for over 12 hours. Left side of the neck pain, left lymph node glands under the arm severely swollen, earache and left side, and extreme fatigue. Now 43 hours later after the injection I can move my arm but still cannot touch the site of the injection, left ear still hurts, left side of neck still painful but better. Can now lift arm above had but still feels very heavy. The lymph node glands under her left arm has reduced in size but still sore to the touch. I?ve been taking ibuprofen for the last two days to help with the discomfort.
54 2021-03-25 lip swelling, mouth itchiness Lip swelling beginning 48 hours following 1st dose of vaccine. Lips swollen, tight, dry and mildly i... Read more
Lip swelling beginning 48 hours following 1st dose of vaccine. Lips swollen, tight, dry and mildly itchy. Little bumps around the edges of both upper and lower lips.
54 2021-03-25 taste disorder Immediately after vaccination patient felt flushed and had "a funny taste in her mouth". She was eva... Read more
Immediately after vaccination patient felt flushed and had "a funny taste in her mouth". She was evaluated by an on-site EMT and symptoms resolved within 30 minutes. Patient has a history of panic attacks.
54 2021-03-26 dry throat Throat tightness and dryness, facial tingling. After 10 minutes, persistent and worsening throat tig... Read more
Throat tightness and dryness, facial tingling. After 10 minutes, persistent and worsening throat tightness, facial tingling. Given Epipen and albuterol. Sent to ED.
54 2021-03-26 ear pain 19th Mar - Day 1 - Slight tightness at the area of injection 20th Mar - Day 2 - no symptom 21st Mar ... Read more
19th Mar - Day 1 - Slight tightness at the area of injection 20th Mar - Day 2 - no symptom 21st Mar - Day 3 - no symptom 22nd Mar - Day 4 - no symptom 23rd Mar - Day 5 - no symptom 24th Mar - Day 6 - irritated throat after dinner 25th Mar - Day 7 - Sore throat, ear ache, full body and joints ache, temperature between 99 and 101, spoke to NP, was ordered Covid test 26th Mar - Day 8 - Sore throat (throat hurts while swallowing), body & joints ache, feverish (no fever), 27th Mar - Day 9 - Sore throat (throat hurts while swallowing), body & joints ache, feverish (no fever),
54 2021-03-26 ringing in ears, smell distorsion Everything smells like rotting meat, ringing in my ears, body pains all the time.
54 2021-03-26 toothache Three teeth and gums on right side of mouth hurt for 24 hours a few days following the 1st vaccine. ... Read more
Three teeth and gums on right side of mouth hurt for 24 hours a few days following the 1st vaccine. I had rapid heartbeat for 2 1/2 weeks after the first dose and almost did not return for the 2nd dose because of this.
54 2021-03-27 dry mouth, eye irritation Fever, chills, joint aches, headache, dry mouth, burning eyes, all body aches
54 2021-03-28 mouth numbness, mouth tingling This side effect randomly happens to me 2-3x/year, I wasn't overly concerned and just watched it. I ... Read more
This side effect randomly happens to me 2-3x/year, I wasn't overly concerned and just watched it. I have no idea what triggers it so it may not be vaccine-related Vaccine: 9am MT. About 25 minutes after the vaccine (9:25am) , my lips started tingling and went numb. Within 10 minutes or so, the tingle/numbness travelled to my entire face and inside my mouth and tongue. I waited 90 minutes then self-treated with two Benadryl tablets (11am). Tingle/numb were gone 1-1:30ish.
54 2021-03-28 mouth ulceration, eye pain it took about 24 hours for: oral ulcers /sores, stye in right eye, 3.5 above normal degree fever. It... Read more
it took about 24 hours for: oral ulcers /sores, stye in right eye, 3.5 above normal degree fever. It took 36 hours for: diarrhea
54 2021-03-28 bloodshot eyes Sudden onset of red flushed face, burning sensation of face, red bloodshot eyes 30 hours post inhjec... Read more
Sudden onset of red flushed face, burning sensation of face, red bloodshot eyes 30 hours post inhjection No other body part impacted. No fever, no other symptoms
54 2021-03-28 mouth tingling heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immed... Read more
heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
54 2021-03-28 ringing in ears Worsening of existing light tinnitus. Prior to COVID vaccine, had only a small, barely noticeable r... Read more
Worsening of existing light tinnitus. Prior to COVID vaccine, had only a small, barely noticeable ringing in my ears. Now, the ringing is accompanied by a heaviness, throbbing. Not painful but distracting and makes me feel foggy.
54 2021-03-29 blindness in both eyes I did not have a reaction until I got home on Jan 4th, 2021. I had a headache for a solid 2 weeks. ... Read more
I did not have a reaction until I got home on Jan 4th, 2021. I had a headache for a solid 2 weeks. Lost my vision right eye on Feb 1st with extreme vertigo ended up in the hospital. After a few tests they found a heart defect ASD. Never in my life have I been told I have had a heart condition. I am correlating it to the vaccination because for the 4 solid weeks before I ended up in hospital I was so sick.
54 2021-03-29 ringing in ears A couple of hours after receiving the 1st dose of the Pfizer vaccine my ears started to buzz. I?ve b... Read more
A couple of hours after receiving the 1st dose of the Pfizer vaccine my ears started to buzz. I?ve been waiting to see if this would improve but 1 week later I still have fairly loud tinnitus in both ears.
54 2021-03-29 eye floaters, vision blurred Noted haziness in left eye and floater 11 days after shot I wear prescription glasses and I noticed... Read more
Noted haziness in left eye and floater 11 days after shot I wear prescription glasses and I noticed a difference in terms of my vision both near and far. I ignored at first but it got worse. I was due for my annual Ophthalmologist eye exam in mid January and they did the visual exam That looks behind the eyes. it was noted that o had CEBTEAL RETINAL VEIN OCCLUSION . I was emergnetly referred to. a retinal Specialist that same day and he injected my eye with AVASTIN. after one month, another visual exam was done and marked improvement was noted but I still had hazy vision despite corrective lenses and Ithat annoying floater seems to be permanent. I will see retinal Specialist again in 2 weeks.
54 2021-03-30 dry mouth 3/27 the morning after the shot Large Scarlet colored blotches were noted all over face and neck. T... Read more
3/27 the morning after the shot Large Scarlet colored blotches were noted all over face and neck. These blotches were 3 to 5 inches in diameter. Face felt "burning hot" Also present were Extreme full body heat flashes, lightheadedness and dry mouth. 3/28 the blotches were not faded but started to become raised. 3/29 the blotches became dry and irritated. Treated with increased water intake and 25 mg Benadryl at night. Cool rags to the face to relieve the heat.
54 2021-03-30 taste disorder Rec'd vaccine at 12:30pm. Next couple hrs were normal, except tasted a fume-like vapor in back of t... Read more
Rec'd vaccine at 12:30pm. Next couple hrs were normal, except tasted a fume-like vapor in back of throat. By 6 pm I started feeling aches, especially my joints and muscles. Was at a laundrymat and pulling clothes out of dryer -felt impossible to hold them up...burning and aching in shoulders and neck. Feel waves of fatigue. Left, went home...felt hot and clammy. Took temp- it was 101.7. Took tylenol, gabapentin, and went to sleep in recliner. Woke up at 11 pm, severe muscle weakness...so much that by the time I got out of the recliner...and on my feet...I already began to urinate on myself. It was like I could not control my body...I had very little ability to get up and out of recliner...everything was so HEAVY....my arms and legs were "weighted". After using restroom...it took 15 min just to change out of soiled clothing and clean up...and re-dress. I laid down in the bed, but was very uncomfortable...so went back to recliner. Was physically unable to get the lid off the tylenol after trying very hard....I fell back to sleep. At 3:15 am I woke up needing to pee, and once recliner was at normal seated position...I struggled to use my arms to lift myself up...my right arm, where I got vaccine hurt badly...it felt like PAIN...like beyond sore. I pitched to floor cuz legs wouldn't hold me. My fever was 103.7... J feel hard-pressed to finish cuz I got a warning im about to time out. Guess I hope someone contacts me. I hav
54 2021-03-31 mouth discomfort Burning lips that day and then swollen, peeling lips for more than 1 mo after
54 2021-03-31 thirst Awoke feeling dehydrated and very thirsty. One hour later experienced extreme nausea and vomiting f... Read more
Awoke feeling dehydrated and very thirsty. One hour later experienced extreme nausea and vomiting followed by fever of 101.4 with chills/body aches and extreme fatigue. Symptoms decreased after one dose of OTC analgesics and continued to improve over next 48 hours.
54 2021-03-31 vision blurred 3/25/21- 6:30 pm vaccine shot 3/26/21 ~ 9:30- 10:00 am Chills, high fever reaching 103 (rising stead... Read more
3/25/21- 6:30 pm vaccine shot 3/26/21 ~ 9:30- 10:00 am Chills, high fever reaching 103 (rising steadily throughout the day after injection), fatigue, confusion, wiped out, couldn't move for 7-8 hours, unable to stay awake or focus/function on anything, Fever broke about 6 pm after taking Tylenol a couple hours earlier. Nausea, and weak 3/27/21- fatigue, body aches (lower back hurt, head hurt), night sweats 3/28/21 fatigue, body aches (lower back hurt, shoulders and neck hurt, stiff neck, body temperature dropped to 96
54 2021-03-31 vision blurred 10:15 - patient complained she was feeling dizzy, had the chills, and blurry vision. 10:16 - vital s... Read more
10:15 - patient complained she was feeling dizzy, had the chills, and blurry vision. 10:16 - vital signs taken BP 158/104, P 108, T 98.0, O2 98% R 16. Charge nurse informed. Patient was advised to sit in the front of observation for monitoring. 10:30 - Patient complained her vision was getting worse. Vital signs taken BP 149/100, P 104, T 98.0, O2 99%, R 16. Patient was given 50mg Benadryl orally as advised by the charge nurse. Monitoring continued 10:38 -Nurse asked the patient if she had eaten anything, patient was given gatorade. 11:15 - Vital signs retaken BP 138/80, P 80, T 98.0, R 16,, O2 98%. Patient without any signs of distress. States she feels better and ready to go. Patient educated about the side effects of the vaccine and what to do. Patient checked out and left in stable condition.
54 2021-04-01 eye irritation Red raised rash on face, small clear pimples on fingers, eye irritation,,inflamed throat
54 2021-04-01 ringing in ears Since I woke from an afternoon nap, I can hardly hear and there is intense ringing in my ears (right... Read more
Since I woke from an afternoon nap, I can hardly hear and there is intense ringing in my ears (right worse than left). My injection was at 11:23am and I woke up with this at 5:20pm. I have no cold or sinus symptoms and never have ear problems.
54 2021-04-02 taste impairment Metallic taste in mouth immediately after injection; stronger over time
54 2021-04-02 lacrimation increased Runny nose, watery eyes, liquid in right ear,
54 2021-04-02 ringing in ears Ringing in my ears began almost immediately, and hasn't improved.
54 2021-04-02 tongue itchiness Itchy tongue/throat, redness of neck and chest 10mg zyrtec given, sx resolved
54 2021-04-03 loss of taste, eye swelling, lacrimation increased Initially rapid heart rate for 15 min then back to normal. later was tired, went to bed early woke... Read more
Initially rapid heart rate for 15 min then back to normal. later was tired, went to bed early woke up at 2 am and had swelling in face, throat and swollen eyes. Took Pepcid for itchy eyes. In the morning took Benadryl and slept on April 2. Hours later, most of the swelling was gone. Felt like a cold was coming on, running eyes, running nose, sneezing and loss of taste. 48 hours later, cold symptoms linger feeling tired. Still feel some swelling in the glands on neck .
54 2021-04-03 ear discomfort Dizziness when turning in bed, getting up from bed or standing from a sitting position. Dizziness w... Read more
Dizziness when turning in bed, getting up from bed or standing from a sitting position. Dizziness will also occur when still for no apparent reason. Periods of vertigo. Head feels heavy and I?m feeling pressure in my ears. Will sometimes need to steady myself by holding on to chairs, walls, counters etc when walking for fear of losing my balance. Sometimes the dizziness is accompanied by a headache. Increased joint pain in my knees but that may or may not be vaccine related.
54 2021-04-03 ringing in ears Ringing constant hissing in the ears. Never had tinnitus prior
54 2021-04-03 ringing in ears Sudden onset of tinnitus in my left ear. Still ongoing as of 10 days later. Very prominent hissing.
54 2021-04-04 mouth itchiness, tongue itchiness, mouth swelling, swollen tongue Headache, itching and swelling of the tongue and roof of the mouth. Onset 11:15am. 50mg oral Benadry... Read more
Headache, itching and swelling of the tongue and roof of the mouth. Onset 11:15am. 50mg oral Benadryl given, vital signs monitored. Progressed to nausea, dizziness and SOB. One IM EpiPen injection in the right thigh. First responder called and transferred patient via wheelchair to Emergency Room after rapid deployment team evaluation.
54 2021-04-04 mouth tingling, feeling of choking left side numbness and tingling throat 1/2 closed, right side lip
54 2021-04-05 taste impairment 1/2 an hour after receiving the vaccine there appeared to be a liquid secreting from my tongue tasti... Read more
1/2 an hour after receiving the vaccine there appeared to be a liquid secreting from my tongue tasting like metal. Later that night I have body aches and was sluggish for about two days after the vaccine. Walking across the room was very tiring.
54 2021-04-05 lip swelling, eye swelling Symptons: swollen face, lips, eyes, lymph nodes, rash on face, bad itching on face, extremely dry f... Read more
Symptons: swollen face, lips, eyes, lymph nodes, rash on face, bad itching on face, extremely dry face and lips Treatment: steroid shot and steroid pack and Benadryl tabs as needed for itchy
54 2021-04-05 mouth tingling Patient waited 15 minutes and then left the store. about 30 minutes later the patient called the pha... Read more
Patient waited 15 minutes and then left the store. about 30 minutes later the patient called the pharmacy stating her tongue started to tingle and her face was starting to swell.
54 2021-04-05 ringing in ears Tinnitus in both ears.
54 2021-04-06 mouth numbness, taste impairment Within minutes of getting the shot I got a metal taste in my mouth and my mouth/lips/cheeks ON THE L... Read more
Within minutes of getting the shot I got a metal taste in my mouth and my mouth/lips/cheeks ON THE LEFT SIDE ONLY started getting numb. Paramedics took my blood pressure (usually normal) and it was very high (around 150/105). Paramedics monitored my blood pressure until it went back to normal (30-40 minutes), then I went home. The numbness got worse for 2-3 hours (eventually the area of my face around my left eye also got numb). Then the numbness started to slowly fade and it was totally gone in 48 hours.
54 2021-04-06 swollen tongue Wheezing, difficulty breathing, swollen throat and tongue... Same reaction as when I take aspirin.
54 2021-04-06 ringing in ears, ear pain Ringing in the right ear. Ear Pain, WORST HEAD ACHE I have ever had in my life. The head ache has... Read more
Ringing in the right ear. Ear Pain, WORST HEAD ACHE I have ever had in my life. The head ache has lasted over a week. The ear pain has lasted over a week. The ringing in the ear comes and goes.
54 2021-04-07 mouth numbness numbness surrounding mouth similar to when she gets B12 injections. No SBO, trouble swallow, etc.
54 2021-04-07 taste disorder Dizzy Bad taste in mouth Chest pressure Went to ER and was monitored and tested to make sure heart... Read more
Dizzy Bad taste in mouth Chest pressure Went to ER and was monitored and tested to make sure heart was fine and all came out fine.
54 2021-04-07 ringing in ears tinnitus started within hours of vaccine
54 2021-04-07 tongue itchiness itchy, arm, face, tongue, back of throat. No difficulty breathing. No swelling of tongue or throat.... Read more
itchy, arm, face, tongue, back of throat. No difficulty breathing. No swelling of tongue or throat. Vitals stable. Given 50 Benadryl oral. symptoms gradually subsided.
54 2021-04-08 loss of taste, swollen tongue, lip swelling Swelling of lips, tongue and neck within 15 minutes of injection. Was monitored for 30 minutes. Sw... Read more
Swelling of lips, tongue and neck within 15 minutes of injection. Was monitored for 30 minutes. Swelling did not progress and went down throughout the day. Lost sense of taste for a day. Arm became very sore the day after receiving injection. Felt like I had the flu in that one arm. Pain was a 7 on 1-10 pain scale with 10 being the worst. Arm continues to hurt from 3 inches above elbow up to shoulder joint to this day. After receiving 2nd shot in right arm on 01/09/2021, the left hurt worse than the right arm. The right arm did not hurt immediately after the shot like the left one did. I can pinpoint and place my finger on the place I received both injections still. Both continue to hurt in the same areas up my forearms.
54 2021-04-08 loss of smell The day after had fever, chills, headache, dermal pain, aches, could not smell, and fever blisters i... Read more
The day after had fever, chills, headache, dermal pain, aches, could not smell, and fever blisters in mouth. The fever has improved, dermal pain went away, still has headache, body is soar, fatigued, and cannot smell. to stay home form work until 10 days from onset of symptoms due to the fact that we are not sure if it is covid or not.
54 2021-04-08 eye itchiness Experienced very itchy eyes approximately 25 minutes after the injection which lasted for about 3 ho... Read more
Experienced very itchy eyes approximately 25 minutes after the injection which lasted for about 3 hours.
54 2021-04-08 oral mucosal blistering Systematic Inflamation 7 days post injection. Swollen hands/feet (10 days), Hiccups, stomach crampin... Read more
Systematic Inflamation 7 days post injection. Swollen hands/feet (10 days), Hiccups, stomach cramping (no nausea or diarrhea ), neck nerve pain that went behind shoulder blade (couldn't move for 3 days), bubbles in the back off my mouth after eating (looked like big blisters filled with fluid but never popped). Low blood pressure (99/65), low body temperature with chills (95.3F), dizzy on standing, blue finger tips loss of balance all lasting 1 day (most likely caused by mild reynod's). Subsided by day 17.
54 2021-04-09 dry mouth 3 days after receiving 2nd dose many side effects presented causing several trips for medical care F... Read more
3 days after receiving 2nd dose many side effects presented causing several trips for medical care Fever, abdominal cramps much like a consistent runner's cramp, high BP, head ache, dry mouth feeling of burnung skin, heaviness/ tiredness in arms and legs, extreme tiredness ER dr confirmed adverse reaction to vaccine, Adverse symptoms are still present after 10 days Dr informed that symptoms may be present for weeks. I have been incapacitated by symptoms
54 2021-04-09 swelling of eyelid, vision blurred Slightly blurred vision after the 2nd dose. It is saturday April 10 now and my right eyelid is a b... Read more
Slightly blurred vision after the 2nd dose. It is saturday April 10 now and my right eyelid is a bit red and puffy. I?ve taken Allegra each day since the 7th and using a cold compress now and it seems to help
54 2021-04-09 ringing in ears My mild tinnitus is now louder and disruptive - got worse after vaccine
54 2021-04-09 toothache, ear pain SUPRACLAVICULAR ADENOPATHY - SWOLLEN, TENDER LEFT SHOULDER, NECK, EARACHE, TOOTHACHE
54 2021-04-10 lip swelling Dizziness, fast heartbeat, swollen lips and throat, chest pain. called health care provider, was tol... Read more
Dizziness, fast heartbeat, swollen lips and throat, chest pain. called health care provider, was told to go to emergency.
54 2021-04-10 swelling of eyelid Right eye swollen shut/ taking prednisone
54 2021-04-10 ringing in ears, deafness Tinnitus, blocked hearing in right ear.
54 2021-04-11 lip swelling Dizzy, headache, nausea, red face & neck, itchy/scratchy throat, labored breathing, swollen lips, ve... Read more
Dizzy, headache, nausea, red face & neck, itchy/scratchy throat, labored breathing, swollen lips, very sweaty, chills, labored breathing, swollen muscle/injection site
54 2021-04-11 ringing in ears Stopped breathing while sleeping, my husband said I was snoring very loudly (which is not typical) a... Read more
Stopped breathing while sleeping, my husband said I was snoring very loudly (which is not typical) and I just stopped. He tried waking me and I didn't wake right away. He got up, turned on the light, noticed that I had wet the bed and he continued to shake me and called my name several times, then I opened my eyes. My speech was a bit slurred at first, I got out of bed, felt nauseous, and my ears were ringing very loudly. I sat up for a while, then went back to bed. I didn't connect it to the vaccine, but wondered about the connection. Then I heard it happened to someone else, so I thought I should report it. I did not seek medical care.
54 2021-04-12 blindness, vision blurred, eye pain Right became pink initially the next day, the on 3rd day eye sight was compromised by film over eye ... Read more
Right became pink initially the next day, the on 3rd day eye sight was compromised by film over eye and throbbing pain behind the eye. Sight was almost completely impaired.
54 2021-04-12 mouth tingling, lip swelling patient felt tingling senstation in lips with slight swelling after fifteen minutes, which the swell... Read more
patient felt tingling senstation in lips with slight swelling after fifteen minutes, which the swelling stopped in lips but the tingling sensation traveled to the tongue. after 1 hour the tingling remained in the tongue but the lips no longer tingled. referred patient to seek urgent care or ER if the tingling sensation spread and persisted
54 2021-04-12 mouth tingling Around 0855, patient stated she was having tingling on tongue and didnt feel well. Gave 25 mg Benadr... Read more
Around 0855, patient stated she was having tingling on tongue and didnt feel well. Gave 25 mg Benadryl po. 0900 pt co tightness in chest. Monitored patient and vital signs until 0945. Pt stated she felt better around 0935. Patient ambulated from clinic without episode
54 2021-04-12 swollen tongue Starting about 25 minutes after the injection I had Minor tongue and throat swelling ,severe headach... Read more
Starting about 25 minutes after the injection I had Minor tongue and throat swelling ,severe headache, pain at injection site with stiff muscles and a lump following about 8 hours after injection.
54 2021-04-12 ringing in ears, deafness Tinnitus, and hearing loss
54 2021-04-12 ringing in ears, ear discomfort, ear pain, hearing loss Experienced significant increase in tinnitus issues-louder ringing in ears, noticeable difference in... Read more
Experienced significant increase in tinnitus issues-louder ringing in ears, noticeable difference in volume and "swooshing" (like air escaping a tire loudly), a sensation of puffiness and impacted hearing, some pain and earaches. Vertigo issues increased significantly, dizziness and unsteadiness.
54 2021-04-12 vision blurred Headache (80 hours), blurred vision (36 hours), brain fog (72 hours), fatigued (72 hours), chills (2... Read more
Headache (80 hours), blurred vision (36 hours), brain fog (72 hours), fatigued (72 hours), chills (24 hours).
54 2021-04-13 eye swelling Hives on face, neck and chest. Itching all over. Eyes swollen. No swelling of tongue or throat.
54 2021-04-13 swollen tongue No adverse events reported by patient to site staff. Pt reported a dry cough, tongue swelling sensat... Read more
No adverse events reported by patient to site staff. Pt reported a dry cough, tongue swelling sensation with mild dysphagia, anxiety and weakness 1 hour prior to ED presentation, roughly 1.5hours after shot provided, suggesting onset ~30 min after injection. Pt took chlorpheniramine with partial relief of symptoms.
54 2021-04-13 vision blurred Patient reports dizzy, "sensation in chest", blurry vision, and "feeling drunk" and short of breath... Read more
Patient reports dizzy, "sensation in chest", blurry vision, and "feeling drunk" and short of breath occasionally about 20 mins after vaccine. blood glucose level checked -315, patient adjusted own insulin pump. Felt better at 1:06pm.
54 2021-04-13 visual impairment Patient reported chest pressure/pain rated 8/10 and dizziness at 14:07. Patient was breathing and ta... Read more
Patient reported chest pressure/pain rated 8/10 and dizziness at 14:07. Patient was breathing and talking. Patient stated her vision was going in and out. Patient offered EMS. EMS activated. Vitals assessed: BP 126/80 mmHg, HR 50 bpm, 94% SpO2. Patient stated she wanted water. Patient given water. EMS arrived and assumed care at approximately 14:15. Patient transported via ambulance. Patient left facility at approximately 14:25.
54 2021-04-13 visual impairment Patient reported feeling ''weird''/lightheaded and seeing green dots. Patient was placed in a wheelc... Read more
Patient reported feeling ''weird''/lightheaded and seeing green dots. Patient was placed in a wheelchair and brought to a private observation area. On arrival patient was unresponsive and drooling. EMS was notified. Upon EMS arrival patient became arousable and was talking without difficulty. Vitals and telemetry wnl. Patient reported a similar syncopal episode with blood draw in the past. Patient was stable AAO x3. Patient agreed to have a friend drive her home, f/u with PCM if recurrent symptoms, and ER if new or worsening symptoms.
54 2021-04-14 ringing in ears My ears started ringing loudly about 5 hours after I received the vaccine and now, four days later, ... Read more
My ears started ringing loudly about 5 hours after I received the vaccine and now, four days later, my ears are still ringing.
54 2021-04-15 swollen tongue tongue swelling, sob
54 2021-04-15 ringing in ears Tinnitus began a few days after I received the vaccination. It has not gone away.
54 2021-04-16 lip swelling I had the 2nd vaccine on Thursday afternoon. My arm was sore but that was it. Then I woke up in mi... Read more
I had the 2nd vaccine on Thursday afternoon. My arm was sore but that was it. Then I woke up in middle of the night (3:00 am) Friday night/Saturday morning and noticed an itchy spot that felt like a mosquito bite. I went back to sleep and when I got up around 7 I was itchy in several spots and had welts. I had them on my left hip and part of stomach, on the right side under bra band, my left thigh, and my right arm. it is not where the shot was, it is under part of arm from underarm to almost my elbow. These all started about quarter size and are now as big as my hand or bigger. One also came up on top of left shoulder but it is still small, that one just came up around 7 pm. And my lip swelled up a little around 5 pm but just on one side of top lip. All of these welts are very itchy.
54 2021-04-16 mouth swelling, swollen tongue Patient received her 1st dose of Pfizer. Patient stated that se began to feel her face swelling. I... Read more
Patient received her 1st dose of Pfizer. Patient stated that se began to feel her face swelling. I asked her to remove her mask and could see the her face, mouth and tongue was swollen and she was tachypneic. I called a Nurse Alert (Rapid Response) and the Nursing staff brought the emergency kit. 911 was called by another nurse. Epi and Benadryl were administered intramuscularly. Patient was placed on continous pulse ox and vital sign monitoring. O2 was given to the patient. Clients vitals began to stabilize despite the continued swelling of her mouth and tongue. Firetruck arrived at 733pm and the ambulance arrived approx 3 minutes later. Patient transported to the hospital accompanied by her spouse.
54 2021-04-16 oropharyngeal discomfort My throat at first starting feeling weird and I realized my throat was starting to close. It then s... Read more
My throat at first starting feeling weird and I realized my throat was starting to close. It then started to feel hard to swallow. I took a Benadryl since I have experienced this in the past if it does not get better within an hour I will go to urgent care.
54 2021-04-16 mouth tingling A family member of the patient state the she felt heavy tongue immediately after getting the shot. ... Read more
A family member of the patient state the she felt heavy tongue immediately after getting the shot. Later the patient started to have trouble breathing and difficulty swallowing. A family member reported that the patient have involuntary movements . nThe patient was given first aid and is transported to the ER
54 2021-04-16 ringing in ears Ringing in my ears
54 2021-04-16 ringing in ears Tinnitus - no known cure
54 2021-04-17 taste impairment, mouth discomfort, swollen tongue, tongue discomfort Within 5 minutes of administration experienced metallic taste. followed by limp and facial tingle an... Read more
Within 5 minutes of administration experienced metallic taste. followed by limp and facial tingle and burn. Did not progress for the 15 min watch time. stopped at store and started having tongue and soft palate swelling and burning. Had taken zrtec in am for seasonal allergies . Went home and took 50 mg of benadryl . No hives, itching on face and neck only ( mild). Reaction did not progress.
54 2021-04-17 taste impairment Metallic taste for approximately 8 hours
54 2021-04-18 mouth discomfort, taste impairment Around 1:15pm on 4/14/21 about 30 minutes after receiving dose 1 of the Pfizer vaccine, my body sta... Read more
Around 1:15pm on 4/14/21 about 30 minutes after receiving dose 1 of the Pfizer vaccine, my body started to feel itchy, mainly on my back and arms. I was able to examine my face and body around 1:30pm when I noticed some blotchy, unraised pink rashes on my face near my ears, on my upper back near my shoulders and on my inner thighs near my knees. With it being allergy season in NJ, I would have typically taken Claritin the night before. But because I was getting the vaccine, I did not as per my understanding of CDC guidelines. At around 1:45pm, I took a Claritin Redi-tab. Approximately an hour later, the blotchiness resolved. However, the itchiness continued throughout the rest of the day, albeit less so. Around 4:30pm, I started to experience a headache, a metallic taste in my mouth, as well as a sensation on my lips that felt like sunburn. The headache was on and off and last until the next day. The metallic taste and sunburn sensation lasted a few hours. I treated with Advil and took a Benadryl before bed to deal with the itchiness. I have had some headaches throughout the week. This weekend I experienced some arm discomfort in my left arm.
54 2021-04-19 eye pain Headache, eye pain, dizziness. Headache started Saturday night 4/17/21. Woke up on 4/18/21 and was d... Read more
Headache, eye pain, dizziness. Headache started Saturday night 4/17/21. Woke up on 4/18/21 and was dizzy and had bad Headache. It progressed all day and the Headache was relieved by taking Aleve (2) around 5:30 pm. The dizziness is still happening as of today 4/20/21 and Headache came back. Took Aleve again and Headache subsided but dizzy still. Almost like I have vertigo.
54 2021-04-19 mouth tingling She states about 30 minutes later she developed throat tightness, chest tightness and tingling to he... Read more
She states about 30 minutes later she developed throat tightness, chest tightness and tingling to her lips. She rates her chest discomfort as a 1/10. She denies difficulty with swallowing, lip or facial swelling, nausea, vomiting, neck discomfort, or shortness of breath. No angioedema
54 2021-04-19 swollen tongue Tongue swelled. I was able to take Benedryl every 4 hours for the next 24 hours. Headache, tired, ... Read more
Tongue swelled. I was able to take Benedryl every 4 hours for the next 24 hours. Headache, tired, and sore arm.
54 2021-04-19 taste disorder, smell distorsion 3/9/2021 After first vaccine I had brain fog, bowels hurts/stinging, headache, fatigue (just like th... Read more
3/9/2021 After first vaccine I had brain fog, bowels hurts/stinging, headache, fatigue (just like the illness), I felt better in about five days. About two weeks later I had an increased/altered sense of smell/taste to certain things such as banana?s, tequila, Baileys Irish Cream, certain sweet foods/fruit (but not ice cream). Other altered smells: Dawn dishwashing soap, Clothes washing detergents three brands (Tide, Arm& Hammer, and Gain). Belching caused the taste to be sensed. Most of the smell/taste had returned to normal in about four weeks (right before the second vaccine).
54 2021-04-19 eye floaters 1-3 days headache 4-18 days painful joints, pain in chest, left side worse - rest, advil day 20 - Vi... Read more
1-3 days headache 4-18 days painful joints, pain in chest, left side worse - rest, advil day 20 - Vitreous detachment resulting in floaters in left eye. Saw Dr to check for torn retina- none 17-present - painful left hip/glute, unable to walk/stand without pain - advil, hot/cold, saw chiropractor, exercises, additional treatment
54 2021-04-20 mouth numbness Patient received vaccine and reported a feeling of chest discomfort, dizziness, and shakiness. BP 1... Read more
Patient received vaccine and reported a feeling of chest discomfort, dizziness, and shakiness. BP 138/84 HR 101 O2 sat 100%. 11:25 am BP 137/77 HR 105 O2 Sat 100. Patient continues to report chest discomfort. 11:34 Given Allegra. 60 mg PO. 11:39 152/77 HR 108 O2 Sat 100% Patient states that she still has numbness in her mouth and jaw. Her chest discomfort is better. She is requesting to be evaluated at the ER. Squad was called. 11:43 Squad arrived and patient taken to hospital.
54 2021-04-20 drooling, eye swelling, mouth swelling, swollen tongue Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of ... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Excessive Salivation-Severe, Additional Details: Patient reveived vaccine at 10 AM, left store around 10:15, and noticed symptoms beginning at 10:35 upon arriving at home. Pt only called her physician after the weekend, but mentioned her symptoms were subsiding Sunday eve into Monday morning. Pt has lupus and believed this was initially at problem with her lupus, but physician office says this could have been a reaction to the vaccine
54 2021-04-20 ringing in ears I developed loud tinnitus in both ears the day after receiving the vaccine. It is very uncomfortable... Read more
I developed loud tinnitus in both ears the day after receiving the vaccine. It is very uncomfortable. I never had this before. I also feel dizzy like vertigo or the flu. I had severe flu symptoms for six days afterwards. I still get waves of flu symptoms.
54 2021-04-20 tongue discomfort, ear discomfort, taste impairment I experienced after my second dose, left side of my face and ear went numb and tingly. I had funny ... Read more
I experienced after my second dose, left side of my face and ear went numb and tingly. I had funny taste to my stomach and felt nauseated. I looked like Bell's palsy syndrome. I went to the ER, they gave me steroid medication. I experienced after my first dose, I had numbness and tingling sensation on my left side of m face, had a metallic taste and when i would eat I would get nauseated, like I was going to throw up, my tongue felt funny, strange only on my left side. I had lob work done for my thyroid, I had a Covid-19 test which was negative. These symptoms lasted abut four days before my second dose.
54 2021-04-21 mouth numbness Ten minutes following administration of vaccine, patient verbalized feeling numbness of the tongue, ... Read more
Ten minutes following administration of vaccine, patient verbalized feeling numbness of the tongue, being able to taste the vaccine and having sweaty hands. Vital signs taken and pt requested to take Benadryl 25mg. Pt able to swallow water and medication without difficulty. Symptoms improved in about 60 minutes and drove self home.
54 2021-04-22 bloodshot eyes Patient received 1st covid vaccination injection and sat in observation clinic for 15 minutes. Compl... Read more
Patient received 1st covid vaccination injection and sat in observation clinic for 15 minutes. Complained of light headed dizziness at 0940, eyes red, left arm red blotchy rash, complained of some throat constriction. Given fexofenadine 60mg, PO @ 0950 with apple juice. Denied shortness of breath. Was advised to go to ER by RN and Nurse Manager, but patient adamantly refused. At 10 am, she stated she felt better, denied further throat constriction, no shortness of breath, faint rash on left arm. Patient asked to leave clinic. Was advised to call 911 or go to ER I any further shortness of breath or constriction developed. Patient verbalized understanding and stated she would. Left Covid clinic at 10 am with husband driving. Patient was escorted to car outside of facility.
54 2021-04-23 sensitivity to light, eye pain Pain behind left eye and left temple. Pain behind eye was severe but has subsided, now a dull ache o... Read more
Pain behind left eye and left temple. Pain behind eye was severe but has subsided, now a dull ache off and on. Pain on left temple still present off and on. Light sensitivity, things seem brighter? Today, the 24th I am still having these symptoms. There are patient threads such as this one where others have experienced the same eye issues from the Pfizer or Moderna vaccine: https://www.drugdiscoverytrends.com/6-questions-about-facial-swelling-and-covid-19-vaccines-answered/
54 2021-04-24 eye pain, eye strain passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; so... Read more
passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-04-24 lacrimation increased flu like symptoms; congestion in her nose; a low grade fever of 99.3; cold and flu like symptoms; ey... Read more
flu like symptoms; congestion in her nose; a low grade fever of 99.3; cold and flu like symptoms; eyes very watery; chill; throat is itchy; just a little tired; shoulder was sore; This is a spontaneous report received from a contactable consumer(Patient). This consumer (patient) reported for herself that the 54-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer- Biontech COVID-19 Vaccine, Batch/lot number : ER8722 or 8732) via an unspecified route of administration, administered in Arm Left on 27Mar2021 at single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing (knee surgery), pain from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing (sometimes she has allergy symptoms). Concomitant medication(s) included paracetamol (TYLENOL) taken for arthritis, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6) taken for an unspecified indication, start and stop date were not reported; glucosamine sulfate (COSAMINE [GLUCOSAMINE SULFATE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced shoulder was sore on 27Mar2021 with outcome of recovered on 30Mar2021, just a little tired on 28Mar2021 with outcome of recovered on 30Mar2021, nose is full on 05Apr2021 with outcome of not recovered, cold like symptoms on an unspecified date with outcome of unknown , congestion in her nose (nose is full and eyes very watery) on 05Apr2021 with outcome of not recovered, a low grade fever of 99.3 (fever, not high, 99.3) on 05Apr2021 with outcome of not recovered, throat is itchy on 03Apr2021 with outcome of not recovered, chill on 04Apr2021 with outcome of not recovered, eyes very watery on 05Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included pyrexia: 99.3 on 05Apr2021. The clinical course was reported as follows: "Caller received the first dose of the Covid vaccine on March 27th. Caller reports doing well only having a sore shoulder and was tired for a few days. Caller states a week later, she started experiencing cold and flu like symptoms that consisted of a sore throat, congestion in her nose, a low grade fever of 99.3. Caller asked if this is side effects of the vaccine? Can I experience side effects a week later? Caller asked if she does get better, should she keep her original appointment or schedule for a later date?" No follow-up attempts are needed. No further information is expected.
54 2021-04-24 pain in jaw cheeks, chin and marionette lines/ swelling; bruising; cheeks, chin and marionette lines/ pain; chee... Read more
cheeks, chin and marionette lines/ swelling; bruising; cheeks, chin and marionette lines/ pain; cheeks, chin and marionette lines/ pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Mar2021 at single dose for COVID-19 immunization, started to receive hyaluronic acid, lidocaine (RESTYLANE L) from 23Mar2021 for unspecified indication. Medical history was not provided. Concomitant medications were not provided. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Patient injected to cheeks, chin and marionette lines with hyaluronic acid, lidocaine on 23Mar2021 and experienced swelling, bruising, and pain in Mar2021. Patient took Arnica, ibuprofen and applied ice; bruising resolved, other events were ongoing. Action taken with hyaluronic acid, lidocaine was unknown. Outcome of the event bruising was recovered while other events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-04-24 visual impairment Severe headache/centered in forehead radiating slightly back; I couldn't eat due to nausea and minor... Read more
Severe headache/centered in forehead radiating slightly back; I couldn't eat due to nausea and minor vomiting in first half of the day; I couldn't eat due to nausea and minor vomiting in first half of the day; couldn't eat due to feeling weak and lightheaded; couldn't eat due to feeling weak and lightheaded; I was hot and cold throughout the day; Unable to locate thermometer to take temperature; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered on left arm 25Feb2021 02:00 PM at single dose for COVID-19 immunisation. Patient medical history included asplenic, cochlear implant, survived bacterial meningitis, PTSD, anxiety, depression, neck and back pain and allergies. Allergies to medications, food, or other products: Bactrim. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Tizanidine, clonazepam, Lamictal and singular. On 26Feb2021 11:00 AM, the patient had experienced severe headache centered in forehead radiating slightly back Ice on patient's head made the headache worse Tylenol helped a bit, couldn't eat due to nausea, minor vomiting, feeling weak and lightheaded, hot and cold throughout the day. Unable to locate thermometer to take temperature and visual impartment. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of event is Recovering. Information on the lot/batch number has been requested.
54 2021-04-25 oropharyngeal discomfort client received the 1st Pfizer Covid vaccine. Client was sitting approximately 25 mins when she aler... Read more
client received the 1st Pfizer Covid vaccine. Client was sitting approximately 25 mins when she alerted EMTs she was feeling flushed in face, palms of hands and itchiness over body. 1005 vitals: blood pressure 140/80, pulse 91, oxygen 97%. PHN joined team. Upon arrival, client with flushing to face and hands. Alert and oriented. Client denied shortness of breath. Per client has history of allergy to shrimp. Medical history of hypothyroid and diabetes. Medications for both medical conditions, unable to recall names and daily vitamins. PHN offered client Benadryl, 50mg given orally at 1007. Per client husband could pick her up. 1010 vitals: blood pressure 110/86, pulse 82, oxygen 98%. Symptoms same per client. New onset of feeling "scratchy throat". Client denied shortness of breath or feeling throat was closing. 1015 vitals: blood pressure: 110/86, pulse 86, oxygen 99%. 1017 noticed redness of palms improving and flushing of face. Per client warmth feeling improving. 1020 vitals: blood pressure: 110/86, pulse 82, oxygen 97%. Per client itchiness resolved. Skin color with slight redness. Per client throat feeling improving. Vitals at 1030: blood pressure 112/78, pulse 87, oxygen 98%. Per client all symptoms resolved. Skin color back to normal. Client advised to speak with primary provider prior to second dose, use of V-Safe. ER precautions also given if symptoms returned after leaving. Per client ready to leave, had completed additional 30 min observation. Client advised to have someone pick her up, client declined. Per client feeling fine to drive herself. Client left facility with a steady gait at 1040.
54 2021-04-25 ringing in ears I have developed a loud tinnitus in both ears that is constant and very upsetting. I can hardly con... Read more
I have developed a loud tinnitus in both ears that is constant and very upsetting. I can hardly concentrate it's so loud and persistent. I have not sought treatment yet.
54 2021-04-26 loss of smell, loss of taste Received COVID-19 vaccine on 1/8/21 and 1/29/21. On 4/23/21 the patient developed chills, cough, h... Read more
Received COVID-19 vaccine on 1/8/21 and 1/29/21. On 4/23/21 the patient developed chills, cough, headache, loss of taste/smell, shortness of breath, and congestion. Tested positive for COVID. Treated with monoclonal antibodies (BAM/etesevimab).
54 2021-04-26 dry throat, oropharyngeal discomfort It started in the middle of night - dry, scratchy throat between the 30th and 31st of December. I wa... Read more
It started in the middle of night - dry, scratchy throat between the 30th and 31st of December. I wasn't scheduled to work again until the 5th of January. I called my employer about getting a COVID test. I never ran a fever. I was congested. I wasn't really coughing (from chest anyway) - just from what was happening from drainage in my throat. I had my test on Tuesday, the 5th, to get my test. It was positive and so I had to quarantine 14 days from start of symptoms. I did a virtual appt with my doctor before going to work and she cleared me to return to work. I waited a week until I re-tested. I took another COVID test and it came back negative. They pushed back my second vaccine until later to give body time to recuperate.
54 2021-04-26 mouth tingling The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is... Read more
The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6200, Expiry Date: unknown) on 22Feb2021 15:00 via unspecified route of administration in the left arm on at single dose for COVID-19 immunization. The patient denied any medical history. She had no known allergies. The patients concomitant medications were not reported. Subsequently at the same time, after receiving the vaccine, the patient felt tingling and numbness in left side of her body. It started on her left calf, and she could mostly feel numbness and tingling on the left side of her mouth. The reporter assessed the events as non-serious. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. There were no relevant test. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-04-27 taste impairment I waited 15 minutes before leaving the facility. I got out to the car and my cheeks and chin start... Read more
I waited 15 minutes before leaving the facility. I got out to the car and my cheeks and chin started tingling and were red, I started to have a slight reaction. On the drive home, I started to get a metallic taste and was starting to have difficulty swallowing. I advised my husband of this. The difficulty swallowing and metallic taste subsided after 2 days. It never got to the point where I needed to go to the ER. NOTE: After the first dose, the only side effect I had was tiredness for 1 day and a headache for 2-3 days.
54 2021-04-27 lip swelling, mouth tingling Patient noted lip and tongue tingling around 3.5 hours after vaccination followed shortly after by s... Read more
Patient noted lip and tongue tingling around 3.5 hours after vaccination followed shortly after by swelling of her lower lip. She denies other symptoms at this time or later. She took diphenhydramine 50 mg that night around 8 pm and continued to take diphenhydramine 50 mg once daily at bedtime for the a total of 5 days. She noted that her lip remained swollen for approximately 2 days before resolving. She specifically denied other skin changes, trouble breathing or other concerns. Of note, she also reported feeling fatigued the day after the vaccine with the fatigue lasting for approximately 24-48 hours. She did not seek medical evaluation for this concern and the issue resolved without further treatment.
54 2021-04-27 mouth tingling Systemic: patient mentioned her tongue was funny. she denied any tingling sensation-Mild, Additional... Read more
Systemic: patient mentioned her tongue was funny. she denied any tingling sensation-Mild, Additional Details: Patient reported her tongue felt funny and wasn't going away. she requested benadryl. Even after dose dispensed she still felt that way. No other symptoms progressed. she waited for about 1 hr and was told to watch out for signs of sever reaction and continue monitoring.
54 2021-04-28 taste impairment patient reported complaints of metallic taste, heaviness of chest, and c/o neck feeling "tight" as ... Read more
patient reported complaints of metallic taste, heaviness of chest, and c/o neck feeling "tight" as though it needed to have pressure relieved. VITALS: T97.5 HR 86 RR 16, BP 122/88 Patient was given snack and gatorade and all symptoms resolved within 10 mins.
54 2021-04-28 tongue discomfort, taste impairment I'll start at the first dose because it's all related, however the events from the 2nd dose have bee... Read more
I'll start at the first dose because it's all related, however the events from the 2nd dose have been more profound. 1st dose 3.27.21 Pfizer Left arm- within 30 seconds a metallic taste in my mouth lasting about 5 hours. Arm soreness that is it. 2nd dose: 4.17.21 Same arm for injection. within 30 seconds metallic taste in my mouth lasting 24 hours about an hour later my tongue felt like I had eaten 10 ghost peppers - this lasted another 24 hours, reappearing off and on for a few days -by Wednesday 4/21/21 the burning subsided. On 4/22/21, I started to feel off, but was able to work. At approximately 4:00pm, I turned away from a coworker to grab a pen - nothing unusual, no swift moves, when the world started spinning and the floor felt unstable, I grabbed the counter but that felt like it was moving. My coworker sat me down, within an hour I was better. I have had many dizzy spells since but nothing as epic as today where I was sent home. My session is running out so that's about all I can say.
54 2021-04-29 taste disorder Aftertaste in mouth. Increase body aches.
54 2021-04-29 ringing in ears Tinnitus. Severe and non relenting . Aches in legs especially left side. Pain in left arm and tingl... Read more
Tinnitus. Severe and non relenting . Aches in legs especially left side. Pain in left arm and tingling in left hand/foot
54 2021-04-29 vision blurred Vaccine administration provided to left deltoid at 8:20a.m. While in recovering in the Obs area, pa... Read more
Vaccine administration provided to left deltoid at 8:20a.m. While in recovering in the Obs area, patient complained of left arm heaviness, left chest pressure and dizziness. The patient was positioned in a wheelchair; during transport to the on site medical tent, the patient started passing out. Prior to arriving at the Medical tent, the patient began flailing her arms, panicking and respiratory rate was observed to be a rate of about 60 breaths minute. She was soothed and was observed to slow down her breathing and was subsequently transferred to a supine position on a stretcher. She was provided water and a granola bar and EMS was summoned; Vital signs were 160/90, HR 76, SPo2 96% on room air. EMS requested. The patient refused transport to the hospital; EMS assessed; BP was 138/88. The patient stated that she felt better and refused transport to a local hospital. She was continued to be observed; approx 5 minutes later she complained of visual blurring, a headache, and was observed to have a facial droop and word slurring. Advised by EMS to be transported to hospital; she then agreed to transport to a local hospital.
54 2021-04-29 vision blurred Pt reports blurred vision within days of the vaccine that has not gone away
54 2021-04-30 visual impairment Weakness on right side of body; Extreme visual disturbances in right eye that won't go away; Nausea;... Read more
Weakness on right side of body; Extreme visual disturbances in right eye that won't go away; Nausea; Chills so bad I was hyperventilating; Chills so bad I was hyperventilating; This is a spontaneous report from a contactable consumer reporting for herself. A 54-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 08:15 (Batch/Lot number was not reported) as single dose, Medical history included hypertension. The patient's concomitant medications were not reported. The Patient received the first dose of BNT162B2 vaccine on 23Mar2021. The patient experienced weakness on right side of body on 13Apr2021 19:00 with outcome of not recovered , extreme visual disturbances in right eye that won't go away on 13Apr2021 19:00 with outcome of not recovered , nausea on 13Apr2021 19:00 with outcome of not recovered , chills so bad I was hyperventilating on 13Apr2021 19:00 with outcome of not recovered. The events weakness on right side of body and extreme visual disturbances in right eye were considered Important Medical Events. The patient visited the ER because of the events and underwent CT scan, ultrasound, multiple medications. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-05-01 ringing in ears Very high pitched Tinnitus-Non-Stop everyday (sounds like the phasers on Sci-Fi all day)
54 2021-05-04 eye pain Itchy; Chills; sore eyes; This is a spontaneous report from a contactable consumer (patient). A 54-y... Read more
Itchy; Chills; sore eyes; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female (non pregnant) patient received first dose of Pfizer BNT162B2 (BNT162B2, Solution for injection, Lot number; EN6203 and expiry date was not provided) via an unspecified route of administration, administered in left arm region on 25Feb2021 16:15 (at the age of 54-year-old) as single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history includes known allergies to Penicillin. The concomitant medications were not provided. The patient was not diagnosed with COVID prior to vaccination. And patient had not tested for COVID post vaccination. On 26FEB2021 12:00 AM, the patient experienced itchy, chills and sore eyes. No treatment was taken for the events. The outcome of the events was reported as not recovered. No follow up attempts are possible. No further information is expected
54 2021-05-05 ringing in ears Tinnitus I have always had Tinnitus but symptoms are worse after getting the vaccine.
54 2021-05-09 taste impairment The second the shot was given a very intense metal taste filled my mouth. My throat was also itchy... Read more
The second the shot was given a very intense metal taste filled my mouth. My throat was also itchy within 30 minutes of the shot. The metal taste that filled my mouth lasted for 4 days and went away but still to this day I get a metallic feel in my teeth every few days
54 2021-05-10 mouth numbness Developed bell's palsy on the left side of my face; My mouth and side of my face started to feel num... Read more
Developed bell's palsy on the left side of my face; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; Within 24 hours the entire side of my face from my jaw to my eye was numb; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN0164 and expiry date was not provided), via an unspecified route of administration, in Arm Left, on 15Apr2021 at 10:00 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included bee venom (known allergies). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 15Apr2021 at 10:30 AM, she developed bell's palsy on the left side of her face. Her mouth and side of her face started to feel numb within a half hour of receiving the vaccine. Within 24 hours the entire side of her face from her jaw to her eye was numb. The patient received Medrol 4 mg dosepak and Valtrex - 7-day dose as treatment for the events. The events resulted in physician office visit. Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
54 2021-05-10 lip swelling pain, swelling, mild redness of lower lip; pain, swelling, mild redness of lower lip; pain, swelling... Read more
pain, swelling, mild redness of lower lip; pain, swelling, mild redness of lower lip; pain, swelling, mild redness of lower lip; This is a spontaneous report from a non-contactable consumer. A 54-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3249) via unspecified route of administration on 27Jan2021 as single dose for COVID-19 immunization. The patient Medical history included Hypertension, allergic rhinitis. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient Concomitant medication included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID [FAMOTIDINE]), hctz (HCTZ), magnesium oxide (MAG OXIDE), multivitamins within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EK5730) via unspecified route of administration on 06Jan2021 as single dose for COVID-19 immunization. After first dose, the patient experienced brief, intermittent sharp pain on Right side of mouth, lasted 2 days. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced pain, swelling, mild redness of lower lip and lasted 2-3days. The Patient didn't received treatment for the events. The clinical outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-05-11 tongue discomfort Tonsil kinda of closes so that i could not breath well for a few seconds; Tonsil kinda of closes so ... Read more
Tonsil kinda of closes so that i could not breath well for a few seconds; Tonsil kinda of closes so that i could not breath well for a few seconds; Burning of the tongue from the tip then to the middle and towards the throat; Burning of the tongue from the tip then to the middle and towards the throat; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered on left arm on 08Apr2021 12:00 (Batch/Lot Number: Unknown) as unknown, single (at the age of 54-year-old) for COVID-19 immunisation. Medical history included undifferentiated connective tissue disorder and allergy to dust and pollen. The patient's concomitant medications were not reported. The patient stated on 08Apr2021 12:00, "burning of the tongue from the tip then to the middle and towards the throat. Tonsil kind of closes so that I could not breath well for a few seconds. They put me on oxygen, gave me Benadryl and Tacid". Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. No follow up attempts are possible; information on the lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported tonsillar disorder with symptom of dyspnea was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
54 2021-05-18 ringing in ears After first dose experience muscle aches and joint pain with significant fatigue and sore arm for 1 ... Read more
After first dose experience muscle aches and joint pain with significant fatigue and sore arm for 1 week. After second dose mild sore arm at injection site, fatigue, and profound tinnitus bilaterally-has continued now for 4 months with no consistent improvement. Have not seen a provider or received any treatment for it. Question 21 should have an option for "Unknown" as I do not know if this will ever resolve or if it will progress with other neurological damage or disability. I plan on seeing my provider since it has not resolved and seems to be worsening
54 2021-05-21 ringing in ears, extreme sound sensitivity, vision blurred, ear pain, sensitivity to light nausea with vomiting resulting in low electrolytes needing hospital treatment; nausea with vomiting ... Read more
nausea with vomiting resulting in low electrolytes needing hospital treatment; nausea with vomiting resulting in low electrolytes needing hospital treatment; low electorlytes; Headache; severe dizziness/feeling faint; balance issues/unsteadiness; right ear pain; buzzing ear sounds; inability to visually focus at times; sensitive to light; sensitive to movement; sensitive to sound; listing to the right when trying to walk,; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 10:30 (Batch/Lot Number: EN6208) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included vertigo, migraine (as a child). The patient previously took Omnicef, penicillin ad sulfa and experienced drug hypersensitivity. Concomitant medications included estrogens conjugated (PREMARIN), cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE); fluticasone (FLUTICASONE). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 15Mar2021, The patient experienced Headache, severe dizziness, balance issues, right ear pain, buzzing ear sounds, listing to the right when trying to walk, unsteadiness, feeling faint, inability to visually focus at times, sensitive to light, sound, and movement, nausea with vomiting resulting in low electrolytes needing hospital treatment. The patient was hospitalized due to nausea, vomiting and low electrolytes. The adverse events resulted in an emergency room visit and physician office visit. Treatment was given for the events which included Meclazine, Droperidol, Electrolytes. The clinical outcome of the events was recovering.
54 2021-05-23 ringing in ears, dry mouth 10 mins post, severe syncope, and headache, severe ringing in ears * Severe headaches every morning ... Read more
10 mins post, severe syncope, and headache, severe ringing in ears * Severe headaches every morning * continued moderate ringing ears * Severe dehydration every morning * Frequent heartburn * lungs tight, a bit shallower breathing * Vertigo all day and night * Chills and hot flashes but no fever * Nausea every morning until I eat; have to eat every few hours to avoid nausea * random dry raspy cough * 100+oz. H20 daily+powerade(S/F)p * urine near clear by afternoon * using RR 3x/night, but avg 5a wake-up with severe headache & PARCHED with very dry mouth
54 2021-05-23 ringing in ears Existing tinnitus suddenly got very loud, louder than I have ever experienced it, and constant. I h... Read more
Existing tinnitus suddenly got very loud, louder than I have ever experienced it, and constant. I have had existing tinnitus for about ten years, but it's always been very low (I would average it as a 3 out of 10) and it would often fluctuate between 0-4. It has never affected my quality of life. Twelve days after my first dose of Pfizer it is now a 7 or 8 out of 10 and is constant. No fluctuation whatsoever. It has now been like this for 12 days. No relief.
54 2021-05-24 ringing in ears Tinnitus spike second day after injection. Has not gone down to baseline prior to injection. Waiti... Read more
Tinnitus spike second day after injection. Has not gone down to baseline prior to injection. Waiting for a doctor's appointment to see if I should get the second dose. But next available opening is 8/23/21.
54 2021-05-24 ringing in ears I have constant ringing in my ears - I was told this is called tinnitus. I HAVE NEVER HAD THIS UNTI... Read more
I have constant ringing in my ears - I was told this is called tinnitus. I HAVE NEVER HAD THIS UNTIL AFTER THE 2ND SHOT. Started about 10 minutes after the shot and has never stopped.
54 2021-05-25 pain in jaw, vision blurred Vibration (feeling of cell phone vibrating) throughout my entire body, my right jaw has locked and ... Read more
Vibration (feeling of cell phone vibrating) throughout my entire body, my right jaw has locked and painful, I have a constant headache, eyesight worse (blurry even with glasses), all over constant body throbbing, stomach issues (sharp pains and cramping), constant numbness (the feeling of when you rub your skin when the novocaine is starting to wear off after a dental procedure) from my feet up to my waist and the feeling of pins and needles (like when you hand is asleep) from my feet up to my pelvic area. This all started with just a small vibration in my right hip and has increasing gotten worse over the last several months.
54 2021-05-25 ringing in ears, ear pain 13 days after 2nd vaccine woke up with extreme vertigo, could not walk, ear pain, severe neck, ear a... Read more
13 days after 2nd vaccine woke up with extreme vertigo, could not walk, ear pain, severe neck, ear and head pain. Existing tinnitus and hyperacusis worsened. Steroid taper, Meclizine.
54 2021-05-25 ringing in ears Intermittent tinnitus that happens in one, or other ear at a time.
54 2021-05-27 mouth numbness After waiting the required 15 minutes left the pharmacy. About 10 minutes later while driving my ent... Read more
After waiting the required 15 minutes left the pharmacy. About 10 minutes later while driving my entire left arm including my hand became numb and my tongue and back of my throat felt like it was swelling. I was close to an ER and went there. They took my blood pressure and sent me back to the waiting room. I was not comfortable waiting as I was having difficulty breathing and was scared so I left and picked up Benadryl and took 50 mg immediately.
54 2021-05-27 mouth tingling, taste impairment Patient experienced tingling of the tongue with a metallic taste in her mouth that began about 15 mi... Read more
Patient experienced tingling of the tongue with a metallic taste in her mouth that began about 15 minutes after getting the vaccine.
54 2021-05-28 ringing in ears, ear discomfort After 1st shot had severe back pain. Experienced again briefly after second. More concerning was on ... Read more
After 1st shot had severe back pain. Experienced again briefly after second. More concerning was on 4/26/2021 I developed tinnitus and vertigo lasting about a week. Still experience some back pain and ear pressure. Never had issues prior to vaccine.
54 2021-05-28 ringing in ears, pain in jaw A few days after the second injection I noticed a pulsing tinnitus in my right ear that lasted a few... Read more
A few days after the second injection I noticed a pulsing tinnitus in my right ear that lasted a few hours in the evening. It only occurred that one time. 6 days ago I woke up with severe tinnitus in my left ear. After a few hours, the ringing was better but has not gone away, 6 days later. The severity varies throughout the day. I also have experienced some pain near the bottom of my left jaw area but it only lasts for a few seconds when it does occur.
54 2021-05-30 visual impairment On 5/5/21, about 7 hours after her second Pfizer COVID vaccine, pt developed R sided visual distorti... Read more
On 5/5/21, about 7 hours after her second Pfizer COVID vaccine, pt developed R sided visual distortion in both eyes, associated with headache. Pt was seen on 5/7/21, Ophtho exam was negative. MRI brain with MRV done showed a 10 mm bright lesion in the L corpus callosum with possible swelling as well as nonspecific white matter disease. Pt was sent to ED, left prior to evaluation and returned the next day. Seen by Neurologist in ED who recommended inpt evaluation. Pt did not wish admission and left. Outpatient Neurologist evaluation was unable to be scheduled in a timely matter, so pt went to another ED on 5/13/21 and had evaluation including LP. Working ddx included MS/ischemic stroke, SLE. Started on ASA and statin. Pt has had outpatient Neurology and Rheumatology followups, planned for Neuro-Ophthlamologist consultation. R visual distortion was improving but still present at her 5/21/21 followup with me.
54 2021-05-31 loss of smell, loss of taste During first vaccine I had a minor vision issue which went away with in 30 minutes, sore arm felt fi... Read more
During first vaccine I had a minor vision issue which went away with in 30 minutes, sore arm felt fine. After second dose I felt as though I had the flu and stayed in bed for several days, approximately two weeks later I lost my since of smell, continued severe body aches, extreme fatigue and constant pressure in the back of my head. I'm now several months out and the symptoms are getting worse. Ive always been very healthy, sleep for 6 hours a night and had high energy. Now after 12 hours of sleep I still fall asleep during the day. My headaches are increasing in severity. I can't smell or taste. I'm having joint issues with my jaw and limbs. I keep thinking I'm going to shake this but I'm starting to loose hope.
54 2021-05-31 taste impairment chills; Nausea; Backache; fever/low grade temp of 99.5; took her temperature and measured 99.6F; sta... Read more
chills; Nausea; Backache; fever/low grade temp of 99.5; took her temperature and measured 99.6F; stated that she has been really fairly ill/being sick; metallic taste; mild soreness in her arm; This is a spontaneous report received from a contactable Consumer(patient) via medical information team. A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 27Jan2021, after 15 minutes of vaccination, the patient experienced having a metallic taste and mild soreness in her arm. On 29Jan2021, the patient ended up being sick at work, stated that she was been really fairly ill experienced chills, nausea, backache, fever. She took alternating dosages of Advil and Tylenol as prescribed by her doctor. Right now, she took her temperature and measured 99.6 F. She mentioned that she normally had low grade temperature 99.5 F in temperature. She was curious if the response was from the vaccine. The patient wanted to know if it would continue longer or may be something else. Stated that she was fine. Stated that anytime she was put under anesthesia that she gets sick. No further details provided. Does not know if what in the vaccine is similar to that. Wanted to know if she was good to go. Stated that she assumed it was a response but wanted to double check before she goes into work tomorrow. Wanted to know how long the response would last. Later clarified that it was for the Covid vaccine. Outcome of the events was unknown.
54 2021-05-31 eye disorder I had, chills, fainting, left eye dropping, headache and body ached.
54 2021-05-31 ringing in ears Ringing in ear consistently since April 21, 2021. Allday/all night.
54 2021-05-31 toothache, deafness, hearing loss, eye swelling, eye itchiness, ringing in ears, bloodshot eyes, ear pain, thirst - Teeth nerve pain - Extreem thirst - Swelling and warm hands and feet and aching - Ear pain and ti... Read more
- Teeth nerve pain - Extreem thirst - Swelling and warm hands and feet and aching - Ear pain and tinnitus and muffled sound (hearing loss) - Neck pain - Lower Back pain (4/19) - Middle back pain - Hiccups - Dry leathery skin (skin around fingernails and toenails peeled, hang nails (toes and fingers), lips cracked peeled overall skin looked dry wrinkled) no amount of oil or lotion helped. - Mouth painful blisters in the back that never popped just went away - Narcolepsy like tired episodes 35 minutes after vaccine 2x since - Dizzy when standing (evening of vaccine) - Knee patella dislocated and both knees seem unstable like they are going to dislocate entirely when leg is twisted like turning. - Tender to the touch and pain under left rib cage 4/13/21 one episode of narcolepsy weird tire episode that lasted a total of maybe 10 minutes with complete waking up just as I laid down to nap. Right arm hurt but not bad. Chills with a temperature of 97.1F and later was drenched in sweat with a temperature of 97.8F. Woke up super thirsty and was so thirsty for several days drinking 1.5 gallons of water and still being thirsty even when I tried some salt pills. 4/16/21 Really red, swollen and itchy eyes (allergies) with sinus headache 4/17/21 lower back went out slowly all day till I was stuck in bed with ice. Right arm tingling like pins and needles. Lips super dry cracking and peeling. 5/14/21 started prednisone
54 2021-06-01 thirst Swelling injection site, chest pain, difficulty breathing, stomach pain, extreme fatigue, excess... Read more
Swelling injection site, chest pain, difficulty breathing, stomach pain, extreme fatigue, excessive thirst, fever, chills, dizziness, back pain, shoulder blade pain, elevated troponin, elevated blood sugar, hospitalization, CAD, pneumonia, antibiotics, fluids / hospital stay 5/24 - 5/26/21
54 2021-06-01 vision blurred Vision in right eye became very very blurry, not matter what I did. woke up the next day not being ... Read more
Vision in right eye became very very blurry, not matter what I did. woke up the next day not being able to see anything in that eye, except blurry lights. The day I received the vaccine my feet developed pins needles and numbness with pain and it comes and goes. It spreads to my hands and arms. I have been very itchy as well, covered in hives.
54 2021-06-01 visual impairment Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness ... Read more
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: got light headed and felt a tingling in her head then vision went black -Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: 4 days after 2nd dose patient felt lightheaded, tingling in her head, then everything went black for a moment. she still feels light- headed
54 2021-06-02 lip swelling, mouth tingling Within minutes of receiving the shot, I started getting a headache and just feeling generally off...... Read more
Within minutes of receiving the shot, I started getting a headache and just feeling generally off...almost a feeling of an adrenaline rush. Felt a bit antsy and foggy for 1 hr. A couple of hours later, I got a small hive on the bottom of my right eye, followed by small hive in my left shoulder. My nose started to run a bit and I called my sister who brought me over some Benadryl. When she arrived, I felt the inside of my bottom lip begin to tingle and mildly swell. Stayed awake for a bit and then took the Benadryl before going to sleep. In the morning, the inside of my bottom lip felt like it had a series of small canker sores which resolved within 24 hours. I had a telemedicine visit with my doctor?s office, and they felt it was a local reaction, perhaps anxiety induced; they ok?d 2nd dose. Discussed with vaccination site coordinator, and they consulted with the County Health Department who will not administer a second dose due to CDC guidance regarding hives, etc.
54 2021-06-03 mouth tingling, swelling of eyelid Initial Evaluation: Throat tightening for few seconds only. Swelling on face near eye, tingling on l... Read more
Initial Evaluation: Throat tightening for few seconds only. Swelling on face near eye, tingling on lips Patient is alert and responsive. Refused to call 911, she stated she felt better. BP 149-91 Pulse: 82 02 96%. Given oral benadryl capsule 25 mg. Patient feels better, throat tightening resolved, little swelling on right side of face on right eyelid. Alert and oriented x4, no shortness of breath, no chest pain. Patient advised to go to the ER for further evaluation. Patient agrees to go to the ER but refused to go via nonemergent ambulance or 911. Patient prefers to go by herself to the ER. Refused to call ambulance.
54 2021-06-05 lacrimation increased About 45 minutes after l received my vaccine, my eyes started to water and nose was runny ( most of ... Read more
About 45 minutes after l received my vaccine, my eyes started to water and nose was runny ( most of the entire day! No allergies before this! About 4 hours after vaccine l had a drink of water had was chocking on a sip( couldn?t breathe ( spitting and sweating) couldn?t catch my breath! Very scary. Shortly a few minutes later ( tried to suck on a piece of melted chocolate and could pass throat. Another chocking event occurred. I find by gagging and spitting to get relief and breathe. Heavy feeling in my chest lasted until evening ! Still very sore arm today
54 2021-06-06 lip itchiness, lip swelling Patient woke up on Saturday 6/5/21 with swollen lips. Symptoms got progressively worse throughout th... Read more
Patient woke up on Saturday 6/5/21 with swollen lips. Symptoms got progressively worse throughout the day. Itching lips and ears. Hives on arms 6/6/21. Patient stated she took diphenhydramine around the clock until symptoms resolved. Advised patient to follow up with her physician.
54 2021-06-07 taste disorder Minor issues in the first 24 hours were unexpected and early onset of menstrual cycle next morning, ... Read more
Minor issues in the first 24 hours were unexpected and early onset of menstrual cycle next morning, and altered taste sensations that lasted one day. Minor arm pain. No actions were taken. On April 22, vertigo began gradually and was intense by the morning of April 23. This included the sensation of intense spinning. The vertigo continued intensely for about three weeks and then tapered off until June 1, when there was no more sensation of spinning. Bonine and the Flonase provided adequate relief during this period.
54 2021-06-08 hearing loss, loss of taste, deafness, ear discomfort Patient reports a few days after her vaccination she lost her taste, but it has slowly came back. Pa... Read more
Patient reports a few days after her vaccination she lost her taste, but it has slowly came back. Patient also reports her hearing is now muffled and feels like "pressure in my ears." Patient reports hearing loss. She also has developed a cough and stated, "I've been coughing like a fool." Patient stated she also developed psoriasis after receiving the vaccination.
54 2021-06-08 lip swelling On second dosage, my lips had swollen, from above my upper lip to mid-chin. Slight breathing diffic... Read more
On second dosage, my lips had swollen, from above my upper lip to mid-chin. Slight breathing difficulty but nothing serious. Lasted a few hours - reduced in swelling after taking Benadryl. I have had, since the vaccinations, issues with periodic raised rashes mainly on my left forearm/wrist and occasionally on my right forearm. Not sure if related but going to contact my doctor to look into it further.
54 2021-06-08 ringing in ears, permanent deafness Following administration of my 2nd Covid-19 vaccine, I experienced common effects such as fever, ext... Read more
Following administration of my 2nd Covid-19 vaccine, I experienced common effects such as fever, extreme fatigue, and warmth/redness/swelling at the injection site, all of which resolved completely within 72 hours. However, about a month after that vaccine, I started having terrible tinnitus, which I've never experienced before. I passed it off as a sinus related issue, but it continued. It severely interferes with sleep, focus, and concentration. I'm a wife, mom, & Registered Nurse and this is definitely having a negative impact on my daily activities.
54 2021-06-08 ringing in ears Ongoing tinnitus in both ears. Started in early hours of the morning the day after vaccination, wak... Read more
Ongoing tinnitus in both ears. Started in early hours of the morning the day after vaccination, waking me up and has persisted ever since.
54 2021-06-09 deafness unilateral, ringing in ears Moderate loss of high frequency hearing in my left ear as diagnosed by an audiologist.; Nonstop tinn... Read more
Moderate loss of high frequency hearing in my left ear as diagnosed by an audiologist.; Nonstop tinnitus in my left ear, which sometimes shifts to static in my head.; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 24Mar2021 16:30 (Batch/Lot Number: ER8730) (at the age of 54 years old) as unknown (dose number), single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. No patient medical history. No known allergies. No other vaccine in four weeks. No other medications in two weeks. On 26Mar2021 20:30, the patient had moderate loss of high frequency hearing in left ear as diagnosed by an audiologist. Nonstop tinnitus in left ear, which sometimes shifts to static in patient's head. The patient received treatment including Prednisone pills. The events resulted in Doctor or other healthcare professional office/clinic visit; and Disability or permanent damage. No COVID prior vaccination. Patient was covid tested post vaccination. The patient underwent lab tests and procedures which included PCR (COVID-19 PCR, Nasal Swab): negative on 26Mar2021 and PCR (COVID-19 PCR, Nasal Swab): negative on 05May2021. The report was assessed as serious (Seriousness criteria-Disabling or Incapacitating) by regulatory authority. The outcome of the events was not recovered.
54 2021-06-09 taste impairment Metal taste in mouth with 30 minutes of vaccine; low fever; body aches and pains; This is a spontane... Read more
Metal taste in mouth with 30 minutes of vaccine; low fever; body aches and pains; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 06May2021 at 09:30 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included metoprolol tartrate and doxazosin mesylate from unknown dates for unknown indications. The patient did not have any known allergies. The patient previously received dose 1 of BNT162B2 (lot number EW0161) on 15Apr2021 at 16:30 as a single dose in the left arm for COVID-19 immunization. On 06May2021 at 10:00 the patient experienced metal taste in mouth within 30 minutes of vaccine, low fever, and body aches and pains. The patient did not receive any treatment for the events. The outcome of metal taste, low fever, and body aches and pains was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
54 2021-06-09 taste disorder, loss of smell Pain in the right arm; affected the rotator cuff; taste and smell were affected; my taste and smell ... Read more
Pain in the right arm; affected the rotator cuff; taste and smell were affected; my taste and smell were affected; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 54-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/Lot number was not reported) administered in Arm Right in Feb2021 as 2nd single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 in Jan2021 (at the age of 54years) for Covid-19 immunization. Medical history included lupus, fatty liver disease (genetic, not caused by any other issues), asthma, heart disorder, rheumatoid arthritis, various food allergy, latex allergy, and allergic to Sulfa drugs; all from an unknown date and unknown if ongoing. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) for an unspecified indication and salbutamol (ALBUTEROL) for asthma; start and stop date of both were not reported. The patient previously took Phenergan and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Feb2021, the patient experienced pain in the right arm following the 2nd dose that never went away, and instead got a lot worse. It has affected her rotator cuff and required a cortisone injection. In 6 weeks, if that has not worked, further testing will be done beyond the X-ray on an unspecified date. Also, following the 2nd dose, her taste and smell were affected, and she has not been able to handle the taste of coffee. She added that she has Lupus and genetic fatty liver disease. The hepatologist had her drinking coffee for that reason. The only thing off on her blood work related to not being able to drink the coffee (as reported). The patient also mentioned that she was having difficulty working at this point in time, because she works at a computer and it's affecting the arm she uses for the mouse. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with cortisone injection and X-ray. She also has tested negative to Covid 19, and negative to the antibodies in Mar2021. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-event temporal association, the company cannot completely exclude a causal relationship between BNT162b2 administration and the onset of the reported, serious events. The event 'pain in extremity' is also expected in the safety profile of the suspect product. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-06-10 eye itchiness, mouth itchiness, eye swelling swollen arm; 2 days later hives under chin on left side/ hives on left cheek/ hives on her left trun... Read more
swollen arm; 2 days later hives under chin on left side/ hives on left cheek/ hives on her left trunk, face, and arm; throat started to close; mouth started to itch; swollen itchy eyes; swollen itchy eyes; sneezing; swollen lump in shoulder immediately; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0167), via an unspecified route of administration in the left arm on 21May2021 17:00 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma, allergies, leaky heart valve, fusion feet, cholesterol, triglycerides, ulcers, and allergy to sulfa and bananas. The patient had a negative COVID-19 nasal swab in Jan2021, and twice in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: montelukast sodium (SINGULAIR), fexofenadine hydrochloride/ pseudoephedrine hydrochloride (ALLEGRA D), diphenhydramine hydrochloride (BENADRYL), citalopram hydrobromide (CELEXA), eicosapentaenoic acid ethyl ester (VASCEPA), budesonide/ formoterol fumarate (SYMBICORT), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 19:00, within 2 hours of vaccination, the patient experienced swollen itchy eyes, mouth started to itch, sneezing, throat started to close; swollen lump in shoulder immediately. Two days later (23May2021), hives under chin on left side. The next day (unspecified date) she got hives on left cheek, then a few days later (unspecified date), hives on her left trunk. It was also reported she had hives on left side of trunk, face, and arm, and had a swollen arm. For treatment, the patient took 3 BENADRYL and 20 mg of prednisone. The outcome of the events was recovering. Since the vaccination, the patient has been tested for COVID-19 on an unspecified date (unknown results).
55 2021-01-01 mouth tingling Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own af... Read more
Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own after 10 minutes.
55 2021-01-05 loss of taste Queasy No taste headache tight neck- stiff
55 2021-01-05 mouth numbness Rash, chest pain, tachycardia, numb tongue, hard to swallow
55 2021-01-07 taste impairment at 10:10pm, started with chills and shivers for over an hour. Muscle aching as a result of the shive... Read more
at 10:10pm, started with chills and shivers for over an hour. Muscle aching as a result of the shivers that last over an hour. Fever of 101.5 at 1am in the morning. Head ache that was first in the temples and then went behind the eyes. Water had a metal taste to it. Did not take a tylenol or anything to relieve the fever or ache. I prefer to allow my body to fight it naturally. Used an ice pack at the nap of my neck to help with fever and also headache. Also took 2 showers to help with body ache. 1/8/21 12:20pm fever is still 100.4. Body is still achy with slight headache.
55 2021-01-07 eye pain, lip swelling Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,... Read more
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
55 2021-01-07 mouth tingling Tingly lips, felt like throat was swelling. I was able to breath fine. Given Prednisone and Prevac... Read more
Tingly lips, felt like throat was swelling. I was able to breath fine. Given Prednisone and Prevacid and symptoms went away.
55 2021-01-07 ringing in ears Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit o... Read more
Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown. No follow-up activities are needed. No further information is expected.
55 2021-01-08 taste impairment, pain in jaw Diarrhea & NauseaVomiting Narrative: jaw pain, metallic taste, cramps
55 2021-01-08 swollen tongue Patient felt tongue swell, and then her throat started to close. -Anaphylaxis
55 2021-01-10 mouth numbness Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased B... Read more
Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine. No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
55 2021-01-10 mouth tingling lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure du... Read more
lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure due to mask or injection) started with soreness/heat to site, joint pain, flu-like symptoms- body aches, tired and headaches. - January 9th. most joint pain gone except to fingers gone. soreness and heat to site of injection. - January 10th finger joints hurt still hurts, site of injection - redness swollen/ heat still - around site a "pinching" pain, which is a new today - Jan11th
55 2021-01-10 vision blurred Left eye blurred vision, ASC. consulted Ophthalmologist on 1/8/2021, Provider stated to ASC. that vi... Read more
Left eye blurred vision, ASC. consulted Ophthalmologist on 1/8/2021, Provider stated to ASC. that vision appears to be impacted by viral infection and should resolve without intervention per ASC., also numbness surrounding orbit of left eye
55 2021-01-11 eye swelling Sharp stabbing pains in right rib then left.; Shortness of breathe; cough; eyes swelled shut; This i... Read more
Sharp stabbing pains in right rib then left.; Shortness of breathe; cough; eyes swelled shut; This is a spontaneous report from a contactable nurse. This 55-year-old female nurse reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3246; Expiration date was not reported) on 30Dec2020 08:45 (at the age of 55-years) as single dose, Intramuscular in left arm for COVID-19 immunisation. Medical history included allergy to hydroxychloroquine sulfate (PLAQUENIL), patient experienced sleep disorder, migraine, and lupus. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications include pregabalin (PREGABALIN), amitriptyline (AMITRIPTYLINE) for sleep, solifenacin succinate (SOLIFENACIN SUCCINATE), leflunomide (LEFLUNOMIDE), omeprazole (PROTONIX), ondansetron (ZOFRAN), mirabegron (MYRBETRIQ), azathioprine (AZATHIOPRINE), and sumatriptan succinate (SUMATRIPTAN SUCCINATE) for migraine. Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 31Dec2020 at 17:15, the patient experienced sharp stabbing pains in right rib then left. Shortness of breathe, cough, and eyes swelled shut. The patient did received treatment as a result of the event with benadryl, aderol inhaler. The outcome of event eyes swelled shut was recovering, Shortness of breathe was recovering, cough was recovering, and sharp stabbing pains in right rib then left was recovering.
55 2021-01-12 taste impairment Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth... Read more
Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth right after injection lasted 1 hour or so
55 2021-01-12 pain in jaw chest tightness with shortness of breath; nausea for 10 minutes. Pain radiating to jaw
55 2021-01-12 mouth tingling, mouth numbness Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed... Read more
Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed on guerney, O2@ 4L via mask placed, vital signs taken (pulse 81, BP 140/80), O2 sat on 4L via face mask 98%. Patient given epi pen injection @1422 and transported to ED. Upon arrival to ED, patient began to cough.
55 2021-01-12 tongue discomfort ITCHY NOSE , BELTCHING, HOT FLADHES, TOUNGUE HAVINESS, TREATED WITH EPI AND BENADRLY
55 2021-01-13 ear pain Got her vaccine yesterday 01/12/2021. Took 2 Tylenol yesterday. Last night at 10pm, Started feeling... Read more
Got her vaccine yesterday 01/12/2021. Took 2 Tylenol yesterday. Last night at 10pm, Started feeling very cold/chills, and had fever of 102, also have headache, very tired. When she had fever her ear hurt.
55 2021-01-13 mouth numbness, mouth itchiness Patient got her shot around 11:15am and around 11:45am started feeling itchy down the arm of injecti... Read more
Patient got her shot around 11:15am and around 11:45am started feeling itchy down the arm of injection (left) and itchy in the mouth and numb in the tongue. Came to report to me (lead RPh for clinic) at 11:50am. I spoke with another staff member to get patient 50mg of benadryl. While I waited for the medicine, I inspected the patients arm, face and inside the mouth. No redness, swelling, hives or other signs/symptoms of allergic reaction. Arm looked normal, no discoloration. Same with face and inside mouth. Patient took 50mg Benadryl at 12pm. Patient also stated having sinus issues currently (before vaccination) and has had off/on reactions with flu shot and other vaccines, mainly itching in the arm that was injected and swelling at the injection site (grapefruit size). Patient reported feeling itchiness gone at 12:10pm but still having some numb tongue. By 12:23pm, patient reported feeling completely better and no more numbness in the tongue.
55 2021-01-13 mouth itchiness, swollen tongue, feeling of choking, eye itchiness Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Mediu... Read more
Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Medium, Systemic: Headache-Mild, Systemic: upper body test rash, itchiness around eyes and mouth, she discribed a tingling sension in the back of her throat, verbilized her tongue was swelling; symptoms lasted 1 day
55 2021-01-13 swelling around the eyes, dry throat I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d... Read more
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
55 2021-01-14 ringing in ears Ringing in ears; This is a spontaneous report from a contactable nurse (patient). A 55-years-old fem... Read more
Ringing in ears; This is a spontaneous report from a contactable nurse (patient). A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1284, expiry date not reported), intramuscular on 06Jan2021 at a single dose into left arm as COVID prevention. There were no medical history and concomitant medications. Patient did not receive any other vaccines on the same day as the COVID Vaccine. Patient received the COVID shot on Wednesday (06Jan2021), and about two hours after she got the shot, she starting having godawful ringing in her ears that lasted the last two days. Patient confirmed that the product was not specifically prescribed to her, but rather it was given via workplace policy. The ringing in her ears started that same day (06Jan2021) and that the ringing has stopped, it stopped around 5:30 am morning of the report date (08Jan2021). Therapeutic measures were taken as a result of ringing in ears. Patient stated that she took Benadryl before bed last night (07Jan2021). The event ringing in ears recovered on 08Jan2021 at 5:30 am.
55 2021-01-14 tongue disorder Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am ... Read more
Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am 1/14, lasted until appx 12noon. On 1/15, appx 8am I awoke with nausea. Began to vomit and all my extremities began to tingle. At that point, my hands and feet became rigid. This spread throughout entire body, including my head. I was unable to move my hands or feet. My fingers were frozen so hard that my husband could not even close my hand for me. My tongue felt thick and I was having difficulty speaking. Husband picked me up off the floor and carried me to our bed. We were getting ready to call 911 when my feet began to wake up and the rigidity subsided for all areas. Epidsode lasted appx 15 mins.
55 2021-01-16 mouth tingling I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for se... Read more
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes. My lips, tongue, lower jaw and teeth started to feel tingly and strange. This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
55 2021-01-17 ear pain Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection sid... Read more
Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection side that spread to top of head, and down to chest and right arm- sensation of face being scaled on right side Day 2- Brain Fog, Generalized Weakness, Generalized pain Right ear remains numb Day 3 1/13- felt like my entire body received a tetanus vaccine Day 4 unchanged Day5- woke up in head to toe hives- was sent to ED Have been having intermittent rashes ( like dermatitis) pop up all over my body and random numbness typically on head/ neck Continue with headache on day 7
55 2021-01-17 lip swelling 12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle ac... Read more
12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle aches, dizziness, headache, disorientation. 20 hours after injection: swelling of lips. Continued body aches, headache, 32 hours after injection: chest pain, continued body aches, headache, swelling of lips.
55 2021-01-17 vision blurred Pt. C/O blurred vision peripherally in both eyes. She denied Hx of migraines, did not have any heada... Read more
Pt. C/O blurred vision peripherally in both eyes. She denied Hx of migraines, did not have any headache. No other symptoms
55 2021-01-19 mouth tingling I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observ... Read more
I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observation area. After release I went to my car and started to drive home. At the 25 minute mark post vaccine (1:55pm) I felt numbness and tingling of cheeks and lips (no swelling and no difficulty breathing). I drove the nearby adult hospital, parked on a side street to wait and see if anything got worse. After 10 minutes symptoms subsided and I continued home. At the 50 minute mark post vaccine (2:20) I felt numbness and tingling of my right arm which subsided after 10 minutes. No further side effects.
55 2021-01-20 mouth numbness, taste impairment HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONG... Read more
HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONGUE, TEETH, JAW, NECK WENT NUMB, I CAN FEEL IT NUMB AROUND MY LEFT EYE TO. ITS LIKE BELLS PALSY WHEN I TRY TO SMILE LEFT SIDE OF LIPS GO DOWN ANSLEFT SIDE OF LIPS ARE NUMB AND THELEFT SIDE OF FACE IS SWALLEN AND JAW IS TIGHT.CHEEK FEELS THICK, TINGALING IN ARM DOWN LEFT ARE TO PINKY FINGER. SORE ARM WHERE SHOT IS. TIGHTNESS IN SHOULDER. CALLED NURSE SAID TO WATCH IT STILL THE SAME AFTER ALL NIGIHT, STILL NUMB ANS SWALLEN BUT CAN EAT BREATH AND TALK.
55 2021-01-20 mouth numbness, mouth tingling, taste impairment, ear pain After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after va... Read more
After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after vaccination and intermittently x 5 days after the vaccine. Following day had tingling to the right side of my upper lip and right side of face felt somewhat numb. Had pain to right side of face up to right ear.
55 2021-01-20 mouth numbness Patient experience nausea same day as injection as well as numbness of tongue and pain when swallowi... Read more
Patient experience nausea same day as injection as well as numbness of tongue and pain when swallowing.
55 2021-01-20 mouth tingling tingly lips; felt like throat was swelling; This is a spontaneous report from a contactable other hc... Read more
tingly lips; felt like throat was swelling; This is a spontaneous report from a contactable other hcp (patient). A 55-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 07Jan2021 14:30 at a single dose for COVID-19 immunization at the hospital. Medical history included high blood pressure and high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin, bupropion, and benazepril. The patient previously took amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. The patient experienced tingly lips and felt like throat was swelling on 07Jan2021 16:30 with outcome of unknown. The events resulted in emergency room/department or urgent care. Treatments were Medrol dose pack and Prevacid. The patient was not diagnosed with COVID prior vaccination and had not tested for COVID post vaccination.
55 2021-01-20 ringing in ears Shortness of breath; Headache; Tinnitus; This is a spontaneous report from a contactable Physician. ... Read more
Shortness of breath; Headache; Tinnitus; This is a spontaneous report from a contactable Physician. A 55-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease and asthma, all from an unknown date and unknown if ongoing. Known allergies reported: drug intolerances with nausea/vomiting to Opiates, TRULICITY, sulfa antibiotics. The patient's concomitant medications were not reported. The vaccine was administered at Hospital Facility. It was unknown If other vaccine were administered in four weeks. The patient did not experience COVID prior vaccination. The patient was tested for COVID post vaccination on 01Jan2021 and was negative. On 31Dec2020 within minutes of vaccination the patient experienced shortness of breath, headache and tinnitus. The events required visit to Physician Office and Emergency Room. The patient was admitted to hospital for 7 days. Therapeutic measures taken as a result of the events included epinephrine without benefit, prednisone course but tinnitus remained about 12 days since vaccination, corticosteroids, and H1 and H2 antagonists. The patient underwent lab tests and procedures which included COVID test post vaccination (Nasal Swab) on 01Jan2021 with negative result. The outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea, headache and tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
55 2021-01-20 toothache Went to dentist thinking i had a toothache on Monday from the pain. it was very painful was on m... Read more
Went to dentist thinking i had a toothache on Monday from the pain. it was very painful was on my whole left side of face did xray was referred to oral surgeon did exam and both confirmed it had to be a reaction to vaccine. was prescribed Flexural and Toradol Aleve. medication takes about an half hour to kick. been in bed for a week with ice on my face. Cant work at all.
55 2021-01-21 ear pain, eye pain I had eye pain, headache, ear pain
55 2021-01-25 ear swelling Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; ... Read more
Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown. Information on Lot/Batch number has been requested.
55 2021-01-25 mouth numbness, mouth tingling Numbness and tingling of the lips; Numbness and tingling of the lips; Inflammation of the tongue and... Read more
Numbness and tingling of the lips; Numbness and tingling of the lips; Inflammation of the tongue and throat; Inflammation of the tongue and throat; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine for hypothyroidism. The patient previously took Demerol and experienced allergy. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021 08:30 AM, the patient experienced numbness and tingling of the lips, inflammation of the tongue and throat. No treatment was given to patient for the events. The outcome of the events was recovering. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. Information on the lot/batch number has been requested.?
55 2021-01-25 mouth numbness Right sided lips and facial numbness half hour post vaccination. Benadryl 25mg IVP Pepcid 20mg IVP S... Read more
Right sided lips and facial numbness half hour post vaccination. Benadryl 25mg IVP Pepcid 20mg IVP SOLU-Medrol 125mg IVPB
55 2021-01-25 lip swelling lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red a... Read more
lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red and swollen; gums red and swollen; soft palate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperthyroidism, menopause and COVID prior vaccination. The patient is not pregnant. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), dexamethasone (DEXAMETHASONE), methimazole (METHIMAZOLE), estrogens conjugated (PREMARIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]), azithromycin (Z-PAK), and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient had no other vaccine in four weeks. The patient previously took Erythromycin (EES) and Levaquin and experienced allergies. The patient experienced swelling of lips, gums red and swollen, soft palate, lymph nodes in neck swollen/tender on 08Jan2021 at 10:00. The patient had not tested for COVID post-vaccination. No treatment was administered for the events. The events had not resolved.
55 2021-01-26 dry mouth, loss of taste does not have much taste/losing taste a little; Mouth dry; This is a spontaneous report from a conta... Read more
does not have much taste/losing taste a little; Mouth dry; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 08Jan2021 (last Friday of 13Jan2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient was calling for herself regrading side effects for the vaccine, she clarified the vaccine to be the COVID-19 Vaccine, the Pfizer one, she got the vaccine on 08Jan2021 (last Friday of 13Jan2021), she was having side effects, she was having issues with her mouth, her mouth was dry and issues with taste, she was losing it a little, she did not have much taste, she stated she had never had dry mouth before and she was trying to figure out if these are symptoms from getting the vaccine or something. The patient experienced mouth dry from 12Jan2021 and ongoing, losing taste a little on an unspecified date. She wanted to know if others had experienced these events. She stated these do not worry her too much, she then added she had heard that mouth dry is a side effect. The patient stated she did not not have a fever, no coughing, or aches. The outcome of the event mouth dry was not recovered, while unknown for the other event. Information about Lot/Batch number is requested.
55 2021-01-26 taste impairment frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back ... Read more
frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back of head and down back of neck; sore injection site; heavy metallic taste; no appetite; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 11Jan2021 08:30 at single dose in right arm for COVID-19 immunization. The patient medical history included obesity and known allergies to sulfa and penicillin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose in left arm for COVID-19 immunization and experienced mild metallic taste and arm soreness (including extreme burning for 10 min following vaccination, the patient believe this was poor administration tech), slight metallic taste 24 hrs post vaccination, lasted a few hours. Concomitant medications in two weeks included metoprolol, colecalciferol (VIT D3), Calcium, ascorbic acid (C) and probiotic. The patient had no covid prior vaccination. It was reported that after the second vaccination, the patient had no burning at site, on 11Jan2021 09:30 the patient had heavy metallic taste approximate 40 mins post vaccine and lasted approximate 12 hrs, at 12 hrs post vaccine (on 11Jan2021 20:30) sudden extreme fatigue, 15 hrs post vaccine (on 11Jan2021 23:30) frequent urination began and lasted approximate 18 hrs. The patient woke up with headache 6/10 that medication would not touch, no appetite but ate and drank anyway hoping would help with headache (it didn't) (reported on 11Jan2021 09:30), approximate 32 hrs post vax headache began receding from the front to back of head and down back of neck. Slept well and woke up 48 hrs post vax feeling normal but with sore injection site (reported as on 11Jan2021 09:30). The patient underwent lab tests and procedures related to covid included nasal swab and PCR with negative result on 04Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
55 2021-01-26 taste impairment mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soren... Read more
mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Workplace clinic. Medical history included obesity from an unknown date. Known allergies included sulfa and penicillin. Concomitant medication included metoprolol, vitamin d3, calcium, probiotics. Patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild metallic taste on 22Dec2020 11:30 with outcome of recovered, arm soreness on 21Dec2020 with outcome of recovered, poor administration tech on 21Dec2020 11:40 with outcome of recovered, extreme burning for 10 min following vax-i on 21Dec2020 11:40 with outcome of recovered. The verbatim as follow: 1st Vax: mild metallic taste and arm soreness (including extreme burning for 10 min following vax-I believe this was poor administration tech), slight metallic taste 24 hrs post vax, lasted a few hours. Patient didn't receive treatment for the adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Jan2021. The covid test type post vaccination was Nasal Swab. The covid test name post vaccination was PCR.
55 2021-01-26 pain in jaw Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a sp... Read more
Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.
55 2021-01-26 taste disorder, dry mouth mouth was dry; sense of taste was not the same; This is a spontaneous report from a contactable othe... Read more
mouth was dry; sense of taste was not the same; This is a spontaneous report from a contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the patient experienced that her mouth was dry and her sense of taste was not the same. The outcome of events was unknown. Follow-up attempts are completed. The following information on the batch number has been requested.
55 2021-01-28 loss of smell, loss of taste Headache, fever, body aches, GI issues, cough feels like something is restricting the back of left l... Read more
Headache, fever, body aches, GI issues, cough feels like something is restricting the back of left lung when taking deep breath, no smell or taste.
55 2021-01-28 dry mouth Pt was waiting her 15 minutes post vaccine administration when pt began to feel hot & flushed, have ... Read more
Pt was waiting her 15 minutes post vaccine administration when pt began to feel hot & flushed, have difficulty swallowing ( constant need to clear throat), dry mouth, numbness & tingling in feet & legs. 2mL of dexamethasone 4mg/mL given IM to left deltoid by FNP. Epinephrine 0.3mg/0.3mL given IM to right upper thigh by FNP. Pt placed on 2LPM O2 via NC for comfort. Pt tolerated well. Pt recovered & left our clinic at 1635.
55 2021-01-28 mouth tingling, feeling of choking Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like ... Read more
Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like her skin was on fire. She also reported some tingling of her tongue and throat. She was administered Benadryl PO x 1 dose and monitored for approximately 60 minutes. Her symptoms improved and she left in improved condition.
55 2021-01-31 loss of taste Report of fever, headache, body aches, lost of taste started day one post vaccination. Treatment: Ty... Read more
Report of fever, headache, body aches, lost of taste started day one post vaccination. Treatment: Tylenol and Ibuprofen. Outcome: body aches, fever and headache has improved. Fatigue and lost of taste remain unchanged.
55 2021-02-01 mouth numbness 2.25 hours after receiving the vaccine, patient began to feel numbness around her mouth, as well as ... Read more
2.25 hours after receiving the vaccine, patient began to feel numbness around her mouth, as well as a constricted feeling in her throat with some difficulty swallowing. Patient was given 25 mg of Benedryl, and later, 40 my of Pepcid, and throat constriction went away but feeling of numbness remained for a while. Her BP generally runs high, but was elevated at 160/100 (1:20 pm), then lowered to 138/89 (1:52 pm). Patient returned to work at 2:06 pm after symptoms had resolved.
55 2021-02-03 deafness, ringing in ears Patient received Pfizer #1 on 1/6/21 and developed muscle cramps and tinnitus and was evaluated by E... Read more
Patient received Pfizer #1 on 1/6/21 and developed muscle cramps and tinnitus and was evaluated by ENT, TMJ specialist,allergist and her PCP. Hearing test revealed mild hearing loss in high frequency. 1/27/21 received the second dose of the vaccine. The following day she developed flu-like symptoms, including fever, chills, headache and fatigue and worsening of Tinnitus. Received Dupixent two weeks prior to the vaccine.
55 2021-02-03 eye itchiness, swelling of eyelid After an hour and a half to two hours after injection, I began to have an allergic reaction but it w... Read more
After an hour and a half to two hours after injection, I began to have an allergic reaction but it was slight. Cheeks turned red and under right eye was slightly swollen and slightly itchy it continued for about 45 min and then my feet and lower legs began to feel the same. The tops of my feet were red for approximately 10 min and then all symptoms subsided. No other problems afterwards
55 2021-02-03 oropharyngeal discomfort Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati... Read more
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially. Her symptoms mildly improved with the initial treatment. Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered. After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms. 1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes. Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
55 2021-02-04 loss of taste, loss of smell Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache an... Read more
Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache and begin to cough. I took another dose of cough meds but it didnt work. That next morning I visited my PCP and my temp was 98.7 when I arrived but the temp elevated to 99.9 while there and another temp was taken shortly after and was 100.8 so I was advised to go back home. Once home I was so tired and weak I could barely make it to the couch. My temp then was 101 so I laid down. The couch was so bad it caused my throat to begin to hurt. I lost my taste and sense smell, my body ached so bad it was unbareable and I developed various bruises all over my body still while continue to cough presistantly. I was off work for about 3 days and those 3 days were the worse days of my life, I was so unconfortable and scared it was almost unbareable I thought I was going to die. And on Thursday the symptoms begin to diminish and by that night it was if nothing had ever happened.
55 2021-02-04 eye pain, vision blurred Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site lim... Read more
Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site limiting movement, eye pain and blurring. All began approximately 12 hours after vaccination. Did report to the ER at Summit Medical Center 2/3/2021 . Labs were drawn, ekg and cxr done. Md stated all normal. (I had pneumonia and was in a fib upon arrival to Vanderbilt Medical Center when I was admitted there with Covid in March 2020.)
55 2021-02-04 mouth tingling Tongue tingling /numbness Diaphoresis Clammy skin Lightheaded Facial flushing
55 2021-02-06 mouth numbness, mouth tingling numbness and tingling of tongue 45 minutes following
55 2021-02-06 toothache, ear pain 3rd day after vaccine, I had severe sore throat on left side, teeth ached on left side, ear ache on ... Read more
3rd day after vaccine, I had severe sore throat on left side, teeth ached on left side, ear ache on left side, no fever, but severe fatigue. Two weeks after I had the 1st vaccine, I ate shell fish. 30 to 45 minutes later, I had a terrible reaction. I had a bad back ache. I felt like I was going to faint and felt very dizzy. I had severe diarreha and had hot flashes and forehead sweats. I barely made it to my bed and went to sleep.
55 2021-02-07 loss of taste, loss of smell PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, C... Read more
PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
55 2021-02-07 taste impairment, eye itchiness, lacrimation increased nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a s... Read more
nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. The patient took vaccine for work, and to get back to a normal life. The patient's medical history and concomitant medications were both reported as none. Shortly after her first dose of the vaccine, she developed nipple drainage. She didn't know if it was coincidental or what. She hadn't noticed it prior to the vaccine. She a work up with a mammogram and ultrasound. There were no masses or anything else. They showed no reason to have the drainage. She was unsure of her weight, but would get 140 or 150 lbs. With the first vaccine, she experienced a sore arm. It started the evening of the 30Dec2020 about 4-6 hours after the vaccine. That resolved, and she recovered completely. She also experienced a metallic taste in her mouth. It happened initially on 30Dec2020. She recovered completely. It only lasted a couple of hours. They were both not serious. She had noticed an increase in the itchy and watery eyes on an unknown date. It was ongoing and persisting. The patient underwent lab tests and procedures which included mammogram: normal, ultrasound breast: normal, weight: 140 or 150 lbs, all on an unknown date. The outcome of the nipple drainage was unknown, the outcome of the events sore arm and metallic taste was recovered on 30Dec2020, the outcome of the events increase in the itchy and watery eyes was not recovered.
55 2021-02-07 taste impairment Ten minutes post receiving vaccination pt reported metallic taste in mouth and 'funny feeling in thr... Read more
Ten minutes post receiving vaccination pt reported metallic taste in mouth and 'funny feeling in throat' that made her constantly need to clear her throat.
55 2021-02-07 eye itchiness, lacrimation increased itchiness and watery eyes; itchiness and watery eyes; nipple drainage/increased again after the seco... Read more
itchiness and watery eyes; itchiness and watery eyes; nipple drainage/increased again after the second dose; nipple drainage/increased again after the second dose; exhausted; nausea; low grade fever; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 55-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 30Dec2020 for COVID-19 immunization and experienced nipple drainage, sore arm, metallic taste in mouth, itchy and watery eyes. The nipple drainage decreased before getting the second dose, and then increased again after the second dose. She noticed an increase in the drainage on 21Jan2021. It was a yellowish to clearish drainage. She was wondering if there was any correlation. She was curious if other women have noticed this. She was unsure of her weight, but would get 140 or 150 lbs. She didn't have a prescribing doctor. She got it through her employer. Also she experienced other side effects. After the second dose she experienced different side effects. She experienced a low grade fever. It started on 19Jan2021 evening into 20Jan2021 morning. It lasted for 18- 24 hours. She recovered completely, and it was not serious. She also developed muscle aches on 19Jan2021, 6-8 hours after the second vaccine. She felt better now. She had a rough night last night. She has been doing Advil, and it had helped significantly. That stated on 19Jan2021. It had improved, and it was not serious. She had also been exhausted after the second vaccine. That started 20 hours after. It started the 20Jan2021. It was ongoing, but had improved. It was not serious. She developed the nausea six hours later on the 19Jan2021. It had improved, but she was not 100%. It was not serious. She had been taking Tylenol and Advil for event low grade fever and muscle aches. She had noticed an increase in the itchiness and watery eyes (She didn't know if it was related to winter and allergies or the vaccine.). It was ongoing and persisting. The outcome of the event low grade fever was recovered on 20Jan2021, of the events muscle aches, exhausted, nausea was recovering, of the events itchiness and watery eyes was not recovered, of the other events was unknown.
55 2021-02-07 mouth tingling, mouth numbness, feeling of choking, taste impairment Patient started by complaining of a metallic taste in their mouth shortly after administration. a fe... Read more
Patient started by complaining of a metallic taste in their mouth shortly after administration. a few minutes later it had evolved into numbness and tingling across the entire mouth and down the throat. Physical exam presented mild swelling
55 2021-02-08 lacrimation increased A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running co... Read more
A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running continuously, I got really congested in my face/nose and my throat felt thick, my heart was racing; it really scared me the nurse gave me Benadryl, I refused the epi-pen because I was starting to feel better and by 2 pm I was good to go
55 2021-02-08 swollen tongue, mouth tingling, lip swelling Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset.... Read more
Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset. Consulted EMTs onsite but as no difficulty breathing and symptoms were reducing, nothing administered by EMTs.
55 2021-02-09 ringing in ears getting a weird ringing, buzzing noise in the ears that keeps coming and going; This is a spontaneou... Read more
getting a weird ringing, buzzing noise in the ears that keeps coming and going; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 17:00 (at the age of 55 years old), as a single dose (Dose 1) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer vaccine at 5PM "yesterday" (20Jan2021) and did fine. This morning (21Jan2021) at 10AM she experienced getting a weird ringing, buzzing noise in the ears that keeps coming and going. She has never had this before. The clinical outcome of the event(s) was not reported. She wanted to know why she is getting this and if it was normal at this point. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
55 2021-02-10 burning mouth syndrome Tongue was sore on the left side. I had a knot under my chin.. In about 8 hours the knot tripled the... Read more
Tongue was sore on the left side. I had a knot under my chin.. In about 8 hours the knot tripled the size looked like a large lymph Node under my chin I went to see a ENT within a week and they stated that my lymph was clogged and congested around the tissue which caused saliva gland to become clogged which causes Salisbury stones in my tongue
55 2021-02-10 vision blurred Clouded vision in one eye
55 2021-02-11 lip swelling, mouth tingling This happen within :15 minutes of the shot. Tongue tingle and swell with lips then nurse gave benad... Read more
This happen within :15 minutes of the shot. Tongue tingle and swell with lips then nurse gave benadryl took the ER to be checkout byt the doctors . The observed and did an EKG and sent home after observation .
55 2021-02-13 swelling of eyelid Swollen eyelids approximately 36 hours after injection.
55 2021-02-16 extreme sound sensitivity About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the compute... Read more
About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the computer could not remember what to do next as I searched for needed files. At the end of the day, I signed off my computer but needed to think about how to turn off the monitor. The next day was better, but by the 3rd day out I became very sensitive to sound. On the 4th morning the brain fog got much worse, my head hurt and I felt like I was moving through life in slow motion. This continued for two whole days and I could not sleep at night due to the intensity of my headache. All of this could have been a migraine which I had in the past, but never to this extent. Past migraines were visual in nature and only lasted about an hour. By the 5th day, I started to feel normal, with the occasional headache or wave of nausea.
55 2021-02-18 mouth tingling, lip swelling Lip swelling on left side of face, also described numbness and tingling. "Felt like I went to the d... Read more
Lip swelling on left side of face, also described numbness and tingling. "Felt like I went to the dentist". Given 50 mg Benadryl. Numbness continued to spread through that side of face, EMS called, transported to ER.
55 2021-02-19 dry mouth, mouth numbness Patient complained of numbness on right side of tongue within 5 minutes of receiving the injection. ... Read more
Patient complained of numbness on right side of tongue within 5 minutes of receiving the injection. The numbness spread across and to the back of her tongue and patient complained that her mouth was feeling heavy and dry within 15 minutes of receiving the injection. Paramedics were on site @nd patient elected to be transported to the hospital.
55 2021-02-20 eye pain, eye swelling Saturday 2-20-21 I woke up with swelling under my left eye. I took ibuprofen and applied ice. Swelli... Read more
Saturday 2-20-21 I woke up with swelling under my left eye. I took ibuprofen and applied ice. Swelling went down slightly but ramped up throughout the day. Sunday 2-21-21 the swelling was under both eyes. The area under the eyes and near the bridge of the nose is sore and sensitive to touch.
55 2021-02-20 eye discomfort, vision blurred The next morning after 2nd COVID-19 vaccination, woke up with darkened/cloudy vision in left eye and... Read more
The next morning after 2nd COVID-19 vaccination, woke up with darkened/cloudy vision in left eye and flu-like symptoms. Presented to ED, where eye pressures 35 (high), prescribed B-blocker drops by an ophthalmologist. She reports she was told her iridectomies looked good. Still able to pass vision test. Pt reports these eye pressures were high as iridectomies performed several weeks ago were preventative and she had no history of high pressure in her eyes. Has ophthalmology follow-up.
55 2021-02-21 vision blurred FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO H... Read more
FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS.. IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM. CHILLS / NO FEVER . COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM. CHILLS/AND SLEPT MOST THE DAY. I DO NOT BELIEVE I EVER HAD A FEVER. SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE. MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE. I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS. OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.
55 2021-02-23 mouth pain At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time.... Read more
At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time. Joint pain followed in ankles, knees, hips, elbows. Next day I had a severe headache with neck and mouth pain. Next day I was terribly weak.
55 2021-02-23 taste disorder Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Me... Read more
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: She had a horrible taste in her mouth
55 2021-02-24 swollen lips, mouth tingling Raised bumps with a white center, white posture-like bumps on face, neck, upper chest, on eyelids, i... Read more
Raised bumps with a white center, white posture-like bumps on face, neck, upper chest, on eyelids, in eyebrows, inside eyes, on pupils of eyes, on lips, inside mouth, on ear lobes, inside ears, on nose, inside nostrils; tingling in tongue, runny nose, extreme fatigue, wooziness, challenges speaking at times,, itching. It is progressing to a different membrane everyday and I am not receiving any assistance.
55 2021-02-24 taste impairment Metallic taste in mouth, no other sx. Hx of anaphylaxis. Evaluated by EMS. So resolved and cli... Read more
Metallic taste in mouth, no other sx. Hx of anaphylaxis. Evaluated by EMS. So resolved and client was discharged at 1:55pm.
55 2021-02-25 mouth numbness Tightness in throat, numbness around mouth. Zytec 10mg po given
55 2021-02-28 swelling of eyelid Angioedema (both eyes swollen shut) took medication prescribed by primary care physician; resolved i... Read more
Angioedema (both eyes swollen shut) took medication prescribed by primary care physician; resolved inn48 hours
55 2021-03-01 swollen tongue, vision blurred Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness... Read more
Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness at localized injection site and felt sleepy, otherwise no adverse reaction signs or symptoms patient reported. On 2-19-21 at 2:30 PM she received her second dose of the Pfizer COVID-19 vaccine at a mall. She reports the lot number of the vaccine was EL9269. She was monitored for 15 minutes after receiving the second dose. She and her husband left and took the car to a car wash where she fell asleep on her way home and her husband woke her up when they got home. At about 320 or 3:25 PM, she noticed that her face felt puffy and she had a sensation that her face was sliding down, she developed tongue swelling, blurry vision, dizziness, and she reports that she was talking funny/slurring her words. Her husband got a flashlight and looked in her throat and said that her throat was swelling. She felt like falling asleep. Her husband used her EpiPen on her. The EpiPen worked right away to improve the symptoms. She took no other treatments at home. Her husband drove her to the hospital where she slept the entire way. She never developed rash, flushing, skin itching, wheezing, coughing, chest tightness, shortness of breath, nausea, vomiting, diarrhea, fevers, chills, or joint pains. She does not know if she passed out, she states it was hard to stay awake. She reports having some abdominal cramping and churning for the following 2 to 3 days afterwards. She was discharged from the hospital ED where she was never admitted. They gave her an albuterol inhaler to use every 4 hours for 6 days after she left the ED. She went home at about 10:00 PM and went to bed about 10:30 PM. She woke up at 3:00 AM crying and then fell back asleep and woke up again around 7:30 AM. She did not develop any local injection site reactions on her arm this time.
55 2021-03-02 visual impairment vision changes Sent to Emergency dept for further observation
55 2021-03-03 mouth tingling C/o throat feeling tickly or itchy, Denied SOB, felt like her lips were tingling as well. Later had ... Read more
C/o throat feeling tickly or itchy, Denied SOB, felt like her lips were tingling as well. Later had itching in her arm. After second co-vid vaccine had a headache for 2 weeks, now has a rash that comes and goes on her antecubital area.
55 2021-03-04 dry eye, thirst March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, na... Read more
March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes. March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine
55 2021-03-05 ear pain Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congesti... Read more
Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congestion, headache, earache
55 2021-03-07 loss of taste, loss of smell Lost senses of smell and taste other than extremely strong tastes and odors (vinegar) for approximat... Read more
Lost senses of smell and taste other than extremely strong tastes and odors (vinegar) for approximately 24 hours. Noticed symptoms improving and completely recovered about 26 hours after initially noticed
55 2021-03-07 taste disorder, mouth tingling Immediately after IM injection, patient stated she had a funny taste and reported lips felt like the... Read more
Immediately after IM injection, patient stated she had a funny taste and reported lips felt like they were tingling. Patient then began having difficulty breathing with throat swelling. Patient was unable to swallow and had difficulty speaking. Epinephrine was administered and EMS was notified. Patient improved after epinephrine administration and was transported by EMS to hospital.
55 2021-03-08 inability to speak, visual impairment Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseate... Read more
Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseated; headache. I felt like everything was it was swollen and tight - I couldn't wear my watch on my wrist. Almost like lymph system - nothing tight in my arm pits; felt like my pants were too tight in my groin - my body was swollen by my lymph nodes. Developed all kinds of gas in my stomach. I was having chest pains - 3 or 4 times a month before the vaccine - after the vaccine - I'm having the chest pains daily. That lasted for about 12 hours. Next day, 22nd, I developed diarrhea for 24 hours. 9 days later - I got numbness and tingling started radiating down my wrist into my fingers; lower calf to my feet and I had to go see my orthopedic surgeon - it was radiating down into my feet. He sent me to a podiatrist and he doesn't know. Those symptoms still haven't resolved. When I wake up - it's a low level and by night time my feet would get so numb and tingly it drove me crazy and then it went into my hands. Went to my doctor on March 2nd - my doctor thought I was having a histamine response in my body. I took an antihistamine - and half my symptoms went away. My esophagus is going into spasms - and I am trying to see a GI specialist. I was taking Benadryl last week but I got too tired. So I take 2 Benadryl at night now and I'm taking a Zyrtec (generic) at the day - it takes the edge off but doesn't resolve the symptoms entirely. Eleven day - I developed a floaty in my right eye - a black spot. I went to my eye doctor - it looks like my eye is healthy -but floaty is not going away. So talking on the phone, My throat is starting to swell up and feels like something back there and the more I talk pretty soon I start losing my voice (happening now on the phone). They added to my meds: Pepsid, Viscus lidocaine; Mylanta after every meal; Pantoprazole; Sucralfate; gave me another one but I haven't taken it yet: Hyoscyamine - for really bad spasms and I haven't had another really bad one since I went to ER (besides taking the antihistamines). I have seen 5 specialists all together.
55 2021-03-08 tongue itchiness Pt reports itchy tongue and lightheadedness. no h/o DM, no meds taken today. juice given
55 2021-03-09 mouth tingling I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started ... Read more
I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started to drive home and in 5 minutes began to feel tingling in mouth, tongue, lips face and itching in throat. Kept checking lips and tongue to see if they were swelling, (which they were not). Event lasted about 15-20 minutes and then subsided after 40 minutes. Itching in throat lasted 24 hours. Whole body felt itchy the next few days.
55 2021-03-09 eye floaters, visual impairment, dry eye Shot was given approximately at 4:50. I left the store after being watched at 5:15. Went to pick u... Read more
Shot was given approximately at 4:50. I left the store after being watched at 5:15. Went to pick up food for supper. While waiting for the food, I was seeing spots (like when you have a photo taken with a flash). This lasted for about 20 minutes. This went away so I continued on my way home. As I was driving I notice that my face was tingling and my eyes seemed to be really dry. Both lasted about 30 minutes. Then I had the headache, arm soreness and light headedness that are "normal" side effects.
55 2021-03-10 eye swelling Acute urticaria. Eyes swelled almost closed. Had trouble keeping them open.
55 2021-03-10 lip swelling Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, h... Read more
Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, had chills , and malaise , 2nd dose had more chills fatigue , GI upset , nausea , swelling at site of injection , arm pain couple of small hives on arm no lip swelling with second dose and migranous headache . Was not as bad as prior reactions to flu vaccine but enough to not feel well enough to go in to work Monday . Was able to go to work Tues though after Sat appt .
55 2021-03-10 mouth pain extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chil... Read more
extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
55 2021-03-10 mouth tingling Swelling on the skin of the chest, arms and leg the day after the injection lasting until the next d... Read more
Swelling on the skin of the chest, arms and leg the day after the injection lasting until the next day. Tingling in the mouth for about an hour and a half on the same day.
55 2021-03-11 eye pain, swelling around the eyes puffiness of eyes, especially left eye. Also bag and dark circle under left eye. Eye balls feel sor... Read more
puffiness of eyes, especially left eye. Also bag and dark circle under left eye. Eye balls feel sore
55 2021-03-11 ringing in ears Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt... Read more
Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt like the Flu, and would not describe as mild. Symtoms began the evening after the shot. Fever gone but still unusually tired as of 3/12/2021 at 4:00 pm. Missed 3 days of work.
55 2021-03-13 mouth pain Full body hypersensitivity reaction rash with oral involvement starting three days after vaccination... Read more
Full body hypersensitivity reaction rash with oral involvement starting three days after vaccination.
55 2021-03-13 mouth pain Full body hypersensitivity rash with oral involvement, starting 3 days after vaccination.
55 2021-03-14 ear discomfort, lip swelling, swollen tongue About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness... Read more
About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness started to go away at 20 minutes later. 15 minutes after I left test site (35 minutes after injections, my tongue, lips, and face started swelling and had trouble swallowing an hour later). I ate a frozen popsicle and the swelling in tongue and lips started to go down. Hours later I took my blood pressure medicine (Lisinopril) I started to have tightness in face and jaw area, burning sensations in ears, jaws and back of my head and headaches. I contacted health care provider after hours number. They scheduled a video appointment with doctor. The doctor advised me not to take blood pressure and any other medications for another day and to put warm compressor on shoulders to relieve some of the tightness in jaws. I was also advised to call 911 or immediately come to healthcare facility if swelling re-occurred. A follow up appointment with primary care provider is scheduled on 3/17/21. I do not have any symptoms at the time of this report, March 15, 2021 at 1:23 pm.
55 2021-03-14 eye itchiness 3-13-21 1:15PM RASH NOTED ON FACE, NECK AND CHEST, EYES ARE ' ITCHY'. NO SOB / DYSPNEA, NO SWELLIN... Read more
3-13-21 1:15PM RASH NOTED ON FACE, NECK AND CHEST, EYES ARE ' ITCHY'. NO SOB / DYSPNEA, NO SWELLING OF MOUTH, TONGUE OR THROAT. GIVEN BENADRYL 50MG PO. PT STATES SHE 'FEELS OK TO GO HOME WITH HUSBAND'. HUSBAND TO DRIVE PT HOME. PT A/O, PINK, W/D, RESP REG WITH EASE. AMBULATORY BRISK/STEADY. NO ACUTE DISTRESS NOTED. 3-15-21 10AM TC: 'STILL HAS VERY SLIGHT RASH, NO OTHER SYMPTOMS'. CHECK WITH PCP R/T DOSE #2.
55 2021-03-14 mouth tingling, feeling of choking Immediate tachycardia, tingling in throat and mouth, hypertension. Treatment in ER. Anaphylaxis pr... Read more
Immediate tachycardia, tingling in throat and mouth, hypertension. Treatment in ER. Anaphylaxis protocol. Days later nausea w dizziness. By day 6 sudden onset of vertigo, diagnosed as vestibular neuritis. PT, supportive meds, continued dizziness.
55 2021-03-14 ringing in ears, hearing loss, deafness unilateral Impaired hearing started on 3/8/2021 in left ear only. Ringing in ear all day on 3/11/2021. Loss o... Read more
Impaired hearing started on 3/8/2021 in left ear only. Ringing in ear all day on 3/11/2021. Loss of hearing progressed each day in left ear. Had doctor appointment on 3/15/2021. Per Doctor, PCP, both ears look clear. Gave referral to see a specialist to check middle ear.
55 2021-03-15 eye disorder, mouth tingling Patient reported tongue heaviness but no swelling. No trouble breathing and extreme tiredness immedi... Read more
Patient reported tongue heaviness but no swelling. No trouble breathing and extreme tiredness immediately following shot. Patient said she could not open her eyes due to tiredness. No other side effects/adverse reaction reported. Monitored for 30 minutes and no medication administered.
55 2021-03-15 mouth numbness, mouth tingling Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on t... Read more
Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on the back of my neck and head, and numbness in my face around my checks, nose, and mouth area. These side effects continued for the next 24 hours along with headache, body aches, tiredness, dizziness, and nausea. I took Tylenol and rested for the first 24 hours, which helped and the side effects subsided. After 24 hours, I still felt tiredness, dizziness, nausea, and tingling/numbness on my left side of my mouth.
55 2021-03-15 mouth pain Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore ... Read more
Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore when biting down on anything, slightly throbbing otherwise. Day 4- soreness in temple subsiding
55 2021-03-15 ringing in ears Ringing in the ears began a few days after the vaccine and has continued
55 2021-03-17 taste impairment Strong metallic taste in my mouth that lasted for about 28 hours. It did stop after 28 hours. No adv... Read more
Strong metallic taste in my mouth that lasted for about 28 hours. It did stop after 28 hours. No adverse impact from having this side effect.
55 2021-03-17 eye itchiness Left arm developed an itchy rash on my wrist and forearm. About 30 minutes later my ears started it... Read more
Left arm developed an itchy rash on my wrist and forearm. About 30 minutes later my ears started itching. About 45 minutes later my right eye was itchy. I took two Benadryl tablets and decided to work from home. I drove home and took a nap. When I woke up the rash and itching were gone.
55 2021-03-17 lip swelling, ear discomfort, tongue disorder, swollen tongue Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, staye... Read more
Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, stayed for observation for about 20min and was feeling better so left - but about halfway home lips started to swell, tongue started to feel thick and throat started hurting - ate a popsicle which seemed to help. Then that evening took her usual dose of lisinopril and about an hour later noticed tightness developing in her neck and new headache, followed by swelling of lips and tongue. Took tylenol arthritis which she usually takes for her neck problems, and went to bed, but a couple of hours later developed burning in her ears and jaw, headache persisted, and swelling seemed to have gone down with ice chips. Lisinopril d/c'd on 3/14, converted 3/17 to losartan which she started at 5pm and within 2 hours had recurrent angioedema for which she was told to call emergency responders, used EpiPen, discharged from ED after 4 hours with another change in BP medication and Medrol dosepak. Allergist recommends no further COVID vaccines.
55 2021-03-17 lip swelling Swelling and painful/stinging lips. No immediate reaction, sore arm and a little fluish the next d... Read more
Swelling and painful/stinging lips. No immediate reaction, sore arm and a little fluish the next day
55 2021-03-18 dry throat, mouth tingling itchy scratchy throat with mild tingling sensation around lips
55 2021-03-18 taste impairment A few hours after first dose I began having a metallic taste in mouth. This lasted for several hours... Read more
A few hours after first dose I began having a metallic taste in mouth. This lasted for several hours, even through sleep. Also had zero food or appetite all day, despite trying, even after metallic taste dissipated. FYI: my boyfriend, who completed both shots of this same brand, said he also had weird taste in mouth.
55 2021-03-18 lip swelling AFTER I LEFT THE VACCINE SITE ABOUT 5 MIN LATER MY FACE AND LIPS STARTED TO SWELL. THE LIP SWELING R... Read more
AFTER I LEFT THE VACCINE SITE ABOUT 5 MIN LATER MY FACE AND LIPS STARTED TO SWELL. THE LIP SWELING RESOLVED ABOUT 15 MINS AFTER ONSET AND THE FACIAL SWELLING ABOUT AN HOUR AFTER ONSET.
55 2021-03-19 eye itchiness Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and ... Read more
Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and chest.
55 2021-03-19 mouth pain With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pai... Read more
With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pain/swollen glands/- 2 days later pain traveled to mouth and throat- on day 5 in the evening starting run a fever with severe night sweats/Chills/no appetite/fatigue . I have never experienced this feeling before --- the amount of sweat coming out of my body was like a demon was being released. I felt these severe symptoms for about 4 days . One week later from onset of night sweats/c hills/ fatigue I still have these symptoms but not as severe.
55 2021-03-20 mouth numbness Patient reported feeling numbness to the lips, mouth, upper palate and throat as well as feeling lik... Read more
Patient reported feeling numbness to the lips, mouth, upper palate and throat as well as feeling like someone was "choking her". She didn't appear to be in respiratory distress but reported that she had had a severe allergic reaction to the shingles vaccine one month ago, and that these were the same symptoms she felt at that time before it escalated. Patient was given epinephrine autoinjection 0.3 mg to the right thigh and EMS was called. Patient was transferred to ED. Patient remained conscious, breathing stable and able to speak the entire time.
55 2021-03-20 mouth discomfort, taste impairment A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in... Read more
A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in mouth was noted; intense flushing and burning sensation from my waist up, mostly in the chest, developed; intense flushing and burning sensation from my waist up, mostly in the chest, developed; increase in heart rate, but no tachycardia; elevation of blood pressure; This is a spontaneous report from a contactable 55-year-old female physician reported for herself. A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,Lot number: FM 9809) on her right arm intramuscularly on 09Feb2021 (at the age of 55-years-old ) at single dose for covid-19 immunisation.Medical history included HBP, RA, Hyperlipidemia. Allergies to medications included NSAID'S. Other medications which patient received within 2 weeks of vaccination included Irbesartan 150mg, Toprol 100mg XL, Plaquenil 200mg, Simvastatin 10mg, Folic Acid 1mg, Methotrexate 15mg sq weekly. On 09Feb2021 14.15 it was reported that less than one minute after receiving the vaccine, a metallic taste and burning sensation in mouth was noted , and then an intense flushing and burning sensation from her waist up, mostly in the chest, developed. There was some increase in heart rate, but no tachycardia, no skin and/or respiratory manifestations. There was mild elevation of blood pressure. The symptoms resolved without any medication and lasted about 10 -15 minutes. No more symptoms or complaints thereafter. The events were considered as non-serious by reporter. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.No treatment received for events. The outcome of the events was reovered.
55 2021-03-21 taste impairment, mouth tingling 1508 C/O LIPS TINGLY METALLIC TASTE MONITORED, BP 142/98 SAT 97% HR 70 1533 148/98 96% 67 1548 148/... Read more
1508 C/O LIPS TINGLY METALLIC TASTE MONITORED, BP 142/98 SAT 97% HR 70 1533 148/98 96% 67 1548 148/99 99% 70 1603 146/100 98% 66 Did not want Benadryl pt told family she will be driving home. encouraged to seek medical help if s/s worsen pt call for an appt with MD this week.
55 2021-03-22 eye swelling Facial itching eye swelling wheezing- occurrred on two incidences treated with Benadryl and nexium ... Read more
Facial itching eye swelling wheezing- occurrred on two incidences treated with Benadryl and nexium first episode. Second episode was seen by dr - dose pack, famotidine, Benadryl, rescue inhaler were prescribed..
55 2021-03-22 mouth numbness After about 40 minutes post-vaccination in my left arm, I experienced some numbness on left side of ... Read more
After about 40 minutes post-vaccination in my left arm, I experienced some numbness on left side of my chin/cheek and general nausea. The numbness proceeded up the left side of my face w/no visible drooping, and also included my left arm, left leg and left side of my tongue. Numbness level was like what it feels like as dental novocaine wears off. Went to ER and had CT scan, bloodwork, and an MRI which ruled out any stroke concerns. Monday, day after vaccine, I was tired (understandably since in the ER until 4 AM Monday) and had some residual numbness, mostly on my face, some on my arm/leg. Nausea went away after an hour or so on Sunday afternoon and I ate variety of food w/no issues on Sunday and forward. Still have some of the numbness sensations as of Tuesday, mostly feel it in my face. Overall, it feels like half my body got the vaccine and the other half wasn't impacted.
55 2021-03-22 mouth swelling, taste disorder Throat swollen and inside cheeks swollen, no taste tongue and cheeks feel burning sensation when eat... Read more
Throat swollen and inside cheeks swollen, no taste tongue and cheeks feel burning sensation when eat or drink.
55 2021-03-23 vision blurred 2:35 pm Client presented self w/ c/o feeling a bit lightheaded. no c/o blurred vision. Respiration... Read more
2:35 pm Client presented self w/ c/o feeling a bit lightheaded. no c/o blurred vision. Respiration even and reg. B/P 190/98, HR 94. Paramedics present. 2:45 pm stated feet better, allowed to leave observation area.
55 2021-03-25 eye bleeding Client reported a ruptured blood vessel in her right eye following vaccine administration. Client w... Read more
Client reported a ruptured blood vessel in her right eye following vaccine administration. Client was evaluated by Fire Rescue. Client was released to go home at 3:59pm. Per Fire Rescue patient does not need further onsite eval.
55 2021-03-25 lip swelling, swollen tongue After minutes of observation, pt was driving home, at about 35 minutes after vaccine was administere... Read more
After minutes of observation, pt was driving home, at about 35 minutes after vaccine was administered pt felt thickening of tongue, feeling tightness in throat, lips feeling thick, stopped at a pharmacy bought OTC allergy medicine Zyrtec , took it & went home. Also took Benadryl when she go home
55 2021-03-25 mouth tingling, mouth numbness Approx 30 minutes after vax my lips started tingling and became numb. Approx 45 minutes after vax m... Read more
Approx 30 minutes after vax my lips started tingling and became numb. Approx 45 minutes after vax my tongue became tingly and numb. Two hours later the condition was the same. I took an herbal antihistamine and it reduced a bit. By approx 10:00am the next morning the tingling and numbness was gone.
55 2021-03-25 ringing in ears, mouth itchiness, swollen tongue 55 yo female received first dose of the Pfizer COVID-19 vaccine on 3/17 at 1309. Pt was observed for... Read more
55 yo female received first dose of the Pfizer COVID-19 vaccine on 3/17 at 1309. Pt was observed for 15 minutes without any symptoms. She left the facility, but returned a few minutes later with complaints of dizziness, nausea, thick tongue, and itching palate. Upon assessment, vitals were BP 145/83, HR 83, SpO2 99%. Given diphenhydramine 25 mg solution. Shortly thereafter, pt experienced increasing tongue thickness and chest tightness. Epinephrine 0.3 mg auto injector administered followed by famotidine 20 mg and hydrocortisone 100 mg. Continued dizziness, ear ringing, SpO2 83%. EMS called and patient transferred to the ED. Presented to the ED without symptoms and observed for 4 hours. Discharged home with...
55 2021-03-26 taste impairment Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal... Read more
Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal taste at time of vaccine.
55 2021-03-26 eye itchiness A few minutes after the injection patient developed left eye itching and throat scratchiness (approx... Read more
A few minutes after the injection patient developed left eye itching and throat scratchiness (approximately 0905). Vitals at 0913: 104/74 BP, 74 HR, 98.3 temp, 100 % oxygen saturation. Gave 50 mg oral Benadryl at 0916. Vitals at 0918: 100 % oxygen saturation, 111 HR, 133/71 BP, chest heaviness noted at this time. Vitals as of 0923: 114 HR, 100 % oxygen saturation, 122/83 BP. Patient transported to Emergency Room.
55 2021-03-27 mouth numbness, swollen tongue Within the first few min of getting the injection my throat got tight and my tongue swelled up and g... Read more
Within the first few min of getting the injection my throat got tight and my tongue swelled up and got numb. I could still breathe fine. Didn't need any additional help. Throat cleared up after a few hours. Tongue still numb and swollen a bit for around 4 days after. Each day got better but took a few days for it to return to normal. Still having some occasional numbness on day 5 but not swollen and only on the edge of tongue. At this reporting I seem to have mostly recovered. I had a video conference with my doctor a couple days after to discuss my reaction.
55 2021-03-27 mouth tingling Pt felt dizziness noted with lip tingling
55 2021-03-27 smell distorsion From 3/22/21 through 3/26/21 (days 2 through 7 after the vaccine), I experienced: 1) my skin felt li... Read more
From 3/22/21 through 3/26/21 (days 2 through 7 after the vaccine), I experienced: 1) my skin felt like it was sunburned, I didn't have redness or a rash 2) I felt extremely cold, had to put on 4-5 layers including a down jacket inside the house, I never ran a fever 3) I had a headache, first on right side, then on upper left, then center of forehand, drinking 90 ounces or more of water a day helped 4) I had hyperosmia, a heightened sense of smell
55 2021-03-28 mouth numbness Severe headache, numbness in lips and tongue l
55 2021-03-28 sensitivity to light Red stripe starting under the vaccinated arm, about 2-3" thick ending just past my rib cage, mid abd... Read more
Red stripe starting under the vaccinated arm, about 2-3" thick ending just past my rib cage, mid abdomen with a thin red line across my chest towards my heart. Gone at 12 noon on 3/10, less than 24 hours after shot. Fatigue, light sensitivity, headache.
55 2021-03-29 dry mouth Shortness of breath, chest pressure, dry mouth, numbness in hands.
55 2021-03-29 ear discomfort Pain in right arm began about 7 hours after injection. I slept on my left side all night because ri... Read more
Pain in right arm began about 7 hours after injection. I slept on my left side all night because right arm hurt. It especially hurts when I lift my arm. It also aches and tingles up and down entire arm and up through my neck, around to back shoulder blade and up through cheek. My ear is "congested" and hearing is impaired and my ear tingles also. I slept the entire night on my left side so it wouldn't be that fluid settled there over night.
55 2021-03-29 eye pain Low fever, bad headache, nausea, fatigue, sore eyes
55 2021-03-29 eye pain A little over an hour after my shot I got extremely hot and started sweating for about an hour and a... Read more
A little over an hour after my shot I got extremely hot and started sweating for about an hour and a half. About four hours after the shot I got an extremely bad headache along with chills and very sore arm. Sometime shortly there after my neck on the left side felt sore and then my face on the left side felt sore. I had shooting pain in the right eye. The only thing that still hurts is my head and left side of my face.
55 2021-03-29 pain in jaw, ear pain, ear discomfort right ear irritation moving to ear pressure to ear pain behind ear lobe; right ear irritation moving... Read more
right ear irritation moving to ear pressure to ear pain behind ear lobe; right ear irritation moving to ear pressure to ear pain behind ear lobe; headache; right side of mouth canker sore; right side of head jaw pain; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9269) via an unspecified route on 11Feb2021 at 12:00 (at the age of 55-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included erratic blood pressure and Von Willebrand Syndrome. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included levothyroxine and hydrochlorothiazide from unspecified dates for unspecified indications. The patient received dose 1 of BNT162B2 (lot number EL9261) on 20Jan2021 at 11:30 as a single dose in the left arm for COVID-10 immunization. The patient did not have any allergies to medications, food, or other products. On 19Feb2021 at 07:00 the patient experienced right ear irritation moving to ear pressure to ear pain behind ear lobe, right side of mouth canker sore, right side of head jaw pain, and headache. The patient visited a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcomes of right ear irritation moving to ear pressure to ear pain behind ear lobe, right side of mouth canker sore, right side of head jaw pain, and headache were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
55 2021-03-30 double vision, eye disorder hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy bey... Read more
hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy beyond itch; Anaphylaxis; Double vision; Right eye is going cross eyed/Left eye is dropping; Right wrist pain increased dramatically after the vaccine; Throat starting to close/Throat started tightening; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 19Feb2021 10:00 (Batch/Lot Number: EN6201), at the age of 55 years, as single dose for covid-19 immunisation. Medical history included ongoing asthma diagnosed 3 years ago, ongoing gastrooesophageal reflux disease diagnosed 4 years ago, ongoing hypertension diagnosed 4 years ago, ongoing food allergy: allergic to eggs, shellfish, dairy/lactose intolerant, ongoing allergies to environmental: standard- hay fever, dust, mold, ongoing allergies to dogs and cats, contrast media reaction (IV contrast CT scan dye- respiratory distress, throat tightens), urticaria, pruritus. She had Covid on 18Dec2020 and "Covid rash it attached her muscular system. She had muscular pain in the wrist and hip on the right side and mild double vision." The patient previously took vitamin k 2 and experienced anaphylactic reaction, Toradol and experienced urticaria, influenza vaccine and experienced rash at the injection site, at the age of 34 years (because she's allergic to eggs). The patient received the first dose of bnt162b2 on 29Jan2021 Lot: EL3247; 9:30 AM; Right arm for covid-19 immunisation and she did not have any symptoms whatsoever with the first shot. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. Vaccination Facility Type: Hospital. Concomitant medications included omeprazole taken for gastrooesophageal reflux disease; lisinopril taken for hypertension; montelukast sodium (SINGULAIR) taken for asthma; salbutamol sulfate (INHALERIN) taken for asthma; start and stop date were not reported for all. The patient experienced anaphylaxis on 26Feb2021 with outcome of unknown, throat starting to close/throat started tightening on 19Feb2021 with outcome of recovered, severe rash- latus stranding, purple dots, and hives from face all the way down to toes on 19Feb2021 with outcome of not recovered, double vision on 20Feb2021 with outcome of not recovered, right eye is going cross eyed/left eye is dropping on 20Feb2021 with outcome of not recovered, right wrist pain increased dramatically after the vaccine on 20Feb2021 with outcome of not recovered, hands got very swollen and rash and itchy beyond itch on an unspecified date with outcome of unknown for Hand swelling and recovered for Localised itching. Therapeutic measures were taken as a result of the events: Benadryl, Zyrtec, Pepcid, New glasses for double vision, Prednisone 7 day ween. The patient underwent lab tests which included Hematology test on unknown date with unknown results; Immune markers on 11Mar2021 with unknown results. Clinical course: The patient received the vaccine on 19Feb2021at 10:00 AM and five minutes after, her throat started tightening and they put her in observation for another hour and then her throat felt fine and they let her go. Caller confirmed she was not referring to this occurrence as anaphylaxis. The anaphylactic reaction occurred days later. She mentioned from 19Feb2021-26Feb2021, her symptoms were progressing and then on 26Feb2021, it was full blown out; the actual anaphylaxis was 26Feb2021. Between this, she had severe double vision, severe rash from face all the way down to toes, one eye going cross eyed (right eye), left eye is still drooping. On 20Feb2021, she started having double vision that started with the sunlight and fluorescent lights and the next day she couldn't see anything without double vision, and her eye started going cross eyed. She still cannot see normally now. She is under eye doctor care for that too. The patient was treated with Epi-Pen into leg and then into the Emergency Room. She received 50 mgs of Benadryl and 125 mg of Solu-Medrol IM injection, but still have to give Epi because her throat was still closing. Her airway was intact and no nebulizer treatment needed. The patient reported also that her hands got very swollen and rash and itchy beyond itch. The patient reported that her weight at that point was 204, the she had been on Prednisone for a week, and her weight has gone up to 210 now. After her throat closed on the 26Feb2021, caller reports she gained 7 pounds while on it for one week. Caller stated she was also put on prednisone when she got diagnosed with asthma, reactive airway. She confirmed her throat stop closing immediately after the Epi. The patient was also treated with 25 mgs of Benadryl, Zyrtec, and Pepcid a day. Outcome for throat closing was improved with medication. Outcome for rash was not improved and she is taking medicine to counteract it; itch went away when she took the Zyrtec. Regarding right wrist pain, it increased dramatically after the vaccine. Caller reports it felt like a spiral fracture down the ulna and it started to ache on 20Feb2021, by the next day it hurt a 5 out of 10. By 22Feb2021, she was wearing a splint, it was 8 out of 10, and she felt like she fractured it and it was swollen on the ulnar side. Regarding eye disorder, she is now under the care of an eye doctor for her severe double vision, eye crossing, and eye drooping. The blurred eyes give bad balance and that kind of stuff. The cross eyedness gives her poor peripheral vision and also her depth perception has now been compromised. They say the glasses will fix it. As of 22Feb2021, a new pair of special lenses with prisms were ordered for her. The patient was not hospitalized.
55 2021-03-30 ear discomfort, ear pain Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe nec... Read more
Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
55 2021-03-30 tongue disorder, lip swelling, ringing in ears ringing in ears,; fat lips, fat throat, fat tongue, Benadryl at 1540; symptom resolved.
55 2021-03-30 toothache, pain in jaw, mouth pain Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/... Read more
Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; sensitive to pressure/heat/cold both upper and lower jaw; This is a spontaneous report from a 55-Year-Old non- pregnant female contactable Other Health Professional reported for herself that she received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 EUA, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 28Jan2021 (age at vaccination: 55 years) at 17:45 at single dose in right arm for covid-19 immunization. The patient's medical history included high cholesterol, Obesity, high blood pressure and known allergies: contrast dye. Concomitant medications included Simvastatin, Lisinopril, Aspirin 81, and Fish oil. On 28Jan2021 at 22:00, the patient experienced significant pain following the trigeminal (CN5) nerve on right side (injection side), Jaw/tooth/gum/cheek pain and sensitive to pressure/heat/cold both upper and lower jaw. The patient did not take any treatment for the events. The outcome of the events was not recovered Information on Lot/Batch number has been requested.
55 2021-03-31 deafness, ringing in ears Severe tinnitus starting in left ear then 1 week later the tinnitus is in both ears. Very loud, low,... Read more
Severe tinnitus starting in left ear then 1 week later the tinnitus is in both ears. Very loud, low, roar causing vertigo, nausea and hearing loss. Horrific headaches.
55 2021-03-31 dry mouth Client received to post vaccination observation with hx of anaphylaxis with influenza and pneumonia ... Read more
Client received to post vaccination observation with hx of anaphylaxis with influenza and pneumonia vaccination when administered together. Guest accompanied by husband. Husband states he is a medic with the fire department. Client has brought Epi-Pen with her today given her previous experiences. Client is seated in observation area with complaint of dry mouth. Pt given water. Client is visibly anxious and it was decided to take a set of vitals to help reassure and calm the client. VSS. Client was visibly relieved when given vitals were normal. Client continued to wait 30 min observation time without incident. Client discharged with her husband.
55 2021-03-31 eye movement disorder After vaccination, while waiting the recommended 15 minutes post vaccination, around 10 minutes, pat... Read more
After vaccination, while waiting the recommended 15 minutes post vaccination, around 10 minutes, patient fainted and eyes rolled back, patient was limb and could not stand. Patient was breathing and talking, however was disoriented, did not know where she was.
55 2021-03-31 mouth numbness, dry mouth Observed wheezing and difficulty breathing. Numb lips and dry mouth. Administered Epi Pen and 5 LPM ... Read more
Observed wheezing and difficulty breathing. Numb lips and dry mouth. Administered Epi Pen and 5 LPM of Oxygen. Called EMS. Patient refused to go to hospital. Breathing resumed normal
55 2021-03-31 mouth numbness Patient received first Covid vaccine around 2:30pm. At 2:42 pm this nurse called out to patients ve... Read more
Patient received first Covid vaccine around 2:30pm. At 2:42 pm this nurse called out to patients vehicle who is c/o difficulty breathing. Patient reports her mouth feels like 'cotton mouth and tongue feels numb'. Patient appears to be very short of breath. Blood pressure 158/72. Pulse 78. At this time, patient reports she is having difficulty breathing and her throat is itchy and feels like it is closing up. Patients voice has changed. 2:45pm - called 911. 2:46pm - 0.5ml Epinephrine given IM left upper thigh. Lot 339384 Exp 8/21. 2:48pm - Patient continues to present with shortness of breath and still c/o throat tightness. Diphenhydramine 50mg given IM left deltoid. Lot 6020400 Exp 9/21. 2:51 pm- Patient reports she is starting to feel better and having a little easier time breathing. Fire dept with responders arrive. 2:57pm - Ambulance arrives and assesses patient. Patient refuses to go to ER. She reports she is feeling much better. She is requesting for brother to be called so he can drive her home. Brother called. 3:15 ambulance and fire dept left. This nurse stayed with patient until brother arrived. Patient left at 3:40pm in stable condition with brother driving patients vehicle.
55 2021-03-31 lacrimation increased Patient presented at Altec for her first covid vaccine shot. Patient stated she has had a reaction t... Read more
Patient presented at Altec for her first covid vaccine shot. Patient stated she has had a reaction to a previous immunization. Patient was counseled about possible side effects and reactions and was counseled to stay in observation area for a minimum of 30 minutes. Vaccine given at 1008. At 1019 patient appeared to be anxious and stated that she felt her heart was racing, eyes started watering and a tightness in her neck. C/O headache. 25mg PO Benadryl given. Pulse 80 BPM. Patient continued to appear anxious and redness noted on neck like hives. 911 called to evaluate patient. Patient declined the need to go to the emergency room. Patient was reported by human resources at Altec that she was able to return to work and they have been keeping a close eye on her.
55 2021-03-31 ringing in ears Ringing in the ears. No treatment as of yet. I started to notice it a couple of days after the va... Read more
Ringing in the ears. No treatment as of yet. I started to notice it a couple of days after the vaccine and it has continued till today, a total of 5 days.
55 2021-03-31 vision blurred, eye movement disorder Bells Palsy Blurry sight-3/30/2021 Couldn?t move mouth-3/31/2021 Couldn?t close right eye- 4-1/2021
55 2021-04-01 mouth numbness, tongue disorder Numbing of lips, face, nose cavity. Thickening tongue. Weight on chest. Symptoms consistent with my ... Read more
Numbing of lips, face, nose cavity. Thickening tongue. Weight on chest. Symptoms consistent with my response to both ibuprofen and strawberry allergies except less severe and no hives. Lasted about 4-6 hours.
55 2021-04-01 oropharyngeal discomfort Patient had left the covid vaccine clinic after being observed for 15 minutes. She came back in bre... Read more
Patient had left the covid vaccine clinic after being observed for 15 minutes. She came back in breathing quickly and hyperventilating. Complaining of "throat feeling funny". Patient was brought into a private room and sat down. She was responsive and coherent at that time. VS obtained and stable. She appeared anxious. Patient continued to complain of her throat feeling tight so a dose of Epi was given and 911 called. After 10 minutes she became more anxious and breathing increased. Another dose of epi was given due to pt still feeling like throat was tight. EMS here at that time and they intervened. Patient transferred to the ER.
55 2021-04-01 swollen tongue her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; al... Read more
her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; allergic reaction to the COVID-19 Vaccine; heaviness with her headache; stroke; Facial droop; Numbness / left half of her face was numb /numbness in her left hand/numbness and tingling all over her body; Tingling; Tiredness; Pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EN6202 and expiry information not provided) via unspecified route in the left arm on 03Mar2021 between 17:10 and 17:30 (at 55-years-old) for COVID-19 immunisation. Relevant medical history included Frozen shoulder (2020-2020), and severe migraines (especially in the past ten years). The patient further stated that she has always had migraines. She said sometimes when her migraines escalate, her blood pressure goes up, and her left side tingles. She said several times in the past, she thought her migraine symptoms may have been a stroke. She said she her doctor is checking her for any kind of things like rheumatoid arthritis, mast cells, constant (chronic) fatigue, and fibromyalgia. She said right before the COVID-19 Virus pandemic she had passed out unexpectedly. She said she doesn't know what caused her to pass out. She said she needs another neurological test done. She said she had a neurological test that maybe showed that veins were dying in her brain, but she wasn't sure. She said her doctor had been doing heart tests too, but because of the pandemic, it was taking longer to have the tests done. The patient also mentioned that her last blood work was probably in/around Nov2020. There were no concomitant medications or past drug history reported. The patient denied receiving any other vaccination within the four weeks prior to the vaccination. The patient also denied receiving any other vaccination on the same date as the vaccination. The patient reported that on 04Mar2021, approximately seventeen hours after she received the COVID-19 vaccine, she had what she thought was a kind of severe reaction. She said she had an inside numbness and tingling all over her body. She said the left side of her body, especially, had a very strong numbness and tingling, like a stroke. She said the numbness was in her left hand, and outside left shoulder. She said the left half of her face was numb. She said at the time she felt weird. She said she was speaking to her friend on a video call and did not want her friend to think she was a cry baby. She said then her friend told her there was something happening with her face. She said the right side of her face had dropped. She said her right eye and the right side of her mouth were drooping. She said she told her friend she thought she had an allergic reaction to the COVID-19 Vaccine. She said it took about three hours for her symptoms to pass. She said afterward she was so tired, had pain, and a headache. She said it was strange for her to have a headache because she was used to migraines. She said she still had a headache today (08Mar2021). She said she had a heaviness with her headache. She said if she had a migraine, she would not be able to do anything, but with the headache she had, she was able to go about her everyday things. She said her stomach was bothering her too, but she was not worried about how her stomach felt. The events did not require any visits to a physician's office nor the emergency room. Treatment for the events included drinking a lot of water and moving around. The outcome of the events, inside numbness and tingling all over her body, very strong numbness and tingling, like a stroke¸ numbness was in her left hand, and outside left shoulder, half of her face was numb, right side of her face had dropped, and tongue looked swollen, and allergic reaction to the COVID-19 Vaccine was recovered on 04Mar2021 after about three hours duration. The outcome of the events so tired, and pain was recovered on an unspecified date in Mar2021. The outcome of the events, headache, and heaviness with her headache was not recovered.
55 2021-04-01 thirst Dizziness after the shot, feelings of disorientation but felt better later. The night of the injecti... Read more
Dizziness after the shot, feelings of disorientation but felt better later. The night of the injection - profuse sweating, extreme body aches, fever, headache, extreme thirst - these were all symptoms I had when I believe I had COVID last Feb 2020. Very similar symptoms except not the dry cough/pneumonia, etc. Most symptoms dissipated after about 2 1/2 days but I didn't feel completely recovered for about 5 days.
55 2021-04-02 burning mouth syndrome My tongue has painful swollen ulcers on the right side.
55 2021-04-03 eye irritation temperature 100.5; She has body aches all over including her hips and joints; eyes burning; Headache... Read more
temperature 100.5; She has body aches all over including her hips and joints; eyes burning; Headache; Chills; This is a spontaneous report from a contactable consumer (patient himself) A 55-year-old female consumer patient received the second dose of BNT162B2 (Solution for injection, lot number: EL3249, Expiration date; unknown), in Left arm on 02Feb2021, 9:30 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included first dose BNT162B2 (lot number: EL1283) left arm on 12Jan2021, at single Covid-19 immunization. The patient experienced Last night the caller started having chills on 02Feb2021 and end of reaction/event on 03Feb2021, the outcome of event of chill was recovered. Patient having temperature of 100.5, body aches to a bad toothache all over body including her hips and joints, eyes were burning might be from the temperature and headache on 03Feb2021. The outcome of the events was not recovered. Follow-up activities have been completed and no further information is expected.
55 2021-04-03 hearing loss, ringing in ears, ear discomfort Right Ear fullness, constant ringing or noise. Hearing impaired in right ear, sounds muffled or som... Read more
Right Ear fullness, constant ringing or noise. Hearing impaired in right ear, sounds muffled or some noise is painful. This has been nonstop since 2-3 days after 1st vaccine. Have taken Claritin, pseudoephedrine as well as Benadryl to relieve the ear fullness, no relief.
55 2021-04-04 dry throat, dry mouth, thirst Rapid heartbeat, extreme thirst 3 hours later. Typical side effects started 18 hours later and some ... Read more
Rapid heartbeat, extreme thirst 3 hours later. Typical side effects started 18 hours later and some still ongoing now for 10 days. Day 9- extreme dry mouth/throat started
55 2021-04-04 mouth tingling, tongue itchiness, mouth itchiness About an hour after receiving the vaccine I developed a large white hive just below the injection si... Read more
About an hour after receiving the vaccine I developed a large white hive just below the injection site. (hive approx 2 inches in diameter) I began to itch on rest of body/ no more hives just itch. I took 50mg of Benadryl. 4 hours later still itching so I took 50mg of Benadryl. Approx, 4.5 hours later, woke up with tightening feeling in throat, itching in throat and roof of mouth, itching tingling of tongue, and tingling sensation of lips. went to the emergency room. Was admitted and monitored, benadryl was administered. Duration of hospital stay 1 day.
55 2021-04-04 eye floaters, light flashes or floaters in the eye 3 episodes of abrupt and transient hypertension (max measured 218/113) with fever (38.1 C), marked h... Read more
3 episodes of abrupt and transient hypertension (max measured 218/113) with fever (38.1 C), marked headache and dyspnea on March 3, 4 and 7, requiring visits at Emergency Department (ED) on March 4 and 7. Episode on March 3 and 4 lasted few hours and self-resolved (2 liters iv saline on 3/4 at ED). Episode on March 7 required use of iv Atenolol at ED and oral Atenolol for the next 5 days. Starting March 5, flashes and floaters (?oily? spot in the right eye). All symptoms disappeared after March 12, except for the floaters in the right eye.
55 2021-04-05 mouth numbness, taste impairment Pt given vaccine at 1130. Has hx of SVT and inappropriate tachycardia. 1131 pt c/o metallic taste.... Read more
Pt given vaccine at 1130. Has hx of SVT and inappropriate tachycardia. 1131 pt c/o metallic taste. 1140 pt c/o increased HR and numbness in lips and mouth. No c/o SOB, dizziness, or nausea. 1140 HR 130s. numbness in lips and mouth 1150 HR 110-115. decreased numbness in lips and mouth1200 HR 114 BP 103/83 100% O2 1205 HR 113 100% O2; MD called to bedside for Pt numbness of mouth and tongue subsided. HR back to 100-110. Cleared to leave clinic. Nurse provided assessment.
55 2021-04-05 lacrimation increased "watery eyes, racing heart beat, shaky"
55 2021-04-05 swollen tongue, lip swelling swelling of lips & tongue
55 2021-04-05 ringing in ears Ongoing Tingling,numbness in hands and fingers then moved to right side of my face.Ongoing ringing i... Read more
Ongoing Tingling,numbness in hands and fingers then moved to right side of my face.Ongoing ringing in my ears!
55 2021-04-05 visual impairment Scratchy throat and eyes pulsating
55 2021-04-06 lip swelling felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Ups... Read more
felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Upset stomach; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 13:00 (Lot Number: ER2613) as SINGLE DOSE for COVID-19 immunisation. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (TIROSINT) taken for thyroid, start and stop date were not reported. The patient previously took thiomersal and experienced allergy to thiomersal. On 22Mar2021, the patient had some reactions to BNT162B2, the patient was curious if she should take the second one, knowing how the patient's body. The patient waited for 30 minutes after the vaccine to make sure something didn't happen. The patient started to have lip swelling so she went back into the facility and waited a little longer, the swelling subsided on their own but then she started having shortness of breath through the evening, but not to the point to go to the emergency room. The patient felt like there was a lot of pressure on her chest, congestion and upset stomach. The main symptom was the heaviness in the chest. The outcome of congestion, lip swelling and upset stomach was recovering and the outcome of the rest of the events was unknown.
55 2021-04-06 mouth pain, mouth discomfort, mouth tingling Driving home from receiving first dose of Pfizer vaccine for Covid 19, So about 40 minutes after rec... Read more
Driving home from receiving first dose of Pfizer vaccine for Covid 19, So about 40 minutes after receiving the shot, I started to experience lip tingling and burning, heart palpitations/racing and a headache that started from out of no where. The burning and tingling would come and go, so I pulled over and took a Benadryl. I made it home and took some Advil. That evening, the heart racing continued with pressure, it would come and go. I also developed a hive/sore on the inside of my upper lip that burned. I felt very tired but simultaneously I had a feeling of anxiousness at the same time. I took more Advil before bed. Day after the shot, I felt better, the hive on the inside of my lip was almost gone and I took Advil and Tylenol during the day when I started feeling not well.
55 2021-04-06 feeling of choking, mouth tingling At 1045am, c/o tingling in lips and mouth. Gave Benadryl 25mg PO at 1048am and contacted Dr. Started... Read more
At 1045am, c/o tingling in lips and mouth. Gave Benadryl 25mg PO at 1048am and contacted Dr. Started shaking at 1050am. At 1100am, no tingling in lips. At 1110am, shaking stopped. At 1116, c/o tingling in throat and right hand swelling. EMS called to assess. At 1120am, monitored by EMS. At 1140am, left site feeling better. Instructed not to schedule second dose at drive through setting and to contact PCP for further recommendations. Instructed to take another Benadryl at home or go to ER for any further reactions. Also instructed to keep Epi-Pen at all times.
55 2021-04-06 ringing in ears Ringing in my ears and nausea, started in the first two hours after getting the shot.
55 2021-04-06 toothache Numbness on the right side of the face after 8 minutes. it lasted for 10 minutes before it subsided ... Read more
Numbness on the right side of the face after 8 minutes. it lasted for 10 minutes before it subsided and then it happened again ten minutes later. I have felt the after effects on the side of my face since then. My teeth hurt and after effects of numbness. Also, 102 temp two days after injection and very painful arm on the injection side.
55 2021-04-06 vision blurred Vision in right eye was markedly blurry for about 60 hours. Was most noticeable at mid to long dista... Read more
Vision in right eye was markedly blurry for about 60 hours. Was most noticeable at mid to long distance. It cleared up on its own.
55 2021-04-07 dry mouth, oropharyngeal discomfort, taste impairment rapid heart rate, dry mouth and metallic taste, throat pressure -- immediate onset, increased in few... Read more
rapid heart rate, dry mouth and metallic taste, throat pressure -- immediate onset, increased in few hours and decreased next day but still symtoms still present
55 2021-04-07 taste impairment, toothache Fever Body aches Sore teeth Metallic taste Headache
55 2021-04-07 lip swelling, mouth numbness, swollen tongue Wheezing, coughing, trouble breathing, swelling of the lips and tongue, numbness of the lips and ton... Read more
Wheezing, coughing, trouble breathing, swelling of the lips and tongue, numbness of the lips and tongue
55 2021-04-07 mouth tingling Pt states that she was experiencing anxiety and tongue tingling on her way out of the clinic. Had pa... Read more
Pt states that she was experiencing anxiety and tongue tingling on her way out of the clinic. Had patient wait in clinic another 15 min and took her vitals. B/P- 130/80, P-72, R-20, SPO2-98% room air.
55 2021-04-07 swollen tongue, lip swelling Patient received her first dose of the Pfizer CoVID Vaccine on 3/30/21 and started to have swelling ... Read more
Patient received her first dose of the Pfizer CoVID Vaccine on 3/30/21 and started to have swelling of the lips and tongue on 4/2/21. She has never had angioedema in the past, no family history. She is not on ace-inhibitors. She did not require hospitalization. She was treated as an outpatient on 4/5/21 with Steroids, Benadryl and Zyrtec. She is slowly improving
55 2021-04-07 swollen tongue Bruised and swollen big toe on right foot. No injury to toe and no pain.
55 2021-04-08 taste impairment Sore arm, hip and calf left side. Lump under left arm. Fever, nausea, metallic taste, chills, wors... Read more
Sore arm, hip and calf left side. Lump under left arm. Fever, nausea, metallic taste, chills, worse than when I had covid
55 2021-04-08 ear itchiness, mouth itchiness Patient reported nausea and headache within 15 minutes of vaccination. She then developed itchiness... Read more
Patient reported nausea and headache within 15 minutes of vaccination. She then developed itchiness in her mouth and ears and was given Benedryl. She developed hives on her scalp and was given epi. Patient was transported to ER by EMS.
55 2021-04-08 mouth numbness 1/20 vaccination 30 Minutes later, my tongue started to go numb. Within 15 min, from eyebrow down to... Read more
1/20 vaccination 30 Minutes later, my tongue started to go numb. Within 15 min, from eyebrow down to my neck was completely numb on L side. Lasted for 2 weeks. I called back to facility and they said they had never heard about it. Then thru the weekend, I recorded everything on an app and did telehealth with PCM. By 3-4 days later before 2nd vaccination, it got better. 2nd vaccination, little numbness, fatigue, tightness across chest. No course of treatment advised by PCM but faired better with second vaccination; 2/10/2021.
55 2021-04-08 mouth itchiness Patient's mouth started itching after her second COVID-19 vaccine (Pfizer), 30 minutes after her inj... Read more
Patient's mouth started itching after her second COVID-19 vaccine (Pfizer), 30 minutes after her injection. Her mouth had been itching the entire time. Patient was given Zyrtec 10 mg PO x 1. She felt better and was discharged to home.
55 2021-04-08 mouth tingling, feeling of choking AT 10:45 AM PT C/O TINGLING IN LIPS AND MOUTH. GAVE PT BENADRYL 25MG PO AT 10:48 AM AND CONTACTED DR... Read more
AT 10:45 AM PT C/O TINGLING IN LIPS AND MOUTH. GAVE PT BENADRYL 25MG PO AT 10:48 AM AND CONTACTED DR. WAITED WITH PT EXTRA TIME. PT HAD STARTED SHAKING AT 10:50 AM. AT 11:00 AM LIPS NOT TINGLING. AT 11:10 AM, STOPPED SHAKING. AT 11:16 AM C/O TINGLING IN THROAT AND RIGHT HAND SWELLING. EMS CALLED TO ASSESS. AT 11:20AM PT BEING MONITORED BY EMS. AT 11:40 AM PT LEFT SITE, FEELING BETTER. PT TOLD NOT TO SCHEDULE 2ND DOSE AT ANY DRIVE THRU SETTING.
55 2021-04-08 sensitivity to light, ringing in ears Vice-like headache, shooting pain in neck and upper back, sensitivity to light, exhaustion, tinnitus... Read more
Vice-like headache, shooting pain in neck and upper back, sensitivity to light, exhaustion, tinnitus, low appetite, back pain shifted to sacrum and hamstrings second day, painful to sit, stand, walk, put on socks, difficult to concentrate, unable to work for nearly 2 weeks, still extremely low energy.
55 2021-04-08 swollen tongue, mouth tingling The patient is a 55-year-old female who presents for a possible allergic reaction status-post receiv... Read more
The patient is a 55-year-old female who presents for a possible allergic reaction status-post receiving her 1st COVID vaccination at 1820 this evening. Approximately 15 minutes after receiving the injection, she developed palpitations, tongue swelling, and tongue tingling. The patient reports an improvement in her tongue swelling, but the tingling still persists. She denies difficulties with breathing. No rash. She reports normal urination and bowel movements.. The onset was 2 hours ago. The course/duration of symptoms is constant. Location: face. The character of symptoms is tingling. The degree at onset was minimal. The degree at present is minimal. Risk factors consist of none. Therapy today: none. Associated symptoms: denies chest pain, denies abdominal pain, denies nausea, denies vomiting and denies shortness of breath
55 2021-04-08 ringing in ears Ringing in the ears all the time
55 2021-04-08 ringing in ears About an hour after receiving the first dose of the vaccine I began having ringing/hissing noise in ... Read more
About an hour after receiving the first dose of the vaccine I began having ringing/hissing noise in both ears. It has not gone away. A week after it started, I saw my primary care physician. There is not much to be done. Suggested taking allergy meds. It has not cleared up. - two weeks after the first dose. It is difficult to sleep as it seems to be worse at night.
55 2021-04-08 toothache March 29, approximately 4:30 PM, I began to experience chills and body aches, and noticed my teeth f... Read more
March 29, approximately 4:30 PM, I began to experience chills and body aches, and noticed my teeth felt sensitive when I ate dinner. March 30, upon waking: Chills and aches were gone, but by 10 AM, my teeth continued to get more and more sensitive (it felt like I had been hit on the right side of my mouth) and my gum tissue became bulbous and sore around the sore teeth (6,7,8,25,26,27) and I wondered if I cracked a tooth somehow. However, the pain radiated to the right posterior teeth, and crossed to both incisors (top and bottom) on the left side. I would describe the pain as throbbing and acutely sensitive to room temperature air, pressure, hot and cold. this happened in a very short span of time, and I was awake and not clenching or grinding my teeth. March 30, afternoon: I called my dentist. He was out of town. I posted on social media, asking if anyone has had tooth pain post vaccine. There were a handful of anecdotal stories (first hand) with a similar issue, so I decided to wait and see if my issue would resolve similarly. April 6: Pain has been intermittently severe and dull over the past week. I see my dentist this afternoon to do an evaluation. He says the tissue looks odd - almost like a herpetic lesion trying to heal, both around tooth 26 and on the palate adjacent to 8. Also, it appears there is no longer any keratinized gum tissue around 26, and the tissue had receded dramatically on this tooth. The doctor takes photos and refers me to a periodontist for a tissue graft to save the tooth. April 9 (today): I have an appointment with a periodontist next week for an evaluation. My dentist assures me the area will need a graft. Today I have less pain, but the gingival inflammation around 26 has persisted. Since I don't know the outcome at this point, I can only hope that tooth 26 can be saved with a facial graft, but that is the course of action.
55 2021-04-10 dry mouth After about 20 minutes mouth got very dry. Mild wave of nauseau and stomach feeling weird. Sides o... Read more
After about 20 minutes mouth got very dry. Mild wave of nauseau and stomach feeling weird. Sides of throat below ears felt full. Breathing fresh air outside helped some. Drank water and ate 2 chocolate marshmallow candy eggs and stomach felt better within 10 minutes. Dry mouth and fullness on sides of throat lasted a bit longer, maybe 1 hour. Pain in left arm at injection site started that evening (about 5 hours later). Pain still present next morning and rubbed Blue-Emu cream on the arm, which helped a little bit. Pain gradually decreased during that next morning and was gone by 24 hours after the 1st dose vaccination.
55 2021-04-10 mouth tingling, swollen tongue Pfizer-BioNTech Covid-19 Vaccine Numbing on my entire right arm and swelling. then soon after I fel... Read more
Pfizer-BioNTech Covid-19 Vaccine Numbing on my entire right arm and swelling. then soon after I felt my throat closing and my tongue swelling. I couldn't even swallow my saliva. There was tingling in my lips and tongue too. Also felt like spasms inside my right arm. For 3 hours I was very scared then little by little there was improvement. Next morning my throat has improved but my arm is the same and I have a headache all over.
55 2021-04-10 mouth tingling The first thing I noticed was occasional tingling in my left hand on April 9. On April 10 a little ... Read more
The first thing I noticed was occasional tingling in my left hand on April 9. On April 10 a little more frequent and almost like it was "going to sleep" slightly. Today, April 11, more of the same but also in my arm. I am also having some stiffness on the back side of my neck, occassionaly that I have had in the past at times. Today, I have also noticed the left side of my tongue feeling a slight tingling.
55 2021-04-11 taste impairment metal test in mouth 30 minutes after injection Bells Palsy set in on 3/23 (6 days after injection
55 2021-04-11 ear discomfort, tongue discomfort Severe headache and neck pain particularly in the anterior neck with redness and burning of anterior... Read more
Severe headache and neck pain particularly in the anterior neck with redness and burning of anterior neck chest and ears. Also on anterior neck a feeling of terrible tightness and muscle spasm like head wants to pull down. Under chin and sides of tounge hot red burning sensation. Much worse after I take my thyroid medicine in the morning. I have called my doctor and am awaiting a call back if it gets worse I will go to urgent care.
55 2021-04-11 mouth numbness Right lower lip numbness and drooping x 2 days.
55 2021-04-11 smell distorsion, taste impairment, dry mouth Within 15 minutes I felt tightness in my chest and throat, 35 minutes after the vaccine I developed... Read more
Within 15 minutes I felt tightness in my chest and throat, 35 minutes after the vaccine I developed a metal taste in my mouth. Soon after I started getting a nasal drip and when I blew my nose I could smell metal. My head has felt "foggy" and dizzy ever since. It is now over 36 hours since the vaccine. I have been drinking plenty of water and woke up dehydrated, my mouth is dry and I have this awful taste. The metal taste is even worse and even tastes like chemically. It is very unpleasant and I can taste my food, but my coffee is tasting weird and the food is too. I still have headaches, slight nausea, but the worst, most unpleasant and worrisome condition is this metal/chemical taste and sensation in my mouth and nose. What is this???
55 2021-04-12 ear pain Starting the morning after 1st dose, burning skin reaction, all over body, bright red skin - no rash... Read more
Starting the morning after 1st dose, burning skin reaction, all over body, bright red skin - no rash, no fever. Following days painful sores on left ear & neck painful head area. Burning sensation comes and goes, still experiencing problem, every 3-4 days it re-occurs starting the whole inflammatory response over again. Asthma is exacerbated.
55 2021-04-12 eye movement disorder, vision blurred, dry eye Headache. Chills/shaking. Numbness on the right side of the head and face. Discomfort in the right a... Read more
Headache. Chills/shaking. Numbness on the right side of the head and face. Discomfort in the right arm and foot. Vision blurred in both eyes but stronger in the right. Dry right eye and difficulty having movement and blinking. On Thursday 4-01-2021 more acute symptoms, headache and severe chest pain as a consequence I had to go to the emergency room. And to this day my symptoms continue.
55 2021-04-12 hearing loss, sensitivity to light, mouth tingling within 5 minutes of receiving injection felt it move through body and felt flushed, an EMT took my ... Read more
within 5 minutes of receiving injection felt it move through body and felt flushed, an EMT took my bp = 165/107 and hr =117, felt super hot in gland areas, tingling in left jaw and tongue, flash headaches, light sensitivity, muffled hearing, itching skin, skin crawling (tingling) all over. Was given total of 75mg Benadryl along with 40mg Pepcid Remained at the clinic for almost 2 hours, symptoms persisted from day of injection Thursday March 25 - Monday March 29
55 2021-04-12 lacrimation increased All was fine till day 9 evening when my right eye kept watering, and I brushed my teeth water shot o... Read more
All was fine till day 9 evening when my right eye kept watering, and I brushed my teeth water shot out right side. Next day same thing with blurred speech. I went to hospital, had CT n MRI. No blood clot determined its bells palsy. I have been healthy accept for mild seasonal allergies
55 2021-04-12 lip swelling, inability to speak Started losing my voice around 6 pm the same day as shot. Then my lip swelled up just on the right ... Read more
Started losing my voice around 6 pm the same day as shot. Then my lip swelled up just on the right side. Little trouble swallowing. Went to ER. Dr. did ask if I was taking Lisinopril and told me to stop taking it immediately. Gave me an IV of Prednisone and Benadryl.
55 2021-04-12 mouth tingling, tongue discomfort, swollen tongue Started Levocetirizine 5mg q24hrs 2 days prior to vaccine. Approximately 20-25min after receiving th... Read more
Started Levocetirizine 5mg q24hrs 2 days prior to vaccine. Approximately 20-25min after receiving the vaccine developed an acute headache (top of head) and tingling/ fuzzy feel to tongue. Tongue appeared visibly more pale than normal and possibly slightly swollen. Symptoms lasted 2-4hrs (gradually improved over that time frame). Breathing/ heart rate normal during the entire time. Burnt tongue feeling lasted for 5-7 days (only noted intermittently over last 2 days). Soreness to arm noted next day (mild) and resolved after 48hrs. Started taper Prednisone dose after reaction x 10 days. No further reactions noted.
55 2021-04-12 ringing in ears ringing in ears
55 2021-04-12 vision blurred, pain in jaw When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoul... Read more
When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoulder pain; Severe left arm and shoulder pain; Fever that gradually went higher to 103.7; Severe headache; Jaw pain; Blurred vision; Tired; Sweaty; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Sulfa's and sulfurs, Unknown blood clotting disorder, Arnold chiari malformation syndrome, sinusitis. Concomitant medication included apixaban (ELIQUIS) taken for Unknown blood clotting disorder. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6199) on 06Mar2021, 04:00AM on left arm for covid-19 immunisation (55 years old). On 28Mar2021, 04:00, the patient stated that she had severe left arm and shoulder pain, fever that gradually went higher to 103.7 then a day later the fever went down. Severe headache with jaw pain, blurred vision. When she was able to fall asleep she woke biting my tongue like a seizure. Currently she is tired and sweaty, fever has gone, arm pain gone within a day and a half. Therapeutic measures were taken as a result of all the events included At home pain and fever medicine. The patient was not pregnant. Outcome of the events pain in arm and fever was recovered on an unspecified date while outcome of the remaining events was recovering.
55 2021-04-13 taste impairment Pfizer-BioNTech COVID-19 Vaccine EUA Metallic taste in my mouth, started right after the vaccination... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Metallic taste in my mouth, started right after the vaccination and lasted about a week.
55 2021-04-13 taste impairment Pfizer-BioNTech COVID-19 Vaccine Metallic taste in my mouth, started right after the vaccination an... Read more
Pfizer-BioNTech COVID-19 Vaccine Metallic taste in my mouth, started right after the vaccination and lasted about three days
55 2021-04-13 eye pain The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her ri... Read more
The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her right eye that never went away. Then on Wednesday morning, March 31st (two weeks after receiving the first dose), she was found in bed by my mother, unable to walk or talk, her face was drooping, she was very sweaty, and had defecated on herself. My mother called the ambulance. She was transported to Hospital where it was determined she had suffered a massive hemorrhagic stroke. She was immediately transported by ambulance to another Hospital. She spent one day in ICU and then was put on palliative care. She died around 12/N on Friday, April 2nd, two days after the stroke.
55 2021-04-13 lip swelling Pfizer-BioNTech COVID-19 Vaccine EUA Woke up on Sunday morning after vaccine with very swollen lips... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Woke up on Sunday morning after vaccine with very swollen lips. By the afternoon I had a rash starting on my upper torso and it continued to cover my face. I began taking Benadryl 25mg q6 and contacted my doctor to see if I should receive the second dose of vaccine. She advised against it. The swelling went down but rash continued. Contacted my doctor on April 12th and began a regimen of a titrating dose of Prednisone 20mg for 12 days on April 13th. As of today, I seem to be responding to treatment
55 2021-04-13 mouth tingling, mouth numbness patient reports numbness, tingling or left upper arm and perioral numbness/tingling about 5 mins aft... Read more
patient reports numbness, tingling or left upper arm and perioral numbness/tingling about 5 mins after vaccination. Benadryl given and symptoms resolved by 2:08pm
55 2021-04-13 ringing in ears Shortly after receiving vaccination I noticed a ringing in my ears. It has continued through today. ... Read more
Shortly after receiving vaccination I noticed a ringing in my ears. It has continued through today. This. morning I woke up to it being a bit more intense which is what prompted this report.
55 2021-04-13 ringing in ears Worsening of tinnitus after vaccination.
55 2021-04-13 eye floaters, light flashes or floaters in the eye, visual impairment 1-WEEK AFTER RECEIVING THE VACCINE I DEVELOPED SPOTS AND LIGHT FLASHES IN MY RIGHT EYE. I WENT TO T... Read more
1-WEEK AFTER RECEIVING THE VACCINE I DEVELOPED SPOTS AND LIGHT FLASHES IN MY RIGHT EYE. I WENT TO THE HOSPITAL AND HAD A ULTRASOUND OF THE EYE TO CHECK FOR HEMORAGE BEHIND EYE. IT WAS CLEAR. FOLLOWED UP WITH EYE SPECIALIST THE NEXT DAY AND WAS DIAGNOISED WITH Posterior Vitreous Detachment. I HAVE NOW SEVERAL LARGE FLOATERS IN THE EYE.
55 2021-04-14 taste impairment About 25 minutes after injection I felt a pain and then numbness that claimed my neck into my jaw, c... Read more
About 25 minutes after injection I felt a pain and then numbness that claimed my neck into my jaw, cheek, nose, eye area, and forehead accompanied by a metal taste in my mouth. All occurred on the left side only. It is now 4:25 and I still have the same numbness. So far, other observations are soreness of muscle in upper left arm and stiffness in left side of neck. My husband was also vaccinated at the same time in a different pharmacy and is experiencing similar side effects with numbness is mouth/jaw and metal taste.
55 2021-04-14 taste impairment Metallic taste in mouth, chest pains
55 2021-04-14 swollen tongue Had a reaction 25 minutes after receiving the vaccine. swelling tongue, hands and feet. Dizzy, nause... Read more
Had a reaction 25 minutes after receiving the vaccine. swelling tongue, hands and feet. Dizzy, nausea, felt like I was going to throw up. Cold sweat. Lasted for about 25 minutes. Felt okay the next two days, then starting Friday 4/9 the dizzy and nausea came back. Tightness in chest and so dizzy having trouble working a full day at work. Some times it would go away and I would feel fine, then it would come back. I haven't had one day where I have felt good the whole day since.
55 2021-04-14 ringing in ears, extreme sound sensitivity Constant Ringing in the ears, hissing, high pitched Humming, sounds like a ?Cicada? chirping in my e... Read more
Constant Ringing in the ears, hissing, high pitched Humming, sounds like a ?Cicada? chirping in my ears all the time.
55 2021-04-14 ringing in ears Continuous Buzzing in my ears that started after my second COVID-19 vaccine
55 2021-04-14 toothache 2days after my teeth! My teeth are in so much pain only on the left side and now I have swollen glan... Read more
2days after my teeth! My teeth are in so much pain only on the left side and now I have swollen glands in my neck left side! My face is getting puffy on the left side as well! I just want to know am I the only one!? I am now laying on a heating pad around that area! And taking tylenol because ibuprofen makes it worse! I would do this over again but want to know if it is normal and how long will it take for it to come out of my teeth!? Thank you!
55 2021-04-14 vision blurred I need to talk about my pfizer experience. I'm 56. January 15 I received my first dose. I had zero s... Read more
I need to talk about my pfizer experience. I'm 56. January 15 I received my first dose. I had zero side effects. The night after that initial dose. I began having what I'd term as cognitive issues. Trouble focusing. Blurred vision. Confusion. My synapsis weren't synapping. My brain and mouth didn't work. I felt like inside my body was shaking. But visibly, outside, was nothing. At that time, I was managing diabetes and I figured it was related to victoza being stopped since I'm not a diabetic now. And it continued about 7 days. Then, dwindled for a few, but it returned. I then began getting panicked about it and having panic attacks. I'm afraid of dementia, and remembering was an issue. It continued 4 days off 4 days on. Oddly enough. The 3rd week, it went away about 3 days in. I had about 7 days of bliss, but on the 4th day I got vaccination number 2. At this point, troubleshooting, I quit all my medications. I thought the issue was meditation related. I got shot number two and 3 days later, it hit and stayed again. 4 days on. 4 days off. By this time, I figured it is not my medications. So I went to my Dr. We did an MRI. Carotid workup. We did every test known to man, inluding heavy metals and found no anomalies except I was dehydrated. So I increased water and raised kidney functions. Weeks went by like this. Off and on. Dr finally told me I had toxic metabolic encephalopathy and I could have died. All testing rules out everything except vaccination reactions. He said my body didn't recognize the vaccine and that my brain attacked the toxins and swellee and caused the TME because of that. I want others to know. TMEs can be deadly. Your brain can swell, and you can die. Fortunately I'm on the upswing. But I still worry about memory. I forget appointments. I still am for the vaccinations. But we never know how our own bodies will react. My physicians diagnosis is a TME caused by Pfizer vaccine. He has ruled everything else out. I advocate this vaccinaction. Do it. I think what I went through is rare. But interestingly enough, online, it states 23 percent of covid victims get TME. I didn't have Covid. I've tested negative. This is also not dementia or anything of that nature. I've been thoroughly examined.
55 2021-04-15 pain in jaw Lock jaw following morning, some pain eased but then reoccurred.
55 2021-04-15 pain in jaw First COVID19 shot felt fast heartbeat but seemed to subside in couple hours Second COVID19 shot sam... Read more
First COVID19 shot felt fast heartbeat but seemed to subside in couple hours Second COVID19 shot same fast heartbeat seemed to subside but I was tired. Next day it felt as if someone threw a fast pitch softball at my chest took my breath away seemed to last several minutes then extreme heartburn set in. Very fatigued, heart burn lasted 9 days. Starting on 4/5/21 joint pain also started in my new hip. On 4/12/21 jaw pain set in at which point went to urgent care.
55 2021-04-15 sensitivity to light, double vision fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial ... Read more
fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial tingling/bilateral hand and foot tingling; double vision; disorientation; joint pain; orthostatic hypotension; chills; photophobic/photophobia; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left deltoid on 26Jan2021 15:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The first dose was received on 05Jan2021 15:00 (lot number: EL1284) on the left arm. Medical history included herpes simplex virus (HSV), Superior Oblique Myokymia, and Lyme Disease; from an unspecified date and unknown if ongoing. Patient was not pregnant. Concomitant medications included calcium citrate, magnesium citrate (CAL/MAG CITRATE), ergocalciferol (VIT D), fish oil (OMEGA 3), and paracetamol (TYLENOL). The patient previously took VICODIN and flu vaccine as a child, and experienced allergies. The patient experienced headache, nausea, dizziness, facial tingling, double vision, disorientation, joint pain, orthostatic hypotension, chills, photophobic from 27Jan2021 05:00. On 02Feb2021, she experienced dizziness, headache, nausea, photophobia, facial tingling, bilateral hand and foot tingling, GFR 47 all other CBC, cmp normal. There was headache, nausea, photophobia, facial tingling on 07Feb2021 and on 10Feb2021, tingling and fatigue from waist to feet posteriorly and bilaterally. She had lab test drawn and blood work done when she was sick and her GFR came back as 47, so everything else was normal, and her GFR was 47 which was out of range. On 03Feb2021 was the first test and it was 2 weeks that she had to repeat test just to make sure it was back in normal range which it was. Thee patient was still experiencing the events but 'not as bad', and stated she can still function. Her side effects were improving but she still have a daily headache and paresthesia. The events resulted in physician/ healthcare professional visit. Patient was recovering from the events. ZOFRAN was given as treatment for the events. Patient stated she takes Tylenol but her doctor want her not to take medication for a while but she had to take Tylenol. Patient had no covid prior to vaccination and has been tested (nasal swab) post vaccination on 29Jan2021 with negative results.
55 2021-04-15 ringing in ears Tinnitus/ringing in ears.
55 2021-04-16 visual impairment On April 9th, I developed a headache at 9pm while watching tv. About 15 minutes later I noticed my v... Read more
On April 9th, I developed a headache at 9pm while watching tv. About 15 minutes later I noticed my vision was changing so I called my daughter to come stay with me and took tylenol fast release capsules. I went to bed and woke up the next morning with the same headache so I asked my daughter to take me to urgent care. Upon arrival they did a Covid test. I told them about my previous stroke in July 2020 and that I had a PFO closure done in October and have been on Plavix (clopidogrel) since then so I wasn't worried about stroke. The dr sent me to the ER immediately and they performed an MRI scan and told me I had suffered a new stroke due to blood clot.
55 2021-04-17 ringing in ears tinnitus
55 2021-04-17 vision blurred Injections burn like crazy/ injection is extremely painful; Rash at the injection site; Experiencing... Read more
Injections burn like crazy/ injection is extremely painful; Rash at the injection site; Experiencing flares; Blurry vision / blurriness; This is a solicited report received from a contactable consumer based on information received by Pfizer. This solicited report (USASL2020210290) was reported to Amgen on 23/DEC/2020 by a consumer from a commercial program (PSP00086) and involves a 55 years old, female patient whose injections burn like crazy [PT: injection site pain] and blurry vision/blurriness [PT: vision blurred] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient's injections burn like crazy. For past three and a half to four weeks in Nov2020, the patient has had blurry vision. The patient saw an Ophthalmologist who stated everything looked fine with her eyes but blurriness persists. No treatment information was received. The outcome of the event vision blurred was reported as not recovered/not resolved. The outcome of the event injection site pain was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain and vision blurred. The causal relationship between the events injection site pain, vision blurred and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected. ADDITIONAL INFORMATION RECIEVED ON 02Apr2021: This case is upgraded to serious. In this follow up, the patient was experiencing flares [PT: rheumatoid arthritis], injection is extremely painful [PT: injection site pain], rash at the injection site [PT: injection site rash] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medications included covid-19 vaccine. On an unknown date, the patient reported that each injection was extremely painful and she gets a rash at the injection site with almost every dose. On 09Mar2021, she has been experiencing flares since having a COVID vaccine on 09Mar2021. She was not home to provide lot. No treatment information was received. The outcome of the events injection site pain, injection site rash were reported as not recovered/not resolved. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events injection site rash and rheumatoid arthritis. The causal relationship between the events injection site rash, rheumatoid arthritis and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts were possible. No further information was expected. Amgen's causality assessment: events injection site pain and injection site rash were related to etanercept, while events blurry vision and rheumatoid arthritis flare up were unrelated to etanercept. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen Comment: This individual case report does not change the safety profile of the product.; Sender's Comments: Based on information provided, the time association and vaccine's safety profile, the possible contribution of suspect BNT162B2 to the events rheumatoid arthritis flare up ,injection site pain and injection site rash cannot be excluded. The event blurry vision occurred prior to the administration of vaccine BNT162B2, considered unrelated to vaccine injection. The causal relationship of the drug etanercept to the events injection site pain and injection site rash is possible given the implied time association, while the events blurry vision and rheumatoid arthritis flare up were assessed as unrelated to etanercept. The rheumatoid arthritis would involve in eye's disorder when the rheumatoid arthritis is in active status. The clinical course of rheumatoid arthritis would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
55 2021-04-17 vision blurred lightheaded/dizziness, nausea, blurred vision, EMT evaluated, pt. refused transport.
55 2021-04-18 ringing in ears, eye pain, dry mouth, eye strain 4/15/2021 Evening: Dry mouth, sore arm 4/16/2021 By 8am: Headache, stiff joint, temp 99.5F 4/16/20... Read more
4/15/2021 Evening: Dry mouth, sore arm 4/16/2021 By 8am: Headache, stiff joint, temp 99.5F 4/16/2021 Throughout the day, headache and temp ranging 99.5F to 100F 4/16/2021 6:30 pm: Took Tylenol 4/16/2021 By 7 pm, the headache is gone 4/16/2021 By 8pm, temp 97.2F, still higher than normal temp (below 96.8F) 4/17/2021 9am. Temp 98.1F. Sharp sting in right eye, mild sting in left eye. They went away after 5 mins or so. Eyes felt heavy through out the day. 4/19/2021 3pm. Tinnitus. Usually it is unnoticeable, but it's very loud. It comes and goes, but this is the worst tinnitus I have experienced.
55 2021-04-18 ringing in ears Flu symptoms beginning the evening of the 2nd injection worsening the second day and ringing in ears... Read more
Flu symptoms beginning the evening of the 2nd injection worsening the second day and ringing in ears began. Third day (April 17th) fever broke, aches were minimal but right arm pit very sore and ears ringing. As of today, 4/19/21, still experiencing ear ringing and my right armpit is still really sore.
55 2021-04-19 eye irritation Lot # unknown. On 4/7/21 very tired for 24 hours. But on 4/11/21 experienced extreme fatigue with so... Read more
Lot # unknown. On 4/7/21 very tired for 24 hours. But on 4/11/21 experienced extreme fatigue with sore body by late evening temp had risen to 100.5. Temp continued ranging from 99.9 to 101, also experienced body aches, headache, eyes burned, decreased appetite, sweating and chills all continued to 4/15/21. 4/15/21 temp normal but fatigue remained and cough started. Hard cough both dry and productive at times. An ache in the middle of my chest. Had doc appointment on 4/16/21. Temp normal but doc stated my labs were at the levels of someone who had covid but I was covid neg. The doctor suggested my illness was related to the vaccine. I missed a week of work and although I have returned to work I am still experiencing a lingering hard cough.
55 2021-04-19 mouth tingling, taste impairment Heaviness in chest; tight throat; numb and tingly lips; metallic taste. Metallic taste lasted thru n... Read more
Heaviness in chest; tight throat; numb and tingly lips; metallic taste. Metallic taste lasted thru next day.
55 2021-04-19 sensitivity to light Approximately 10-12 hours after vaccine body aches & headache began, 12-24hrs added chills, sweating... Read more
Approximately 10-12 hours after vaccine body aches & headache began, 12-24hrs added chills, sweating, sleeplessness, 24-36 very bad headache w/sensitivity to noise & light, added low fever, muscle aches, dizziness, light headed when sitting up, getting up to walk. 36-48 hours continued body aches lessened, headache lessened, nausea & dizzy w/lightheadedness. 60-72 hours diarrhea for 12 hours & stiff sore muscles, but headache lowered in pain, as with body aches, chills & sweating.
55 2021-04-19 ringing in ears, hearing loss I am experiencing continuous buzzing/humming in my left ear, decreased hearing and mild dizziness.
55 2021-04-19 ringing in ears Have tinnitus in LEFT ear. Constant low roaring. Still present and not lessening at this time.
55 2021-04-20 loss of taste, loss of smell Extreme symptoms for a full week after 1st Pfizer vaccine. Extremely painful muscle aches everywhere... Read more
Extreme symptoms for a full week after 1st Pfizer vaccine. Extremely painful muscle aches everywhere but worse in my legs. Constant nausea, could not taste or smell food, watery diarrhea, profound weakness, extreme fatigue, nightmares.
55 2021-04-20 taste impairment, mouth numbness Metallic taste in mouth and tongue numbness. Gets better then starts again. Administered 25mg Benadr... Read more
Metallic taste in mouth and tongue numbness. Gets better then starts again. Administered 25mg Benadryl and monitored
55 2021-04-20 hearing loss Received shot on 4/1/21 and on 4/13/21 in the pm I started to experience a loud noise in my left ear... Read more
Received shot on 4/1/21 and on 4/13/21 in the pm I started to experience a loud noise in my left ear like a roaring sound and on 4/14/21 the noise was intensyfying I contacted my MD (ENT) office as soon as they opened and received an appointment. My hearing has dropped some in the left ear according to the hearing test and I was placed on high dose steroids and a repeat hearing test to be done on 4/22/21. Currently experiencing a whisper of a noise in my left ear.
55 2021-04-20 mouth numbness Patient experienced self-limited angioedema of the lips resulting in perioral numbness that persiste... Read more
Patient experienced self-limited angioedema of the lips resulting in perioral numbness that persisted for 2 weeks before resolving. Errythematous papulovesicular rash on dorsum of both great toes. Thrombocytopenia with platelet count of 129,000.
55 2021-04-20 oropharyngeal discomfort, taste impairment This was my second dose. About 1 minute after vaccination Both sides of my mouth released saliva th... Read more
This was my second dose. About 1 minute after vaccination Both sides of my mouth released saliva that tasted like copper. My neck started swelling up like a bullfrog and I felt pressure on both sides of my throat and had difficulty swallowing. I was closely monitored in the clinic and treated with Pepcid and Zyrtec. The swelling receded. Within 10 minutes after medication and I went home. The coppery taste lingers.
55 2021-04-20 ringing in ears Nausea, exhaustion, dizziness, headache, tinnitus the day after the vaccine. Rested all day. Day 2 a... Read more
Nausea, exhaustion, dizziness, headache, tinnitus the day after the vaccine. Rested all day. Day 2 after the shot, feeling better but intermittent dizziness and tinnitus have continued. 2 weeks after shot, full day of being very dizzy, brain fog, and tinnitus. Tinnitus not overbearing but bothersome as I have never had this before.
55 2021-04-20 ringing in ears headache, ringing in ears, vertigo, chills, sweats, no fever, exhaustion
55 2021-04-20 ringing in ears tinnitus; constant buzzing, day and night, evenly in both ears since onset.
55 2021-04-20 ringing in ears I have developed terrible Tinnitus ringing in my ears.
55 2021-04-20 vision blurred A few hours after I received the vaccination, I was working at my computer. I experienced vision is... Read more
A few hours after I received the vaccination, I was working at my computer. I experienced vision issues where my eyes became unable to focus on words I was trying to read, no matter how I tried, even by squinting. And along with it, in my field of vision were translucent, zig-zaggy or wavy lines. I've never experienced this before. I Googled the symptoms, and I believe it may have been an ocular migraine. Later I had a headache. I recovered within a short time, within a couple of hours.
55 2021-04-21 lacrimation increased Severe cold after day 2. Day 3, I have a stuffy and very runny nose, runny eyes, cough, tight chest... Read more
Severe cold after day 2. Day 3, I have a stuffy and very runny nose, runny eyes, cough, tight chest and slight chills.
55 2021-04-22 blindness 2 days after vaccine around 3pm i felt heart palpitations. went for a walk to see if it would subsid... Read more
2 days after vaccine around 3pm i felt heart palpitations. went for a walk to see if it would subside. as i was walking my left leg buckled a bit, within a few seconds of that happening my entire body went limp. the person i was walking with grabbed me, i could not stand. i looked up and i could not see, it did not go black, all i can see were wavy lines. that lasted about 10 min until i came to . since that day i feel the nausea coming up and my head pushing down, as if it is in a vice. i feel tired and disoriented (loopy) It has been difficult to funtion. It is now almost 1 week since 2nd dose and I still have the same symtoms.
55 2021-04-23 eye irritation Intense heat through body after vaccine Tremors, borderline convulsions Fever 103 Blacked out 24 hrs... Read more
Intense heat through body after vaccine Tremors, borderline convulsions Fever 103 Blacked out 24 hrs after vaccine Headache Tylenol could not relieve Body pain especially in legs and back Unable to lay down Shaking chills lasting 36 hrs Burning sensation in right eye Nausea Stomach cramps
55 2021-04-23 eye pain pain behind both ears, migraine, nauseousness, facial numbness and paralysis
55 2021-04-23 mouth tingling 4/24/2021 Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screeni... Read more
4/24/2021 Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, he experienced an adverse reaction with the following symptoms: tingling of tongue. Assessment : Time of assessment 1100 Alert and oriented. Denies dyspnea, no visible swelling noted,. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. VS taken at 1055- BP- 142/105, P- 116, O20 99%, recheck at 1110- BP- 150/89. P- 105, recheck at 1140- BP- 147/98, P- 113 Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1100. Administered by RN. Famotidine (Pepcid) 20 mg by mouth. Time: 1100. Administered by RN. Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1110. Administered by self supply by patient. Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/24/2021 10:21 AM 0.3 mL 2/25/2020 Intramuscular
55 2021-04-23 ringing in ears Low level tuning in the ears . Constant.
55 2021-04-24 eye swelling Anaphylactic reaction; Eyes swollen; This is a spontaneous report from a contactable Other Health Ca... Read more
Anaphylactic reaction; Eyes swollen; This is a spontaneous report from a contactable Other Health Care Professional (reporting on her-self). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP6955 and Expiry date was not re-ported), via an unspecified route of administration on 06Apr2021 13:35 as single dose for COVID-19 immunization. Medical history included diabetes mellitus, fibromyalgia, intervertebral disc de-generation, post-traumatic stress disorder, back disorder all from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; gabapentin (GABAPENTIN) taken for fibromyalgia, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for fibromyalgia, post-traumatic stress disorder, start and stop date were not reported; naproxen (NAPROXEN) taken for back disorder, start and stop date were not reported. The patient previously 'Incurin' and 'Epitab' and experienced anaphylactic reaction. Historical vaccine includes first dose of bnt162b2 for covid-19 immunisation. It was reported that on 06Apr2021 at 13:35, patient had her second BNT162B2 vaccine. she ended up having an anaphylactic reaction was hospitalized and just got out today. She also want to say she have a history of having anaphylactic reaction from three different medication 'Incurin' and 'Epitab'. Patient stated that she had nothing wrong after the first one. Patient is a Nurse but not working right now. she was disabled (Further not clarified if consumer is physically disabled or financially) but she was a nurse. Patient was hospitalized on 06Apr2021. patient stated, she, was better. Her eyes are still swollen but she breathing when she went to hospital. Consumer stated for laboratory work Well in hospital they got lab, not before the vaccine and in the hospital they did lab when she got admitted in the hospital. Patient stated since she got in the hospital she have to take Prednisone for 5 days and Benadryl (treatment) for 5 days. she just got out of the hospital. The outcome of the event Anaphylactic reaction was recovering and for event eyes swollen was not recovered.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded.
55 2021-04-24 lip swelling lips were swelling; swelling inside of cheek as well; heaviness in chest/felt like someone was stepp... Read more
lips were swelling; swelling inside of cheek as well; heaviness in chest/felt like someone was stepping on her chest; shortness of breath; really bad stomach ache; Inside of cheek felt rough; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration (at the age of 55 years) on 22Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient reported that she was very sensitive to a lot of things, so she opted to stay for half an hour (after vaccination). Once she got in the car, she took her mask off, and realized her lips were swelling. She turned around and went back, and they let her sit for a little while longer. The swelling eventually stopped, but she did have swelling inside her cheek as well. It also felt like someone was stepping on her chest the rest of the day, she experienced shortness of breath, heaviness in chest, a really bad stomach ache, but didn't really eat much so didn't think that it was from food. Inside her cheek felt rough. The lip swelling went away without medication. The outcome of swelling inside her cheek, felt like someone was stepping on her chest, shortness of breath, heaviness in chest, a really bad stomach ache, cheek felt rough was unknown. No follow-up attempts are possible, information on lot number cannot be obtained.
55 2021-04-24 oropharyngeal discomfort, taste impairment, dry mouth felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; ... Read more
felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 56-Year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot was not reported) via unspecified route of administration and administered in left arm on 07Apr2021 14:00 as single dose for COVID-19 immunization. The patient no medical history and known allergies includes shellfish allergy and penicillin allergy, Levaquin, doxycycline were reported. The patient concomitant medications within two weeks included as Linzess, Prilosec, miralax, vitamin D were reported. Patient was not on other vaccines within four weeks. Patient had no Covid prior to vaccination and not tested for covid post vaccination. On 07Apr202 14:00 PM, the patient experienced rapid heart rate and metallic taste and dry mouth and throat pressure- felt like precursor to an anaphylactic response. Symptom onset was immediate and was decreased in 8 hours but still present 24 hours later. No therapeutic measures were taken. The outcome of the events was recovering.
55 2021-04-24 tunnel vision, ear discomfort Woke up Monday (3/29) with clogged ears that would not pop. I felt like I was in a a tunnel, couldn?... Read more
Woke up Monday (3/29) with clogged ears that would not pop. I felt like I was in a a tunnel, couldn?t hear myself talk and couldn?t really hear others. I was also dizzy, my head was spinning. It was usually tolerable but it got progressively worse to the point where I had to call off work a few days later. When I would look down I would get dizzier.
55 2021-04-25 ringing in ears In the morning on Saturday, April 24, woke up with general malaise, buzzing in both years, feeling n... Read more
In the morning on Saturday, April 24, woke up with general malaise, buzzing in both years, feeling nauseous, with headache, no apetite and difficulty drinking water. No energy, and every attempt to get up or sit up failed, after just a few minutes, I had to go back to laying down in a dark room most of the day. Unable to listen to radio or music, or watch anything on tv. No food intake, and less than 1 cup of water the whole day. On Sunday, able to rally in the afternoon, to eat a cup of soup, dring a cup of water, then had to lie down, unable to sit. In the evening, around 6 pm, able to force myself to get up and eat another cup of soup and some fruit. Able to drink a glass of water. Feeling better on Monday April 26. Symptoms subsiding, except for the buzzing in both ears. Constant buzzing in both ears, began after the first shot (EN6208), given on March 31, 2021, after the second shot is much louder and never stops. Buzzing is ongoing today (Monday April 26).
55 2021-04-26 double vision Employee woke up with triggered trigeminal nerualgia (previously diagnosis), and double vision, caus... Read more
Employee woke up with triggered trigeminal nerualgia (previously diagnosis), and double vision, causing vertigo and nausea. Her vision was better if she closed one eye. She was vomited throughout the day on 4/24/21, 4/25/21 - with the nausea, double vision and vertigo getting better on 4/26/21 and completely resolved on 4/27/21. On 4/27/21 employee reports aching, sore arm and fatigue. States she feels like she did when she had COVID 19 which she reports having in January 2021. Messaged her provider to see if she should get dose 2 of the COVID 19 vaccine.
55 2021-04-26 eye discomfort pt says on 4/17/21 she developed a rash on her face under her eyes. On 4/18/21 she noticed some bru... Read more
pt says on 4/17/21 she developed a rash on her face under her eyes. On 4/18/21 she noticed some bruising on her right eye. She had started having a headache that kept getting worse and worse and it was only on the right side of her head. Pt has only taken aspirin for pain every 4 hours. She contacted her PCP and was instructed to contact vax administrator to let them know. Patient says her symptoms are better.
55 2021-04-26 swollen tongue Feels like heart beating faster. Tongue a little "swollen". Evaluated by EMS-Cleared.
55 2021-04-26 ringing in ears, deafness unilateral Since 2nd dose
55 2021-04-27 eye twitching, double vision I developed a twitch in my right eye within 4-5 hours of the shot that has not resolved apprx. 24 ho... Read more
I developed a twitch in my right eye within 4-5 hours of the shot that has not resolved apprx. 24 hours after the shot I experienced double vision that lasted 2 hours, the double vision has not returned as of now however the eye twitch has increased in severity. More common side effects I have experienced is fever (second day), chills (three days), body aches, headaches, sore/hoarse throat, heart palpitations., extreme exhaustion, Injection site pain.
55 2021-04-27 double vision, ear discomfort, vision blurred, ringing in ears Extreme Dizzyness, Fatigue, Double Vision/eyes not tracking, Headache on left side of head behind ea... Read more
Extreme Dizzyness, Fatigue, Double Vision/eyes not tracking, Headache on left side of head behind ear, burning left ear, Left ear fullness, Left eye pain, Wavy sensation in scalp, tingling on left side of face, left arm and leg, Pain in left arm. Slight tinnitus, Neurologic symptoms in head
55 2021-04-27 dry eye, double vision The day after the 2nd vaccine, there was widespread rash over trunk of body - front and back. This ... Read more
The day after the 2nd vaccine, there was widespread rash over trunk of body - front and back. This started about one week after the first vaccine, with a few areas on the abdomen; I did not connect this with the vaccine, until after the 2nd dose. The areas started as round, crusty areas (almost like a ringworm look); no blisters or oozing. within the week after the 2nd dose, my full torso was covered in this rash. It was not itchy, unless I got overheated or sweaty; my entire skin became severely dry and flaky. The rash spread beyond the trunk to the arms and upper legs. I received a steroid injection, after several weeks. There was a biopsy done of one area; it returned as being guttate psoriasis. I have NEVER had any rash this severe. I did not fit the causes of this diagnosis (strep throat for most); I did not even have a slight sore throat, and I certainly am not in the adolescent or young adult category. I have mostly recovered, but not fully. I also developed pronounced vertical double vision. With regular hydrating eye drops, this is being corrected.
55 2021-04-27 mouth numbness, lip swelling 4 to 5 days after receiving vaccine, she noticed rash under left arm extending to deltoid area to el... Read more
4 to 5 days after receiving vaccine, she noticed rash under left arm extending to deltoid area to elbow, itchy red. Used cortisone cream to help with itch. next morning she noticed her left lip was swollen, numbness on left upper lip and swollen face. Only lasted for around 24 hours. Notified Dr and hasn't heard much from them. Was advised to speak with Dr in regards to it and getting approval for 2nd dose. She feels better today and never seeked care for this.
55 2021-04-27 swollen tongue tongue swelling, R arm swelling, b/l arm hives 13h after immunziation
55 2021-04-28 taste impairment Dizziness, Nausea, metal-like taste in mouth
55 2021-04-28 hearing loss 2 hours after the 2nd Pfizer Covid vaccine my LEFT EAR went NUMB. It's still numb 53 hours later I c... Read more
2 hours after the 2nd Pfizer Covid vaccine my LEFT EAR went NUMB. It's still numb 53 hours later I can't tell if I'm hearing worse or the same, but hearing SEEMS to be intact I hear some "whooshing" noises from time to time but thankfully not all the time It does not hurt It feels like had local anesthesia that won't wear off
55 2021-04-28 ringing in ears After second dose on 4/2/21 I had a shooting pain go across my forehead, instant migraine behind rig... Read more
After second dose on 4/2/21 I had a shooting pain go across my forehead, instant migraine behind right eye. Pain then shot down right arm and elbow and right hand began throbbing with pain. I could not find someone, but felt ok after drinking water and sitting for the 15 minutes. I did leave with a slight headache behind right eye that lasted until 4/3/21. On 4/5/21 I woke up with tinnitus. I thought it would go away. It continued to get worse and is now 24 hours a day. I went to my Dr on 4/14/21 and was told to see an ENT. I went to an ENT on 4/26/21
55 2021-04-28 ringing in ears Extreme change in the volume of tinnitus
55 2021-04-29 eye disorder Shingles outbreak 5 days after injection over right eye with ocular involvement.
55 2021-04-29 mouth numbness Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 1... Read more
Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 171/105.
55 2021-04-29 lip swelling Shot burned severely on injection in right arm. In less than 5 minutes, a wave of numbness started ... Read more
Shot burned severely on injection in right arm. In less than 5 minutes, a wave of numbness started at left ear and progressed in a wave across about 3/4 of face. Both lips swelled; more in lower lip. Burning sensation in arm continued for approximately 3 hours. Minor arm pain for approximately 24 hours. Periodic low fever (99.4-99.9) for 3 days. Still no recovery of face.
55 2021-04-29 vision blurred, eye pain I had a lot of pain everywhere after the 2nd dose on 4/6-7/21. On 4/7/21 I had blurred vision most o... Read more
I had a lot of pain everywhere after the 2nd dose on 4/6-7/21. On 4/7/21 I had blurred vision most of the day. I had pain in my eyes on 4/8/21. On 4/12 at 12-5PM my body felt hot, but my temp kept showing 98.6; at night since 4/12 I've had chest congestion & coughing. On 4/19 during the day my body felt hot & didn't feel like myself.
55 2021-04-29 visual impairment Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe
55 2021-05-07 ear pain 4/15/21 - right outer ear pain. 4/19/21 - saw Dr. on demand - prescribed Amox-Clav 875-125 mg 2X a d... Read more
4/15/21 - right outer ear pain. 4/19/21 - saw Dr. on demand - prescribed Amox-Clav 875-125 mg 2X a day. 4/20/21 - right facial swelling - went to urgent care. Dr. said to stay on prescription given to fight bacteria infection. 4/27/21 - saw Dr. - prescribe Azithromycin 250 mg 2 tablet a day and Ciproflox-dexamerh ear drop. Again - diagnose as bacteria ear infection. 4/29/21 -right face paralysis-extreme pain. 4/30/21 - went to urgent care - extreme pain - Dr. directed to go to Hospital Emergency Room for CT scan and blood work. Diagnosed from Hospital ER is 1. Otitis external of right ear. 2. Facial nerve palsy 3. Ramsay Hunt Syndrome - auricular. Prescription-Acyclovir 400MG tablet 5x per day for 7 days. Prednisone 50 mg daily for 7 days. Hydrocodine-acetaminophen 5-325 mg as needed. Ask to follow up with ENT specialist on paralysis. Appointment made for 05/10/21 afternoon. Pain and swelling persisted throughout ordeal.
55 2021-05-07 mouth pain Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/... Read more
Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/fever broke; but I had body aches; My ear my neck my nose my mouth and underneath my chin the lymph node was swollen; Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side; my mouth was horrible much difficulty eating and pain was pretty intense; my mouth was horrible much difficulty eating and pain was pretty intense; This is a spontaneous report from a contactable consumer. This patient reported for 2 patients. A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 10:30 at the age of 55 years-old(Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure , Vertigo, Meniere"s Disease, Gallbladder removed, Cluster of Calcifications and Nodules removed in left breast (benign) , Plaque Psoriasis ( had it very bad on hands and feet) Methotrexate (7 tablets I take on Saturdays)Methotrexate ( 7 tablets i take on Saturdays), also lots of enviromental allergies I was tested few years ago, possibly Augmentin and Clindamycin The patient's concomitant medications were not reported. The patient reported that on 13Mar2021, I was awoken up with bad back pain and I felt like something was not right . I checked my temperature and it was 102.1 . The fever broke but I had body aches etc And the left side of my face wasn't feeling right . My ear my neck my nose my mouth and underneath my chin the lymph node was swollen. Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side, my mouth was horrible much difficulty eating and pain was pretty intense. Immediately scheduled appointments with my medical doctor and my dermatologist. The dermatologist biopsy and came back as Shingles . He immediately put me anti viral drug and my medical doctor put me on amoxicillin, Acyclovir, Gabapentin. I was out of work for 4 weeks cause I work in a Supermarket ( Deli). The patient did not have COVID prior to vaccination nor tested positive after vaccination. The outcome of the events was recovered with sequelae. No follow-up attempts are needed. No further information is expected.
55 2021-05-17 dry mouth, lip swelling, taste impairment 5/7/21 1:15 pm - Couple of minutes after my top lip felt swollen and felt tingling with a slight he... Read more
5/7/21 1:15 pm - Couple of minutes after my top lip felt swollen and felt tingling with a slight headache. Had a bit of dry mouth. 5/8/21 7:30 am. - Heart started racing with elevated blood pressure. Had a headache and fatigue all day. 5/9/21- headache and fatigue. Felt an electrifying sensation upon waking throughout my body. 5/10/21 - left side pressure headache, fatigue. Felt an electrifying sensation upon waking throughout my body. Felt tingling in my face. 5/11/21 - left pressure headache throughout the day then at 9:30 pm my left arm went numb and felt left sided pressure headache with tingling in my face. 5/12/21 - mild headache. Had metal taste in my mouth. 5/13/21. Mild headache 5/14/21 - heart racing with elevated blood pressure 5/15/21 - pressure headache
55 2021-05-18 mouth numbness, loss of taste, tongue discomfort Loss of taste and mild numbness on right side of the tongue. Noticed it the morning after my first ... Read more
Loss of taste and mild numbness on right side of the tongue. Noticed it the morning after my first dose of vaccine. After I brushed my teeth, I proceeded to brush my tongue and could not feel the right side. weird sensation like when the anesthesia is starting to wear off after a dental procedure. Later that morning, I couldn't taste a cinnamon gum i put in my mouth, except on the left side. Anything I eat, I cannot taste it on my right side. Only on the left side. Neither the taste or feeling has returned to this date (5/18/21 - almost two months)
55 2021-05-19 vision blurred, mouth numbness racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; ... Read more
racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; fatigue; loss of strength and coordination in fingers and arms/ residual arm & leg weakness; loss of coordination.; right lower lip became numb; difficulty with concentration; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the right arm on 26Apr2021 at 02:30 AM as single dose for COVID-19 immunisation. Medical history included lumbar disc degeneration, spinal surgeries x2, stem cell injection (lumbar disc) a little over a year ago, allergies to shellfish. Concomitant medications reported as none. No other vaccine in four weeks. None other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 26Apr2021 at 14:30 PM, (reported as after approx 15 min), racing heart, dizziness, disorientation, blurred vision (inability to focus), forearm muscle pain, fatigue affecting ability to perform my job, loss of strength and coordination in fingers and arms, right lower lip became numb, lower leg muscle pain and loss of coordination. Symptoms that continued to persist after 10 days were right lower lip numbness, difficulty with concentration and fatigue that was affecting my ability to perform my job, and some residual arm & leg weakness and coordination. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Unknown if treatment received for events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
55 2021-05-25 mouth discomfort swelling of my lips and nose; sensation of having an allergic reaction; my lips are red and feel as ... Read more
swelling of my lips and nose; sensation of having an allergic reaction; my lips are red and feel as if they are burning; This is a spontaneous report from a contactable consumer (patient) A 55 year old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730) on 13Feb2021 at 12:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included venlafaxine, levothyroxine sodium and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient received first dose of BNT162B2 on 23Jan2021 on left arm. On 15Feb2021 at 09:30 the patient experienced had slight swelling of her lips and nose. She had the sensation of having an allergic reaction but can breath fine. The edge of her lips were red and feel as if they were burning as does the skin adjacent to the lips. Consumption of most foods makes it feel as if her lips are on fire (as reported). At the time of the reporting the patient had not yet recovered from reported events.
55 2021-05-25 ringing in ears A short time after receiving the vaccine I began experiencing a constant low buzzing and a ringing i... Read more
A short time after receiving the vaccine I began experiencing a constant low buzzing and a ringing in my ears that has not gone away. I do not have a history of tinnitus or anything like it. It is extremely unnerving. I think it is related to a reaction to the vaccine. Incidentally, while not the adverse effect I am reporting, I developed a resurgence of left arm injection site pain and a small bruise about 14 days after the shot that has lasted for days.
55 2021-05-26 ringing in ears Tinnitus not resolved Vertigo
55 2021-05-27 mouth tingling Tingling in the lips, received 50 mg of diphenhydramine, s/s continued transferred to ED. ED EKG do... Read more
Tingling in the lips, received 50 mg of diphenhydramine, s/s continued transferred to ED. ED EKG done, and normal rhythm, IV Pepcid 20mg given, with 1L 0.9% Normal Saline. Patient discharged home.
55 2021-05-27 mouth tingling Patient received her first dose of the Pfizer vaccine today. She has a history of multiple allergies... Read more
Patient received her first dose of the Pfizer vaccine today. She has a history of multiple allergies and had been cleared by her allergist prior to vaccination. Approximately 15 minutes after administration, she developed tingling to her lips, dizziness and nausea. She was diaphoretic and pale. She had no other symptoms at this time. See vitals below. EMS was called immediately. A 20G IV was started in her right AC. She was given solu-medrol 125 mg IVP, Pepcid 20 mg IVP and Benadryl 50 mg IVP. She then felt like her throat was closing. She was talking in complete sentences without any issues. Her heart rate was in the 90's and her oxygen was 96%. EMS arrived and she was transferred to the nearest hospital. The patient notified her husband. 05/28/21 1250 BP: 130/80 Pulse: 82 Resp: 14 SpO2: 97%
55 2021-05-31 lip swelling, mouth tingling Two days after shot my bottom lip started to swelling, this happened fur more times on random days ... Read more
Two days after shot my bottom lip started to swelling, this happened fur more times on random days each time getting worse and spreading on my face. Dr put me on steroid, pepcid and allergy pills for a week . Not getting swelling anymore but still have tingling in lip often ?
55 2021-05-31 ringing in ears Severe tinnitus in right ear. It has not improved.
55 2021-06-01 eye pain, loss of smell, eye irritation, loss of taste Pt called 5/6/2021 regarding of covid vaccine side effects. Noted pt has no emergency s/sx. Pt stat... Read more
Pt called 5/6/2021 regarding of covid vaccine side effects. Noted pt has no emergency s/sx. Pt stated she got 1st covid vaccine Pfizer 5/1/2021 and pt got headache(pain score 8/10), eye pan and burning sensation on eyes, cough, runny nose, sore throat, loss of taste and smell for 3 days. Pt is taking tylenol and OTC allergy medicine Zyrtec. Noted hx of DVT, asthma, severe obesity (BMI 51.2). Pt is taking wafarin regularly. Pt scheduled urgent care visit 5/6/2021.
55 2021-06-02 taste impairment 5-4-21 11:15AM; feeling flushed, taste of rubbing alcohol on tongue, sinus pressure, nose bleed. Fol... Read more
5-4-21 11:15AM; feeling flushed, taste of rubbing alcohol on tongue, sinus pressure, nose bleed. Followed by nose bleeds with blowing nose. Tongue turned blotchy white 4-13-21 approx. 11:30AM; taste of rubbing alcohol on tongue.
55 2021-06-02 burning mouth syndrome, tongue discomfort I had the normal reaction of most of my coworkers the day following the second injection (slight fev... Read more
I had the normal reaction of most of my coworkers the day following the second injection (slight fever, aching, etc) but symptoms disappeared within 24 hours. 9 days following the second injection I again had fever, but also had a headache, sore throat, and general achy feeling. This time the fever and headache continued for 4 days, but the sore throat turned into severe burning pain in my tongue. I have continued to have a burning and stabbing pain around the edges of my tongue since that time.
55 2021-06-02 lip blister After first shot (4/19/21), roughly 6 hours later, I got a numb patch on my head that wrapped from o... Read more
After first shot (4/19/21), roughly 6 hours later, I got a numb patch on my head that wrapped from one temple over the top of my head to other temple. It wend away after approximately 48 hours. After second shot (Monday 5/10/21), roughly 6 hours later, my entire face had a numbing and tingling sensation. By Weds 5/12, mid afternoon, it went away on the right side of my face only. Left side of face, Nose and mouth still had the sensation. Thurs and Friday the sensation was getting weaker. On Saturday 5/15, the sensation became stronger, still on the left side of face, nose and mouth, but now also moved down the back of my neck, my entire left shoulder, arm and hand. Also, by saturday afternoon, I had a series of blisters on the inner edge of my upper lip. I do not get blisters in my mouth. The blisters were gone within 2 days. I have not lost feeling at all, just an annoying numbing/tingling sensation. I did see my family Dr, and she ruled out Bells Palsy, as there is no weakness, and did routine testing to verify it is not neurological. Her suggestion was to wait for 6 weeks, to see if it just goes away. It has now been 3.5 weeks and is no better, or no worse. I am not comfortable just sitting and waiting 6 weeks. My online research shows that during testing of this, other people had the same reaction. I would love to know how they treated it.
55 2021-06-03 dry throat pt c/o dizziness palpatation and dry scratchy throat, alert, and verbal. no change of LOC no SOB v/s... Read more
pt c/o dizziness palpatation and dry scratchy throat, alert, and verbal. no change of LOC no SOB v/s o2 99% RA 18cpm, 72bpm, 165/99 bp pt advised to lie on gurney breathing relaxation and drank water. pt. advised to relax. at 212pm pt still feels dizzy and having palpations vitals 175/94,18,88,96% RA o2 SAT. 220pm pt advised to seek medical advise or send to hospital for further eval. due to elevated BP. and not recovering from symptoms v/s 167/99,74,18,96% RA CODE CAMPUS ACTIVATED. 230pm 911 paramedics came pt declined to be transported by ambulance to hospital. after being assessed by 911 staff and declined resident assisted ! wheeled to her car pt. was informed of risks.
55 2021-06-03 hearing loss Two weeks after the first shot, I noticed that I was fatigued and it is 8 weeks later and I still f... Read more
Two weeks after the first shot, I noticed that I was fatigued and it is 8 weeks later and I still feel fatigued. I also lost my desire to have any type of alcohol, loss of appetite and for the same amount of time. I noticed on May 21 that noises seem louder than normal.
55 2021-06-03 swollen tongue Due to allergenic history the patient was to be observed for 30 minutes. After 20 of the 30 minute o... Read more
Due to allergenic history the patient was to be observed for 30 minutes. After 20 of the 30 minute observation the patient complained of tongue swelling, and some feeling of distress. Clinic RN and physician assessed patient and she was taken to the ED for evaluation and treatment.
55 2021-06-03 ringing in ears I started to have ringing in my ear on left side. It started about 30 after i got the shot; This is ... Read more
I started to have ringing in my ear on left side. It started about 30 after i got the shot; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), via an unspecified route of administration, administered in left arm on 16Mar2021, at 09:00 as single dose for covid-19 immunization. Medical history included blood pressure high from an unknown date, type 2 diabetes mellitus from an unknown date. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; metformin, metformin hydrochloride, sitagliptin (JANUMET) taken for an unspecified indication, start and stop date were not reported. The patient previously took lisinopril and experienced drug allergy. The patient reported "I started to have ringing in my ear on left side. It started about 30 after I got the shot " on 16Mar2021, at 09:00 with outcome of not recovered. No treatment was given for the event. No follow-up attempts are possible; information about lot number cannot be obtained.
55 2021-06-04 lip swelling, mouth tingling, swollen lips The upper lip was slightly swollen and tingled.; The upper lip was slightly swollen and tingled.; Th... Read more
The upper lip was slightly swollen and tingled.; The upper lip was slightly swollen and tingled.; The gum area above upper teeth and the inside of the top lip were bright red, inflamed, and the had a weird texture when I touched it with my tongue.; The gum area above upper teeth and the inside of the top lip were bright red, inflamed, and the had a weird texture when I touched it with my tongue.; This is a spontaneous report from a non-contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186), dose 1 via an unspecified route of administration, administered in arm left on 27May2021 at 10:00 as single dose for COVID-19 immunisation. Medical history included hypothyroidism (diagnosed 3 years ago, but not longer require meds) and was allergic to erythromycin, Keflex and sulfa. The patient's concomitant medications included One a Day Brand Multi Vitamin received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27May2021 at 15:00, the patient experienced the upper lip was slightly swollen and tingled and "the gum area above upper teeth and the inside of the top lip were bright red, inflamed, and the had a weird texture when I touched it with my tongue". The patient did not received any treatment for the events. The outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.
55 2021-06-06 swollen tongue Patient w/ history of anxiety, Pt felt dizzy, complaining of SOB, tongue swelling. Gave 0.3mg IM epi... Read more
Patient w/ history of anxiety, Pt felt dizzy, complaining of SOB, tongue swelling. Gave 0.3mg IM epi immediately. RRT called. Patient given 50mg of IM Benadryl. Patient escorted to the ED. In the ED, serial exams normal since vss, nad, d/c around 10pm after more obs.
55 2021-06-07 burning mouth syndrome Mouth full of canker sores??at least 20. They were on my gums and under my tongue. Lasted about 2 ... Read more
Mouth full of canker sores??at least 20. They were on my gums and under my tongue. Lasted about 2 weeks. I received my 2nd shot on 5-14-21 and 3 days later I developed sores in my mouth again. There were about 10-12 this time. Started clearing up June 2nd.
55 2021-06-07 extreme sound sensitivity VAERS ID from previous report 1036950 Headache and confusion that started 20 hours after 1st dose of... Read more
VAERS ID from previous report 1036950 Headache and confusion that started 20 hours after 1st dose of the Pfizer vaccine. Hearing sensitivity by day 3. In ER for high blood pressure on day 8 with no explanation. Nursing Staff at my place of employment informed me I needed to be in the ER that day due to BP of 187/120. I had an MRI of my brain showing migraine-like activity. It is almost 4 months from the date I received the vaccine and I have had only 9 days with no migraine. I'm tired of all the headaches that are completely new since the vaccine. Thankfully my doctor instructed me not to get another dose. I'm tired of feeling like this and feel I have no one to turn to for help. The migraines are affecting my daily activities and my work.
55 2021-06-07 ringing in ears Onset of fever (38.4 degree C) and tinnitus on the right ear 13 hours following the second vaccinati... Read more
Onset of fever (38.4 degree C) and tinnitus on the right ear 13 hours following the second vaccination. The fever broke after 23 hours from the onset but the tinnitus persists up to date.
55 2021-06-08 eye itchiness fever; Pain at injection site; Headache; Runny nose; itchy eyes; Body aches; Swollen glands; This is... Read more
fever; Pain at injection site; Headache; Runny nose; itchy eyes; Body aches; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 16:00 (at the age of 55-years-old) as single dose for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive other vaccines in 2 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 03Mar2021 at 07:00, the patient experienced pain at injection site, headache, runny nose and itchy eyes, body aches, swollen glands. On 07Mar2021 at 07:00, after day 6, the patient started running a 102 fever. Adverse events resulted in doctor or other healthcare professional office or clinic visit. Post vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Fever: 102 on 07Mar2021, Nasal swab test on 09Mar2021: Result pending. The clinical outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-06-09 mouth tingling Had tolerable off and on body aches, fatigue and tachycardia for months before the vaccine. I coul... Read more
Had tolerable off and on body aches, fatigue and tachycardia for months before the vaccine. I could go a month or more without symptoms. vaccine 3/15 Fatigue, body aches and tachycardia got much worse and intolerable after vaccine 3/15 8 days later at physical doctor gave me thorough exam and I become much sicker which escalated (I couldn?t do anything including work) Got to the point I was in constant horrible pain Severe body aches and fatigue Increased HR especially when upright Very dizzy SOB Some Headaches Nauseas almost always when I am upright Terrible Brain fog Body ache Symptoms improved some with prednisone but have gotten worse again since being off prednisone Struggling to function / work Left / middle Chest pain Tingling lips, finger tips and toes Weak Shaky
55 2021-06-10 dry mouth Within 30-40 min of vaccination on the way home (around 7 pm) , friend developed sudden headache; fe... Read more
Within 30-40 min of vaccination on the way home (around 7 pm) , friend developed sudden headache; felt tingling around the nose and face; felt dizzy; had dry mouth; She was trembling; had rash around the collar for about 45 min to 1 hour; swollen right arm (injection site but no redness, vaccination arm); floating sensation; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (Lot Number: EN6202), via an unspecified route of administration on 12Mar2021 at 18:15 (at the age of 55 years old) as single dose for covid-19 immunization. Medical history included breast cancer left, cholecystectomy for stones, deep vein thrombosis (DVT) during pregnancy, oophorectomy. The patient's known allergies included chocolate-since 1997 received epinephrine and additional food allergy: banana, orange, almonds, fresh tomato, avocado and strawberries (burning of moth and tingling around the nose). The patient's concomitant medications were not reported. It was unknown that patient had other vaccine in four weeks. Within 30-40 min of vaccination on the way home (around 7 pm), friend developed sudden headache, felt tingling around the nose and face, felt dizzy and had dry mouth. Her husband was driving the car. They drove to (Name withheld) Emergency Room/Urgent Care in (Name withheld) where she was admitted for care and observation. Additional details: She was trembling and was brought in on the wheelchair, had rash around the collar for about 45 min to 1 hour. She was dizzy, felt like "floating". Eventually improved overtime. She stated that her vitals were stable, oxygenation was 98%. Per her report, she did not receive epinephrine. Diphenhydramine hydrochloride (BENADRYL) was suggested but she did not want to take it as she had "bad headache" post diphenhydramine hydrochloride. She remained in ER for about 5 hours and eventually was discharged home. She was improving on the 13Mar2021, but continued to have headache and dizziness/floating sensation throughout the day. Also reported swollen right arm (injection site but no redness, vaccination arm). All events occurred on 12Mar2021 at 06:15 PM. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. Treatment for events included paracetamol (TYLENOL). The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
55 2021-06-10 smell distorsion This is a spontaneous report from a contactable consumer, the patient. A 55-year-old [non-pregnant] ... Read more
This is a spontaneous report from a contactable consumer, the patient. A 55-year-old [non-pregnant] adult female received a dose (unspecified dose number) of BNT162B2 (solution for injection; Lot unknown and expiry not provided) as a single dose via unspecified route in the left arm on 27Apr2021 at 12:30 (at 55-years-old), for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medications sans indication, posology and therapy dates included fluoxetine hydrochloride (PROZAC), and bupropion hydrochloride (WELLBUTRIN SR). The patient denied any COVID diagnosis prior to vaccination. The patient was not pregnant at the time of vaccination and denied receiving any other vaccine within four weeks of this vaccine. On 14May2021 the patient began to experience smelling cigarette smoke when none was there. The patient stated that sometimes it makes her choke a little. The patient also began to experience extremely painful and swollen breasts since 14May2021. The patient has not been tested for COVID since the vaccine. The outcome of the events smelling cigarette smoke when none was there, makes her choke a little, and extremely painful, swollen breasts was not recovered. Information on the Batch/Lot number has been requested.
56 2020-12-31 lip swelling, tongue disorder Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores o... Read more
Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores on tongue, lips swollen later in day and next day. No breathing issues.
56 2021-01-03 taste impairment, mouth tingling My tongue felt swelled and I had a metallic Taste in my moth
56 2021-01-03 mouth tingling, lip swelling Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling ,... Read more
Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling , headache
56 2021-01-03 toothache After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was... Read more
After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was not to bad and I tought is a normal symptom but the pain and swelling an my face is increasing every day, even my teeth hurts and I'm taking Gabapentin 100MG 3 times a day. I am not sure if the vaccine components triggered my Trigeminal Neuralgia and if it's okay to get the second dose, I will see my Dr. tomorrow 01/05/21
56 2021-01-04 loss of taste, loss of smell Loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable he... Read more
Loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the right arm on 23Dec2020 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020, the patient experienced loss of taste and smell, reported as non-serious. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the loss of taste and smell were not recovered.
56 2021-01-05 ear pain Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Rig... Read more
Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Right arm. Shoulder pain moved into and included the axilla approximately 9 hours post vaccination. During the night, approximately 16 hours after vaccination, I began to have radiating, shooting pain up both sides of my neck up into the ears. This neck pain lasted approximately 72 hours. The arm pain had resolved at approximately 30 hours. The neck pain lessened and resolved with repeat applications of heat and Ibuprofen.
56 2021-01-05 mouth numbness Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left ... Read more
Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left upper lip 2-3 hours after vaccine, but noted facial droop 3 days later. Numbness is improving at this time. Some fatigue.
56 2021-01-05 mouth numbness Numb lips, tongue. Benadryl given
56 2021-01-06 inability to speak Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunc... Read more
Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunch, she passed out and a code blue was called. She never lost a pulse, but when in the ER she could not speak. She responded to commands without speaking. About 30 minutes later, she finally spoke.
56 2021-01-06 mouth numbness, mouth tingling, feeling of choking Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk ... Read more
Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk back to work area and started to feel numbness and tingling in tongue and throat, face as itching and cheeks red. Patient taking in observation room and emergency response team called for precaution. Patient remained alert. Team arrived taking taking blood pressure which was 185/108, Benadryl given, patient monitored. Team and patient agreed no emergency department care needed. Patient monitored for another 30 mins, blood pressure rechecked 158/95 . Patient allowed to return to unit. Had no signs of distress, denies shortness of breath or any throat discomfort. Patient was stable when leaving unit.
56 2021-01-06 mouth tingling, mouth discomfort Patient received COVID vaccine at 0939, during observation period reported tingling of tongue and li... Read more
Patient received COVID vaccine at 0939, during observation period reported tingling of tongue and lips approx. at 1010. Benadryl 25mg by mouth administered. Patient continued to be monitored for additional 1hr. Benadryl improved symptoms, patient denied SOB and remained calm throughout. Swelling and tingling improved. Patient went back to work in hospital where received vaccine. Patient confident in monitoring return of symptoms while on site working. Patient reports list of allergies and has dealt with symptoms of allergic reactions before. This RN checked on patient after vaccine clinic and residual tingling remained but otherwise patient "felt good". Called patient at 1707 to follow up. Patient reports minor residual burning on lip otherwise other symptoms resolved. Continues to denies difficulty breathing, " I feel fine"
56 2021-01-06 mouth tingling Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red la... Read more
Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red lacy rash all down my arm a little itchy. Headache and lips tingle .
56 2021-01-06 ringing in ears Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
56 2021-01-06 ringing in ears Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
56 2021-01-07 loss of smell, loss of taste I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not t... Read more
I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not taste and smell and congested.
56 2021-01-07 tongue discomfort 35 minutes After vaccination.... complaints of chest tightness, "funny" tongue
56 2021-01-08 taste impairment Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ... Read more
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
56 2021-01-08 eye pain Fever 103.9 , headache, body aches, eye pain, fatigue Symptoms lasted for 48 hours. Fever responded ... Read more
Fever 103.9 , headache, body aches, eye pain, fatigue Symptoms lasted for 48 hours. Fever responded to Tylenol but returned as Tylenol wore off.
56 2021-01-10 eye itchiness, bloodshot eyes, eye swelling I noticed a runny nose for the entire first day and the next day I had an appointment. My right eye ... Read more
I noticed a runny nose for the entire first day and the next day I had an appointment. My right eye was puffy, swollen, red, itchy. I got a shot of dexamethazone and the next day I felt better. I also had a script for prednisone.
56 2021-01-10 eye itchiness, swelling of eyelid The day after the employee received her 2nd COVID vaccine, she woke up with swollen, itchy eyelids. ... Read more
The day after the employee received her 2nd COVID vaccine, she woke up with swollen, itchy eyelids. She had a telehealth visit with doctor on 1/10/21 - she reported that the itchiness and swelling were along her upper eyelid near the brow line. Denied ocular pain, EOMI, conjunctive is not infected. Noted slight particles in the corners of her eye but it was not crusting. Had used hydrocortisone cream on the area but was advised by doctor to stop. Dr encouraged cold compresses, increased fluid intake and avoid salt/caffeine.
56 2021-01-10 mouth numbness Numbing of tongue, possibly mild Bell's Palsy, and occurred about 7 minutes after vaccination
56 2021-01-10 mouth pain Fever, chills, arm ache, mouth ache, body aches, sore throat, dry cough, rash and exhaustion
56 2021-01-10 mouth tingling, swollen tongue 01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completel... Read more
01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.
56 2021-01-10 mouth tingling Patient's reaction(s) noted during COVID vaccine observation period: lips tingling  Actions Taken:... Read more
Patient's reaction(s) noted during COVID vaccine observation period: lips tingling  Actions Taken: Vital signs taken and within normal for pt. Pt felt okay enough to leave  Disposition: Patient declined ED visit
56 2021-01-11 eye swelling sudden onset nausea, malaise, fatigue, later that day developed eye swelling
56 2021-01-11 drooping eyelid Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight ... Read more
Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed.
56 2021-01-11 mouth numbness Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hou... Read more
Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hours after injection. 5 days after injection; chills and major lower back pain.
56 2021-01-11 mouth numbness Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling wit... Read more
Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling within 10 hours after injection. 5 days after injection resulted in massive lower back pain and chills.
56 2021-01-11 mouth itchiness, lip swelling Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine dif... Read more
Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine diffuse rash with mild lip swelling. The following morning she reported that the rash was gone but still had an itching sensation in her mouth and throat, no swelling just irritating itch.
56 2021-01-11 visual impairment I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha... Read more
I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
56 2021-01-12 ear pain Body aches, fever, chills, headache, nausea, sore throat, left ear pain, COVID exposure w/in 14 days
56 2021-01-12 eye irritation, loss of taste, ear pain, loss of smell Congestion, loss of taste/smell, diarrhea, ear pain, eye irritation
56 2021-01-12 eye irritation, ear pain exposure with ear pain , sore throat and eye irritation test negative
56 2021-01-12 eye swelling Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt sw... Read more
Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt swollen then began to feel nauseous (tried to vomit, but no food came up) and then a runny nose (clear fluid). I took another Claritin 10mg and also Zofran 8mg ODT which resolved the nausea. Had to blow my nose 2 times. Went to sleep with my Epipen at bedside but didnt have to use it. Woke up at 815am and only symptom remaining was arm soreness. Felt like my normal self and played 3 hrs of tennis. Arm soreness at injection site worsened during the day. By 72 hrs post-injection, arm soreness resolved.
56 2021-01-12 sensitivity to light, extreme sound sensitivity 1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar... Read more
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
56 2021-01-13 eye pain Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck ... Read more
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
56 2021-01-13 mouth tingling Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. ... Read more
Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. Upon return to PACU at 10:57, felt foggy and didn't feel right. Employee sat down. Left upper lip started to tingle, patient experienced palpitations and difficulty breathing, requiring surgical mask to be removed. Code EMA (code for non-patient called). Employee taken to emergency department for evaluation.
56 2021-01-13 thirst "Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began t... Read more
"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began to feel dizzy and drank the provided bottled water. The dizziness lasted for 2 hours. Within 10 minutues I also started having numbness and tingling from my right elbow to my hand, anterior and posterior. This continued throughout the day. After being observed by staff, after 30 minutes I was given Benadryl tablet25 mg by mouth. The adverse event has also been reported to my manager and employee health.
56 2021-01-14 mouth tingling Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left... Read more
Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left side of face. On exam, she had left facial droop consistent with Bell's palsy. She was monitored for about an hour with no further progress, and some visible improvement. She had tremor of right hand. By next day, patient reported complete resolution of symptoms. Of note, patient has multiple sclerosis and will have similar symptoms when she has a flare. Jen Silvey spoke with patient on 1/6/2021 @ 2051: "Her face - no droop to left side of her face and lips- back to normal. But her tongue is still tingling."
56 2021-01-14 ringing in ears This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), via an unspecified route of administration from 19Dec2020 11:00 AM at single dose on left arm for COVID-19 immunization. Age at vaccination was reported as 56 years. Patient was not pregnant at the time of vaccination. Medical history included cancer and penicillin allergies. Concomitant medications (received within 2 weeks of vaccination) included Irbesartan, Pantoprazole, Levothyroxine and Calcium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. On 26Dec2020 13:00 (reported as 01:00 PM), patient experienced vertigo, then dizzy-lighted since. Patient also experienced loud hissing sounds in her ears. Patient's arm (site of injection) became sore again, numb to the touch and she felt like she had a sunburn when her clothes touch the skin. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for "vertigo-dizziness". The events were assessed as non-serious. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since the vaccination.
56 2021-01-15 sensitivity to light, extreme sound sensitivity, smell distorsion vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizzines... Read more
vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizziness); a heightened sense of taste, sensitivity to light, and increased startle reaction to sudden sounds
56 2021-01-17 ear discomfort Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the follow... Read more
Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the following day. The first symptoms were ear and sinus pressure. Then malaise/fatigue, headache, mild stomach upset. Fever occurred in the middle of the night and got up to 101.1. Also developed shakes/tremors and severe back and body aches. My arm was sore at site of injection.
56 2021-01-17 mouth swelling swelling of mouth
56 2021-01-17 swollen tongue, mouth tingling AFTER VACCINE PATIENT WAS COMPLAINING OF HER TONGUE AND THROAT FEELING A LITTLE TINGLY AND SWOLLEN. ... Read more
AFTER VACCINE PATIENT WAS COMPLAINING OF HER TONGUE AND THROAT FEELING A LITTLE TINGLY AND SWOLLEN. PATIENT DID NOT APPEAR TO BE IN ANY DISTRESS AT THE TIME BUT BASED ON HER COMPLAINT SHE WAS ADVISED TO HAVE THE AMBULANCE TRANSPORT HER TO THE HOSPITAL. IT TOOK ABOUT 20 MINUTES BUT AFTER TALKING TO HER FOR AWHILE AND FOUND OUT HER SON WAS AN RN I TOLD HER WE WOULD TRANSPORT HER THERE. SHE AGREED AND WAS TRANSPORT TO THE REQUESTED HOSPITAL. I SPOKE TO HER TONIGHT AT 9:40 PM AND SHE STATED SHE FELT FINE
56 2021-01-18 taste impairment 10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour... Read more
10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour went away and came back later in the day. 13 hours after the vaccine injection I developed extreme rigors lasting atleast 60 minutes followed by very hot body temperature to touch unable to sleep body not comfortable cold then hot and very bad headache. Next day rested all day terrible headache, body aches and chills on and off. The next night did sleep for 5 hours then woke up soaked hair night garments had to change still had headache and just felt achy and tired all day mild headache arm was sore warm at inj site and very itchy. Third day headache was gone just felt extreme fatigue and today tired but feel more like myself.
56 2021-01-18 mouth numbness 1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes ma... Read more
1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes mark which subsequently resolved spontaneously at 30 mins (closely monitored by MD, NP) 2nd vaccine: spontaneous tachycardia, and elevated BP (160/100) at 10 minutes mark (monitored by MD and NP), normalized after 1 hour of observation. On 1/8/2020 I developed severe fatigue, fever, numbness on lower lip, bitter taste in my mouth, fever, chills, headache until Sunday 1/10/2021. Went to work on 1/11/2021 with worsening symptoms. Ended up in ER on 1/12/2021 due to weakness, high BP, numbness on lower lip, difficulty focusing. BP is normalizing as of 1/19/2021 but still have weakness, equilibrium is off and difficulty in focusing
56 2021-01-18 mouth tingling, mouth numbness itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache.
56 2021-01-18 mouth tingling tingling tip of tongue and upper extremities
56 2021-01-18 vision blurred, bloodshot eyes Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side ... Read more
Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
56 2021-01-19 loss of smell, loss of taste I'm exposed you know I do the testing at my office at school; Loss of taste; Loss of smell; Sneezing... Read more
I'm exposed you know I do the testing at my office at school; Loss of taste; Loss of smell; Sneezing; This is a spontaneous report from a contactable nurse (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # not clarified, Expiry Date 30Apr2021) intramuscular at single dose in the deltoid on 08Jan2021 15:00 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified several drugs. On 08Jan2021 22:00, the patient experienced loss of taste, loss of smell, sneezing with outcome of unknown. No treatment required. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Jan2021. Nurse stated: "I just wanted to know the Covid Vaccine would it have given me that symptoms I mean obviously I'm exposed you know I do the testing at my office at school." When probed for causality, Nurse stated, "No, I don't think it would be from the vaccine, probably you know just exposure." Information on the lot/batch number has been requested.
56 2021-01-19 taste impairment Bitter taste and itching (General) Received Benadryl 50 mg and improved
56 2021-01-19 hearing loss My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am l... Read more
My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am little congested; I have a trouble hearing today as I am little congested; My arm is got really red but it's itchy; like skin allergy; My arm is got really red but it's itchy; like skin allergy/ small red spot; This is a spontaneous report from a contactable Nurse. This 56-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: 30Apr2021) at single dose for COVID-19 immunization on 07Jan2021. Relevant history included blood pressure (abnormal). Relevant concomitant drug included Lisinopril 5 mg for blood pressure. The patient had the first BNT162B2 and she had no problems with this one. She had some side effects for this one, it's been 48 hours since she had the vaccine. On 08Jan2021, the patient had a very small red spot but its probably 6 inches long and probably 2 inches wide on 09Jan2021. Her arm was got really red, but it's itching almost like an skin allergy. Itching was much in the night. The patient want to know if it is okay to take Benadryl? The patient also had a trouble hearing on 09Jan2021 as she was little congested. The patient was taking Tylenol (not appropriately paraphrased and clarified). Outcome of events was unknown.
56 2021-01-19 mouth tingling, feeling of choking Approximately 25 minutes after receiving the vaccine I experienced tingling sensation of throat and ... Read more
Approximately 25 minutes after receiving the vaccine I experienced tingling sensation of throat and lips. Lips were not swollen. This lasted 40 minutes then resolved without any medication taken.
56 2021-01-19 mouth tingling Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", ... Read more
Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", tingling in legs. Patient was monitored for approximate one hour total in the clinic. Patient vital signs were stable at the beginning and continued to be stable. No other signs or symptoms of an allergic reaction.
56 2021-01-19 vision blurred acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7... Read more
acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7 minutes then stopped - 30 minutes after injection given blurry vision - 30 minutes after injection given mild shaking - following morning lasting for about 2 hours extreme fatigue - lasting for 48 hours - Sunday evening through Tuesday evening
56 2021-01-20 eye irritation Severe fatigue, fever, chills, nausea, vomiting one time, head ache, eyes burning
56 2021-01-21 ear pain Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ea... Read more
Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ear ache, nausea for one day, headache, and shortness of breath with coughing and stairs. She had a telemedicine appointment with her MD office and they recommended her not to work and to use her inhaler and some cough medicine.
56 2021-01-21 lip swelling, mouth numbness Swelling to upper ridge of top lip, irritation to outer upper gum, and numbness to tip of tongue and... Read more
Swelling to upper ridge of top lip, irritation to outer upper gum, and numbness to tip of tongue and itching. I took Benadryl to help control symptoms.
56 2021-01-24 swelling around the eyes, lip swelling face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on ... Read more
face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on 1/22/21 and then my eyes were swollen, bruised and painful upon waking 1/23/21 and lasted until early morning of 1/25/21. My whole face was sore to touch during this time. I also had fatigue and headache starting 1/21/21 which lasted a few days along with fever, chills, body aches and sore left armpit which started early morning 1/22/21. I had expected these last symptoms so was not alarmed. I was not warned about the facial swelling and that was a bit scary.
56 2021-01-25 taste impairment little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense ... Read more
little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense of smell; decreased sense of taste; everything she eat or drinks has a metallic taste to it; muscle stiffness; Fatigue; arm soreness/right arm was still tender to touch/The first shot hurt way more and hurt all over the whole arm, it was throbbing; sinus pressure and congestion; sinus pressure and congestion; felt really lightheaded; low grade headache; chest feeling tight/chest tightness; she is not feeling good; wheeze; cough; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular (IM) in right deltoid on 07Jan2021 15:30 at second single dose for preventative. The patient medical history was not reported. There were no concomitant medications. The patient previously took H1N1 flut shot in 2015 or 2016 for immunisation and experienced muscle stiffness and fatigue, first dose bnt162b2, via IM in left deltoid for preventative on 18Dec2020 at 18:00 and patient was tender in her left arm, the first shot hurt way more and hurt all over the whole arm, it was throbbing. No additional vaccines administered on same date of the pfizer suspect. No prior other vaccinations administered within 4 weeks. The patient took the second dose of the Pfizer Covid vaccine on Thursday 07Jan2021 at 15:30. She called employee health and was advised to call Pfizer to report side effects since she is not feeling good. She had never had the covid diagnosis. On Friday (08Jan2021) she worked all day and felt arm soreness and sinus congestion but nothing out of the ordinary. The patient reported her right arm was still tender to touch, if she rotated her arm she can feel that she had the shot and she was still tender in her left arm from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing. On 08Jan2021 evening she felt really lightheaded, she thought maybe it was her sinuses since it is dry due to winter. She felt like a truck hit her. She had a low grade headache. On 09Jan2021, she felt a little nauseous, queasy, no vomiting. On Saturday (09Jan2021) she had a low grade temp of 100.3 degrees F. She had the chills and shakes on Saturday and most of yesterday. She got up today (reported on 12Jan2020) at 5:30 am, she checked her temperature and it was 97.2 after the shower, an hour later it was 98 degrees F. She felt like she had to keep clearing her throat, her chest felt a bit tight which started Friday evening, the chest tightness was not terrible but it was there. She was not wheezing but when she took a deep breath she felt a little like a wheeze and she had to cough, she had a scratchy throat on 09Jan2020. She stayed home from work yesterday. The patient did not feel lightheaded today, felt it yesterday and did not notice it at all this morning, reported it has resolved. The sinus pressure and congestion started Friday night, she felt stuffy. She had a decreased sense of smell and taste on 09Jan2021. Unless something is right in front of her, she could not smell anything. She felt quite nauseous this morning but at the moment her nausea is under control. She had a decreased sense of taste, everything she ate or drunk had a metallic taste to it, on 09Jan2021. She felt that all the side effects mentioned were related to getting the vaccine. On 08Jan2021, she also experienced muscle stiffness and fatigue which had improved after a hot shower, that helped. She felt like she had a bad flu shot. The only time she ever felt similar to this was when she received the H1N1 flut shot in 2015 or 2016. She did not have lot number, NDC, or expiration date to provide. Treatment included: took Tylenol on Saturday. The events did not require a visit to emergency room and physician office (she is trying to get an appointment to see the doctor). Outcome of the event lightheaded was recovered on 12Jan2021, of events low grade headache, chest tightness, scratchy throat, sinus pressure and congestion, decreased sense of smell, decreased sense of taste, everything she eat or drinks has a metallic taste to it, arm soreness was not recovered, of events chills and shakes, muscle stiffness, fatigue was recovering, of other events was unknown. Information about Lot/Batch has been requested.
56 2021-01-26 mouth tingling Tingling in lips
56 2021-01-26 vision blurred, double vision headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision ... Read more
headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose in the left arm for COVID-19 immunization. The patient received the vaccine in a skilled nursing facility or long term care facility. The patient received no other vaccinations recently. Medical history included attention deficit disorder diagnosed at least 5 years ago for which the patient was taking Ritalin; hypothyroidism diagnosed a long time ago, probably 10 years and depression diagnosed a long time ago, probably at least 25 year, she takes a cocktail of anti-depressants for this (no further details provided about her anti-depressants). The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus before when her doctor put her on an antibiotic (unspecified). The patient was also very overweight. Concomitant medications included methylphenidate hydrochloride (RITALIN; lot: unknown, expiry: 28Jul2021) for attention deficit disorder and the patient takes a cocktail of anti-depressants (unspecified) for her depression. The patient received the first dose of the covid vaccine on 11Jan2021 at 3 PM and by 5PM she was experiencing bad headache, fever, L arm (injection site) pain that was severe. Later that evening she had blurred double vision and couldn't function. She also got a fever of about 100 degrees Fahrenheit, was dizzy and her eyes could not focus and were almost like double vision but not quite, it was hard to explain. She just remembered that she had a similar reaction with her eyes before, when her doctor put her on an antibiotic. She cannot recall what antibiotic that was. The patient also experienced dizziness on 11Jan2021. The patient treated her side effects with ibuprofen and most of these improved. The injection was given in her left arm, her non-dominate one. She says that the pain was so bad it woke her up, and she doesn't take any pain meds, but that was really bad. She says that she took some Ibuprofen (lot: P113671, exp: Jan2022), about a total of 800mg over a few hours. Her fever had started pretty fast, by 05:00PM on the 11th, and it was better after taking the Ibuprofen, as was her arm pain, and headache. She says that the dizziness went away probably around 02:00AM the following day (12Jan2021). She says her eyes can focus again as well. The patient thinks that these effects are medically significant, mostly that her eyes were not able to focus, it was very scary. The patient stated that the purpose of this call is to have this documented, and possibly find out if there are recommendations that she should not get the second dose, since she had to call out of work because she couldn't function. The outcome of the event "blurred double vision and couldn't function; eyes wouldn't focus, couldn't function" was recovered on an unspecified date and dizziness recovered on 12Jan2021 at 02:00. The outcome of the event "she had to call out of work because she couldn't function" was unknown while the other events were recovering. Information on the lot/batch number has been requested.; Sender's Comments: The 56-year-old female patient had medical history included attention deficit disorder; hypothyroidism and depression and she takes a cocktail of anti-depressants for this. The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus. Based on information reported, the reported double vision and difficulty focusing eyes were more likely due to pre-existing condition (s); and less likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The rest events fever, headache, vaccination site pain and dizziness were likely causally related to the use of vaccine due to plausible temporal relationship and known safety profile of this product. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-01-27 taste impairment metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chil... Read more
metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chills weakness, fatigue the next day aches, weakness and fatigue headache continued for 5 days fatigue and headache continues daily
56 2021-01-27 eye swelling I had facial swelling where my eyes were almost swollen shut and violent diarrhea.
56 2021-01-27 lip swelling, lip itchiness Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After app... Read more
Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After approximately 40 minutes noted itching in throat. Returned to vaccination area approximately 60 minutes after injection for guidance and instructed to ED. Noticed lip swelling and facial swelling later in ED, had mask on entire duration, did not note when first occurred. Lip itching, throat itching relieved with Benadryl, prednisone and pepcid all given po, released to home after 4 hours observation. Throat itching persists on day 2, some relief with benadryl Q 4 hours.
56 2021-01-27 oropharyngeal discomfort Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizzines... Read more
Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizziness and I went out for help from a physician in hallway. Next thing I remember I was on an exam table and I had not strength in my limbs and core. I had a rash on neck and chest. They monitored my vitals and decided I needed to go to urgent care or ER. Since the urgent care was on the way to the ER they took me there. They moved me from wheel chair to ecam table. Gave me epi and Benadryl injections, prednisone by mouth and started an IV. They monitored my vitals and said if I worsened are didn't respond then they would send me to ER. They gave me some Pepcid and eventually over the 3 hours I was able to stand on my own and they decided to discharge me around 14:00, making sure that I had someone who could stay with me at home.
56 2021-01-27 vision blurred, eye pain On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw ... Read more
On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw my PCC provider. Woke up 1/17 with blurry vision and continued eye pain. Talked to my Rheumatologist 1/19. I saw my PCC in person 1/20. Got sent to ER got admitted. Had an MRI and a lumbar puncture. I was diagnosed with optic neuritis by the neurologist. I continued to do 5 days of out pt iv steroids.
56 2021-01-29 swollen tongue, lip swelling Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands fa... Read more
Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands face lips and tongue. At 6 hrs post vaccine. Core temperature below 95. Severe headache , lightheaded dizziness at 4 1/2 post vaccine Severe muscle weakness and pain start at 8 hrs post vaccine . All symptoms last 48 hrs post vaccine Took aspirin, ibuprofen and Benadryl
56 2021-01-30 mouth tingling Distal third thumb numbness. Numbness in soft palate, tingling of the lips. Resolved after given Be... Read more
Distal third thumb numbness. Numbness in soft palate, tingling of the lips. Resolved after given Benadryl P.O. Discharged home with husband driving, advise to continue Bendaryl every 4-6 hours and to follow up with PCP.
56 2021-01-31 mouth numbness Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest p... Read more
Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest pain; Persistent increase in blood pressure; Intermittent tachycardia; This is a spontaneous report from a contactable nurse. This nurse reported for herself that the 56-year-old female patient who received econd dose of bnt162b2 (BNT162B2, COVID 19 Pfizer) via Intramuscular on 07Jan2021 04:00 PM on Left Arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included Known allergies: Taxotere and Breast cancer. Concomitant medications included Tamoxifen. The patient previously took first dose of bnt162b2 at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Generalized weakness Numbness in lower lip Prolonged malaise Headaches Poor equilibrium Chest pain Persistent increase in blood pressure Intermittent tachycardia from 08Jan2021 3:00 PM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was unknown. No treatment received. No COVID prior vaccination. COVID tested post vaccination included Covid test post vaccination: Nasal Swab, PCR panel on 12Jan2021 with covid test result: Negative. Information Requested on Lot/ batch number.
56 2021-01-31 mouth tingling tingling in tongue but especially with eating
56 2021-01-31 swollen tongue, taste impairment Patient complained of metallic taste in mouth w/in 5 mins of vaccine on 1/22/21. On the next day, pa... Read more
Patient complained of metallic taste in mouth w/in 5 mins of vaccine on 1/22/21. On the next day, patient was biting tongue and felt was swollen, and took Benadryl. On 1/24/21, patient noticed tongue swollen and went to ER where was given prednisolone 60mg. Went to allergist 1/28/21 to perform allergy testing and was told allergic to the PEG (polyethylene glycol) and advised to defer dose #2.
56 2021-02-01 taste impairment After dose #1- sore left deltoid lasting for 1 week and severe fatigue lasting for 48 hrs. After do... Read more
After dose #1- sore left deltoid lasting for 1 week and severe fatigue lasting for 48 hrs. After dose #2-12 hours post injection, myalgias, chills and cough set in. Took to bed and became febrile @100.4, noted a metallic taste in mouth a/w headache. Lasting 48 hours.
56 2021-02-01 ear pain fever, headache, muscle aches, diarrhea, nausea, breast on injection site painful, sore throat, righ... Read more
fever, headache, muscle aches, diarrhea, nausea, breast on injection site painful, sore throat, right ear ache, malaise
56 2021-02-01 eye pain Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Pa... Read more
Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.
56 2021-02-02 loss of taste, loss of smell Loss my sense of smell and taste; three days got sick with cold - still have stuffy nose; three days... Read more
Loss my sense of smell and taste; three days got sick with cold - still have stuffy nose; three days I felt dizzy and I wake up to go to the restroom and I feel like I will fall. I treat with fluids .And I have an antiobiotics from appt with doctor. I had a little cough but not a bad one. My head hurts a little but not that much. COVID test on the 13th or so of January. Results on 16th - positive. They told me not to go to work. On the 30th I went to work.
56 2021-02-02 bloodshot eyes This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 16Jan2021 21:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Jan2021, the patient experienced right side of her eye was completely blood shot. This morning 17Jan2021 there seems to be a raised vessel which is dark red in the same eye. The patient was not in pain, nothing scratching. The outcome of the event was unknown. Information on the lot/batch number has been requested.
56 2021-02-02 ringing in ears Few Seconds of High Pitch Tinnitus night of vaccine - awoke with ongoing low level tinnitus that is ... Read more
Few Seconds of High Pitch Tinnitus night of vaccine - awoke with ongoing low level tinnitus that is not resolved
56 2021-02-03 loss of taste Loss of taste 30 minutes after injection of my second dose.
56 2021-02-05 taste impairment PATIENT EXPERIENCED A SALINE TASTE IN HER MOUTH, SHE REFUSED EXTENDED OBSERVATION.
56 2021-02-06 eye swelling Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, sw... Read more
Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, swelling in eyes, hands, face, neck.
56 2021-02-07 eye twitching Significant left eye twitching, with involuntary eye closure for a second, that occurred every 3-10 ... Read more
Significant left eye twitching, with involuntary eye closure for a second, that occurred every 3-10 minutes starting 2/5/21-2/8/21. Minimal occurrence on 2/8/21. Instructed to see hospital Ophthalmologist today.
56 2021-02-07 lip itchiness, mouth itchiness, tongue itchiness, lip swelling, swollen tongue my lips and tongue started itching and got swollen; my lips and tongue started itching and got swoll... Read more
my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; itching and got hives; itching and got hives; This is a spontaneous report from a contactable Nurse reported for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included Asthma, food and environmental allergies, allergy to PCN and Sulfa. Concomitant medications included montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), loratadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient previously took acetylsalicylic acid (ASA), levofloxacin (LEVAQUIN), codeine and azithromycin (ZITHROMAX) and experienced allergy. 8 minutes after the vaccine was given on 22Jan2021 16:08, patient started itching and got hives. She was given Benadryl. About 5 minutes after that on 22Jan2021 16:13, her lips and tongue started itching and got swollen. At that time she was given an injection of Epinephrine and transferred to the Emergency Department. The outcome of the events was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Pfizer comment: Based on the information currently available, a possible contributory role of the BNT162B2 in the reported events lip and tongue itching and got swollen cannot be excluded in this 56 years old female patient, who with medical history of allergy to food, environment and multiple medications. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
56 2021-02-07 oropharyngeal discomfort Within a few miniutes, became slightly dizzy. After a few more miniuts, I became very dizzy, short o... Read more
Within a few miniutes, became slightly dizzy. After a few more miniuts, I became very dizzy, short of breath, something was going on in the back of my throat, heart rate went way up and I felt like I was going to pass out. About 09:10, I received an epi pen in my left thigh. After the epi pen, my symtoms resolved very quickly. I was then sent to the ED for a 4 hour observation. While in the ED, I received a unit of fluids. After which, I was discharged home.
56 2021-02-07 swelling around the eyes within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next da... Read more
within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next day; 1-2 hours later my legs/feet from the knees down became numb/tingling with tightening muscles; 2 hours later left side entire face became numb with puffy left eye lid which lasted for 8 days; by the 8th day my symptoms began to resolve only to return with 4 days with left face/throat numbness & left side numbness/tingling with tightening forearm muscles both hands/fingers/arms from elbows down & numbness/tingling/muscle tightening in both legs/feet/toes from the knees down along with pain in both knees which lasted another 2 days; I continue to have some residual symptoms of numbness on the left side of my face that comes and goes as well as the same symptoms of numbness/muscle tightening and tingling in both legs/feet that comes & goes.
56 2021-02-09 ear pain vertigo/dizziness; vertigo/dizziness; Chills; body aches; extreme tiredness; bilateral ear pain; nau... Read more
vertigo/dizziness; vertigo/dizziness; Chills; body aches; extreme tiredness; bilateral ear pain; nausea; No appetite; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at let arm on 19Jan2021 17:00 at single dose for covid-19 immunization. The patient was not pregnant. The COVID-19 vaccine was administered at Hospital. The patient medical history reported as none. Concomitant medication included cimicifuga racemosa (BLACK COHOSH), curcuma longa (TURMERIC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 on 29Dec2020 07:00 at left arm for covid-19 immunization. The patient experienced Chills, body aches, extreme tiredness (slept for 30+ hours), bilateral ear pain, nausea - this all started 15 hours after 2nd dose on 20Jan2021 08:00, and then vertigo/dizziness started 4 days after 2nd dose on 23Jan2021, and also experienced no appetite from an unknown date in Jan2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
56 2021-02-09 feeling of choking, mouth tingling tingling sensation in throat and lips; tingling sensation in throat and lips; This is a spontaneous ... Read more
tingling sensation in throat and lips; tingling sensation in throat and lips; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE)Lot # EL0142, via an unspecified route of administration on 12Jan2021 09:30 at single dose at left arm for covid-19 immunisation. Medical history included Grave's Disease, Lobular carcinoma of breast (LCIS), allergies: sometimes reddened skin from tape/bandaid. Concomitant medications included levothyroxine sodium (SYNTHROID), tamoxifen and vitamin D3. The patient experienced tingling sensation in throat and lips on 12Jan2021 09:45 AM. It was also reported that tingling sensation in throat and lips approximately 25 minutes after vaccine given, lasted approximately 40 minutes and resolved completely on 12Jan2021 with no medications to treat it.The patient was not pregnant. No other vaccine received in four weeks. If COVID prior vaccination: No. If COVID tested post vaccination: No.
56 2021-02-09 visual impairment dizziness while lying in bed after turning over onto her back/ dizziness when standing up quick, tur... Read more
dizziness while lying in bed after turning over onto her back/ dizziness when standing up quick, turning over onto her back or side while in bed, and getting out of her car; had been a few times while lying in bed that her vision was affected when this dizziness comes on; This is a spontaneous report from a contactable consumer (reported for herself). A 56-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration on 07Jan2021 15:00 at single dose in right arm for COVID-19 immunization. Medical history included Hypothyroidism, No Allergies to medications, food, or other products. Concomitant medication received within 2 weeks of vaccination included levothyroxine. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine was given on a Thursday afternoon, on Saturday morning, the patient experienced a dizziness while lying in bed after turning over onto her back. She only experienced the dizziness when standing up quick, turning over onto her back or side while in bed, and getting out of her car. She had never had any trouble with dizziness. There had been a few times while lying in bed that her vision was affected when this dizziness comes on. To date she was still having problems. The events started on 09Jan2021 06:30. No any treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
56 2021-02-13 dry mouth, vision blurred Reported blurry vision, dry mouth. HTN 170-200/90-110, Did not take her BP medication or eat this... Read more
Reported blurry vision, dry mouth. HTN 170-200/90-110, Did not take her BP medication or eat this morning. She normally takes her BP med at night. EMT evaluation. Given juice and water. BP 185/98, reports no further blurry vision. MD evaluated. BP 160/88 by paramedic. Patient released home, will call her primary physician and seek immediate care if symptoms recur
56 2021-02-14 eye swelling 1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels res... Read more
1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels rested or wants/needs to sleep, a lot. Noticed abdominal pain, but did not connect the two. 2/11/2021- 2nd dose- Two hours later (approx) moderate pain at site, my head/mind felt "off", out of sync like one side of brain slower, affected balance. It was strange, and unpleasant. 2/12/2021- Groggy, face/eyes swollen, did not feel well, but not so bad I could not go to work. It was a 50 mile drive, and as I drove the same feeling of not thinking straight did not want to drive. The feeling of being unwell escalated quickly. Congestion, muscle aches throughout, sore throat, chills, and a need to catch my breath caused dizziness. I pulled over, called work, and made my way home where I went directly to bed. My head ached, abdominal (sharp) pains, especially after ingesting fluids. or food similar to gall bladder pain, but not close to its worse intensity still, continues. 2/15/2021- Update- Nearly 96 hrs. passed: What remains is: Feeling exhausted, need to sleep, more frequent and intensifying abdominal pains, headaches, pain in left lung/easily winded, and site pain expansion. Injection arm (left) pins & needles, and fingers ice cold, neck pain (stiffness).
56 2021-02-14 mouth tingling Patient developed diffuse redness of the skin and itchiness less than 15 minutes after receiving the... Read more
Patient developed diffuse redness of the skin and itchiness less than 15 minutes after receiving the vaccine. Vital signs initiall BP 178/92, HR 98, spo2 98%. Denied shortness of breath or other symptoms at that time. Patient took benadryl 25 mg PO, after about 10 minutes verbalized tingling of her tongue. No further progression of symptoms. 911 called & patient sent to ED for evaluation in stable condition. Medical staff
56 2021-02-14 smell distorsion After first dose severe headache for two days with some dizziness. After second dose sleepless that... Read more
After first dose severe headache for two days with some dizziness. After second dose sleepless that night then around 4AM chills and hot flashes with sweating, got up to walk around and had shortness of breath, teeth chattering, slept most of Friday had aches, headache, nausea.. had to concentrate on not vomiting, heightened sense of smell, had 101.7. Saturday initially felt ok the terrible headache and nausea, achey and still 101.7 temp. Sunday initially felt good and then with the headache, nausea, shortness of breath, achey, 101.7 temp. Monday felt ok all day until around 5pm and then chest hurt and shortness of breath.
56 2021-02-14 swollen tongue, thirst Numbness lower face; swelling lower face and tongue; lump in throat (throat closing); extreme thirst
56 2021-02-15 loss of smell, loss of taste fever; severe chills; diarrhea; vomiting; loss of taste and smell; extreme fatigue
56 2021-02-16 ringing in ears tinnitus/she had 2 seconds of a very high pitch and then the following morning, she began having a l... Read more
tinnitus/she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved; This is a spontaneous report from a contactable pharmacist (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via intramuscular on 12Jan2021 17:30 at single dose on left arm for prevention. Medical history included hashimoto's hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL), both for Hashimoto's Hypothyroidism; cyanocobalamin (VIT B12), selenium, VITAMIN D3, ascorbic acid (VITAMIN C), calcium + magnesium, all for many years for vitamin supplementation. She also had a hormone replacement therapy patch that she had been taking for 5 years. She had experienced some tinnitus on 12Jan2021 21:00 and it had not resolved. She went to ENT (ear, nose and throat) for an ear exam. They were fine. They did not think it was the vaccine but did not know. After she received the vaccine, she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved. It started the evening of around 9pm. She went after work at 17:30 to get the vaccine. It was further reported that tinnitus started at 21:00 for just 2 seconds and then hearing was normal. However, the following morning, she woke up with this low level like if you leave TV on the like a hum. Very mild. This started at 06:00. No ER (Emergency Room) or physician's office required. On 29Jan2020, patient did an ear exam and hearing exam. Ear exam was perfect. Hearing exam revealed slightly hearing loss consistent with age. It was pretty normal. The part of the hearing that goes first as the age. Outcome of the event was not resolved. This case was reported as serious with seriousness criteria: medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
56 2021-02-18 ringing in ears, eye pain Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and ... Read more
Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and eye pain. Tinnitus and dizziness. Also had chills. Remained pretty consistent for a day and half.
56 2021-02-20 taste impairment Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea,... Read more
Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea, vomiting
56 2021-02-21 sensitivity to light, extreme sound sensitivity, ringing in ears After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water o... Read more
After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens, About 12:30 or 1pm I wanted to sleep and slept 4 hours. The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex. The Imitrex didn't even tough the headache, it just made me tired.
56 2021-02-22 eye swelling, swelling of eyelid Swelling of eyelid and around the eye
56 2021-02-23 eye swelling, ear pain sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft pala... Read more
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
56 2021-02-24 pain in jaw Tightness in my chest like a panic attack - I've never had one but this is what it seemed like. I wo... Read more
Tightness in my chest like a panic attack - I've never had one but this is what it seemed like. I would deep breath to calm down. Took my Pulse/O2 and it was 98% and 62BPM and BP was 107/58 that day (6 Feb). Took it the next day and we had a 98% and BPM of 58 and BP went to 148/72 ( very unusual for me). 4 days later took Pulse/O2 at 98% 58BPM and BP at 120/62. I feel pain in the center of my chest where my heart is and I have never had this in my life until 2 days after the vaccination. I am now taking a lung support (Clear Lungs - Nutritional Therapeutics) in case I have a lung issue. I live at 5000' and can walk and I now only do light exercise so I don't feel the heaviness or "stress" feeling in my heart. I have not gone to the dr yet. On 8 Feb my chest was really hurting and did feel some pain on my lower jaw and this went on for about 2 hrs. I did not go to the hospital. Something is wrong since getting this shot even though the symptoms are subsiding. Again, for someone without comorbidities or a history of her heart ever hurting to have this happen 1 1/2 days after the vaccine is not a coincidence and from all data that can be found this is an anomaly. I am troubled and concerned about my reaction.
56 2021-02-24 swollen tongue Chest pain, difficulty breathing, tingles in the face, tongue swelling, cold sweats
56 2021-02-25 hearing loss, ringing in ears Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As... Read more
Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As the day went on she realized that her ear was ringing. It started as a buzzing and now a high pitched ringing that she still has in her left ear. She also had a nose bleed that occurred twice on her right nostril. She has had nose bleeds in the past, but none recently. She was sitting working and her nose just started bleeding. The vaccine site itself was sore, minor and not unbearable. It's just the humming and buzzing in her ear that will not go away.
56 2021-02-25 vision blurred 15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport ... Read more
15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport to ER, Left side weakness, loss of speech. Er evaluated for sudden onset left sided weakness, facial droop.Code stroke was called CT angiography was unremarkable and patient admitted for bp control. Bp normalized with Clonidine , neurological exam is stable. Md felt that thus was a combination adverse reaction to vaccine in combination with Wellbutrin. Discharge after 24 hours
56 2021-03-01 mouth numbness On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke o... Read more
On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke out in hives on both arms and across upper torso that alternated between itching and burning like fire. It quickly spread over entire body. I called my PCP to speak to a nurse and while on the phone, I begin experiencing tingling around nose and mouth, nose stuffed up making breathing difficult, and tongue became numb. PCP office told me to hang up and go to the nearest emergency room.
56 2021-03-01 lacrimation increased, bloodshot eyes, eye pain On February 14, five days after second Covid shot, patient woke up with ulcer in corner of left eye ... Read more
On February 14, five days after second Covid shot, patient woke up with ulcer in corner of left eye and growing pain in eye itself. Eye was watering and red and very painful. Symptoms persisted. On February 24, patient went to Urgent Care who found ulcerations on cornea and referred to ophthalmologist, Dr., who suspected herpes sores, perhaps due to an immune system reaction to the second Covid shot. Treated with eye drops (Moxifloxacin, 0.5% 4 times daily), and oral antiviral (Valaclyclovir HCL, 500 mg 2 tablets three times daily). Eye is MUCH improved, but the ulceration has not entirely disappeared. It is to be hoped that completing the Moxifloxacin and Valclyclavir regimen will completely clear the damage, but there is some concern that there may be permanent scarring. A fourth examination is scheduled for March 10.
56 2021-03-02 taste disorder After getting the vaccine and driving home, one side of my face started to feel like it was getting ... Read more
After getting the vaccine and driving home, one side of my face started to feel like it was getting a little numb. It has stayed the same all day and has not gotten worse. There has been no facial drooping. Also, I have had a metal taste in my mouth.
56 2021-03-03 mouth numbness swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbnes... Read more
swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration at the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 30Jan2021 10:45, both times the patient had right face numbness (felt like Novocaine) that started in her right cheek and spread to her lips and up into her eye and ultimately radiating throughout her head, and also swelling throat/ear canal on right side. It was unknown if treatment was received for the events. Clinical outcome of the events was not recovered.
56 2021-03-03 mouth tingling Lips felt like being shocked - then labored breathing. That resolved. Head felt like exploding with... Read more
Lips felt like being shocked - then labored breathing. That resolved. Head felt like exploding within minutes of shot. That lasted into 2nd day. Lots of dizziness, nausea & headache into day 2
56 2021-03-04 eye swelling pt described doing fine during initial observation period. She went grocery shopping and within abou... Read more
pt described doing fine during initial observation period. She went grocery shopping and within about 3 hours of receiving the vaccine, her eyes swelled "like bugged out" and she had her blood pressure taken at home with a systolic measurement of 214. Someone else in her home checked the functioning of the B/P cuff and theirs measured normally. The patient rechecked hers at that point and it was 200+. She does not had a history of hypertension and has never been on anti-hypertensives.
56 2021-03-06 eye swelling Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after... Read more
Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after vaccine) my cheeks and eyelids became slightly red and felt irritated and felt like a bad sunburn.. Woke up on Saturday 3/6/21 at 8:00AM and the left side of my face and eye was swollen and red rash covered most of cheeks on both sides and well an the entire eyelids on both eyes as well as my far head. Was very painful and felt like a bad burn. Went to Urgent Care and was prescribed over the counter products and said rash is most likely a related to Covid Vaccine and to report it to VAERS. As of 6:45 PM on 3/7/21 as I am filling this out my face is still the same as it was Saturday still red in the same places and still sore.
56 2021-03-06 tongue disorder, dry mouth Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute wa... Read more
Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute waiting zone as she has had anaphylactic reactions in the past. At 2008 patient stated she felt hot. She had a rash developing on her neck, noted a dry mouth and thickening tongue. EMS brought in for evaluation. Blood pressure 204/102, pulse 65, oxygen 100% on 2L nasal cannula. 50 mg benadryl administered IM left deltoid 2011. 20g PIV started left antecubital, 125 mg administered. Ambulance on site. Patient able to speak clearly, verbalized the need to void her bladder. Patient accompanied by 2 RNs to the restroom. She was stable on her feet, escorted back to EMS stretcher. She was taken to hospital. VAERS submitted.
56 2021-03-08 ear pain Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigu... Read more
Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigue
56 2021-03-08 eye itchiness, bloodshot eyes On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm... Read more
On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm my left eyes was bloodshot. Really, really red. I put some over the counter eye drops in both eyes on Tuesday night and Wed every 4 hours. Redness subsided 24 hours later, but eyes were still itchy. They Thursday night my left gland started swelling. On Friday it was very swollen. I could cup my hand around the swelling from check to neck. It hurt to swallow. I took my temperature every few hours and it was never elevated. It was always normal . I took an ibuprofen, 800 mg and just relaxed around 5:00 pm. Still swollen on Saturday, but going down, Took another 800. mg of ibuprofen Saturday night around 8:00 pm and swelling continues to go down, but still swollen as of Tuesday, March 9, my birthday. I did receive my Tetanus shot, preventative on February 15, 2021.
56 2021-03-08 lacrimation increased was speaking to patient as she has had hx of anaphylaxis to sulfa medication. she was fine speaking ... Read more
was speaking to patient as she has had hx of anaphylaxis to sulfa medication. she was fine speaking to me and 9mins after vaccine developed blank stare eyes became watery and told me she needed Benadryl she didn't feel well. asked her what she felt and her response was delayed and stated "throat felt like it was closing: trouble breathing. Called a code and told RN to get me epi 0.3mg which was administer to opposite arm (right upper arm) . brought patient to the floor and kept legs elevated. Benadryl 50mg IM given to Left deltoid. unable to get BP as the machine was not giving me BP :manual cuff to small. code team responded within 5mins. EKG leads placed on patient showing sinus tach 140 O2 sat 99% .. patient continued to be responsive and once epi was given spoke more requesting husband.. patient was put on stretcher and taken to ED by code team.
56 2021-03-08 mouth tingling, feeling of choking, mouth numbness, dry mouth I had a headache and sudden lethargy. I ended up sleeping for 3 hours. Throughout that time, I wok... Read more
I had a headache and sudden lethargy. I ended up sleeping for 3 hours. Throughout that time, I woke up several times with 'cotton mouth' and a strange feeling that the back of my mouth, roof of my mouth and maybe a bit of my throat had a numb and tingly feeling. I drank quite a bit of water, but kept falling back to sleep. I can only compare it to when you receive novacane at the dentist but the sensation starts to goes beyond your mouth and a bit into your throat. This feeling stayed about the same for 3 hours and then over the next 3 hours started to dissipate. After that I just hand a mild lingering headache and general feeling of tiredness. By the next morning I just had a slight headache and physical feeling of tiredness.
56 2021-03-09 taste impairment had immediate strong metallic taste in mouth
56 2021-03-10 dry mouth, blindness, visual impairment, thirst, vision blurred The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxie... Read more
The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxiety and then relief of receiving the vaccination causing that effect. I had dry mouth and I was thirsty. The second vaccine EN 6201 I had a headache the next day. Throbbing headache. I read not to take Advil or anything right after. February 09= vaccine February 10=headache February 11= headache didn't go away. I took Advil in the evening. February 12=headache worsened. I took Advil in the afternoon. February 13=I woke up and couldn't see out of my left eye. There was a fog in central vision. About an hour later there was a strange aura. A tornado like tunnel in the central vision started and then shot out from the corner of my left eye. The aura lasted seconds and then the foggy center dissipated throughout the day. The headache throbbed and throbbed. I took Advil around the clock every four hours instead of just one a day. February 14= Full head-ache was gone but sinus throbbed above both eyes. February 16= Eye doctor visit. Know clue if the vaccine caused the ocular migraine or not. I've never had one before and it is super scary. My vision hasn't been clear since then and my dry stable MD turned into wet which I don't think has anything to do with the vaccine. Maybe the headache and the Ocular Migraine was caused by the vaccine. Who knows. I just thought I would report it in case other people have the same. Collecting data is a good thing.
56 2021-03-11 deafness unilateral Loss of hearing in right ear. After hearing test completely deaf in right ear.
56 2021-03-11 swollen tongue, mouth tingling Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I h... Read more
Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I had chills. Moved to the clinic area. While under observation, symptoms increased. Tongue was reported to be swelling on right side. In retrospect, believe this was lymph nodes.Administered 2 doses together of Benadryl. Oxygen level and blood pressure remained strong. Hands turned bright red and itched. Left at 2:30. Took Benadryl and Tylenol at 3:00. Rashes and itchy throat continued for 48 hours as well as chills and aches. Overall outcome, positive health returned. Lack of energy. Bit of brain fog still remain.
56 2021-03-12 eye bleeding, bloodshot eyes At my OMT (Oestopathic Manipulative Therapy) Dr. appt on Wednesday, 3/10/21, my BP was 134/80. On 3/... Read more
At my OMT (Oestopathic Manipulative Therapy) Dr. appt on Wednesday, 3/10/21, my BP was 134/80. On 3/12/21, Friday afternoon around 2:30pm, I noticed my left eye didn't feel right. I looked in the mirror and my left eye was slightly red in the corner of my eye towards my nose. When I woke up this morning on 3/13/21, my eye was completely red in that same corner of my left eye. I went to the a walk-in clinic this morning to have it checked out. The doctor indicated that it was a burst blood vessel in my eye and that the redness should go away in about a week. My BP was 148/100. The doctor asked if I had a history of high blood pressure and I told him no and showed him 3 of my previous BP card records that I keep in my purse. He said I should monitor my blood pressure and follow up with my primary care doctor. I have had a blood vessel burst in my eye before a few years back. I do not remember which eye. I have had fibromyalgia for over 20 years. I was diagnosed with Occular Myesthenia Gravis in January 2017 which affects my left eye only.
56 2021-03-13 ringing in ears Light-headed and tired immediately following vaccination that lasted a few minutes; mild labored br... Read more
Light-headed and tired immediately following vaccination that lasted a few minutes; mild labored breathing around 30 minutes post-dose but fine after using inhaler (may have been due to wearing multiple masks vs. vaccine; tension, dull headaches starting 1hr post-dose lasting several hrs; high-pitching ringing in ears starting approx 7-8 hrs post-dose and still have as of March 14 at 5:00pm; systemic itching starting 8-9 hrs post-dose and still have as March 14 at 5:00pm and managing with Benadryl/zyrtec. Alerted Dr. to ringing in ears and following up with Dr tomorrow on ringing in ears and itching.
56 2021-03-14 eye irritation, mouth discomfort woke up with my mouth on fire like it had been dipped in jalapeno oil; Eyes then started to burn sa... Read more
woke up with my mouth on fire like it had been dipped in jalapeno oil; Eyes then started to burn same way; This is a spontaneous report from a contactable Health care professional (Patient). A 56-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 03Feb2021 09:30 at SINGLE DOSE for covid-19 immunisation. Facility where the COVID-19 vaccine was administered: Nursing Home. The patient's medical history included Antiphospholipid antibody syndrome, arthritis, allergic to Sulpha. Concomitant medication (list of any other medications the patient received within 2 weeks of vaccination) included warfarin, eplerenone, furosemide, oxycodone hydrochloride. On 04Feb2021 02:00, the patient reported that, I felt fine, went to bed, woke up with my mouth on fire like it had been dipped in jalapeno oil. Eyes then started to burn same way. Called advice nurse, she recommended benadryl. Followed up with pcp at noon next day. Advised against 2nd shot. The patient has received treatment with antihistamine. Outcome of the events were not recovered. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
56 2021-03-15 deafness, ringing in ears Sudden hearing loss/tinnitus in right ear.
56 2021-03-15 taste impairment Moderate fatigue, metallic taste in mouth, burning sensation in nose, muscle aches, bilateral ankle ... Read more
Moderate fatigue, metallic taste in mouth, burning sensation in nose, muscle aches, bilateral ankle and knee soreness, headache, very sore left arm, flu-like -ache in nipples Arm soreness declined over two weeks, ankle and knee soreness currently persist, fatigue lasted one week, other symptoms stopped after third or fourth day Treatment was acetaminophen, increased water intake and rest
56 2021-03-15 mouth tingling flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and g... Read more
flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and gas approximately 35 to 40 minutes after injection. Self dosed with Benadryl, alerted my physician
56 2021-03-16 mouth numbness, dry mouth Patient with numbness of lips, chest heaviness and lightheadedness with onset approximately 25 minut... Read more
Patient with numbness of lips, chest heaviness and lightheadedness with onset approximately 25 minutes after administration of vaccine. Normal SpO2 97%. BP initially slightly elevated 147/87, repeat 126/72. RR 20, HR 91. No wheeze, stridor or difficulty breathing. Dry mouth reported, no swallowing difficulty. Patient calm, no diaphoresis or pallor. Skin warm and dry. EKG (3 lead) with normal sinus rhythm, occasional premature ventricular contractions, no significant ST/T wave changes. Symptoms of chest pressure resolved spontaneously within 30-45 minutes with monitoring, no treatment required. Lip numbness significantly improved, minimal upper lip sensation changes persisted . No swelling of lips or tongue or throat. Patient never experienced tachypnea, tachycardia or diaphoresis. Patient declined ER transport via EMS. Precautions discussed - if persisting or recurring symptoms, encouraged patient to call 911 or contact PCP.
56 2021-03-17 mouth numbness Client received the 1st dose of Pfizer Covid vaccine (Lot #ER 2613, Exp. 7/2021). Client was sitting... Read more
Client received the 1st dose of Pfizer Covid vaccine (Lot #ER 2613, Exp. 7/2021). Client was sitting on post-vaccine waiting area approximately 10 minutes and alerted EMT at 1408 of numb sensation on tongue. PHN joined EMT to further assess client. Client alert and oriented, stated numb sensation at mid top of tongue. Sensation not radiating anywhere else. Vitals at 1411: Pulse 87, blood pressure 176/108, oxygen 99, respirations 22. Minor headache per client on left side. Client denied tingling sensation, dizziness, shortness of breath, chest pain. PHN assessed for swelling around face and inside mouth. 1417 PHN reassessed blood pressure and obtained 172/102, pulse 80. Client stated history of brain aneurysm 2yrs ago, brain tumor, diabetes, and hypertension. No history of allergies. Per client takes metoprolol in the evenings and yesterday's last reading 113/67. Per client blood pressure has been controlled and follows up with provider. Medication she currently takes: metformin, multivitamins, and metroprolol. PHN informed client due to medical history and high blood pressure it was recommended to be further assessed at the hospital. Client agreed, PHN called 911 at 1423. Client's daughter waiting in car, client called her to update her. Paramedics assumed care at 1426. Client transported to Hospital.
56 2021-03-17 mouth tingling, mouth numbness Patient spent 15 min in observation and left the site, but came back shortly complaining of numbnes... Read more
Patient spent 15 min in observation and left the site, but came back shortly complaining of numbness and tingling in the mouth and tongue . Vitals assessed, within normal limits, liquid benadryl 12.5 MG administered. Patient Vitals within normal limits x3 every 10 min. After 30 min Patient states numbness significantly improved. Patient left site with partner and educated to call 911 for any severe side effects and to reach out to hcp regarding incident.
56 2021-03-17 swollen tongue, tongue discomfort, mouth tingling Swollen tongue, lips tingling, tongue felt "burnt"
56 2021-03-17 ringing in ears Approximately 30 minutes after my injection I experienced tinnitus. It is very loud and has not stop... Read more
Approximately 30 minutes after my injection I experienced tinnitus. It is very loud and has not stopped since the vaccine.
56 2021-03-18 lip swelling Swollen lip and chin about 12 hours after vaccine; doctor has advised to try Tylenol PM
56 2021-03-18 swollen tongue 30 minutes after receiving the COVID 19 vaccine, the patient experienced an allergic reaction with f... Read more
30 minutes after receiving the COVID 19 vaccine, the patient experienced an allergic reaction with facial and tongue swelling and difficulty swallowing. A rapid response was called and the patient was taken to the emergency department where she had an IV placed and received IV famotidine, IV diphenhydramine, IV methylprednisone, a NS bolus, and epinephrine. Patient was then monitored in the ED. Patient has plans to discharge from the ED to home. COVID vaccine was placed as an allergy in the patient chart.
56 2021-03-20 taste impairment metallic taste in mouth; This is spontaneous report received from a contactable consumer. A 56-year-... Read more
metallic taste in mouth; This is spontaneous report received from a contactable consumer. A 56-year-old female patient (non-pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9269), via an unspecified route of administration on left arm on 03Feb2021,15:45 at single dose for COVD-19 immunization. The patient medical history included High blood pressure, Allergies: Raw Eggs. Concomitant medication included hydrochlorothiazide taken; verapamil; biotin, calcium pantothenate, chromic chloride, cholecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, sodium ascorbate, sodium molybdate dihydrate, sodium selenate, thiamine mononitrate, zinc oxide (CENTRUM VITAMINTS). The patient previously took prednisone, metoprolol, lisinopril, losartan and all had Allerges. No Covid prior vaccination and no Covid tested post vaccination. It was reported that, the patient experienced metallic taste in mouth on an unspecified date in 2021. The outcome of the event was reported as recovered on 2021.
56 2021-03-20 mouth numbness, swollen tongue Swollen tongue, diarrhea, throat closing, numb tongue, numbness on left cheek on face.
56 2021-03-23 mouth numbness, mouth tingling, lip swelling, mouth discomfort Woke with a swollen bottom lip on day 8 post injection. Day 9 same swelling but additional numbness... Read more
Woke with a swollen bottom lip on day 8 post injection. Day 9 same swelling but additional numbness and uncomfortable feeling. Day 10, still swollen and some numbness and upper lip is now tingling and slightly swollen.
56 2021-03-23 oropharyngeal discomfort Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of ... Read more
Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of incident: vaccine hub triage area Pertinent patient history: History of severe anaphylactic reaction to gabapentin in 2018. Patient had discussed with PCP and allergist who agreed that patient should receive her COVID-19 vaccine. Description of incident: Patient was brought back to the triage area for vaccinator to administer the vaccine near emergency equipment and patient had her own epi pen with her (this was not used). Patient agreed and consented to receive the COVID-19 vaccine. Patient received the COVID-19 vaccine at 1013. At 1023 patient started feeling "off" BP was 177/105, pulse 96 and oxygen 97% Dr. was notified and was present in the triage area and 1st dose of epinephrine was administered in patients right thigh. Patient was coughing and feeling like her throat was closing. Patients BP at 10:25 was 197/109 and 10:26 pulse ox 95% and pulse 64. Patient continued to cough and experience shakiness and unable to catch her breath oxygen was applied at 6 L/minute per VORB from Dr. Patient received 2nd dose of epinephrine at 1026 per VORB from Dr. Patient received 125 mg of IM solumedrol in left deltoid VORB from Dr. at 1032. No benadryl was given due to allergies. EMS arrived at 1035 and administered a 3rd dose of epinephrine. IV started by EMS. EMS transported patient to ED. Patients wife was present during event and drove to meet patient at ED. Orders initiated per RN protocol: EpiPen administered per protocol Additional verbal order for 6 L oxygen by nasal cannula, 2nd dose of epinephrine & 125 mg of solumedrol given by Dr. - read back by RN Patient outcome: Transported via EMS to ED Patient left vaccine clinic via Patient Transport: Ambulance: EMS Called at 1023 arrived at approximately 1033. Other notes: Other RN's involved in this event were RN, RN, RN, Dr., and Dr. RN .................... 3/24/2021 11:04 AM
56 2021-03-23 swollen tongue Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue s... Read more
Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue swollen, slurred speech, dysphonia. Was given benadryl, epipen and decadron transferred to ER where she was given additional benadryl and solumedrol and observed. Pt discharged from ER after period of observation.
56 2021-03-23 vision blurred Suffered being tired; Put on my glasses to watch movie and screen looks fuzzy; wondering seems my ey... Read more
Suffered being tired; Put on my glasses to watch movie and screen looks fuzzy; wondering seems my eyes are little bit weaker; seems like my eyes are little bit weaker; Heart feels like racing; This 56- year-old female consumer (patient) reported for herself, received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6201 ), via an unspecified route of administration, on 20Feb2021 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated: "I had my second shot of Pfizer vaccine yesterday (20 Feb 2021), today, I suffered being tired. I put on my glasses to watch movie and screen looks fuzzy. It seems like my eyes are little bit weaker or something. My heart feels like racing. I don't think it is racing but it feels like it is. I was wondering if there is any side effects like slightly less accurate vision." The outcome of the events looks tired, fuzzy, eyes weaker, and heart feels racing was unknown.
56 2021-03-24 taste impairment, swollen tongue About 30 minutes after the injection, my throat felt tight like it was closing up. Then I started to... Read more
About 30 minutes after the injection, my throat felt tight like it was closing up. Then I started to have a funny taste, almost like metal in my mouth and my tongue started to fatter as though it was swelling. I never lost the ability to breath but felt a little constricted in my throat. The "puffy tongue side effect lasted for about 15 minutes and drinking water seemed to help. The throat constriction went away after about 5 minutes. We were already away from the vaccine site so we did not see any health professional for these symptoms but would have if they did not go away.
56 2021-03-24 swelling of eyelid, eye itchiness Experienced swelling of eyelids (both L/R), intense itching primarily in eyes, some itching on hand... Read more
Experienced swelling of eyelids (both L/R), intense itching primarily in eyes, some itching on hands and feet, sneezing, runny nose Took 1 25mg Benadryl tablet within 5 minutes of start of symptoms, had to take another 25mg Benadryl tablet approximately 30 minutes later because eyes were continuing to swell and itch Also experienced onset of severe headache about 45 minutes after shot Went to bed and slept for 3 hours after taking the second Benadryl. Felt better after waking, still had slight swelling in eyelids. Experienced minor itching at 10:30 pm, took 2 more Benadryl tablets at 11 pm. Minor eyelid swelling next morning, minimal itching.
56 2021-03-24 visual impairment Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingli... Read more
Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingling like it had fallen asleep but I was not laying on it. I moved it around until it finally stopped. Pain continued all not. On 3/24/21 was very tired and foggy. On 3/25/21 have a headache and slight nausea. I had an ophthalmic event where I saw lighting flashes in my right eye so it could be this causing instead of the vaccine. I am fine just thought I should report these occurred. Thanks!
56 2021-03-25 loss of smell, loss of taste Loos of taste and smell
56 2021-03-25 eye swelling, bloodshot eyes About 10 days after first Pfizer shot I developed red, itchy rash on left side of neck (same side as... Read more
About 10 days after first Pfizer shot I developed red, itchy rash on left side of neck (same side as shot). It was improving then 2 weeks after second shot in other (right) arm it flared back up and worsened significantly. Bright red, itchy painful rash all over neck, red swollen eyes, rash patches on face, down arms and hands. Treated with antihistamines and cortisone ointment. Overall rash symptoms lasted about 6 weeks, while worst symptoms lasted several days. While not formally diagnosed with covid, I believe I had it Jan-March 2020 and the final symptom was a very similar rash on my neck. These are the only 2 times I have ever had such a rash. I have photos to share of you want to see them.
56 2021-03-25 mouth itchiness Patient made online appointment for Covid Vaccine. On immunization consent form, she noted that she ... Read more
Patient made online appointment for Covid Vaccine. On immunization consent form, she noted that she didn't have any allergic reaction to another vaccine or to an injectable medication but she has allergy to sunflower, flaxseed, and latex. So she received Pfizer vaccine. 9 minutes after the vaccine, patient started to feel itchiness on her face especially around the nose and mouth, then she felt it going down to her chest. Vaccinating pharmacist noticed that the patient was getting redness around patient's neck, she called other pharmacist and they both went to talk to the patient. When patient was asked about symptoms that she was feeling, patient mentioned that it was the itching that bothered her the most. She denied that she has difficulty breathing or dizziness. So I drew up 1 mL of diphenhydramine and injected it IM to the other arm. Pharmacist watched her for another 20 minutes in the room. Patient kept complaining about the itchness but no other symptoms. Patient called her husband to come and pick her up. Patient was instructed to take benadryl at home if symptoms persist. And patient was also instructed to see medical help if symptoms were getting worse. Husband came and picked up the patient and patient went home
56 2021-03-25 mouth tingling About 20 minutes after vaccination when I was released and in my car headed home, my lower lip, left... Read more
About 20 minutes after vaccination when I was released and in my car headed home, my lower lip, left side only, started tingling. My tongue felt fat but didn?t appear fat. However, I slurred about six words. Then one tip of finger started tingling. I had no other symptoms. I immediately took one child Benadryl pill (half an adult dose). I had an epi-pen ready but didn?t need it (I?ve never had anaphylactic reaction before, but my throat has tightened from malic acid before, so I wanted to be prepared). I went home and slept rest of afternoon, probably because of the Benadryl. I had no respiratory issues; no hives; throat did not swell. Just lip tingling, ?fat? feeling tongue, and finger tip tingling.
56 2021-03-26 ear discomfort March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the ch... Read more
March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the chest and palpitations. I was given anti-nausea medication. I found the longer that I spoke the tighter and more sore my throat felt. Symptoms of lightheadedness, headaches, brain fog, pain in throat, ear pressure, nausea, diarrhea, body aches and pain, chills, fever of 102 at 6am on March 27th, neuropathy was exacerbated, palpitations and sore left arm. I feel a sharp pain in my right arm, deltoid muscle, when I try to lift it, I can barely move it. It feels as if I had the shot there but I know it was in the left arm for both doses. March 27th all symptoms continue and my temp is fluctuating between 99.5 and 100.5 so far today. March 5th 2021- Dose 1 Within 10 minutes I started to feel the vaccine. I felt a few pangs, brain fog, and exhaustion. The first night I had terrible nightmares. The first three days I experienced dizziness, light headed and off-balance, headaches, brain fog, pain in throat, ear pain, tinnitus and pressure, nausea, diarrhea, body aches and pain, difficulty breathing, chills, fever of 99.5, neuropathy was exacerbated, heart racing and palpitations and sore arm. On the fourth day, I felt normal but was very tired. On the fifth day (March 9th) I again felt exhaustion, brain fog, throat and ear pain, loose stools, body aches and pain, sharp chest pain and neuropathy.
56 2021-03-27 light flashes or floaters in the eye almost immediate crushing pain in forearm, hand went numb and fingers tingling. sensation of back in... Read more
almost immediate crushing pain in forearm, hand went numb and fingers tingling. sensation of back into neck and head. black out feeling.. headache left temple. flashing orange in eyes. lasted for up to 90 minutes.
56 2021-03-27 swollen tongue Woke up at 6{00 am the next morning with a left swollen cheek, swollen tongue and a left stiff neck.... Read more
Woke up at 6{00 am the next morning with a left swollen cheek, swollen tongue and a left stiff neck. I took half of a Zytec antihistamine, one Advil and drank extra water. Applied an ice pack. Stiff neck stopped at 36 hours. Swollen tongue stopped at 48 hours. Left cheek swelling went down by 50 % at 72 hours.
56 2021-03-27 visual impairment, swollen tongue Swollen tongue with lesion, extreme fatigue, muscle aches, vision disturbances, stomach issues, elev... Read more
Swollen tongue with lesion, extreme fatigue, muscle aches, vision disturbances, stomach issues, elevated liver enzymes
56 2021-03-28 mouth numbness Rapid heart rate, elevated BP, rash on neck & face, headache, numbness on lips & tongue. Monitored ... Read more
Rapid heart rate, elevated BP, rash on neck & face, headache, numbness on lips & tongue. Monitored for about 45 mins until heart rate & BP went down. Took Benadryl. Headache lasted 24 hours. On 3/22 started experiencing outbreak of hives, red dots (looked like chicken pox), extreme itching - mainly on torso and down legs. Saw family doc 3/23 prescribed Methylprednisolone 4mg, Trimcinolone and continue with Benadryl. As of today 3/29 outbreak continuing hives, itching and red marks on torso, buttocks, thigh.
56 2021-03-28 feeling of choking 3/26/2021 - Approximately 20 minutes after the injection I started having tingling in my right hand.... Read more
3/26/2021 - Approximately 20 minutes after the injection I started having tingling in my right hand. Same side as injection. I started having tingling and itchy gums itchy throat and itchy ears. My throat swelled up on both sides. All of the above in mild form. I was still sitting in my car in the parking lot & remained there for an additional 30 minutes to make sure it did not get worse. I subsequently ate lunch and continued with my day. Around 9:45pm I went to bed and found that when I would lie down I experienced increased difficulty in swallowing as neck was still swollen both sides under ears and around jaw line. At 10:00pm I took 1 single 25mg Benadryl tablet. Swelling subsided noticeably within 20 minutes. The following day (3/27/2021) much improved with only slight swelling on the left side of my throat under my left ear and along jaw line. Right arm sore from shoulder down to my wrist. By the end of the day my arm was no longer sore. Left side of my throat was still slightly swollen. At bedtime I took 1/2 of a 25 mg Benadryl tablet. Felt fine on Sunday however i still feel as if i have slight swelling
56 2021-03-28 ringing in ears Inability to lift arm (muscles in left upper arm became very painful and could not be lifted more th... Read more
Inability to lift arm (muscles in left upper arm became very painful and could not be lifted more than a few inches from my side, problem began about 4 hours after injection and lasted approximately 24 hours). Tinnitus (ringing in both ears increased steadily each day after injection, ringing reached a peak at approximately 1 week after injection and still persists)
56 2021-03-29 dry mouth 3/27-right hip hurts, blotches, feverish/diaphoretic, mouth dry What happened as a result of the adv... Read more
3/27-right hip hurts, blotches, feverish/diaphoretic, mouth dry What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Took ibuprofen and diphenhydramine Advised patient to seek medical attention for worsening symptoms; go to urgent care or contact PCP first thing on Monday morning. 3/29-Spoke with caller, states that she is back to her "old self", rash resolved, no longer diaphoretic, Took benadryl, ibuprofen and B12. Advised to contact us if she needs anything.
56 2021-03-29 taste impairment, lip swelling, swollen tongue Immediately could taste the vaccine in the middle of my tongue, started to feel jittery, hands grew ... Read more
Immediately could taste the vaccine in the middle of my tongue, started to feel jittery, hands grew cold after 4 minutes, felt spacey, felt numbness in the tips of middle fingers of right hand, face started to feel slightly numb from right to left, tongue started to swell on the left side, lips felt thick. This was a progression of 15 minutes. Vitals taken by EMT - all in normal range. I could walk cautiously. It was a matter of drinking water, eating oyster crackers without salt, and waiting. Left the facility about 11:30am and went for Benadryl. Benadryl helped some (taken about 11:45am) This also affects my serotonin levels making me sad and edgy. Restless afternoon, initial event subsided. Right arm hurt. Needed more Benadryl (1 tablet again) the next day. Added 2 ibuprofen in evening. Spacey, unsettled, fatigued. No fever. Monday: Brain fog most of day. Tuesday: brain fog lifting, but pain occurring in left hand in knuckles and fingers.
56 2021-03-29 taste impairment Metallic Taste in mouth
56 2021-03-29 lip swelling about 30 hours after the shot was administered, my lips swelled up for about 24 hours. I took Bened... Read more
about 30 hours after the shot was administered, my lips swelled up for about 24 hours. I took Benedryl around the clock until they were back to normal
56 2021-03-29 mouth tingling, mouth numbness Patient received vaccination around 12:10-12:56. RN saw EMS arriving to get patient at 12:56. Patie... Read more
Patient received vaccination around 12:10-12:56. RN saw EMS arriving to get patient at 12:56. Patient stated about 5-10 minutes after getting the vaccination she felt numbness and tingling of tongue. Wanted to go to ED to be examined. Stable at time of departure with no visible edema. Airway intact. Patient did go to the ED, and was triaged. Left without being seen.
56 2021-03-29 sensitivity to light, eye irritation, eye swelling, mouth swelling rt eye irritation, infection that showed up as white spot on cornea...sensitive to sun, mouth and ey... Read more
rt eye irritation, infection that showed up as white spot on cornea...sensitive to sun, mouth and eyes swelling
56 2021-03-29 swollen tongue, eye swelling The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vac... Read more
The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vaccine and sat down in the chairs to wait the required 15 minutes. Within 2-3 minutes my face got very hot. I could feel the heat under my mask. Another minute or two, just below my knees to my toes started tingling. Another two minutes or so, I felt like my eyes were swelling. I took my glasses off and looked at my husband and asked if my eyes are swelling, he said, they sure are and called over one of the paramedics that were there. They directed me to a more private are and put me on a monitor and monitored my vital signs. My blood pressure which is well controlled on my meds (which I did take that morning) climbed and climbed to 200s/100s. My chest was tight and uncomfortable and getting more difficult to breath. They put and 02 mask on and gave me Benadryl IM. By that time the squad was there and took me to the local hospital ER. In the squad my tongue started to swell. At the hospital they gave me Solumedrol IV which took care of it all. The swelling quickly went away in my tongue and face, the chest pressure went away, and all the other little annoyances like the tingling. The hospital did a chest x-ray and bloodwork. I went home after 3-4 hours with a prescription for Prednisone 50 mg daily for 5 days. No further reactions after that.
56 2021-03-30 ear itchiness, ear discomfort Approximately 10 min after receiving the injection, and while waiting in the observation area, my le... Read more
Approximately 10 min after receiving the injection, and while waiting in the observation area, my left ear began to itch and then both my inner ears felt funny. I paid attention to it for about 5 minutes, and then went to notify the person monitoring the observation area following the vaccine. I was asked if I wanted Benadryl, which I did accept. I was given 1 tablet, but they told me they had no water to give me. So, I had to find water and another several minutes passed before actually taking the pill. The symptoms I was experiencing were no longer noticeable within 30 min of taking the Benadryl.
56 2021-03-30 lip swelling Swollen lip and cheek, chin right side(3/24) Welts on both thighs 3/25, 3/25 Dr. prescribed prednis... Read more
Swollen lip and cheek, chin right side(3/24) Welts on both thighs 3/25, 3/25 Dr. prescribed prednisone 10 day pack
56 2021-03-30 thirst Joint aches for 48 hours; Fever & chills followed by severe headache beginning 8 hours post injectio... Read more
Joint aches for 48 hours; Fever & chills followed by severe headache beginning 8 hours post injection and continuing all night and next morning. Terrible. Truly painful and worse than a flu. Followed by intense Fatigue fir an additional 24 hours. And brain fog. Hungry but eating food made me nauseous. Total duration 48-72 hours scariest part was racing heart fir 8-12 hours, incredible thirst but water added to nausea.
56 2021-03-30 ringing in ears Tinnitus after 2nd dose - started 10 hours after and still continuing after 24 hours when I?m report... Read more
Tinnitus after 2nd dose - started 10 hours after and still continuing after 24 hours when I?m reporting this Arythmia few minutes after first dose. Lasted a few hours and no issues since
56 2021-03-30 ringing in ears Tinnitus (both ears) First vaccine. Second vaccine due on April 19th.
56 2021-03-31 ear pain Ha,malaise, body aches, nausea , vomiting,diarrhea,, bilateral ear aches, swollen glands under chin... Read more
Ha,malaise, body aches, nausea , vomiting,diarrhea,, bilateral ear aches, swollen glands under chin,
56 2021-03-31 mouth numbness, mouth tingling Tingling, numbness starting in right upper lip, spreading up to orbital area/temple - stroke-like sy... Read more
Tingling, numbness starting in right upper lip, spreading up to orbital area/temple - stroke-like symptoms
56 2021-03-31 lacrimation increased Watery eyes, rhinitis, headache, feeling feverish, fatigue,
56 2021-03-31 lip swelling, mouth numbness angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a cont... Read more
angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 16Mar2021 09:30 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant. No Known allergies. The patient took other medications (many, none new) in two weeks. The patient experienced angioedema, swelling of lips, numbness in tongue and mouth on 16Mar2021. The AEs resulted in Doctor or other healthcare professional office/clinic visit. The patient received zyrtec and allegra and epi pen for prn use. No covid tested post vaccination. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the compatible temporal association and the product's known safety profile, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the event angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-03-31 ringing in ears, ear discomfort Ringing/hissing in ears and clogged feeling
56 2021-04-01 ringing in ears Headache, dizziness, fatigue, ears ringing, muscle aches
56 2021-04-01 ringing in ears Minor ringing in ears started day after vaccination. Did not originally connect it with the vaccina... Read more
Minor ringing in ears started day after vaccination. Did not originally connect it with the vaccination. It has progressivley gotten worse. I now have ringing in the ears 2-3 times a day for 1/2-1 hour each time.
56 2021-04-01 vision blurred I experienced blurry vision. I was experiencing the other common effects as well, but the blurry vi... Read more
I experienced blurry vision. I was experiencing the other common effects as well, but the blurry vision came towards the end of the time I was experiencing the other effects and continued until the all of the other side effects were over. I did not seek any treatment.
56 2021-04-02 taste impairment This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant femal... Read more
This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EM9809), via unspecified route of administration on left arm on 03Feb2021 08:30 (at the age of 56-year-old) at single dose for Covid-19 immunization administered at Workplace clinic. The patient medical history included Atrial tachycardia and Meniere's disease. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EK4176), via unspecified route of administration on left arm on 19Jan2021 15:00 (at the age of 56-year-old) at single dose for Covid-19 immunization. Concomitant medication include Metoprolol, Pantoprazole, Crestor and Famotidine. Past drug events include Pyridium and Cleocin and experienced Allergy. The patient experienced, chemical taste and odor for 1st vaccine, right after administration for a minute or so 2nd vaccine, 30-45 minutes after which lasted at least 5 minutes on 09Feb2021 09:15. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovered.
56 2021-04-02 oropharyngeal discomfort Chest cavity very sore, coughing, sore throat, throat congested, nose congested, fatigue, back pain ... Read more
Chest cavity very sore, coughing, sore throat, throat congested, nose congested, fatigue, back pain and leg pain?
56 2021-04-03 lip swelling, swollen tongue swollen lips and tongue about 2 and 1/2 hours after recieving 2nd dose of covid vaccination
56 2021-04-03 visual impairment within a few minutes I started getting very hot and then I got very sweaty. I removed my coat and pu... Read more
within a few minutes I started getting very hot and then I got very sweaty. I removed my coat and put on the air conditioner. Next I started seeing blue colors before my eyes and at that time honked my horn for help. My blood pressure tanked, my heart rate increased. I was given 2 does of EpiPen, and Benadryl. I then was brought to the hospital and was given oxygen en route. At the hospital, I was monitored and given 10mg of Decadron
56 2021-04-04 eye twitching Leg cramps started about 1 hour after the vaccine was administered. About 6 hours after vaccine, deb... Read more
Leg cramps started about 1 hour after the vaccine was administered. About 6 hours after vaccine, debilitating headache. Numbing of hands and feet along with headache. On the next day: diharrea, joint pain, burning sensation in hands and feet, nausea, mild rash on both arms, increased heart rate, eye twitching
56 2021-04-04 dry throat Pt @1055 reported tingling and numbness, then flushed through all body and felt palpitations for a m... Read more
Pt @1055 reported tingling and numbness, then flushed through all body and felt palpitations for a minute. @ 1125 pt verbalizes that she "feels fine" and denies any new or continuing symptoms. States that her throat is dry but declines to drink water stating she has water in her car and will just get that. @1204 attempted to contact pt on mobile phone for FU but no answered. LVM
56 2021-04-04 lip swelling After waiting the 15 minutes in observation, patient started to leave. She felt some swelling of he... Read more
After waiting the 15 minutes in observation, patient started to leave. She felt some swelling of her lower lip and returned for evaluation. Denies shortness of breath, no trouble swallowing, no swelling of tongue. BP 161/81, p 107, O2 sat- 98% Took own OTC Benadryl 25 mg tab at 09:40 am . Noted decrease in swelling within 5 minutes. Continues to deny swelling of tongue, throat, or difficulty swallowing. Discharged home with relative. She will notify her PCP prior to next injection to make sure she is okay to have the second shot.
56 2021-04-04 mouth tingling, loss of taste, taste impairment, mouth numbness Within the hour of receiving the vaccine: Lips began tingling, feeling numb, similar to my allergic ... Read more
Within the hour of receiving the vaccine: Lips began tingling, feeling numb, similar to my allergic reaction. Next morning I had a metallic taste in my mouth but by afternoon had lost my sense of taste.
56 2021-04-04 ringing in ears Within 2 hours was nauseous and vomiting. Prior to vaccine had very minor barely noticeable tinnitu... Read more
Within 2 hours was nauseous and vomiting. Prior to vaccine had very minor barely noticeable tinnitus in left ear. Since vaccine and now 7 days later I have a very loud bothersome tinnitus in the same ear.
56 2021-04-05 eye twitching, taste impairment Day 1: injection was in right arm immediate strong taste of metal in mouth after injection right sid... Read more
Day 1: injection was in right arm immediate strong taste of metal in mouth after injection right side of face had tingling all symptoms were greatly lessoned by the end of the 20 minute wait Day 2: major injection site soreness/no other symptoms Day 9: right side of face severely numb middle tip of eyelid had constant twitch tightness in right check and side of face, up into the eye socket severe tingling, like after a dental appt with too much Novocain slight metal taste no drooping/drooling/sagging of face vision seemed fine/motor skills fine Day 10: same symptoms as day 9 with added right arm pain bicep in right arm, wrist and fingers numb Day 11: Drs appt 9:20am same numb/Novocain feeling in face more heav
56 2021-04-05 deafness, visual impairment After about 15 min I started to get numbness, tingling , and swelling on my entire left side. It inc... Read more
After about 15 min I started to get numbness, tingling , and swelling on my entire left side. It included difficulties seeing and lack of hearing on the left side. I could feel the "blood flow" in my head, which was super uncomfortable, because I was afraid of getting a stroke. I went to report to the Medical Doctor on side at the Convention Centre. They kept monitoring blood pressure and my responses. Nothing really was done. Symptoms stayed for about 1.5 hours the same. After that they decreased but my side was still numb and swollen (not back to normal). However, I left to go home. After about 24 hours those symptoms were gone and only headache, fatigue remained. I received my second vaccination on 04/04/2021 at about 1:15P: Pfizer, Lot#ER8733 There, I used my right arm. Same thing, after about 15 min, I started to get tingling, numbness, difficulties hearing and seeing. Headache was worse than the first time. Again I remained under observation for about 1h. No results. Symptoms lessened. I went home. At night I developed nausea, severe kidney pain, had to vomit several times, and had a weird hot feeling inside my body=could feel my blood flow. It felt as if it was really hot. it was extremely scary, as I again was afraid of developing a stroke. Now, 2 days later, I still am feeling extremely weak, nauseous, headaches, some numbness.
56 2021-04-05 deafness Acute hearing loss in left ear. Began approximately 36 hours after injection.
56 2021-04-05 mouth tingling, lip swelling, thirst Swollen lips and face/ tingling Difficulty swalling Difficulty breathing VERY thursty Very soar thro... Read more
Swollen lips and face/ tingling Difficulty swalling Difficulty breathing VERY thursty Very soar throat Racing heart rate High blood pressure Went to the ER. They were able to lower my racing heart with a beta block. Still suffering elevated heart rate and high blood pressure. No prior history of heart problem or high blood pressure.
56 2021-04-05 vision blurred, taste impairment while receiving the shot, I had a sudden metallic taste in my mouth that took hours to go away. 10 m... Read more
while receiving the shot, I had a sudden metallic taste in my mouth that took hours to go away. 10 minutes after the shot, I started to have blurry vision, which lasted for the next 28 hours and then went away on its own. Beginning 2 hours after the shot, I began to have vertigo when standing. The vertigo, accompanied by nausea lasted for approximately 8 hours.
56 2021-04-06 dry mouth shortness of breath and xerostomia, discharged from vaccine clinic after 30 min observation
56 2021-04-06 eye swelling patient came into the ed for bilateral eye swelling that started Monday night two days after vaccina... Read more
patient came into the ed for bilateral eye swelling that started Monday night two days after vaccination - treated for allergic rxn Benadryl solumedrol Pepcid
56 2021-04-06 vision blurred Received first dose Pfizer (LOT# EW0150) on 4/02/21. Pt raised hand and stated to EMT that she had p... Read more
Received first dose Pfizer (LOT# EW0150) on 4/02/21. Pt raised hand and stated to EMT that she had pain in her chest, shoulders, back/neck and down both of her arms 4-5/10 on pain scale. Pt stated that she started feeling dizzy with blurry vision and a tight feeling in her head. EMT moved pt to gravity chair. Pt progressively got weaker and more drowsy. PHN offered pt EMS. Pt declined EMS. PHN recommended EMS to be called. Pt agreed for EMS to be called. EMT took pt vital signs at 1317. BP: 124/76, HR: 78. EMS arrived on scene at 1325 and took over. Pt left vaccination site via gurney with paramedic. Pt was transported and left in ambulance at 1335.
56 2021-04-07 taste impairment Tongue started to enlarge; Throat tighten up; Strange metal taste; This is a spontaneous report from... Read more
Tongue started to enlarge; Throat tighten up; Strange metal taste; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 56-year-old female patient received the first dose of BNT162B2 (PFIZER -BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 24Mar2021 at 10:45 AM, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to sulfa. The patient's concomitant medication included clopidogrel. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 30 minutes after injection (24Mar2021 at 11:15 AM), the patient felt throat tighten up and tongue started to enlarge. Also, the patient had strange metal taste but never lost ability to breathe. After drinking some water and about 15 minutes, the symptoms went away. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Mar2021 at 11:30 AM.
56 2021-04-07 swollen tongue, mouth swelling 4/7/21 at 7pm Felt faint a little breathing off. Sore throat 8pm and started to feel uncomfortable a... Read more
4/7/21 at 7pm Felt faint a little breathing off. Sore throat 8pm and started to feel uncomfortable and trouble swallowing a little bit.. 10pm felt like lump in throat. 11pm more trouble swallowing and tongue swollen and throat felt swollen. 6am under chin tongue still felt swollen. 2:45pm 4/8 trouble swallowing and felt odd in mouth/throat. Soft palate and uvula swollen and throat felt swollen. 7pm felt faint and breathing off a little. 9:45pm Mouth still swollen. All of this with Benadryl and Motrin in me.
56 2021-04-08 loss of taste, loss of smell Pt reports loss of taste and smell after receiving dose #1 of Pfizer mRNA vaccine
56 2021-04-08 ear swelling Swelling of inner ears and throat
56 2021-04-08 eye swelling, lip swelling Angioedema; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling fac... Read more
Angioedema; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration on 17Mar2021 06:00 PM as single dose in right arm for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included idiopathic angioedema and no chronic health conditions. Patient had allergies to medications, food, or other products included Zithromax - anaphylactic, several other antibiotic - rash, hornet and wasp sting allergies. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 18Mar2021 at 10:00 AM, the patient experienced angioedema - swelling face, eyes, lips and throat which occurred 16 hours after injection. Event resolved with use of Benadryl. Prior history of angioedema. Since symptoms resolved with Benadryl, I did not seek further medical care. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events were recovered in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-04-08 swollen tongue Patient reported tongue swelling within 30 minutes of vaccination. Resolved without treatment and w... Read more
Patient reported tongue swelling within 30 minutes of vaccination. Resolved without treatment and was released to home.
56 2021-04-08 taste disorder, mouth discomfort, mouth numbness, swollen tongue After 25 minutes of having vaccine had a strong medicine taste in mouth which burned inside of mouth... Read more
After 25 minutes of having vaccine had a strong medicine taste in mouth which burned inside of mouth for next 5 days. Then tongue swelled up, lips numb and could not swallow. I was short of breath sweating and throat and chest tightness. Sought treatment at Emergency room was given Benadryl IV and oxygen.
56 2021-04-09 taste impairment I taste salt; This is a spontaneous report from a contactable consumer. A 56-year-old female patient... Read more
I taste salt; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EP7533) dose 1 via an unspecified route of administration in Arm Right on 24Mar2021 11:45 as single dose for COVID-19 immunization. Medical history included Degenerative disc disease and moderate arthritis. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEBREX) estradiol and omeprazole magnesium (PRILOSEC) and calcium pantothenate, folic acid, vitamins nos (MULTI-VITAMINS VITAFIT). On 24Mar2021 17:00 it was reported as the patient experienced i taste salt. Seriousness was reported as non-serious. Outcome of event was not recovered.
56 2021-04-09 mouth ulceration Soreness from injection left arm subsided after a day Bad Migraine next day - Migraines / headaches ... Read more
Soreness from injection left arm subsided after a day Bad Migraine next day - Migraines / headaches are chronic condition already prescribed meds helped Mouth sores - still experiencing Mild sore throat - still experiencing
56 2021-04-09 mouth tingling, tongue disorder she had COVID and also had COVID like symptoms after receiving the first dose.; tingling sensation o... Read more
she had COVID and also had COVID like symptoms after receiving the first dose.; tingling sensation on the mouth/ sensation of tingling around her lips; skin very tight/ face very very tight/face got very tight around her nose, cheeks, and under her eyes; first half of her tongue started feeling thick; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9261), dose 1 via an unspecified route of administration on 27Jan2021 as single dose for COVID-19 immunisation. Medical history included COVID-19 (in fall) and allergic to Penicillin (a very long time ago as child and she got a fat upper lip from it). There were no concomitant medications. She had her first dose 27Jan which was 90 days after she had COVID. On 27Jan2021, 30 minutes after the vaccine, the patient experienced she had COVID and also had COVID like symptoms after receiving the first dose, tingling sensation on the mouth/ sensation of tingling around her lips, skin very tight/ face very very tight/face got very tight around her nose, cheeks, and under her eyes and first half of her tongue started feeling thick. The physical assistant examined her and said it didn't not look swollen. She asked her doctor about this and she was given 50 mg of Benadryl at the vaccine site, approximately 1 hour say after the shot or either 1 hour after her symptoms but it was approximately during that time period. She was wondering if she can take the second dose. The patient did not used any other product. The episode lasted about 3 hours she would say. She is not one to have a lot of allergies. She is in good health. She does not have any issues or diabetes or any type of medical condition. She says it has recovered completely. The patient asked whether to take this vaccine every year and wanted to know if she absolutely needs to take the second shot for full protection. According to her she had COVID and also had COVID like symptoms after receiving the first dose. Would she have developed enough antibodies to protect herself that the first dose would be considered like a second shot. She heard people generally have COVID like symptoms after receiving the second shot. She is just trying to understand if she need to take a second dose or one dose is enough. She has been reading what the CDC guidelines are about, but she is looking into it further to see what Pfizer's guide lines are on whether or not she should still get the second vaccine. The patient's husband mentioned Benadryl was given as precaution and believe the physical assistant was a student and didn't have much medical knowledge. The patient underwent lab tests and procedures which included sars-cov-2 test: COVID in fall. The outcome of COVID and also had COVID like symptoms after receiving the first dose was unknown. The outcome of tingling sensation on the mouth/ sensation of tingling around her lips, skin very tight/ face very very tight/face got very tight around her nose, cheeks, and under her eyes and first half of her tongue started feeling thick was recovered. Follow-up attempts are completed. No further information is expected.
56 2021-04-10 eye irritation, taste impairment, eye itchiness Within 10-15 minutes after receiving vaccine I got burning itchy eyes, nausea & metallic taste in mo... Read more
Within 10-15 minutes after receiving vaccine I got burning itchy eyes, nausea & metallic taste in mouth
56 2021-04-10 mouth pain Prior to the first dose of COVID vaccine on 16Mar2021, I had a small mouth sore on the inside upper ... Read more
Prior to the first dose of COVID vaccine on 16Mar2021, I had a small mouth sore on the inside upper right of my mouth. I am not prone to mouth sores but had bit my lip in this location. Following the first vaccine, this mouth sore became larger and painful accompanied by visible lip swelling. Duration of lip swelling was approximately 4 days. Treatment included salt water gargles a few times a day. Prior to my second vaccine on 08Apr2021, I had no mouth sores. Approximately one day following the immunization, I experienced a small mouth sore on the inside left lower area of my mouth on the inside of my lip. Over the past few days, the sore has gotten larger with associated pain. This morning (11Apr2021), I awoke to visible swelling in this area.
56 2021-04-10 mouth tingling, taste impairment Tingly tongue shortly after the injection that is still there the day after. I think it's going dow... Read more
Tingly tongue shortly after the injection that is still there the day after. I think it's going down. Also, a little metallic taste in the mouth right after getting the shot too. Feeling flush in the face and sweating a lot about 2 hours after but that went away about an hour or two later. Soreness in left arm where the injection was given.
56 2021-04-11 loss of smell, loss of taste My cheeks went numb instantly. My arm hurt right away, but that is normal for me. Then I got extr... Read more
My cheeks went numb instantly. My arm hurt right away, but that is normal for me. Then I got extremely fatigued. I waited the 30 minutes and went home. Within two hours I had chills, low fever, shortness of breath, muscle and body aches, sore throat, congestion. By the morning I still had all of the other symptoms but worse and I had no taste or smell. I had nausea and diarrhea along with all of the other symptoms. I felt terrible for four days. I remained very fatigued and my chest still feels heavy.
56 2021-04-11 eye itchiness allergic symptoms - itchy throat, itchy eyes, hives less than an hour after the injection Symptoms ... Read more
allergic symptoms - itchy throat, itchy eyes, hives less than an hour after the injection Symptoms lasted the remainder of the day and all through the night. Minimal relief with allergy medication -Claritin
56 2021-04-11 ringing in ears Severe ringing in the ears. It started a couple of days after I got the vaccine. It's been a week an... Read more
Severe ringing in the ears. It started a couple of days after I got the vaccine. It's been a week and I'm scheduled to get my second shot on April 27th. If it persists I'll see the doctor.
56 2021-04-11 ringing in ears Patient reported side effects - Onset: 45 minutes after getting vaccine; Severity: moderate; Symp... Read more
Patient reported side effects - Onset: 45 minutes after getting vaccine; Severity: moderate; Symptoms: Dizziness for 2 hours, can't think clearly. Second Pfizer vaccine -- Got shot at 8:20 AM and started to feel warm at 9 AM, and got dizzy with vertigo. Feels foggy, needs to hold onto furniture to walk. No fever. (With 2nd shingles shot -- next morning achy, exhausted, low grade fever. Only time has ever reacted before). Other symptoms = Ringing ears, fogginess in thought. HISTORY OF PRESENT ILLNESS A 56 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine. Second Dose in Series: Vaccine was obtained from the following clinic/location: on the date of: 4/9 and approximate time of 8:15 AM Vaccine was administered to patient's: Left Deltoid Vaccine manufacture was: Pfizer Past Reaction to other immunizations- yes: symptoms: second dose of shingles causing flu like symptoms Known COVID Exposure since receiving vaccination?: No Patient notes the following symptoms: disiens, tight throat, scratchy voice, ringing ears. Modifying Factors or additional details: by the time got home after vaccine today - dizzy, ears ringing and symptoms haven't improved. Denies lightheadedness or feeling like she is going to pass out. Voice sounds scratchy, feeling unbalanced. Denies history of vertigo. Throat feels tighter but denies difficulty breathing. Denies tongue or lip swelling. Did take atarax one hour after without relief. Dramamine as needed -Benadryl at night - may make you sleepy -Daily antihistamine (e.g Claritin) -Increase rest and fluids Signs and symptoms that require an Emergency Room Evaluation-rapid breathing, using accessory muscles to breathe, difficulty breathing, severe wheezing, tongue/lip/airway swelling, altered mental status, weakness, visual changes, lightheadedness, not eating or drinking, severe headache, chest pain, neck pain or stiffness, the development of high fevers/chills/overall feeling unwell despite medications, or any new concerning symptom. -Follow up with PCP if no improvement over the next three days
56 2021-04-11 ringing in ears dizziness tinnitus
56 2021-04-12 dry mouth, pain in jaw, mouth numbness On 4/8 I woke up with a sore jaw on the left side. Got better as the day went. That night woke up ... Read more
On 4/8 I woke up with a sore jaw on the left side. Got better as the day went. That night woke up with no saliva on that side of my throat. Drank water but happened several times. Next day same exact thing. My back teeth on the left felt numb. Same extremely dry on left side of throat and woke with less jaw pain. Day 4 completely gone.
56 2021-04-12 eye swelling Hives on face 20 minutes after injection, angioedema follow with swollen face, eyes and itching on f... Read more
Hives on face 20 minutes after injection, angioedema follow with swollen face, eyes and itching on face. Within 5 hours all over itching, drainage from eyes throat itching
56 2021-04-12 mouth numbness, lacrimation increased weakness numbness on right side of face, numbness in tongue, gums, cheek, and eye, mild dropping wat... Read more
weakness numbness on right side of face, numbness in tongue, gums, cheek, and eye, mild dropping watering of eye. 2 days after vaccine, increasing over following days. Diagnosis-bell's palsey treatment prednisone
56 2021-04-12 oral mucosal blistering Rash all over, redness, fever, chest pain and heaviness, fainting, severe itching, sore throat with ... Read more
Rash all over, redness, fever, chest pain and heaviness, fainting, severe itching, sore throat with blisters in mouth, Migraine, and HBP. Treatment: ER-IV Solu-medrol X1, Pepcid x1, Fiorcet x1, Toradol x1, Caffeine pill by mouth.
56 2021-04-12 smell distorsion, taste disorder elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; s... Read more
elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
56 2021-04-12 taste disorder i have had what my dentist called a geographic tongue since I received the first vaccination. It is ... Read more
i have had what my dentist called a geographic tongue since I received the first vaccination. It is not thrush but does effect my taste and causes a gagging reflux. My throat is clear and have no swollen glands. I received the second dose on April11 and it has gotten worse.
56 2021-04-12 ringing in ears Tinnitus in both ears. Left arm was sore for a few days after shot. Had mild headache on day 2-3.
56 2021-04-12 visual impairment Pt reported to the ER two days after vaccination on 03/12/21 with complaints of visual difficulties ... Read more
Pt reported to the ER two days after vaccination on 03/12/21 with complaints of visual difficulties and gaze abnormalities. Stroke code was activated at 1445. After CT, pt was flown to Hospital for work up by neurology. Underwent CTA, throbus in right PCA. Underwent thrombectomy. Complications from stroke and difficult airway led to intubation and mechanical intervention, extubated the next day. Pt discharged from hospital 03/17 on Eliquis.
56 2021-04-13 mouth discomfort, tongue discomfort Patient received COVID vaccine (Pfizer) dose 1 and afterwards experienced heartburn, tingling in bot... Read more
Patient received COVID vaccine (Pfizer) dose 1 and afterwards experienced heartburn, tingling in both arms, and developed tongue/hard palate discomfort immediately following the vaccination and states BP was elevated. Patient had vitals taken and noted systolic BP 205, then RRT called and taken to the ED for further monitoring. In the ED patient had CBC, CMP, and Troponin drawn and no abnormalities seen and EKG was normal. Patient was monitored and then discharged home from the ED.
56 2021-04-13 mouth tingling Patient complained of tongue tingling and chest tightness approximately 15 minutes after administrat... Read more
Patient complained of tongue tingling and chest tightness approximately 15 minutes after administration of vaccine. Pt has severe COPD, Anxiety, and possibly heart failure. She was observed for one hour and treated with 50 mg of Benadyl which she frequently takes for these symptoms with her medications. She used her personal inhaler and began feeling better. Vitals were stable throughout the hour, pulse ox was 99% on her usual continuous nasal cannula O2. Rapid response team evaluated the patient and the responding RN and MD felt the patient was improved. Complaints of tongue tingling and chest tightness were improved. The patient denied a history of allergic symptom relapse after taking Benadryl. The patient requested discharge from the clinic accompanied by her caregiver. She was discharged in her wheelchair with home O2 at 4:10 p.m.
56 2021-04-13 ringing in ears Tinnitis, began the day after the vaccine and has not abated. High-pitched ringing in the ears.
56 2021-04-14 taste impairment Fever 102.7 for 24 hours, body aches and pain, headache, chills, metallic taste in mouth, large lump... Read more
Fever 102.7 for 24 hours, body aches and pain, headache, chills, metallic taste in mouth, large lump and painful swelling at injection site. All resolved in 24 hours except the metallic taste and lump at injection site which still exist 72 hours post injection.
56 2021-04-14 mouth tingling tingling in lips and mouth
56 2021-04-15 taste impairment Metallic taste in mouth almost immediately after injection.
56 2021-04-15 mouth tingling Patient's husband reported to the pharmacy that she was having a hard time breathing. When I reache... Read more
Patient's husband reported to the pharmacy that she was having a hard time breathing. When I reached the patient she had already taken two puffs of her albuterol inhaler. She said it felt like her throat was closing so 911 was called. She continued to labor in her breathing and said her lips were tingling. She was no longer able to talk and she took one more puff of her albuterol inhaler. Then she began gasping and an epinephrine 0.3mg pen was administered. Paramedics arrived and took her to the hospital.
56 2021-04-15 ringing in ears Tinnitus
56 2021-04-16 ear pain Pain all over, very fatigue, foggy, chest tiredness, exhaustion with ambulation, plum size swelling,... Read more
Pain all over, very fatigue, foggy, chest tiredness, exhaustion with ambulation, plum size swelling, pain and redness under right armpit, slight sore throat, ear ache, and stuffy nose gradually got worse since 23 April
56 2021-04-16 mouth tingling Before vaccination patient stated she had allergies to iron and epinephrine that caused anaphylaxis.... Read more
Before vaccination patient stated she had allergies to iron and epinephrine that caused anaphylaxis. Pt appeared anxious. Asked pt if she would like to receive vaccination in a quiet area w/ observation by EMTs, patient stated yes. Post-vaccination, pt complained of SOB, dizziness, lightheadedness, nausea, tingling to mouth. Patient appeared lethargic. Responded appropriately to questions from on-site EMTs. VS taken - HR 108, RR 24, BP 180/120, SPO2 99% RA. Pt was asked if she would like to be taken to ED for additional assessment, patient stated yes. Pt transported to ED by ambulance for further assessment.
56 2021-04-17 eye bleeding one eye is red like it has vessels like broken or bleeding in there; This is a spontaneous report re... Read more
one eye is red like it has vessels like broken or bleeding in there; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was feeling ok and everything, but one eye was red like it had vessels like broken or bleeding in there on 02Apr2021, she said it didn't hurt. The outcome of event was unknown. Information on the lot/batch number has been requested.
56 2021-04-17 ringing in ears Dizziness, pulsatile tinnitus, fatigue, lightheadedness Blood pressure is normal
56 2021-04-17 ringing in ears left ear began to itch, and then the inside of both ears felt a little 'funny"; left ear began to it... Read more
left ear began to itch, and then the inside of both ears felt a little 'funny"; left ear began to itch, and then the inside of both ears felt a little 'funny"; experienced intermittent tinnitus in both ears.; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 23Mar2021 at single dose for COVID-19 immunization. The relevant medical history included ovarian cancer and allergy: Penicillin, from unspecified date. Concomitant medications included colecalciferol (VITAMIN D 3). On 23Mar2021, within about 10 min of receiving the vaccine, her left ear began to itch, and then the inside of both ears felt a little "funny". Since having the vaccine, she had experienced intermittent tinnitus in both ears. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures included 1 tablet of Benadryl were taken as a result of the events. The outcome of the event was recovered with sequel on an unspecified date. Information on the lot/batch number has been requested.
56 2021-04-18 double vision Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spont... Read more
Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm. On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
56 2021-04-18 taste impairment, vision blurred 12 minutes after the injection, I felt very dizzy, nauseous, a few minutes later, I totally blacked ... Read more
12 minutes after the injection, I felt very dizzy, nauseous, a few minutes later, I totally blacked out, they took me into the emergency room and took my blood pressure, which was very low and my heart was racing. I came to about 7-10 minutes later with very dizzy feeling, a itchy throat and was feeling very dizzy. The hospital staff gave me water and took a EKG - I was told to just rest. I got the chills and felt waves of dizzy/nauseous for a while. After about an hour, I felt strong enough to go home. I went home and was very tired and still dizzy. I was tired and was too tired to do anything other than stay in bed for three days. I lost my appetite, had weird metal taste in my mouth and had a few dizzy episodes the next day where I couldn't walk to the bathroom without help. I am usually a very healthy person, never have passed out before and now three days later, I can only work a few hours a day without getting tired and my brain feels foggy - hard to focus.
56 2021-04-18 ringing in ears Tinnitus - ringing in both ears
56 2021-04-18 ringing in ears The onset of symptoms began 10 hours after the second dose injection, including severe headache, fev... Read more
The onset of symptoms began 10 hours after the second dose injection, including severe headache, fever, arm pain, fatigue, and tinnitus. All symptoms persisted intensely for 24 hours, then started to lift -- with the exception of headache and tinnitus. The headache resolved at about 48 hours. Tinnitus remains severe and consistent since the day of the shot. No prior history of tinnitus or auditory disorder.
56 2021-04-18 toothache, ear pain 7.5 hours after receiving the Covid19 Vaccine, my nasal passages started burning. After about 30 min... Read more
7.5 hours after receiving the Covid19 Vaccine, my nasal passages started burning. After about 30 min of my nasal passages burning (they continued to burn), I had a sudden onset of severe pain across my face in my sinus's. My upper teeth were also in pain. I could not drink anything hot or cold because it would cause a sharp shooting pain through my sinus's and would take several mins to subside. The pain continued the next day, so I went to immediate care but they refused to give me an antibiotic. They gave me a Covid test which was negative. 4 days after the extreme pain in my sinus's and teeth, I still had severe pain on the left side of my face, ear and teeth. I called my primary care physician and she prescribed a 10 day Augmentin antibiotic. Finally my pain subsided 7 days after my vaccine (3 days after the start of antibiotics). 2 days after I finished the antibiotics, I had a sudden onset of severe pain in my hips and lower back, the pain persisted for a week. I went for acupuncture treatment and this eased my pain. I just had my 2nd dose of the Covid19 vaccine and did not have any side effects.
56 2021-04-19 eye irritation Zoster without complications Valtrex 1gm q8hrs for 7 days that has been extended for 3 more days du... Read more
Zoster without complications Valtrex 1gm q8hrs for 7 days that has been extended for 3 more days due to the persistence of the symptoms Symptoms: nerve pain, red rash, burning sesnsation at the left part of the brain/face (specifically on the left forehead, eye, chick, ear and scalp).
56 2021-04-19 smell distorsion, taste disorder Gurgling stomach all hours of day and night. Diaharea first thing in morning. Urgency to go and diah... Read more
Gurgling stomach all hours of day and night. Diaharea first thing in morning. Urgency to go and diahrea a few times a day for three days. Gurgling stomach still continuing through 7th day. INCREASED sense of smell and taste after first shot for about a week. Renewed after second shot, continues as of now.
56 2021-04-19 ringing in ears I have constant tinnitus last 6 days and nights, since the April 14th. That is something new for me.... Read more
I have constant tinnitus last 6 days and nights, since the April 14th. That is something new for me. I had usual side effects; nothing significant. Arm pain and tiredness were the top two. I didn't pay much attention to tinnitus, but I noticed it the second night after the vaccine when I went to bed, and two more times after that, and it didn't last long. However, it started again 13 days after the vaccine, and the hissing sound is more lauder and constant. It is in both ears. It bothers me especially at night. It could be a coincidence, but it could be a vaccine side effect as well. I am afraid that the second doze could make this tinnitus worse.
56 2021-04-20 ear discomfort, ringing in ears One week after shot there was a consistent low faint buzzing in left ear. Ear felt a bit clogged. Bu... Read more
One week after shot there was a consistent low faint buzzing in left ear. Ear felt a bit clogged. Buzzing is constant and has not yet resolved.
56 2021-04-20 mouth numbness, mouth tingling Tingling and numbness in left side of face and tongue
56 2021-04-20 mouth numbness feels heart beating faster, numb lips, rash on chest, EMT evaluated, self-resolved, pt. refused tran... Read more
feels heart beating faster, numb lips, rash on chest, EMT evaluated, self-resolved, pt. refused transport.
56 2021-04-20 ringing in ears Tinnitus in both ears, began about 22 hours after second dose of Pfizer vaccine
56 2021-04-20 ringing in ears Started ringing in the left ear. Got much worse after the 2nd shot on April 1, 2021. It is now extre... Read more
Started ringing in the left ear. Got much worse after the 2nd shot on April 1, 2021. It is now extremely loud and interfering with my quality of life, work, being able to hear.
56 2021-04-20 vision blurred Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; L... Read more
Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; Lymph nodes in head, neck and under arms swollen; very high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Six days after the vaccine (on 23Mar2021 10:15 ), the patient started to feel light headed, unbalanced. Blacked out on March 23rd for a very short time. Having trouble to focus with his eyes. Head feels full. Lymph nodes in head, neck and under arms swollen. Very high blood pressure and now needing medication for that. These last two weeks have been a nightmare and thinking he was going to die and was in the Emergency room. No treatment was received for the events. Event blacked out seriousness was medically significant. The events outcome was not recovered.
56 2021-04-21 dry mouth I had diarrhea, extreme chills, slight cough, and an extremely dry mouth. After getting about 12 hou... Read more
I had diarrhea, extreme chills, slight cough, and an extremely dry mouth. After getting about 12 hours of sleep, I woke up feeling totally normal.
56 2021-04-21 eye pain Periodic, pinpoint, sharp headaches above right eye. Originally attributed them to my new Fitbit and... Read more
Periodic, pinpoint, sharp headaches above right eye. Originally attributed them to my new Fitbit and stopped wearing it at night when my arm could end up near my head. I get one every few days. I have a high threshold of pain and they are unbearable. They last about 15 minutes.
56 2021-04-21 swollen tongue Immediate: body flushing, racing heart (about 40-50 bpm higher than normal), and lightheaded/dizzy ... Read more
Immediate: body flushing, racing heart (about 40-50 bpm higher than normal), and lightheaded/dizzy Same day: tongue felt funny/slightly swollen Same day evening & next day: hives on upper and lower torso
56 2021-04-21 vision blurred The second day at night when standing for more than 10 minutes I start to see blurred to cold sweat ... Read more
The second day at night when standing for more than 10 minutes I start to see blurred to cold sweat as if my blood pressure dropped and I feel like I am going to faint I have to sit or lie down immediately, I spent the second day after get vaccinated at night and today, which is the third day when I get up after standing for more than 10 minutes, on the second day I also had, a little fever, headache, pain in the body, chills and a little nausea Today the third day I only have a slight headache, and what I have felt is that I am going to faint after a while of standing.
56 2021-04-22 eye movement disorder 3:15PM PT GOT VERY 'WARM'. PLACED IN WHEELCHAIR; SYNCOPAL EPISODE/EYES ROLLED BACK APROX 30 SECONDS... Read more
3:15PM PT GOT VERY 'WARM'. PLACED IN WHEELCHAIR; SYNCOPAL EPISODE/EYES ROLLED BACK APROX 30 SECONDS. PLACED ON FLOOR, ELEVATED LEGS AND PT BECAME RESPONSIVE. PT GOT ONTO COT PER SELF. ELEVATED HEAD OF BED; DRINKING TEA. STATES SHE DID'NT HAVE MUCH TO EAT TODAY AS SHE WAS HAVING A DENTAL PROCEEDURE DONE THIS AM. BP 120/68, HR 60, R 20, 02 SAT 98%. A/O, PINK, W/D, RESP WITH EASE. 'FEELS MUCH BETTER NOW'. 3:45PM HUSBAND HERE TO DRIVE PT HOME. PT AMBULATORY TO EXIT- GAIT BRIS AND STEADY.
56 2021-04-22 mouth swelling, swollen tongue pt had the 1st dose of COVID-19 vaccine and had oral swelling, tongue swelling and difficulty swallo... Read more
pt had the 1st dose of COVID-19 vaccine and had oral swelling, tongue swelling and difficulty swallowing. patient was transferred to the ED. IV access was established and patient was given IV fluids, IV Benadryl, famotidine and Solu-Medrol for initial management of possible allergic reaction. Patient was later given 0.5 mg IM epinephrine for treatment of anaphylaxis. Patient was observed in the emergency department for 3 hours with no return of symptoms. and discharged.
56 2021-04-22 ringing in ears, ear discomfort Date and time adverse event started: 3/10/2021 at approx. 12:30pm, a few moments after rcvding the v... Read more
Date and time adverse event started: 3/10/2021 at approx. 12:30pm, a few moments after rcvding the vaccine. Pt reported that a few moments of rcvding the vaccine she felt pressure in her whole head, ears were clogged up, and had lumps in her throat; these symptoms lessen as the days goes by and she felt better by day 3. On day 4 (3/13/2021), pt reported she felt like she had a bad cold which turned into bronchitis and that lasted for 2 weeks that was accompanied by symptoms of stuffy head, stuffed up sinus and drainage, had low grade fever, and coughed up phlegm). Pt reported that she have history of tinnitus and post-nasal drips, the ringing in her left ear and the post-nasal drip was still ongoing prior to rcvding the COVID vaccine and these symptoms seems to have been exacerbated after she got the vaccine because she felt like it has gotten worse. Pt reported that she took otc Mucinex and Claritin on the 5th or 6th day from rcvding the vaccine. She went to see her PCP and got a chest x-ray (results: negative for any infections). Pt also reported she got tested twice for COVID-19 on 3/17/2021 & 3/23/2021 (results on both dates: negative). Pt reported that her PCP had advised her against getting the second dose. Advised pt that per her ADEs these are not a contraindication to getting the 2nd dose per CDC guidelines and per consulted Dr. The decision to get the second dose is up to her and her PCP. Advised pt that there is not knowing if the 2nd dose will make her tinnitus worse or if she will experience any ADEs. Also advised per CDC guidelines, "if it is not feasible to adhere to the recommended interval, the second dose of BioNTech COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose. There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered beyond these intervals, there is no need to restart the series". 4/18-Patient feeling much better, symptoms have resolved with the exception of weakness and fatigue. Patient has taken Advil to help alleviate migraine. No longer has migraines. Caller called back to adv that she is still having tinnitus and post nasal drip from the 1st shot.
56 2021-04-22 ringing in ears Excessive tinnitus, ringing in ears since April 14.
56 2021-04-22 ringing in ears Horrible Ringing in Ears post the second dose
56 2021-04-23 pain in jaw TMJ problems jaw pain masseter muscular pain pain - all pain only on left side of face
56 2021-04-24 smell distorsion, taste disorder chills; vomiting/wanted to puke; extraordinarily tired and dizzy like she was getting flu symptoms; ... Read more
chills; vomiting/wanted to puke; extraordinarily tired and dizzy like she was getting flu symptoms; extraordinarily tired and dizzy like she was getting flu symptoms; extraordinarily tired and dizzy like she was getting flu symptoms; diarrhea; Nauseous; felt dehydrated; she normally drinks coffee and it smelled nasty and she felt like she was eating a nickel everything tasted funny; felt like she was eating a nickel everything tasted funny; Sore Left Arm/Arm Pain 10 minutes later; felt like she was stung by bee; felt like a little sting; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 01Apr2021 11:39 as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure (diagnosed 4 years ago), ongoing high cholesterol (diagnosed 4 years ago), and ongoing asthma (diagnosed 10 years ago; she doesn't get it very often and if she does uses her nebulizer). Concomitant medications included losartan potassium from 2017 and ongoing taken for high blood pressure; lovastatin from 2017 and ongoing; hydrochlorothiazide from 2017 to an unspecified date for high blood pressure. The patient previously received flu vaccine and experienced no adverse effect. The patient experienced sore left arm/arm pain 10 minutes later (01Apr2021 11:49); felt like she was stung by bee, husband had no side effects. The next 2 days she felt fine and took Tylenol for her arm then 04Apr2021 in the morning, she normally drinks coffee and it smelled nasty and she felt like she was eating a nickel everything tasted funny. The patient got the first dose of the vaccine on 01Apr2021 and felt like a little sting the first 3 days, which she thought was normal and didn't have to take Tylenol. On the 4th day, 04Apr2021, she started feeling chills, vomiting, couldn't hold down food, extraordinarily tired and dizzy like she was getting flu symptoms, wanted to puke, couldn't get out of bed, and diarrhea. Today (unspecified date) was the first day she was doing little things. She asked if this is normal and if it could happen 4 days later and how long it will last? She asked if she should take Imodium for the diarrhea? She stopped hydrochlorothiazide for now because she felt dehydrated (04Apr2021) and wanted to keep fluid in her body. Also reported as three to four days later she started feeling nauseous, dizzy, chills and very very tired. She tried to drink water but things were not staying in her. The patient was asking is this a side effect that will go away or has anyone else complained about this? Caller stated it was almost like she had the flu. She didn't want to get out of bed. Her concern was the vomiting and diarrhea. Treatment: Zofran 4mg works for a little bit for nausea; Imodium, Tylenol. The patient clarified she normally gets up early in the morning and then couldn't get up because she was so tired. She took something for her nausea and got to bed and then tries to get up at 11:00a.m. Then of course she had chills and has been running the heater in the house and its 90 degrees outside, but she has had no temperature. Her stomach and chills were concerning to her. The patient stated her mom passed away 09Feb2021 from kidney failure. The doctor started her on Zoloft 50mg once a day, but she only used it for 2 weeks in February because she didn't like way she felt. States it is an antidepressant, but she was put on it because her father passed away then her mom passed 2 months later. She was also prescribed Xanax but she didn't take them either because she didn't like feeling like that. She was started on Wixela for her asthma, 250mg inhale 2 puffs twice daily but she hadn't use. No additional vaccines administered on same date of the Pfizer Suspect. No emergency room or physician office visit. She had read a lot about it and reactions from the vaccine; she wanted to know how long does it last and does she need to see the doctor? She tries to stay away from the doctor office because of Covid until she gets fully vaccinated. No prior vaccinations (within 4 weeks). The outcome of events arm pain, chills, vomiting, tired, dizzy, diarrhea, and felt dehydrated was recovering, nauseous was not recovered, the other events was unknown. No follow-up attempts are needed; No further information is expected.
56 2021-04-24 taste disorder tightening sensation in throat air way restricting; tightening sensation in throat air way restricti... Read more
tightening sensation in throat air way restricting; tightening sensation in throat air way restricting; Taste in mouth followed by burning sensation throughout my body; Taste in mouth followed by burning sensation throughout my body; Turned red skin hot to touch; Turned red skin hot to touch; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (Brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Known allergies: Sulfa drugs. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. The patient previously received first dose of BNT162B2 on 23Mar2021 01:15 PM (Lot number: ER5732), in left arm, at the age of 56-year-old for COVID-19 immunization. 1st shot hot spot red swelling at injection area. 2nd shot severe instant adverse reaction. The patient experienced taste in mouth followed by burning sensation throughout her body. Turned red skin hot to touch. Immediately followed by tightening sensation in throat air way restricting on 13Apr2021 at 01:45 AM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment was received for the events which included Medics treated oxygen Dr administered Benadryl. The patient was recovering from the events.
56 2021-04-24 ringing in ears Ringing in my ears started shortly after and had not home away.
56 2021-04-24 ringing in ears Constant (permanent) ringing in the ear (I looked it up on the internet and it is known as Tinnitus)
56 2021-04-24 ringing in ears experiencing tinitus in right ear; no history of ear problems before the vaccine
56 2021-04-24 ringing in ears Ringing in ears- tinnitus
56 2021-04-24 visual impairment immediate crushing feeling on same forearm; hand numbness/numb feeling up back, neck; hand numbness ... Read more
immediate crushing feeling on same forearm; hand numbness/numb feeling up back, neck; hand numbness and tingling; headache; seeing orange spots; faint feeling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 56-years of age), dose 1 via an unspecified route of administration, administered in arm right on 26Mar2021 18:00 (Batch/Lot Number: EP7534) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date and unknown if ongoing. She had no covid prior to vaccination. She had not been tested post vaccination. Concomitant medications included calcium and cetirizine hydrochloride (ZYRTEC), and multivitamins, all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient had not taken any other vaccine in four weeks prior to covid-19 vaccine. On 26Mar2021 18:00, the patient experienced immediate crushing feeling on same forearm, hand numbness and tingling, numb feeling up back, neck and headache; she was seeing orange spot; and she had faint feeling. The patient did not receive any treatment for the events. The outcome of the events was recovered with sequel.
56 2021-04-25 loss of taste, loss of smell After receiving my first shot in my left arm, I started to lose my sense of smell and taste. I notic... Read more
After receiving my first shot in my left arm, I started to lose my sense of smell and taste. I noticed it four days after my first shot. I had a COVID test performed on 4/13/21, to make sure I didn't contract the virus, but was told I was negative on 4/15/21. I have taken my second shot on 4/24/21. As of today's date 4/26/21 I am still without my full sense of smell & taste.
56 2021-04-25 ear discomfort, ringing in ears, permanent deafness Sudden onset of bilateral aural fullness, tinnitus and hearing loss several hours after receiving he... Read more
Sudden onset of bilateral aural fullness, tinnitus and hearing loss several hours after receiving her first injection.
56 2021-04-25 lip swelling Approx 10 minutes after vaccination, pt felt transient diffuse itching that resolved after a 2 minut... Read more
Approx 10 minutes after vaccination, pt felt transient diffuse itching that resolved after a 2 minutes. No skin eruptions. After another 10 min, pts upper lip began to swell. VSS and airway remained intact. EMS activated. Pt given 50mg IM benadryl. EMS gave IV solumedrol during transport to ED. In ED given 20mg PO famotidine and observed for 2 additional hours. Discharged with Prednisone 40mg PO daily, PO Famotidine 40mg daily and diphenhydramine 25mg PRN.
56 2021-04-25 pain in jaw, eye pain Started with a fever at 6 pm on 04/202021! I had fever 3 days before it broke! My head, jaws, behind... Read more
Started with a fever at 6 pm on 04/202021! I had fever 3 days before it broke! My head, jaws, behind my eye pain(L)! All of these are continually goii in no! I get the later systems when I have a bad sinus infection! Lung congestion for 3-4 days and I used my safety inhaler and used breathing treatment x2. I have a history of asthma but I was good until I took the shot! All over body pain X3 days . Nausea x4 days ! I could not eat didn?t want to throw up!
56 2021-04-25 ringing in ears, deafness Significant hearing loss and tinnitus started evening of the injection and got worse over the next 2... Read more
Significant hearing loss and tinnitus started evening of the injection and got worse over the next 2 days.
56 2021-04-25 ringing in ears Ringing in my ears and a sharp headache began about 4 hours after vaccine. It is a high pitched, no... Read more
Ringing in my ears and a sharp headache began about 4 hours after vaccine. It is a high pitched, non-pulsatile ringing and hissing noise. The headache comes and goes throughout the day and evening and is of the sharp, stabbing variety along temples and at base of skull. I have never had ringing in my ears before this time so I know it is directly related to the vaccine. I had no other adverse effects except a mild headache the day after the vaccine.
56 2021-04-26 lip swelling Bumps on abdomen - 4/14/21. Hives on thigh, swollen upper lip - morning of 4/20/2021. Injection site... Read more
Bumps on abdomen - 4/14/21. Hives on thigh, swollen upper lip - morning of 4/20/2021. Injection site pain - right after vaccination, subsided next day. Covid-19 positive (PCR test verified), swollen lips, itchy hives on thighs half the size of a dime in clusters, bumps on abdomen (looks like little water blisters - burst and crust over; doesn't itch) - still occurring Per poison specialist - Wait 90 days to get 2nd dose. Contact PCP in regards to swollen lips, hives, and bumps. Can put hydrocortisone cream on to help with itching, but still consult with PCP. Inform PCP of Covid-19 positive test, will be best to remain in isolation and contact PCP over the phone first to limit the spread of Covid-19.
56 2021-04-26 mouth tingling, visual impairment, eye itchiness Prior to administering vaccine, nurse discussed anaphylactic reactions to mango and bee stings. Not... Read more
Prior to administering vaccine, nurse discussed anaphylactic reactions to mango and bee stings. Not a component in vaccine but will monitor for 30 minutes after. discussed risk vs benefit. Answered pt questions and administered vaccine. 11:23am pt reported to nurse tingling sensation around mouth and lump in back of throat. breathing WNL. Administered benadryl at 11:23am with consent of pt. Continued to monitor. 11:45am pulse 85, BP 168/98, respirations 16. Denies SOB. Pt feels sensation in back of neck going up to head. Tightness in throat and compares it to her previous anaphylactic reactions. Notices vision changes. 11:50am pulse 82, strong and steady, BP 158/90. respirations WNL. Discussed epinephrine with pt. pt agreed. administered 0.3 mg 11:52am, called EMS. Continued to monitor pt. 11:59am pulse 88, BP 160/100, respirations WNL denies SOB. Normal pallor. Responding appropriately. Pt stated feeling tired and wants to just close her eyes, "feeling my body react". Continues to complain of lump in throat, itchy eyes. 12:03pm discussed, consented and administered second dose of Epinephrine 0.3mg. EMS arrived, pt still responding appropriately. Pt left via stretcher to ER.
56 2021-04-26 ringing in ears Could not raise right arm. Symptoms began at 6pm the day of the injection and persisted until 10am t... Read more
Could not raise right arm. Symptoms began at 6pm the day of the injection and persisted until 10am the following morning. Tinnitus from first dose intensified a few days after the second dose and still persists.
56 2021-04-26 ringing in ears I developed tinnitus several days after the vaccine. I can't be sure how many days later because I i... Read more
I developed tinnitus several days after the vaccine. I can't be sure how many days later because I ignored it at first. It took me a while to realize it could be connected to the vaccine. Low level hissing is fairly constant and once in a while a high-pitched whine. I've never had tinnitus before. I'm going for my second COVID vaccine tomorrow.
56 2021-04-27 blindness in both eyes Notices loss of vision in right eye. . . everything is blurry about a week after first vaccine. O... Read more
Notices loss of vision in right eye. . . everything is blurry about a week after first vaccine. Other adverse events - 1st shot: Raging headache for 3 days and slight fatigue. Other adverse events - 2nd shot: Fever and chills for ~36 hours, moderate fatigue, raging headache for 2 days, achy joints (ankles and wrists) for first 24 hours, and vision right eye is worse. (Have scheduled appointment with eye doctor for evaluation)
56 2021-04-27 ear discomfort, ringing in ears Right ear echoing. When people talk it would vibrate. My ear also seemed clogged at first, but now a... Read more
Right ear echoing. When people talk it would vibrate. My ear also seemed clogged at first, but now after 7 days continues the same.
56 2021-04-27 eye swelling We received a call to the call center that the patient Right eye was swelling closed. Patient did n... Read more
We received a call to the call center that the patient Right eye was swelling closed. Patient did not speak with medical personnel and did not respond to phone call attempt. Patient was advised to seek assistance at the Emergency Room.
56 2021-04-27 lip swelling My throat felt sore and my lips were swollen. I took Benadryl all day and that seems to help. Went t... Read more
My throat felt sore and my lips were swollen. I took Benadryl all day and that seems to help. Went to see my doctor on Monday and he gave me Zyrtec. Back to normal in three days. I will not be getting the second shot
56 2021-04-27 swollen tongue Closed throat, swollen tongue, cough
56 2021-04-27 tongue itchiness Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Itching/tingling in fac... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Itching/tingling in facial area. The same happened during first dose.-Mild, Additional Details: Post vaccine, patient experienced itching in facial area/tongue. No difficulty breathing. Diphenhydramine 25 mg x1 given with patient's consent. She was observed for approximately 45 minutes post-vaccine, and was walked to her car after. She feels comfortable to drive home, as she lives 10 minutes away and was feeling better. She was counseled and given instructions for appropriate measures (911) if necessary.
56 2021-04-28 loss of smell, loss of taste 12/22/20 - Focal early cellulitis complicating Covid 19 immunization injection site reaction. 12/31... Read more
12/22/20 - Focal early cellulitis complicating Covid 19 immunization injection site reaction. 12/31/20 -Fever or Chills Fatigue Headache New loss of taste or smell 01/04/2021 ED - She has cough, shortness of breath with exertion, indigestion type chest pain, nausea, vomiting, and profuse diarrhea. There is also fevers and chills and body aches
56 2021-04-28 taste impairment Client complained of throat closing minutes after getting to observation tent. Then she c/o right si... Read more
Client complained of throat closing minutes after getting to observation tent. Then she c/o right side abdominal pain, "hot and tight." Then "weird taste in my mouth." I spoke with client and she seemed not clear and a little confused.
56 2021-04-28 ringing in ears shaking, muscle spasms, eyeball spasms, fatigue, tightness in thigh and arms, come and go rash on ba... Read more
shaking, muscle spasms, eyeball spasms, fatigue, tightness in thigh and arms, come and go rash on back of arm, headache, fuzzy-headed, ringing in ears that sometimes sounds like an ambulance siren, had menstrual cycle 1 week after shot and haven't had one in two years. intermittent chills, cold and sweat at same time, takes longer to find words, brain seems slower - something I've been doing for years I have to look up because I can't remember. severe shakes from waist up I think it's called convulsions but only once so far, chest tight and shallow breathing, forgetfulness
56 2021-04-29 dry throat Onset of sx started several hours after first Covid vaccine. Started with severe injection site pain... Read more
Onset of sx started several hours after first Covid vaccine. Started with severe injection site pain, diffuse pruritis, body aches, fever 101.7 axillary, chills/sweats, and severe HA. Took acetaminophe, alternated w ibubrofen every 4 hours overnight. Next AM woke w T 99.7 axillary, HA, weakness, severe body aches, fatigue, sore throat and dry throat. Injection site swollen to ~7 mm diam with bruised appearance, extremely tender, unable to lie on L side. Able to sip sports drink; warm, clear liquids (soup) without appetite. Continued w Ibuprofen HA formula. Sleep difficult due to chills/sweating. Also frequent cough, SOB with ADLs. Recd Dose #2 Pfiz 4/5/21 - s/sx worsened significantly and CONTINUE.
56 2021-04-29 ringing in ears I developed tinnitus. At first it was intermittent, but progressed into a very constant high pitche... Read more
I developed tinnitus. At first it was intermittent, but progressed into a very constant high pitched sound. It occurs in both ears and sometimes feels like buzzing at the back of my skull.
56 2021-04-30 eye discomfort, ear pain only on my left side I had: muscle and joint pain; only on my left side I had: muscle and joint pain... Read more
only on my left side I had: muscle and joint pain; only on my left side I had: muscle and joint pain; earache; goopy eye; headache; exhaustion; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration, administered in arm left on 13Jan2021 13:30 (at the time of 56-years-old) as single dose for covid-19 immunisation. Medical history included Von Willebrand's and history of lyme disease, allergies: Peanut and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received vitamin supplements within 2 weeks of vaccination. Concomitant medication included vitamin supplements. After first shot in left arm, only on my left side I had: muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered on Jan2021. The patient received treatment as epipen on hand. Therapeutic measures were taken as a result of events. The outcome of events was unknown.
56 2021-04-30 eye discomfort About 24 hours after my second COVID vaccine I was asleep and started having strange dreams. Woke my... Read more
About 24 hours after my second COVID vaccine I was asleep and started having strange dreams. Woke myself up several times talking in my sleep. I woke up to chills, fever, vertigo, muscle weakness and pain, shin sensitivity on back only. A lot of pan on vaccination site. Pressure behind my eyes, fatigue.
56 2021-05-03 ringing in ears Tinnitus; severe headache; Fever; arm pain; Fatigue; This is a spontaneous report from a contactable... Read more
Tinnitus; severe headache; Fever; arm pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 AM (at 56-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included known allergies: Sulfa drugs. No prior history of tinnitus or auditory disorder. No covid prior vaccination. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 AM (at 56-year-old) at single dose for COVID-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. On 10Apr2021 07:00 PM, the onset of symptoms began 10 hours after the second dose injection, including severe headache, fever, arm pain, fatigue, and tinnitus. All symptoms persisted intensely for 24 hours, then started to lift with the exception of headache and tinnitus. The headache resolved at about 48 hours. Tinnitus remains severe and consistent since the day of the shot. The events resulted in disability or permanent damage. No treatment was received for the events. The outcome of the events was not recovered. No Covid tested post vaccination.
56 2021-05-04 ear pain, pain in jaw Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spon... Read more
Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 27Mar2021 12:45 (Lot Number: EP6955) as single dose (at 56 years old) for COVID-19 immunisation. Medical history included none. Concomitant medications included atorvastatin, cetirizine hydrochloride (ZIRTEC), Forces of Nature Skin Tag. On 13Apr2021, the patient experienced Bell's Palsy (medically significant), headache, jaw ache, ear ache, numbness in face, assuming ear infection. Therapeutic measures were taken as a result of the events included Prednisone. The outcome of the events was recovering. The patient required a visit to the emergency room and diagnosed with Bell's Palsy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination.
56 2021-05-07 vision blurred faint; I start to see blurry; I start to sweat; nauseous; blood pressure was dropping; headache; fev... Read more
faint; I start to see blurry; I start to sweat; nauseous; blood pressure was dropping; headache; fever; chills; joint pain; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 56 years) for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]); fish oil (OMEGA 3 [FISH OIL]); zinc (ZINC); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient received the first dose of COMIRNATY on 30Mar2021, 11:00 in the left arm at the age of 56-years for covid-19 immunization. On 21Apr2021 at 19:00, when the patient stood up for 10 minutes she started to see blurry, start to sweat, felt nauseous and felt like going to faint, she had to sit or lie down immediately so she don't fall. Patient sweat cold as if her blood pressure was dropping, this was happening to her on the second day after the second dose, also headache, a little fever, chills and a little nausea, on the third day (at the time of the report) she got up and stood up for 10 minutes again the same thing happened to me, although I no longer have fever or joint pain only a slight headache. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on data given and temporal association, the event syncope is assessed as possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
56 2021-05-10 deafness unilateral Complete deafness in right ear; This is a spontaneous report from a contactable consumer (patient). ... Read more
Complete deafness in right ear; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: eng199), via an unspecified route of administration, in left arm on 24Mar2021 09:00 (at the age of 56-years-old) as single dose for COVID-19 immunization. Medical history included known allergy to penicillin. The patient received other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant at the time of vaccination. Patient received vaccine at the Pharmacy or Drug Store. The patient experienced complete deafness in right ear on 11Apr2021. Hearing loss was not regained with current aggressive medical care. The event resulted in physician or other healthcare professional office or clinic visit and considered as serious due to disability. Since the vaccination, patient has not been tested for COVID-19. The patient was treated with steroids, several other medications and oxygen. Outcome of the event was not resolved.
56 2021-05-10 ear discomfort she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; ... Read more
she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; her heart is beating fast and she is nervous.; burning sensation in her ear; tiredness; headache; heaviness on her back and chest on the left side; heaviness on her back and chest on the left side; no appetite; nauseous; diarrhea; throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh she could feel crushing and throbbing; her heart is beating fast and she is nervous.; sharp pain in her thigh/pinching sensation on inner thigh; sick; throbbing; muscle pain; weird sensation; throbbing sensation to the left side of her belly button/It was like at her stomach; fever of 100.3F; had a feeling of heat on her neck, face, and ears; redness and itchiness at the injection site; redness and itchiness at the injection site; the injection was large, red, hot, and itchy; the injection was large/ the swelling went down; dizzy; This is a spontaneous report from a contactable consumer reported herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included disability, obese, covid-19 when she was sick with COVID last year, she has never been that sick. she thinks she made it through because she owns a nebulizer and can say her lungs have never felt like they were full of fluid. If anything, they felt heavy. It was heavy in her back and chest. She also had a fever. She guesses she would be considered obese. Concomitant medications included paracetamol (TYLENOL). The patient received the first dose of the Pfizer COVID vaccine last week and she has experienced several side effects and is very anxious and nervous. She experienced redness and itchiness at the injection site, pinching sensation on inner thigh that she thinks may be blood clot or a muscle but not really sure, fever of 100.3F from 24Apr2021, burning sensation in her ear, tiredness, headache, heaviness on her back and chest on the left side, no appetite, nauseous, diarrhea, had a feeling of heat on her neck, face, and ears, throbbing sensation to the left side of her belly button from 26Apr2021 and she felt dizzy from 22Apr2021. The patient stated there was a bad connection and she was having difficulty hearing. The patient was a little nervous. Maybe this was a psychosomatic issue and she was thinking of things too much. She was sick for 5 weeks. She was never in the hospital or intubated. The site where she had the injection was large, red, hot, and itchy. It was from 22Apr2021 (Thursday) for the next maybe 3 days. Now the color is diminishing, the color is going down more like to pink and smaller and it not itching anymore. Once in a while she got a pinching sensation on her inner thigh ever since she had the injection. In the last couple days, she has been feeling a that a little more. She wanted to make sure it was not a symptom of a blood clot. She doesn't feel short of breath. She was nervous talking the call handler so that is why she is talking fast. She doesn't want to feel so sick like she did last year when she had it in March or April. She wanted to know that it's not a symptom of a blood clot. It was a throbbing pinching pain that goes and doesn't come back for a little bit, but it might come back a little bit later. It happened when she woke up. She has no swelling in her legs or thighs or anything else. She says she would not be talking this fast, but her heart was beating fast and she was nervous. She tended to be an anxious and nervous person. The patient never had blood clot issues. She wanted to make sure with everything that she has heard about Pfizer she hasn't heard of anyone having blood clot issues. She had to read to calm herself down a bit. It is a sharp pain with throbbing that comes and goes. She didn't read where it could be a blot clot, she just wanted to know. She is horrible at running to the hospital when she feels something because she gets so nervous and she thinks knowing is better because she's a realist. It takes her a minute to go to the hospital to figure it out. If she continues to feel like this she and her daughter will go to the emergency room. It is 5 blocks away. It is a small little hospital and they will be able to ease her mind. It could be her nerves getting to her too. Her fever got up to 100.3 and that was only on Saturday, 48 hours after the vaccine. Once she took Tylenol it was gone and didn't return again. She took her temperature; it was a beeping one. She always says she would take like 2 out of 3, and every time she took it went up. She felt a weird sensation of burning in her ears, the same as when she first had Covid, feeling like a fever. It brought her back to a bad place and it freaked her out. She is on disability and has people go to the store for her. She did that for 3 to 4 months. She is not agoraphobic, but she hadn't gone out until she got the vaccine. It took her all day to get back home because she loves the outdoors. It is kind of sad, and she knows she is not the only one who experienced that. She was able to actually stay at home, and when she went out, she wanted to stay. She still has her second dose to take, not everyone in has this and she doesn't want to feel that sick again. Eventually she will perish away one day, from God knows what but a slow death of not being able to breathe she cannot picture for herself or anybody else. She tries not to watch the news, it was depressing, because it is all over the news, she tries to stay in the loop. She was tired and had a headache. She took Tylenol and slept for an hour or hour and half. When she woke up she felt heaviness on her back and chest on the left side, and as she moved around more it was on her back and less on her chest. It was the same as she felt when she had Covid. She didn't have any aches or pains. The other thing was she had no appetite for the next 3 days. Every time she woke up, she felt extremely nauseous but had nothing to vomit. For the next 3 days or 72 hours, she had diarrhea. If she ate anything, she was in the bathroom. On 24Apr2021 (Saturday) after 48 hours she started to feel the heat in her neck and face and ears like right on her ears. She was talking to her daughter and her daughter said these are normal. Where she got the injection was itchy and a little more red. She told herself not to scratch it in her sleep, she is one of those people if something itches, she scratches. What she would do is rub her arm up and down on the site. It was almost the size of an 8 ounce tomato sauce can or maybe the size of a baseball. Then the third day it got redder. In her sleep she was rubbing her arm because it got itchy. Today the swelling went down, the color is like a light pink, and the size is also minimized. The fever lasted that night. She took her temperature again the next day and it was 97.9. That is usually what it is when she wakes up. She is not just tired; she is exhausted and feels like she has to go to sleep. Her daughter came with her granddaughter who is a baby, and she didn't know how to tell them. She was happy to see them but so exhausted. She worries about the sharp pain in her thigh. The other thing is she started getting pain in the middle of her thigh, her inner thigh. A sharp pain with like a throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh, she could feel crushing and throbbing. She can feel it from touching the area. She had this before like when she is stretching. It started maybe 3 months ago and went away but then after she took the injection and heard about thing, she worried about a blood clot with Johnson & Johnson, not that she would know because she has never had a blood clot. It could be psychosomatic and all working in her head. It started the last 2 days when she woke up, she felt fine and as she was lying in bed, she started feeling a sharp throbbing pain that eventually goes away. She has no swelling of her legs or thighs, and her daughter said it looks fine. She is semi-terrified of hearing bad news. It takes her longer to go to the hospital. If she starts feeling worse, she will be there in no time. She does not want to wait until it is worse, but she does not want to spook herself into going. She suffers from anxiety. She definitely had the fever not like she was just tired it was like she was exhausted. She got up early and would take a little nap because she was doing a bunch of stuff. That hasn't happened, but that's her. It will be 2300 when she goes to sleep. She was doing a bunch of stuff and felt like she just needed to take a nap. Maybe it is part of that too, but usually she doesn't feel tired like this. After her daughter left, she read something on her phone and passed out. When she woke up, she saw she actually dropped her phone. Her thigh is now not a pinch but more a little bit of a muscle pain. Now it is not like the inner thigh, it is more behind the thigh now, but not below the knee, right behind the thigh, closest to the knee but not on the knee. It is the same thing as if the middle had gone behind her thigh a bit. The little pillow on her chair is not helping anything either. It feels like it maybe muscular, its deep feeling. It feels like it could be muscle, if she rubs it, she can feel it. When asked has it improved persisted or worsened, caller states it is there, but it is dull. She can say there is pain, but it is a little duller just because it is more in the muscle. It is hard to explain, it was not the same throbbing pain but there is a dull pain, it goes around the chunkier part of her thigh, like the inner thigh. When she rubs it there is pain but a dull pain. When she rubs it, it feels better but she can still feel the site where it hurts. When she rubs it, it is still located right in the lower middle going toward her knee but not at the knee, maybe 3 to 4 inches away from the fold of her knee, almost at the center of her thigh almost. Almost like a dull muscle ache, there is a bit of throbbing with it. She will go to the doctor if something weird happens and will call back when they have an idea of what happened to her. This will sound crazy. The next thing she felt was a light throbbing where her belly button is but more to the left side, but not at the belly button. It was like at her stomach, not right at the belly button but right on the same line as her belly button but more at her waist. It was a small throbbing started today about an hour ago. She is hoping it is gas. Her fever went away pretty fast. She was on the phone and took her temperature to tell what it was. The woman said to take some Tylenol. It went from 99.9 to 100 to 100.3. She thought oh no. That was the highest she saw. Then eventually it started going down to 99.4, and then by morning it was back to normal. She only took Tylenol the one time. She is thinking maybe it is from being nervous and causing her body to heat up. She doesn't know she is just thinking. She thinks the fever went away the same day within an hour to 2 hours. She also wasn't drinking enough water. When asked if her fever has recovered completely or with last effects, caller states that is fine now, her temperature today was 99.4 without the fan on, she says she thinks that was pretty normal. When she first wakes up it is 97.9 usually. There was also a 98.4. The redness and itching at the injection site started 3 hours after the injection. She took her 2 sons with her. She took it and then her son took it. They said to wait 15 minutes. As soon as she stepped out, she looked up and felt so dizzy. It looks like when in summer and it seems to be boiling hot, that is how it got for her. Things got blurry. It was not like she was going to black out, but she had to close her eyes because the room was going to spin. She knocked back on the door and took a seat, so she sat down because she was not feeling right. When she gets nervous, she chews gum as a coping mechanism. Her son got some gum for her. She felt better but kind of nervous waiting for 15 minutes to go by, what if she felt dizzy again. She let 20 minutes go by and she got up and was fine. She wanted to be out of there and in the cool air outside. That is the first reaction that she had. She is one of those people that feel so nervous she is sure that happens that they feel like, oh they are so nervous, and they read so much, and it is in our faces everyday no matter what. Maybe it had nothing to do with the injection, maybe more that she was so nervous, but it was a weird sensation after. She knows when people first started getting the COVID vaccine, people were just like falling to the ground, she was like that would be terrible. She went with high expectations and was also nervous. Her heart was beating, and she could hear her own heartbeat. She still feels tired and like she can go take a nap now. She asks if that is normal. She would rather talk to Medical Information now. She is over this statistics part of it. She doesn't feel a release, she is just giving her information and she doesn't feel any better. Outcome of the event throbbing sensation to the left side of her belly button/It was like at her stomach was not recovered; of the event dizzy was recovered; of the events the injection was large, red, hot, and itchy/ the swelling went down, tiredness was recovering; of the other events was unknown. Information about lot/batch number has been requested.
56 2021-05-10 bloodshot eyes Patient had a subconjunctivial hemorrhage in her left eye that was noticed after receiving the vacci... Read more
Patient had a subconjunctivial hemorrhage in her left eye that was noticed after receiving the vaccine. There were not symptoms other than the redness in the left eye. It was not noticed before receiving the vaccine but was noticed right after.
56 2021-05-10 vision blurred anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache... Read more
anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache; blurred vision and nausea from headache; has been trapping food since in her throat; had irritation in her throat; coughing; coughing; off balance; couldn't see straight; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Left Arm on 18Mar2021 10:30 (at age of 56 years old) as single dose for COVID-19 immunisation. Relevant medical history included: Asthma, immune problems, upper respiratory stuff, all ongoing; Her Diagnosed allergies include iodine fish, Propofol, and preservatives, sleep apnea, had COVID in Jan2021, and had a cough (Jan2021) from that. There were no concomitant medications. The patient previously took iodine, propofol and had allergies. Patient took first dose on 18Mar for reason that patient has lost all allergies that cannot be detected by blood work. After first short she was told to wait an extra 15 mins not vitals taken she can leave a felt like a specimen unpaid but paying with life. Patient started coughing while everyone watched her so she said she better take Benadryl cause she doesn't wanna die. Patient left had off balance couldn't see straight. She was the one that had all side effects from vaccine as well as COVID signs. She had research medicine/food that cause her to have anaphylaxis. Patient found same ingredients in vaccine but food and drug said it ok. Patient was an experiment. She need to no from your board it is ok for me to take 2nd vaccine. Patient should be getting paid. Her doctor making it seem it up to her she gotta go out and get and epi pen she cant afford. In running out of gloves and mask. The patient experienced Anaphylaxis, has been trapping food since in her throat, headache with numbness, Cough, blurred vision and nausea from headache, all on 18Mar2021. Caller has been coordinating with the CDC by email. Since day one she had a bad reaction to the COVID vaccine. This has been going on a month now. The CDC advised her not to get the second shot. She has went back and forth with the doctor. She had anaphylaxis from the vaccine. Her throat closed. She had irritation in her throat. She has been trapping food since in her throat. This has been since the anaphylactic reaction. She has to chew her food as fine as possible. She tries not to eat that much. This is still the same. It hasn't improved or worsened. She has also had a headache with numbness that is pretty much 24 hours a day. This started right after. She really felt it the next day. She tried to take Tylenol for four days, three times a day, and nothing happened. It was not going away. Her doctor also put her on a migraine medication, but it didn't work either. The headache has worsened over time. No medication is helping, and the doctors are confused. The migraine medicine is not helping. Her pressure is going up and down. She is wondering if she needs an emergency echo to see what is going on. She is still having bad effects. No doctor knows what to do. She has been to a lung specialist. Her cough just keeps getting worse. The cough started to get worse after the vaccine. She had COVID in Jan2021, and had a cough from that, but the vaccine made it worse. It is a ruff cough. She is on cough suppressant medication. Caller did not have a prescribing doctor. She got it at the hospital. She figured that was the safest, and since she is a patient there they emailed her because she was eligible to get it. She is mostly calling because the doctors don't know how to help. She is about to pass out from this headache. She is even losing vision from the headache. She feels like she is going to have a heart attack before her time. They are trying to figure out why her head is hurting. They do not think it is a migraine. Her headache is a 9/11 or a 10/12. She feels like after the vaccine she has been chemically off balance. She wants to get her thyroid checked too. Mostly because her food is getting trapped in her throat. Her throat is irritated and hoarse. The headache has given her blurred vision, and a felling like she is going to throw up. She feels off balance from the blurred vision. Caller had difficulty seeing information on Tylenol and Nurtec. She asked her husband to help. They cannot read the lot on the Tylenol. She has been to so many specialists to try to find answers, and no one has a clue. She saw on Pfizer's paperwork that she needs to reach out to a immunologist. Her allergist had no clue. From the world trade centers falling she has ongoing issues from that. She has sleep apnea, allergies, asthma, etc. She spent 30 minutes being monitored at the hospital. She had started coughing. Her husband said she needed water. She always carries Benadryl with her. Finally she felt like she needed to take her Benadryl. It saved her. She knows the Benadryl probably won't work forever, but she cannot afford an epi Pen. Time of Onset (24 hours clock): right after vaccine (18Mar2021). All events require a visit to Physician Office. She didn't have to go the ER. She was lucky with the Benadryl. She takes Benadryl with her everywhere even to restaurants. No Prior Vaccinations (within 4 weeks). Treatment received for coughing, headache with numbness, blurred vision and nausea from headache. The outcome of the event has been trapping food since in her throat, had irritation in her throat, headache with numbness, blurred vision and nausea from headache was not recovered, for other events was unknown.
56 2021-05-13 mouth tingling Following 15 min observation period, patient reported tingling face and lips and throat closing. Pr... Read more
Following 15 min observation period, patient reported tingling face and lips and throat closing. Prior to vaccination, patient was nervous and reported anxiety regarding the vaccination. Vitals 6:39 p - BP 170/85, SpO2 95%, 71 bpm 6:50 p - BP 156/81, SpO2 96%, 78 bpm 6:55 p - BP 135/73, SpO2 96%, 80 bpm Patient reported tingling went away; left clinic with daughter who could drive.
56 2021-05-18 ringing in ears, ear pain, hearing loss left ear felt very sore; severe intestinal cramps; Severe diarrhea; mild hearing loss/partial hearin... Read more
left ear felt very sore; severe intestinal cramps; Severe diarrhea; mild hearing loss/partial hearing loss; fever; chills; headache; nausea; loss of appetite; Tinnitus/new tinnitus from the vaccine was much louder; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EP7533 and expiration date: 31Jul2021), via an unspecified route of administration, in arm right, on 30Mar2021 15:45 (at the age of 56-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included myopic degeneration/glaucoma, mild tinnitus in both ears since childhood. Patient was not diagnosed with COVID-19 prior to vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included brimonidine, timolol, latanoprost eye drops, and pramlintide. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6202 and expiration date not provided), via an unspecified route of administration, in arm right, on 09Mar2021 15:45 (at the age of 56-year-old), at single dose, for COVID-19 immunization. Other past drugs included ciprofloxacin (CIPRO), cefprozil (CEFZIL), sulfamethoxazole, trimethoprim (BACTRIM), azelastine nasal spray. The patient experienced tinnitus in left ear started about 30Mar2021 17:00 (reported as "1 hour after vaccination"), it was much louder on 31Mar2021 (reported as "the next morning") with mild hearing loss. Patient woke up in the morning with the fever and chills, and was accompanied by headache, nausea, loss of appetite. Patient had severe diarrhea on 03Apr2021, 04Apr2021, 05Apr2021, fever and severe intestinal cramps on 07Apr2021. All symptoms improved except for severe tinnitus in left ear. Sometimes it was so loud it feels like patient's whole brain was getting affected. Patient's blood vessel in left ear was pulsing too. Pulsing tinnitus. 5 weeks in from second COVID vaccine.Patient had a very loud tinnitus, ringing in the ear and the left ear felt very sore, it was like partial hearing loss, which lasted for few days. So, now the hearing came back and my hearing was normal. Patient visited Audiological/ENT on 14Apr2021 and had hearing tests, it was normal but patient had very loud tinnitus. Patient had a severe tinnitus. This new tinnitus from the vaccine was much louder with additional piercing hissing/whooshing sounds. Patient was still experiencing this discomfort, it is the same, this it is not getting better, it was very loudly.The adverse events result in doctor or other healthcare professional office/clinic visit. Patient stated she was finding that so many people those who have the same side effect (further clarification unknown), it was the tinnitus, the ringing in the ears and partial hearing loss either temporary or permanent and it is a pretty big side effect and its pretty much severe lasting many weeks and months. Patient had not been tested for COVID-19 Since the vaccination. The outcome of the event "tinnitus aggravated" was not recovered; of other events was recovering.
56 2021-05-18 visual impairment now she was losing vision in her left eye too; after first shot, I lost vision in my right eye overn... Read more
now she was losing vision in her left eye too; after first shot, I lost vision in my right eye overnight . . . eye doctor believes it is a cataract. After second shot, right eye became worse and now I am losing vision in my left eye too; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 05Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single (at 56 years of age) and via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) 2nd dose, single (at 57 years of age) for COVID-19 immunisation. The patient's medical history included melon and coconut allergy and hay fever. The patient's concomitant medications were not reported. The patient previously took Darvon [betahistine mesilate] and Darvocet [dextropropoxyphene napsilate;paracetamol] and experienced drug hypersensitivity on both. The patient was not pregnant. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 post vaccination. On 09Apr2021, after the after first shot, the patient had lost vision in her right eye overnight in which the eye doctor believed it was a cataract. After second shot, right eye became worse and now she was losing vision in her left eye too.The outcome of the events was not recovered. Therapeutic measures were taken as a result of the event. No follow-up attempts are needed. No further information is expected.
56 2021-05-19 loss of taste, taste impairment, loss of smell Unbearably metallic taste in the mouth interfering with taste/smell for ~1 week; better by day 8 but... Read more
Unbearably metallic taste in the mouth interfering with taste/smell for ~1 week; better by day 8 but still not completely gone.
56 2021-05-22 swollen tongue Patient received 1st dose Pfizer COVID19 vaccine @ 10:30 AM Around 7PM of the same day she developed... Read more
Patient received 1st dose Pfizer COVID19 vaccine @ 10:30 AM Around 7PM of the same day she developed irritation on the right side of her tongue followed one hour later by swelling of the right side of the tongue with change in voice and difficulty swallowing. Presented to the Emergency Department shortly after and symptoms resolved rapidly with administration of Tranexamic acid @ 0001 on 5/23/21. On the morning of 5/23/21 she had no further symptoms and there was no recurrent tongue edema.
56 2021-05-23 mouth numbness, loss of smell, taste disorder, mouth discomfort Tingling in face, then numbness sensation on lips, numbness sensation on tongueminutes after injecti... Read more
Tingling in face, then numbness sensation on lips, numbness sensation on tongueminutes after injection. Later sensation of palate and tongue having been burned by hot liquid or hot food. Slightly feeling of swollen throat. Altered sense of taste (example coffee did not taste the same as usual) slight loss of smell Feeling winded when breathing. Pain on let side of neck on Sunday. Still numbness and feeling burnt on Sunday
56 2021-05-23 lip swelling, eye swelling, lip swelling She got her vaccine, she told her about the medicine that she had anaphylaxis too, she asked if she ... Read more
She got her vaccine, she told her about the medicine that she had anaphylaxis too, she asked if she had any lip fillers. She waited the 15 minutes and then left, then started with a really bad headache and nausea, which she was fine before that. On the way home her husband wanted to stop and she said no as she was sick, made it home and started throwing up, very tired and went to bed which she never does but was extremely sick. Had fever of 100.1. She would go from sweating to fever, aches and pains, flu-like symptoms, everything hurt, pain in the arm, couldn't use her dominant arm but has lymphedema in the other arm due to having her breast removed due to cancer. Her lips were hurting her and never has chapped lips and had a lot of pain in them. Looked in the mirror on Friday as her lips were really hurting and found they were swollen and her eyes looked like somebody had punched her in them. She called her doctor and they did not return her call. She didn't feel it was anaphylaxis as she did not have any other symptoms. She put ice on her lips, had take a Zyrtec before the vaccine, but did use the Nasacort and couldn't figure out was going on. She had not used anything new on her lips or anything. Was thinking she had partial anaphylaxis. Went online and saw the reactions as they did not give her a list of them. She called her doctor and they told her to go to the ER. She still has some swelling and redness with pain, but not an emergency for her to go to the ER. Her lips are swollen, very tiny flat things in her mouth. Wants to know if she's OK to get 2nd vaccine as her PCP will not call her back.
56 2021-05-24 ringing in ears Received second dose of Pfizer vaccination on 5/10/21. On 5/11 had severe symptoms all day (cold, a... Read more
Received second dose of Pfizer vaccination on 5/10/21. On 5/11 had severe symptoms all day (cold, achy, chills, fatigue), all expected and manageable. Went to bed at 8PM on 5/11, awoke the next morning (5/12) with a distinct, loud ringing in my left ear. This has not gone away. My concern is that tinnitus is not curable, and this has been persistent without relief. I had to purchase a white noise machine to try to drown out the ringing. It doesn't help much. I saw my physician on 5/18, but there was nothing they could do. They are sending me to an Ear, Nose, and Throat specialist. Hopefully they will have an idea of how to help. This appt is on 6/3.
56 2021-05-25 mouth numbness Pt w/ history of severe allergy to "antibiotics and dyes". Pt c/o difficulty swallowing and numb ton... Read more
Pt w/ history of severe allergy to "antibiotics and dyes". Pt c/o difficulty swallowing and numb tongue. BP 138/97, HR 103 -- > 160/100, 81 -- > 140/90. Pt administered 50mg IM Benadryl 20mins post vaccination. Pt reports symptoms resolved w/ benadryl. Referred to PMD for 2nd dose. Pt stable and released from the vaccination site.
56 2021-05-25 mouth tingling, mouth numbness Within three minutes of getting the injection, I felt a surge, like adrenaline, going through my bod... Read more
Within three minutes of getting the injection, I felt a surge, like adrenaline, going through my body, then my heart started pounding rapidly. I also had shallow breathing, like panting. I drank water and it gradually subsided. As it subsided, I felt a tingling in the left corner of my mouth. It then went entirely numb. After ten minutes, my heartbeat went back to normal. Also, although I had urinated at 6:10 p.m., I had to urinate again at 6:30. This was not due to drinking the water, since I only drank about four ounces of water.
56 2021-05-25 swollen tongue Rash on face; Swollen Tongue; This is a spontaneous report from a contactable consumer, the patient.... Read more
Rash on face; Swollen Tongue; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162B2 (Pfizer BioNTech covid 19 vaccine) (Lot/batch no.: EN6206), first dose via unspecified route of administration on right arm for COVID-19 immunisation on 05Mar2021 at 18:00. Medical history included PSA and rheumatoid arthritis. The patient had not reported any allergies. Concomitant medication included Xjejanz (MANUFACTURER UNKNOWN) within 2 weeks for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination and had not tested positive for COVID-19 after vaccination. On 09Mar2021 patient had experienced rash on face and swollen tongue. Therapeutic measures were not taken for the events. The clinical outcome of the events of rash on face and swollen tongue was unresolved. No follow-up attempts are needed. No further information is expected.
56 2021-05-26 inability to speak Missed second dose of the Pfizer COVID vaccine; left arm swollen; face swollen and whelped up; can't... Read more
Missed second dose of the Pfizer COVID vaccine; left arm swollen; face swollen and whelped up; can't use her left arm like she used to; started losing her voice; asthma attack: coughing and wheezing, became short of breath; As per agent, caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness.; caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness.; As per agent, caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that the 56-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 17:00 (Batch/Lot Number: ER8731, Expiry Date: 11Apr2021) as 1st dose, single for covid-19 immunisation. Medical history included covid-19 from Nov2020 to Dec2020 (She says she got COVID around Thanksgiving. She says she is not sure when she recovered but that it was within 2 weeks. She says it was somewhere in the first or second week of DEC2020), ongoing asthma when she was 28 she thinks, ongoing chronic obstructive pulmonary disease (COPD, She says she is not sure when this condition started because they are off and on with it. She says they started treating her 3 or 4 years ago for it.), ongoing high blood pressure (She says they started treating her about 2 maybe 3 years ago for this condition.), ongoing hypersensitivity: allergic to penicillin, sulfa, aspirin, iodine, CAT scan dye, roaches, tree pollen, grass pollen, cat and dog dander, roach droppings, everything, dust mites since in her 30's: for about 20 some years, ongoing arthritis condition since about 5 or 10 years ago. Concomitant medications included fluticasone (FLUTICASONE) nasal spray at 50 mcg, 2 squirts in each nostril once a day for allergies for over 10 years; meloxicam oral at 7.5 mg as needed (2 tablets by mouth every with meals)(She says she doesn't have to take it every day); omeprazole at 40 mg every day for acid reflux for over 10 years; sertraline at 100 mg, 2x/day for depression (When asked how long she has been taking this she says it hasn't even been a year yet; about 6 or 9 months.); furosemide oral at 40 mg, 1x/day for over 20 years for buildup of fluids; azelastine nasal spray via Nasal at 1x/day (spray in nose once day in each nostril) for allergies; montelukast sodium Singulair at 10 mg, 1x/day for asthma and allergies for over 20 years; amlodipine at 5 mg, 1x/day for high blood pressure 2, maybe 3 years ago; potassium at 20 meq, daily to put the potassium back in that the water pill takes out for over 20 years, Trellogy for about 2 years she thinks and all ongoing. The patient experienced asthma attack: coughing and wheezing, became short of breath (medically significant) on 08Apr2021 with outcome of recovered on 13Apr2021 , as per agent, caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness on 08Apr2021 with outcome of recovered, left arm swollen on 09Apr2021 with outcome of unknown , started losing her voice on 08Apr2021 with outcome of recovered on 13Apr2021, face swollen and whelped up on 09Apr2021 with outcome of not recovered , can't use her left arm like she used to on 08Apr2021 with outcome of not recovered , missed second dose of the pfizer covid vaccine on 29Apr2021 with outcome of unknown. The outcome of the event itchy was recovered on 14Apr2021. The outcome of the event wrist started hurting was recovered on 08Apr201. The outcome of the event shoulder started hurting was not recovered. The clinical course was reported as follows: the consumer developed a severe allergic reaction after the first dose of the pfizer covid vaccine. As per agent, caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness. advised by hcp not to get 2nd dose what can she can do get fully covered. She says she wish she had know this back when she had the shot. She says on 08APR2021 she had the first shot and had a severe allergic reaction to it. The consumer says she had a severe allergic reaction. She elaborates and says her shoulder started hurting and it went down to her wrist, then all of the sudden she was itchy, she started losing her voice like her voice is doing right now, and she ended up having an asthma attack, the next day her arm swelled up, and her face swelled up and whelped up. For her shoulder she says she can't really do hardly anything with that arm. She says she means her left arm and that she is left handed. She says if she puts too much weight on it is sore. For the itchiness she says that lasted for over a week but on Tuesday she went to her primary care provider and they gave her a prednisone shot which helped a whole lot. She says her breathing went back to normal and her voice came back. The consumer does not know the dosage of the prednisone; she says it was Solu-Medrol and that's all she knows about it. She says quietly that she went to the doctor on 13Apr2021. The consumer says she forgot to say that she was coughing and wheezing too. She confirms that this was a part of the asthma attack and that she also became short of breath. She says all of that was on 08APR2021. She says the issues she is having with her voice right now is from something else. No further information provided. The consumer clarifies that when she lost her voice on the 08Apr2021, that ended 13Apr2021 and she recovered completely from that. She says her left arm is sore but not swollen. She says the swelling lasted for over a month. She is not sure the exact day it ended and says the only effect is she can't use her arm like she used to. For the face swollen and whelped up she says it goes down, the welts go away, and they come back in the morning. She confirms it is ongoing and persisting. She says the shoulder started hurting right after the shot which was at about 4:00pm or 5:00pm. She says the wrist started hurting about 5 minutes after the shoulder did. She says the itchiness occurred about 5 or 10 minutes after the shot. She says that everything occurred between 4:00pm and 5:00pm within 5 to 10 minutes after the shot. She confirms that by everything she means everything that occurred on 08Apr2021. She says she noticed her left arm was swollen, the next day in the afternoon and that her face was swollen and whelped up the next day, in the morning. The consumer says that 08APR2021 was her first dose and that she hasn't had the second shot. She says she was supposed to go back on the 29Apr2021 to take the second shot but didn't get it. The caller says her doctor told her not to get it. She asks does she need to get the second shot and what can she do to get fully covered. She says she takes just the normal medicine that she always takes. Vaccination Facility Type: The Pipkin Building. She says it was a pop-up station. No Vaccine administered at Military Facility. She says the military was there. Additional Vaccines administered on same date of the Pfizer suspect was none. AEs require a visit to not emergency Room but Physician Office and She says she went to the doctor because she thought she was having an allergic reaction to the COVID shot. She confirms she went to the doctor on 13Apr2021. Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)) was none. AE(s) following prior vaccinations: She says no, not to vaccines. No further information provided.The caller denies being sick at the time of vaccination. Family Medical History relevant to AE(s) was none. She says she is the sickest person. Relevant Test was none.
56 2021-05-27 mouth numbness Patient developed lip and mouth numbness and itchy throat within minutes of receiving Pfizer vaccine... Read more
Patient developed lip and mouth numbness and itchy throat within minutes of receiving Pfizer vaccine. She was treated with Benadryl. She was monitored for about 1.5 hours and symptoms gradually resolved.
56 2021-05-30 deafness, ringing in ears Severe Tinnitus
56 2021-05-30 taste impairment I noticed a new persistent bitter / metallic taste on my tongue that would not go away; I also have ... Read more
I noticed a new persistent bitter / metallic taste on my tongue that would not go away; I also have experienced, for the first time, nerve tingling in my feet (especially toes, but sometimes heels as well). The symptoms were so strong, I took a covid test to confirm I hadn't somehow come down with covid at the time of vaccination, but my test was negative. I also had a blood sugar test done to confirm it wasn't diabetes, but my fasting blood sugar level was in the normal range (95).
56 2021-05-30 swollen tongue Subjective tongue swelling, started 30 minutes later, lasted a few hours. Recurred iwth second dose.
56 2021-05-31 loss of taste, loss of smell The patient received the Pfizer COVID-19 vaccine on 3/10/21 and 4/5/21. They tested positive for COV... Read more
The patient received the Pfizer COVID-19 vaccine on 3/10/21 and 4/5/21. They tested positive for COVID-19 via the SOFIA antigen COVID-19 test on 5/29/21. The patient was exhibiting the following symptoms at the time of testing: fatigue, loss of taste and smell, headache, and body aches.
56 2021-05-31 swelling around the eyes Since 1 week after my first Pfizer Covid19 vaccine, I have had dark circles under my eyes, swelling ... Read more
Since 1 week after my first Pfizer Covid19 vaccine, I have had dark circles under my eyes, swelling under my eyes and swollen glands in my neck (beneath both ears)
56 2021-06-01 tongue discomfort, tongue disorder hives like on side of my neck and under my chin/ hives down my throat and left side of my face; I go... Read more
hives like on side of my neck and under my chin/ hives down my throat and left side of my face; I got blisters and burning sensation on my tongue; I got blisters and burning sensation on my tongue; redness; It's just little bumps; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 30Apr2021 at 23:30 (at the age of 56-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included thyroid condition. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EW0151) on 08Apr2021. Seven hours after dose 2 of the vaccine (01May2021), the patient experienced hives like on side of her neck and under her chin. She put water on it and it went away. Around 12 midnight that night she started to get the hives down her throat and left side of her face. She got blisters and burning sensation on her tongue. She did not know what to do. The patient received treatment with diphenhydramine (BENADRYL). The hives went down and redness went away but she still had a little bit of hives. Her tongue still had bumps and like a burning sensation. The hives were still there but it was not red or itchy. It was just little bumps. Her tongue was still burning. It felt like when you drank something really hot and burned your tongue. She guessed she was allergic to it. The outcome of redness was recovered. The outcomes of hives and tongue still had bumps and burning sensation were not recovered. The outcome of blisters on tongue was unknown. No follow-up attempts are needed. No further information is expected.
56 2021-06-01 vision blurred, deafness, loss of smell, loss of taste Loss of taste smell hearing and blurred vision about 10% after second injection. Increase in Psorias... Read more
Loss of taste smell hearing and blurred vision about 10% after second injection. Increase in Psoriasis all over my entire body! Gout !Everywhere. I felt horrible for three weeks, no energy unable to eat or sleep. My bones still ache in May 2021. I did not tell anyone for fear they would not get vaccinated.
56 2021-06-02 eye irritation 30 minutes after receiving the shot I became dizzy, head hurt, burning eyes, fatigue and nauseous. T... Read more
30 minutes after receiving the shot I became dizzy, head hurt, burning eyes, fatigue and nauseous. The second day to present day, all the symptoms from first day plus a stomachache. Over the course of the next week, all symptoms continued then chest pains and a high resting pulse began. Eight days after the shot I went to the emergency room for chest pains and all the symptoms from above. I followed up with primary care three days after ER visit and was told of a possible pancreatitis. My gastroenterologist does not have time in his schedule to see me anytime soon. I?m in the process of trying to get an appointment with a gastroenterologist. If symptoms worsen I will go back to emergency room. I?m waiting to be accepted by a office for treatment.
56 2021-06-02 ringing in ears 4/14/21 - 1st CoVid shot 11:30 a.m.- arm pain over the next 2 days, few days later noticed a ringing... Read more
4/14/21 - 1st CoVid shot 11:30 a.m.- arm pain over the next 2 days, few days later noticed a ringing in my ears that didn't go away. Not certain exactly when it started as it wasn't very loud and other sounds would mask it. 5/12/21 - 2nd CoVid shot 11:00 a.m.- arm pain, felt like my equilibrium was off that afternoon (a little dizzy, etc), constant ringing in the ears became louder. Next day after the shot had arm pain, fairly bad headache, light nausea, low fever 100.2 in the morning but was gone later in the day. (Felt like a really bad hangover) Took a few days to feel normal, however the constant ringing in the ears has not subsided as of this writing (6/3/21) and can be quite annoying.
56 2021-06-03 mouth tingling, swollen tongue, lip swelling Severe rash all over my body; Swelling and tingling of tongue and lips; Swelling and tingling of ton... Read more
Severe rash all over my body; Swelling and tingling of tongue and lips; Swelling and tingling of tongue and lips; Swelling and tingling of tongue and lips; slight heart beat increase; have a big bump on my left arm that is warm to the touch; have a big bump on my left arm that is warm to the touch; This is a spontaneous report from a contactable other health care professional reporting for herself. A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 27Feb2021 13:30 as single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, essential tremor and patient reported she had too many allergies to list. The patient had COVID prior to vaccination. Concomitant medication included chromic chloride, cinnamomum spp., gymnema sylvestre, thioctic acid (DIABETES). The patient did not receive any other vaccine in four weeks. Patient tested COVID post vaccination. On 27Jan2021 13:45 the patient experienced and reported that, "severe rash all over my body, swelling and tingling of tongue and lips, slight heartbeat increase, I still have a big bump on my left arm that was warm to the touch". Therapeutic measures taken as result of adverse events: treatment included Benadryl and Motrin. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab test) negative on 31Jan2021. The outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.
56 2021-06-05 ear pain 1. Swollen lymph nodes--axillary, left upper chest, arm. Also left side of face--cheek, jaw, throa... Read more
1. Swollen lymph nodes--axillary, left upper chest, arm. Also left side of face--cheek, jaw, throat (tonsil). This began within half and hour of vaccination and lasted about 3-4 days. Also happened similarly on second dose (4-16-21, same location). 2. Left upper arm pain. Still ongoing at this time (June 6, 21). Mild to moderate. Occasionally up into neck to behind ear. Difficult to lift left arm from straight out (away from body) further up. Was not affected by second dose.
56 2021-06-07 loss of smell, loss of taste This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (no... Read more
This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 56-year-old) at single dose for COVID-19 immunization. No other vaccine received in four weeks. Medical history included hypertension, thyroid disorder, prior to vaccination, patient was diagnosed with COVID-19. No known allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); azilsartan medoxomil, chlortalidone (EDARBYCLOR); nebivolol hydrochloride (BYSTOLIC); cetirizine hydrochloride (ZYRTEC) and antibodies. The patient experienced fever 104.2 fahrenheit for 3 days, sore arm 10 days, hot arm, bones hurt. Loss taste and smell for 10 days (30% better). Pulse ox dropped down to 92 and shortness of breath 3 days. Because she had Covid and was in a long haulers study, patient still had antibodies 11 months post Covid and when she took the 1 vaccine. It was like her body knew this and it rallied. She could not get out of bed for 24 hours. Symptoms began 12 post vaccine on 16Apr2021 at 02:30 AM. She had antibodies drawn 4 weeks after 1 dose and was at the highest limit. The patient also underwent lab tests which included sars-cov-2 test: negative on an unspecified date. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events fever and shortness of breath was recovered on 19Apr2021 for 3 days; sore arm was recovered on 26Apr2021 for 10 days; could not get out of bed was recovered on 17Apr2021 02:30 for 24 hours; outcome of the other events was recovering. This report was reported as non-serious by reporter, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
56 2021-06-09 ringing in ears I had to get a white noise machine to try to drown out the sound in order to sleep; Next morning on ... Read more
I had to get a white noise machine to try to drown out the sound in order to sleep; Next morning on 12May2021, woke up with severe ringing in my left ear.; On 11May2021 I had the typical reactions, cold, achy, chills, fatigue.; On 11May2021 I had the typical reactions, cold, achy, chills, fatigue.; On 11May2021 I had the typical reactions, cold, achy, chills, fatigue.; On 11May2021 I had the typical reactions, cold, achy, chills, fatigue.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 56-years-old via an unspecified route of administration, administered in arm left on 10May2021 13:30 (Batch/Lot Number: EW0168) as 2nd dose, single dose for covid-19 immunisation. The patient received that vaccine in a Public Health Clinic/(Name) Administration facility. Medical history included none. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included atorvastatin calcium taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and ibuprofin. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 56-years-old, administered in arm left on 19Apr2021 18:00 (lot number: ER8735) for covid-19 immunisation. The patient reported that on 11May2021, she had the typical reactions, cold, achy, chills, fatigue. She went to bed at 8PM that night and the next morning on 12May2021, woke up with severe ringing in her left ear. This has been debilitating, she had to get a white noise machine to try to drown out the sound in order to sleep. She was hoping this would go away after awhile (which is why she waited to report), but it has not diminished. She saw her doctor on 18May2021, but they weren't able to help. They referred her to an Ear, Nose, and Throat Specialist. Her appointment is on 03Jun2021, so she was hoping they will find something. Her concern is that tinnitus is not curable, and she don't think she can stand this ringing for the rest of her life, as she is only 56 years old. The adverse event required doctor or other healthcare professional office/clinic visit. The patient did not recover from the events. Follow-up attempts are needed. Further information is expected.
56 2021-06-10 ear pain Head spinning; Body ache/Intense body ache; Aching or having such an intense ache that even her thum... Read more
Head spinning; Body ache/Intense body ache; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Felt horrible; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Temperature of 101/Had a temperature of 101; She just feels like the remnants of how you feel after you have a headache ; did not want to move; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 03Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04Jun2021 the patient experienced head spinning , body ache/intense body ache, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, felt horrible, thumbs and ears on the inside were aching, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, Temperature of 101/Had a temperature of 101. Also, At 5:00 am this morning, she took 325 mg Aspirin (treatment) and is feeling so much better now. She just feels like the remnants of how you feel after you have a headache ; did not want to move. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The outcome of event was recovering. Follow up attempts are needed. Further information has been requested.
56 2021-06-10 lacrimation increased Runny nose; Runny eyes; Sore arm; Nauseated; I couldn't make a fist with my hand. I couldn't close m... Read more
Runny nose; Runny eyes; Sore arm; Nauseated; I couldn't make a fist with my hand. I couldn't close my hand; Had left side numbness and tingling from my fingertips down to my toes; little tingling and stuff today in my legs and on the bottom of my feet; Had left side numbness and tingling from my fingertips down to my toes; little tingling and stuff today in my legs and on the bottom of my feet; Every day I was experiencing that, like my skin was burning, like I was on fire and my skin was burning all over; My blood pressure went up it was elevated a little bit in the ER on Friday. When I got to Urgent Care, my bottom number was like 102 when I checked it here at home, it was like 105 bottom number; Felt like something popped in my head like air or something like that; This is a spontaneous report from a contactable consumer (reporting on herself). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: EW0179 and Expiration Date was not reported), via intramuscular route of administration in Arm Left on 27May2021, as 1st dose, single dose for COVID-19 immunization; hydrochlorothiazide (HYDROCHLOROTHIAZIDE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 12.5 mg, 1x/day (12.5 mg, one tablet every day ) for blood pressure measurement. Medical history included hyper-sensitivity from an unknown date and unknown if ongoing , blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity, start and stop date were not reported. It was reported that patinet had received the Pfizer Vaccine on 27May2021 and had some side effects and her PCP had told her to call you guys to report it and what she had went through and see what advice you give me as far as getting the second dose scheduled on 16Jun2021. she guess you all don't send out like a confirmation or nothing like that she mean to say will something be emailed to me or nothing she won't hear anything else from you guys now that Pfizer will call back with other questions. Patient just saying do she get an email or anything on confirmation that she just called in or anything or she will need anything like that. Patient stated that well, her blood pressure went up and so it was elevated a little bit in the Emergency Room on Friday. But when she got to the Urgent Care, her bottom number was like 102 and when she checked it here at home, it was like 105, the bottom number. So the doctor at Urgent Care, she prescribed me some blood pressure medicine (Hydrochlorothiazide) and so she started on that (Hydrochlorothiazide) on Wednesday and her blood pressure went down but it's still like going up and down, up and down but the most part it is down. Like she said today she had some of the tingling in her leg and then the bot-tom of her feet but not all over like it was before the burning sensation like her skin and stuff. Yeah, also they tried the morning when she was lying in there, when she was, you know, experiencing all of this, all of this on left side, it felt like something popped in her head like air or some-thing like that, she cant, really can't just describe it. she mean it just felt like something popped in the inside of her head, like air or something like air or something like air, its hard to describe. But like she said they did a CT on my brain and all of that stuff and they ruled out stroke and heart at-tack and they ruled out blood clot at the Urgent Care. The outcome of the events was unknown. Follow up needed, further information has been requested.
57 2021-01-02 mouth tingling Patient received vaccine and was fine through her 15 minute observation period. She left the clinic ... Read more
Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.
57 2021-01-03 taste disorder right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headach... Read more
right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headache. I also had a chlorine taste in my mouth. I told the nurse I wasn't feeling well. she sat with me and was asking about how I was feeling. I the started trying to clear my throat. it felt like I had something in my throat. I kept trying to swallow and it just felt like my throat was getting tighter and tighter. that's when they got me on a stretcher and took me to the ER
57 2021-01-03 visual impairment, eye pain, eye irritation, lacrimation increased, sensitivity to light, vision blurred Took covid shot Thursday 12/17. On Friday 12/18 had avastin shot to right eye. That afternoon had EX... Read more
Took covid shot Thursday 12/17. On Friday 12/18 had avastin shot to right eye. That afternoon had EXTREME inflammation, irritation, tearing, pain and light sensitivity. Vision became "whited out". Saw Dr. sunday 12/20, received two antibiotic shot and steroid shot all to right eye. Prescribed Levaquin po and antibiotic and steroid eye drops. Followed up with retinologist again today 1/4/21, symptoms fairly resolved but vision is still blurry. Hoping to completely regain my sight.
57 2021-01-04 taste impairment metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs... Read more
metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
57 2021-01-04 ear pain I had most of side effects described. My ears hurt, like inside, but the most that bothers me today ... Read more
I had most of side effects described. My ears hurt, like inside, but the most that bothers me today is that my heart feels like its beating and racing fast, sometimes feels like its pounding. Very uncomfortable, my chest feels.
57 2021-01-04 eye itchiness, bloodshot eyes allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and i... Read more
allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and itch; Chills; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Lot: EH9899), via an unspecified route of administration on deltoid right on 22Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure high, hypothyroidism, and environmental allergies. Concomitant medications included amlodipine besilate (NORVASC) at 10 mg, daily for blood pressure high, and levothyroxine sodium (TIROSINT) at 112 mcg (ug) for hypothyroidism. Patient got Covid Vaccine on Tuesday (22Dec2020) night and was fine on Wednesday (23Dec2020). She expected the normal side effects like maybe a little fever like that but she believed she was having allergic reactions. It started from 24Dec2020 and she got a rash on all her chest and in abdomen and also just like itchiness feeling all over. So she took some diphenhydramine hydrochloride (BENADRYL) and a PPI 'a cup of' them on 24Dec2020 and she thought that she only had to do that one's today (25Dec2020) and the only thing she noticed when she got the shot (Covid Vaccine) they kept her there for like 15 minutes and her eyes got red and itch. She didn't scratch them but they felt like itchy and she never had that before. She never had a problem with the vaccine before. She didn't know if that was the true allergic reaction to the vaccines or if it just something she had internal allergies and she just didn't know what it was. But she was okay at the time of the report. She took some diphenhydramine hydrochloride a little while before and a PPI (unspecified medication). She was still itchy but it was not that bad and she seemed to be doing fine. Her arm was fine. She was not having any (unspecified), except sometimes. 24Dec2020 she had chills which she expected and she was all good but the side effects whatever happened that way was not the allergic portion. She tried to contact the doctor. The doctor just switched his clinic only for geriatric patients. She had to find another doctor. She knew a Doctor whom she could try and call and she actually went to the infectious disease physician and he said she should go to get the vaccine, now she was trying with that too. She got allergic to anything. Covid Shot was the only thing new that she had in her life but like she was not sure if it was triggered by something out like (unspecified) because she had always environmental allergies too. She didn't know because she was going to consult the Physician on Monday. She was just going to see the regular doctor. She was just seeing that first that anything because she knew it didn't happen very often but the Covid vaccine she just wanted to make report. She was going to the Physician on Monday because right now she thought she didn't know how long it lasted like. Outcome of the events was unknown.
57 2021-01-04 smell distorsion, taste disorder cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebr... Read more
cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebrile; chills; intense headache; nasal congestion; malaise; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EKS730, expiration date: unknown), via an unspecified route of administration on the left arm on 18Dec2020 at 13:00 at a single dose for COVID-19 immunization administered at the workplace clinic. Relevant medical history included hypertension (HTN), hypothyroidism, high cholesterol, and COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included levothyroxine, amlodipine, and pravastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain on 19Dec2020 at 12:00. The events were assessed as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered with sequelae/lasting effects from the events "feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain" on an unspecified date.
57 2021-01-04 sensitivity to light Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diar... Read more
Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diarrhea, nausea, vomiting and headache that became worse over time and on day os presentation to our hospital on 1/2/2021 she was having photophobia. Current headache at time of admission had been persistent for over a week. Patient has no immunocompromising risk factors and was diagnosed with confirmed CMV meningitis. She was also admitted with transaminitis.
57 2021-01-04 ringing in ears Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swel... Read more
Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry ("like a big dose of steroids"). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling "hungover/groggy/nauseated". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.
57 2021-01-05 taste impairment Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at les... Read more
Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect); Intermittent dizziness after an hour; H/A after an hour; that diminished over the next 12 hours but slightly lingered; Metallic taste in the mouth after an hour; Nausea after 8 hours (diminished by the next morning); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on the left arm on 29Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included Hashimoto. Concomitant medication included omeprazole, rosuvastatin calcium (CRESTOR), levothyroxine, magnesium and ascorbic acid, retinol, tocopherol (OCUVITE). The patient previously took zinc and experienced allergies. On 29Dec2020, the patient experienced intermittent dizziness after an hour, metallic taste in the mouth after an hour, H/A (headache) after an hour (that diminished over the next 12 hours but slightly lingered) and feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect), and nausea after 8 hours (diminished by the next morning). No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovered with sequel.
57 2021-01-05 ear pain 10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes wh... Read more
10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes which lasted until the next day; This is Spontaneous report from a contactable Other-HCP (patient). A 57-years-old female patient (No pregnant) received first dose bnt162b2 (BNT162B2, lot: EL1284), via an unspecified route of administration on 30Dec2020 17:00 at single dose on Right arm for covid-19 immunisation. Medical history was none. Concomitant medication included celecoxib (CELEBREX), black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]) and multivitamins. The patient previously took erythromycin and experienced drug hypersensitivity. The patient experienced Headache within 5 minutes (30Dec2020 17:05) which lasted until the next day, then about 10 hours later (31Dec2020 03:00) severe pain in the tragus of both ears which woke her up. It felt like someone was grabbing them with pliers. Still recurs mildly from time to time. No treatment received. The events were reported as non-serious.
57 2021-01-05 eye pain Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left ey... Read more
Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
57 2021-01-05 lip swelling Described started "itching 30 minutes after shot administered. That night she noticed a "rash all ov... Read more
Described started "itching 30 minutes after shot administered. That night she noticed a "rash all over her body, no problems breathing". The next day she experienced "swollen lips and tingling and itching from head to toe". She reports she is taking Pepcid and Benadryl. She also reports " no problems with breathing".
57 2021-01-05 bloodshot eyes Pfizer-BioNTech COVID-19 Vaccine EUA Approximately, 1 hr after receiving COVID-19 vaccine, noted ge... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately, 1 hr after receiving COVID-19 vaccine, noted general pruritus without rash, mild scleral injection. No other systemic symptoms. Pt treated with Benadryl 25mg x1. Symptoms resolved within 30-45 minutes.
57 2021-01-05 mouth tingling 10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, dev... Read more
10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, developed nausea. 1 hour and 45 minutes after vaccine, developed laryngitis. Sent to ED for evaluation and treatment. Received Solumedrol and Pepsid in ED with improvement. Discharged home by or before 8pm with resolution of laryngitis and other symptoms. Reports "feeling great" this a.m.
57 2021-01-05 swollen tongue Patient c/o tongue swelling minutes after vaccine. Also c/o itchy throat. No shortness of breath. gi... Read more
Patient c/o tongue swelling minutes after vaccine. Also c/o itchy throat. No shortness of breath. given IM Benadryl and symptoms resolved. Previous similar reaction to crab.
57 2021-01-06 loss of smell, loss of taste I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever w... Read more
I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever which progressed to a head cold and further progression to full Upper Respiratory infection, viral in nature. 168 hours later, lost sense of taste and smell and had some GI discomfort.
57 2021-01-06 oropharyngeal discomfort WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WI... Read more
WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.
57 2021-01-07 lip swelling, mouth tingling Patient experienced lower lip swelling and tingling. Patient given 12.5 mg of Benadryl and monitore... Read more
Patient experienced lower lip swelling and tingling. Patient given 12.5 mg of Benadryl and monitored for 30 minutes. Symptoms resolved.
57 2021-01-07 pain in jaw Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: R... Read more
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: Recommended that she seek emergent care
57 2021-01-07 mouth tingling Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. ... Read more
Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. in clinic for pt. assessment. Pt. uneasy/anxious with increased facial flushing to face and some mild swelling to lips. Pt. with tingling sensation to right side of body. Benadryl 100mg IM administered immediatly per Dr.'s order. Epi-Pen also available if needed. Pt. with improved redness to face and lips after administration.
57 2021-01-07 mouth tingling Mouth and lips tingling
57 2021-01-08 deafness, ringing in ears I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, ... Read more
I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, fever up to 100, severe fatigue, went home after work and slept til the next morning, went to work, took ibuprofen, and the myalgias improved and felt better. But around 3 pm, Jan 6, I got mild vertigo. By about 7pm Jan 6, I noticed my L ear didn't hear well. I changed the battery in my hearing aide and cleaned it but It made no difference. I woke up on Jan 7 with severe vertigo and hearing loss. I did Epley's maneuvers with no effect. I have had similar episodes. I went to work, but gave up when I could not hear patients talking to me. I went to the Emergency Dept and got admitted. I was too unsteady on my feet. Audiogram showed profound hearing loss both ears and almost complete loss of discrmination in R ear. I was put on high dose steroids. Also having tinnitus (mostly whooshing sound of my own pulse). MRI negative. Blood work negative. Some mild improvement now, after 1 dose steroids.
57 2021-01-08 mouth tingling 2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all... Read more
2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all right side of face became numb.Was sent for evaluation by employer to hospital.dx with adverse reaction.bells palsy I was given Decadron IM and medrol dose pack.
57 2021-01-08 ringing in ears Ringing in ears
57 2021-01-10 vision blurred experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elev... Read more
experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
57 2021-01-10 vision blurred injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, l... Read more
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during 3 days
57 2021-01-11 loss of smell, loss of taste Loss of taste/smell, sore throat, chills. Positive swab for Covid 12/29/20
57 2021-01-11 double vision DOUBLE VISION STARTED 24HR FOLLOWING VACCINE
57 2021-01-11 mouth tingling pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling a... Read more
pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling around lips, pt was calm sitting on chair
57 2021-01-11 swollen tongue Symptoms: About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine, Patient went to... Read more
Symptoms: About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine, Patient went to ER with complaints of sensation of ?foreign body? in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Treatment: Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition.
57 2021-01-11 taste disorder STRANGE TASTE IN MOUTH RIGHT AFTER INJECTION
57 2021-01-12 dry eye Bell's palsy HISTORY OF PRESENT ILLNESS Patient is a 57 y.o. female with a history of glaucoma, pre... Read more
Bell's palsy HISTORY OF PRESENT ILLNESS Patient is a 57 y.o. female with a history of glaucoma, pre-diabetes, and osteoporosis s/p recent fibular fracture who presents for facial weakness. Patient is a research MD in the neurology department. Patient reports that she woke up this morning with weakness of the right face and inability to close the right eye. She reports mild discomfort in the area of her right jaw, but no ear pain. Denies any change in hearing or taste. She denies any difficulty chewing or swallowing, but has noticed that water will come out the side of her mouth when she tries to drink. She reports mild dry eye on the right. No history of similar symptoms. Today is day 18 after her first COVID vaccination. No recent URI symptoms. No unilateral numbness or weakness. No autoimmune history.
57 2021-01-12 vision blurred 1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red ... Read more
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms, blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to be all systemic.
57 2021-01-13 loss of smell, loss of taste COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID v... Read more
COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EJ1685, expiration date: 31Mar2021), intramuscularly on 20Dec2020 17:43 at left deltoid, at single dose for vaccination. Medical history included asthma and diabetes. There were no concomitant medications. The patient received the first dose of vaccine on 20Dec2020. On 22Dec2020 she was exposed to Covid, on 28Dec2020 developed symptoms of cough, chills, lost of taste and smell, she had onset of COVID virus symptoms on 28Dec2020 with positive COVID result from COVID nasal swab test performed on 29Dec2020. She has already completed her Bamlanivimab infusion therapy to treat COVID virus on 31Dec2020. Her 2nd dose is due on 10Jan2020 and she wanted information on the use of antibody therapy with the Covid-19 vaccine. She asked if she should still get the second dose of Pfizer-BioNTech COVID-19 Vaccine as scheduled on 10Jan2021 relative to these events. She reported she still has COVID symptoms which have improved, but the symptoms she can't taste or smell are ongoing and persistent. Seriousness criteria: she thought it was serious but she was not injured or anything with it; she thought event was offset it by taking some medication and the Bamlanivimab infusion. In addition to Bamlanivimab infusion for treatment of the COVID virus she was also prescribed Azithromycin for 5 days started on 29Dec2020 which she completed; and Prednisone for 7 days started on 29Dec2020 which she stopped after 5 days of therapy because she did not like how it made her feel. The outcome of the event was recovering. Event relatedness between Pfizer-BioNTech COVID-19 Vaccine and COVID virus was unrelated.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
57 2021-01-13 taste impairment throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Wa... Read more
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
57 2021-01-13 eye disorder, light flashes or floaters in the eye Pfizer-BioNTech COVID-19 At about 7:30 pm, approx 7-8 hour post injection, I had some jaw tightness ... Read more
Pfizer-BioNTech COVID-19 At about 7:30 pm, approx 7-8 hour post injection, I had some jaw tightness and began to see flashing lights out of the left side of my left eye. They were still present when I awoke at 5:30-6:00 am on Tuesday.
57 2021-01-13 eye irritation Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; Th... Read more
Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 06Jan2021 16:45 at a single dose on right arm for COVID-19 immunization. Medical history included, lactose intolerance. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.), probiotics (PROBIOTICS), clarithromycin (MACROBID [CLARITHROMYCIN]), ibuprofen (MOTRIN [IBUPROFEN]), paracetamol (TYLENOL). The patient previously took Parafon Forte and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730) on 17Dec2020 17:15 at a single dose on left arm for COVID-19 immunization. The patient experienced aches, chills, menstrual like cramps, fatigue, eye burning, and low grade temp on 07Jan2021 15:00. The outcome of the events was recovering. The events were assessed as non-serious. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
57 2021-01-13 eye swelling, mouth tingling, lip swelling THE PATIENT RECEIVED THEIR 2ND DOSE AND WAS OBSERVED FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. IT W... Read more
THE PATIENT RECEIVED THEIR 2ND DOSE AND WAS OBSERVED FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. IT WASN'T UNTIL THE PATIENT WAS HOME, ABOUT 11 HOURS POST VACCINATION, THAT THEY REPORTED SWELLING & ITCHINESS AT THE INJECTION SITE, SWOLLEN, TINGLY LIPS AND SWELLING UNDER THE EYES. THE PATIENT REPORTED TAKING BENADRYL, WHICH EFFECTIVELY RESOLVED THE REPORTED SIGNS & SYMPTOMS.
57 2021-01-13 mouth tingling tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; g... Read more
tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; given water& crackers - lightheadedness subsided but states is itching all over; offered to call 911 - refused. stated is going to primary care physician. total observation 45 min
57 2021-01-13 tunnel vision Upon arising at 7AM I had tunnel vision. Just a little headache that morning. By 1:30pm I was chilli... Read more
Upon arising at 7AM I had tunnel vision. Just a little headache that morning. By 1:30pm I was chilling and could not get warm. Fever reached 101 degrees. I took 2 Tylenol every 4 hours. While I had a fever, I could not seem to drink enough water. I consumed about 90 ounces of water from 2pm til 9pm. The fever and chills became less prevalent by 9pm. Continued the Tylenol through 7AM the morning of 1/12/21. My chills were gone and I had no fever by then.
57 2021-01-14 taste impairment, tongue disorder 20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth... Read more
20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth, feeling of thick tongue, tingling from the neck to the top of her head. Took 25 mg Benadryl while in her car. No swelling and no respiratory distress. After 30 minutes, she didn't feel worse so she drove home (50 minute drive). Her symptoms resolved around 9pm (about 1 hour, 20 minutes after taking Benadryl).
57 2021-01-14 lacrimation increased Dizziness, Body ache Teary eyes pain to right arm Headache
57 2021-01-15 bloodshot eyes, visual impairment On 12/22/2020 the day of vaccination in the evening around 6:30pm when I was driving I started havin... Read more
On 12/22/2020 the day of vaccination in the evening around 6:30pm when I was driving I started having visual disturbances. The next morning 12/23/2020 I woke up with a bloody eye it was my right eye it lasted one day. On the following Monday on 12/28/2020 I was not feeling good I started getting headaches, feeling aching, at night I started getting fevers, congestion, & fatigue. It went away on 1/1/2020. Seen doctor on 12/29/2020
57 2021-01-15 visual impairment Debilitating dizziness and vision impairment
57 2021-01-16 eye pain, mouth tingling I had the same reaction with the first dose on 12/27/20, and it resolved, I received the 2nd dose to... Read more
I had the same reaction with the first dose on 12/27/20, and it resolved, I received the 2nd dose today and about 40 minutes after dose I had some tingling in lips, and then left sided facial pain, along cheek behind eye. hurts to smile and use that side of face. have taken a Benadryl I haven't read about this as a side effect. With the first dose this did resolved after 24 hours
57 2021-01-17 dry eye, drooping eyelid Vertigo, eye drooping, tenderness to head, pressure in head, inflammation of the head, neck and shou... Read more
Vertigo, eye drooping, tenderness to head, pressure in head, inflammation of the head, neck and shoulders. Has been to PCP x 3. Scheduled for MRI 01/23/2021
57 2021-01-17 mouth pain sore mouth and tongue was stiff and extreme fatigue feels tired even a week later
57 2021-01-18 oropharyngeal discomfort Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. W... Read more
Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. Was treated with a single dose of Dexamethasone 10 mg IV. Symptoms resolved and patient was sent home.
57 2021-01-21 loss of taste, sensitivity to light, eye pain, loss of smell received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/... Read more
received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/tested positive for COVID-19; irritable all day; the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on.; eyes were also hurting; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the vaccine on 04Jan2021 and yesterday (11Jan2021) she tested positive for COVID-19. Patient would like to know if she should follow-up for the second dose of the vaccine on 25Jan2021. Patient mentioned that maybe she should follow up with the second dose. It was also reported that the patient wanted to know if the vaccine could have given her COVID-19 and tested positive. Patient further clarified it to be the Pfizer BioNTech COVID-19 Vaccine. Patient mentioned she is a caregiver and received the vaccine on last Monday (04Jan2021). On Friday (08Jan2021), the patient started to notice she was getting headaches. The headache started in the morning. Patient realized she was irritable all day and as a caregiver, this is not an attitude to have. Patient did not feel great that day. Patient also realized that the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on. That night patient got home and was able to eat, but the next day on Saturday (09Jan2021), she did not have any sense of taste or smell. Patient had lost her sense of taste and smell. Patient realized this when she woke up at 6 am for coffee and could not taste or smell it. Patient was calling to find out if there was any way one could get Coronavirus only after the first shot and if she still needs to go and get her follow-up vaccine on 25Jan2021. Patient stated she forgot the name of her HCP. Patient also mentioned she has chest pressure. Patient noticed it about an hour ago, later stated it was like 11 something. It comes and goes. Patient mentioned that it was like shortness of breath. Patient would breathe in a little bit and it will bring the chest pressure back down. Patient would also walk around a bit to get the blood pumping back through. Patient also added, that due to these symptoms, she's locked off in a different room away from her husband. Patient stated they are both quarantining since her husband was exposed too and has not had the shot yet. Patient's eyes were also hurting, but that is due to the headache. Patient also stated that her eyes hurting has gone away. Patient will be getting to get a Coronovirus test done later today. When probed for the time of vaccination, patient that she was not sure. She knew she had to wait 30 minutes under observation because she had allergies. Patient initially stated that she would guess she received the vaccine thirty minutes prior to 3:55. Patient later clarified and stated it was possibly 2 something when she got it. Patient tested positive for COVID-19 on 11Jan2021 (COVID-19 virus test positive). Outcome of the event 'eyes were also hurting' was recovered, while unknown for the remaining events.
57 2021-01-21 dry throat Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irri... Read more
Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irritation while in waiting area. Monitor personnel promptly identified patient?s condition and notified the team while staying with the patient ensuring she kept talking while the provider arrived. Officer in Charge was notified during the process and was at patient?s side approximately 0756; provider followed within seconds. Decision was made for immediate transport to ED. While in route patient stopped talking, coughed and grabbed throat prompting CPT to deliver x1 dose of Epinephrine to left deltoid at 0758 with provider?s consent. Shortly after dose administration patient resumed speech but continued to complain of dry and tight throat. Patient was able to continued speaking reciting ABCs and personal information when prompted. Patient did not experience altered mental status or loss of consciousness. Arrived to Emergency Department (ED) at 0805; report given to nurse and patient was checked in promptly. ED provider plan included observation until 1100 and discharge pending follow up assessment.
57 2021-01-21 ear pain 1/14/21 9pm chills 1/15/21 8am chills, muscle aches, headache, nausea, fatigue, rigors low grade fe... Read more
1/14/21 9pm chills 1/15/21 8am chills, muscle aches, headache, nausea, fatigue, rigors low grade fever. 2 pm temp 100.8, bilateral ear drum pain 1/16/21 8 am fatigue. 1/17/21 2am woke up with chills nausea and ear pain. 1/17 in morning fatigue . 1/18/21 asymptomatic.
57 2021-01-21 ringing in ears Received vaccine at 13:45 on 1/19. Awoke around 04:00 on 1/20 with loud ringing/buzzing in ears. The... Read more
Received vaccine at 13:45 on 1/19. Awoke around 04:00 on 1/20 with loud ringing/buzzing in ears. The intensity continued until approximately 07:00 1/21. I still have low buzzing sound/ tinnitus. I had the day off work but probably could not have worked (as a pharmacist) if I hadn?t. I returned to work on 1/21 though. I have a hearing test on 1/28.
57 2021-01-24 mouth numbness, mouth tingling Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right ... Read more
Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right entire side from the back of my head, face and down to my right foot, which included my back scapular region and both right extremities; sore tender lymph nodes under right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. Concomitant medication included levothyroxine. The patient previously took essential oils and experienced known allergies. The patient experienced tingling and numb tongue and lips, loss of sensation to her right entire side from the back of her head, face and down to her right foot, which included her back scapular region and both right extremities. Also, sore tender lymph nodes under right arm. All events started from 08Jan2021. This has been going on for 4 days as of 12Jan2021. No other vaccine in four weeks. Covid test done post vaccination: nasal swab on 12Jan2021, pending result. The outcome of the events was unknown. Information about lot/batch number has been requested.
57 2021-01-24 eye discomfort Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contacta... Read more
Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf. A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm on 30Dec2020 10:30 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Since 03Jan2021, the patient has been sick. Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away. Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00 The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit; 101.2 Fahrenheit then up 102.7 Fahrenheit ; 101.5 Fahrenheit. Sars-cov-2 test: positive on 11Jan2021 . Further information has been requested
57 2021-01-25 ear itchiness Numbness & tingling hands & feet, throat itching, b/l ear itching
57 2021-01-25 mouth tingling Pt states her hands were turning red at which time RN was called to assess. Bilateral hands were red... Read more
Pt states her hands were turning red at which time RN was called to assess. Bilateral hands were red and blotchy. She states she feels the need to frequently clear throat but is not short of breath. She states her lips feel tingly. No angioedema noted, redness is not spreading from palms of hands. No redness or rashes noted at injection site. Pt was given 50mg of diphenhydramine prior to leaving. She waited in lobby with staff observation for another 15 minutes, Redness in hands was resolved. Educated pt to call emergency services should symptoms persist or worsen. Pt verbalizes understanding. This RN will call later today and tomorrow to follow up with pt.
57 2021-01-25 mouth tingling Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning starte... Read more
Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning started having difficultly swallowing, went to ER-1-6-21 On 1-7-21 started itching from all over, blood pressure was 262/106, went back to ER
57 2021-01-25 swollen tongue Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaint... Read more
Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Intermittent episodes of acute sharp back pain; This is a spontaneous report from a contactable pharmacist reported that a 57-year-old female patient (no pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1284 and Expiration Date unknown) via Intramuscularly on 30Dec2020 03:00 PM (Left arm) at single dose for covid-19 immunisation. Medical history includes mild asthma, B-Cell Thymoma (Resected), multiple allergies. Diagnosed allergies included Sulfa drugs-swelling; Celebrex-Itchy; Clindamycin- Unknown reaction; Doxycycline- Sick to stomach; Iodinated radiocontrast dyes- Iodinated radiocontrast dyes cause generalized swelling (takes diphenhydramine prior to contrast use when needed); Keflex- Rash; TDAP Vaccine; Levofloxacin- Unknown Reaction; Penicillin; Prednisolone- Itchy; Septra- Eyes get glossy and lips swell.The concomitant medication was not reported. There is no other vaccines within 4 weeks prior to the COVID vaccine. About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine (30Dec2020 30Dec2020 08:00 PM), Patient went to Emergency room (ER) with complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition. The outcome of event was recovered on an unknow date without treatment. There is no covid tested post vaccination.
57 2021-01-26 drooping eyelid Pt reported to POD for vaccine very anxious and concerned about her allergies to Nsaids, Morphine an... Read more
Pt reported to POD for vaccine very anxious and concerned about her allergies to Nsaids, Morphine and pnc. she reports that her they cause HA and facial swelling. Pt received vaccine at 1405 and went to 30 min observation area. at 1420 this provider was contacted by the patient and she reported that feeling numbness and drooping to the right eye lid. The patient was then brought for eval by this provider and EMT. The patient continued her observation until 1510 and at that time she reported that she was back to normal and continued to be without HA.
57 2021-01-27 light flashes or floaters in the eye seeing flashing lights out of the left side of the left eye; This is a spontaneous report from a con... Read more
seeing flashing lights out of the left side of the left eye; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the left arm on 11Jan2021 12:30 at single dose for COVID-19 immunization at a hospital. The patient has allergies whisk laundry detergent and mosquitoes. There were no concomitant medications. Patient previously took tetracycline, metronidazole (METROGEL) and experienced allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 21Dec2020 12:30, at the left arm. Approximately 7-8 hour post vaccination, patient started seeing flashing lights out of the left side of her left eye on 11Jan2021 19:30. No treatment for the event. The patient has not recovered from the event.
57 2021-01-28 eye bleeding fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar... Read more
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-01-29 mouth tingling Patient with tongue tingling 10 minutes after vaccine. No other symptoms, vitals and exam normal.
57 2021-01-30 vision blurred, eye twitching Paresthesia from the neck down, labored resp., weakness, poor coordination, blurred vision, slurred ... Read more
Paresthesia from the neck down, labored resp., weakness, poor coordination, blurred vision, slurred speech, rapid eye lid movement, uncontrolled leg moment. Given IV solumedrol, Ativan, and po Benadryl
57 2021-01-31 ear discomfort Minor shock like feeling, which happens sporadically, behind right ear.
57 2021-01-31 lip itchiness I had the vaccine 3 days ago, and this morning my arm got really red snd hot around the injection si... Read more
I had the vaccine 3 days ago, and this morning my arm got really red snd hot around the injection site. About an hour later, my lips and throat starting itching a little bit,
57 2021-01-31 mouth tingling, ear pain, loss of taste Headache over right forehead started 1/28/21 for 24 then sudden runny nose on right nostril, then lo... Read more
Headache over right forehead started 1/28/21 for 24 then sudden runny nose on right nostril, then loss of taste in right side of tongue started 24 hours later and the other symptoms improved. Mild pain over right cheek and into ear have remained over the past 72 hours along with the loss of taste and funny feeling on right 1/2 of tongue. No facial muscle weakness noted. No change in hearing or vision.
57 2021-01-31 swollen tongue had rash on left hand after shot in 10 minutes (same arm having vaccine) then was given one tablet ... Read more
had rash on left hand after shot in 10 minutes (same arm having vaccine) then was given one tablet of zyrtac after ~15 to 20 minutes, having swelling tongue after ~10 to 15 minutes, took one dose of benadryl ~1 to 2 hour, all symptoms go away
57 2021-01-31 ringing in ears, ear discomfort Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lum... Read more
Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lump in my throat , almost 2 hours after vaccination ears ringing and lump in throat. I took 2 Benadryl and in about hour the lump feeling was not as bad, lump feeling subsided. I had muscle joint pain the next 4 days and stayed on Benadryl those days until throat and ears felt better. On day 5 my left arm started stinging and broke out in hives , some on torso but mainly vaccinated left arm. I went to primary care to talk to her about my reactions on day -7 . She documented in my records but told me to report through Vsafe app. I did. I do not want to take 2nd dose after having this happened and no one able to tell me the 2nd wont be worse,
57 2021-02-01 eye twitching Twitching of L eye since 1/13/21
57 2021-02-01 taste disorder Nausea, mild on the day of the vaccine. Five days after the vaccination I felt nausea again, a stran... Read more
Nausea, mild on the day of the vaccine. Five days after the vaccination I felt nausea again, a strange taste in my mouth, and a headache. resembling the senses with the injection of prolia.
57 2021-02-02 ear pain Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the f... Read more
Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the following symptoms: injection site pain, fatigue, headache, muscle pain, chills, fever (ranging from 100.3 to 101.7) nausea, swollen lymph nodes Jan 29 achy, chills, headache, injection site pain, swollen lymph nodes, trouble falling asleep Jan 30 - headache, throat hurt, achy, slight sniffles, got a cold sore, ear pain, trouble falling asleep Jan 31 - ear pain, headache, slight aches, trouble falling asleep Feb 1 - feeling better, some ear pain, trouble falling asleep
57 2021-02-02 swelling around the eyes, eye pain My left eye hurts and feels like it's twitching. It is also getting puffy and once in a while a shar... Read more
My left eye hurts and feels like it's twitching. It is also getting puffy and once in a while a sharp pain shoots through my eye. Thanks.
57 2021-02-03 loss of taste, loss of smell she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 w... Read more
she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 with the symptoms she has now; was feeling bad; she lost her taste and her smell; she lost her taste and her smell; tired; sleeping all the time; she is sick; She still hasn't eaten a whole meal since Friday; not able to eat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL0142, exp date not reported), intramuscular (by injection once left arm, below shoulder blade in muscle) on 13Jan2021 for COVID-19 immunization (because of job). Medical history included two stroked from 1998 and 2005. Concomitant medication included oral donepezil started taking 3 months ago (Oct2020) for something having to do with muscles because of stroke. She takes a blood thinner, as she had 2 strokes; and takes muscle relaxers too. By 15Jan2021 (Friday morning) the patient was feeling bad, she couldn't go to work, she lost her taste and her smell, part of smell. Part of taste was back at the time of reporting, but she was tired and sleeping all the time (onset date reported as 15Jan2021). She saw her neurologist because she had 2 strokes, they referred her to Pfizer, as they said she may have already had COVID 19 with the symptoms she has, but as far as she knows, she didn't have it, she took a test with the center a month before giving the vaccine, she took the vaccine because of her job, because of the kind of job she has, and they wanted her to let Pfizer know she was sick. She doesn't know if she wanted to get the other dose, as she was not feeling well at all. She was laying down sleeping every day. Her doctor said to tell Pfizer what was going on. She still doesn't feel good the day of reporting. She still hasn't eaten a whole meal since 15Jan2021. She thinks she was probably getting better, but was getting better slowly, she has no taste, she was not able to eat, no smell at all, which was really not a good thing. She can't tell the outcome of no smell she thinks. She can't smell nothing at all. She can't smell what she was cooking. It was the same as taste, she thought that is probably why she can't eat, she can't taste what she was eating. Taste was improved, but not well enough for her, it is hard to explain, you know how you enjoy food, like how it tastes, and if you can't taste, you can't eat. She sleeps all day, she was up now, but is probably going to go to sleep, she feels tired and needs to lay down. She told her doctor she will call and see what Pfizer says, they will go from there. She doesn't know if she will have to go see if she has COVID 19, or what was going on. No further investigation assessment was performed. The patient took a test a month before (results unknown). No taste was recovering (ongoing at the time of reporting) while outcome of other events was not recovered.
57 2021-02-03 loss of smell, loss of taste I had the 1st vaccine on 1/26/21 and on 2/2/21 I woke up that morning and could not smell or taste a... Read more
I had the 1st vaccine on 1/26/21 and on 2/2/21 I woke up that morning and could not smell or taste anything. I went and got tested, both rapid and PCR, and both came back negative. I have no other symptoms at all. Within 32 hours, my taste and smell have returned.
57 2021-02-03 dry throat Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 pos... Read more
Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 post vaccination. Treatment: Tylenol, Outcome: no improvement does not interfere with ADLs.
57 2021-02-03 swollen tongue Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130... Read more
Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130 am 6 hours later at 6:30 pm ate packaged veggie dumplings and 15 min later my tongue swelled and my face felt swollen and itchy. Took Benadryl 25mg, Allegra 180mg and Pepcid 20mg with relief. 6 hours later, awoke with itchy throat and face and took Benadryl 25mg with relief. Next morning, 2/1/2021: 8 am ate my regular breakfast of peanut butter on toast and 15 minutes later my face started itching. Took Allegra 180mg with relief. 11:30 ate pretzels and face started itching `15 minutes later. Everything I ate that day caused me to itch 15 min afterwards just like when I would have food reactions when first diagnosed with Alpha Gal and my IGE histamine levels with 3x normal. I increased my Allegra 180mg to 3x a day for 24 hours and Pepcid 20mg to 2x a day for 24 hours. 48hours after vaccine I was able to decrease Allegra 180mg to 2x a day with Pepcid 20mg to 2x a day and was able to eat bland food without itching afterwards. My allergist felt the 2nd vaccine may have caused an inflammatory response and flared up my alpha gal symptoms.
57 2021-02-04 permanent deafness Sudden sensorineural hearing loss, left ear.
57 2021-02-05 loss of taste, loss of smell Sore throat, body ache, 99 temp highest, lost of taste and smell. Was coughing sneezing and are sti... Read more
Sore throat, body ache, 99 temp highest, lost of taste and smell. Was coughing sneezing and are still coughing. I tested positive on the 25 January.
57 2021-02-06 swollen tongue, lip swelling, mouth tingling C/O Tingling, swelling in tongue & lips states had same reaction with 1st dose. Denies Chest Pain, S... Read more
C/O Tingling, swelling in tongue & lips states had same reaction with 1st dose. Denies Chest Pain, SOB 2 tablets Benadryl 25mg given. Monitored X 20 min ER precautions given. Understood was D/C
57 2021-02-07 dry throat My throat became dry and irritated, white or nude colored bumps appeared on back of throat and palat... Read more
My throat became dry and irritated, white or nude colored bumps appeared on back of throat and palate. Eventually became sore after the 2nd vaccine Lot # EL1284 on 1/23/21 worsened and throat became red under the bumps. To date bumps and redness remain. Soreness comes on and off, lasts hours improves then returns. Also headaches daily since initial vaccine. I saw PMD am currently on Amoxicillin 875 and it is not helping at all.
57 2021-02-07 mouth numbness Pt reports chest tightness, tongue numbness, normal EKG. Pt recovered
57 2021-02-07 oral mucosal blistering Chills Blisters in mouth Fever
57 2021-02-07 pain in jaw, mouth tingling Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, w... Read more
Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, was pounding, became jittery, felt pressure in my left jaw, couldn't catch my breath with mask on. I lifted my mask to be able to get air as I attempted to check my pulse rate, but it was too fast to count. I quickly took my coat off. I sat back down and was going to get help, but noticed my heart rate decreasing, jittering decreasing, and was able to breath with mask on. Pulse was down to 80 bpm. The skin on my face and neck felt like they were burning. The tip of my tongue felt tingly. All subsided until next day, felt fluish, temp 101.5.
57 2021-02-07 mouth tingling several minutes after vaccine dose patient reported funny sensation in her tongue
57 2021-02-07 mouth tingling complained of lips tingling; observed additional 15 minutes; still had some tingling in lips but no ... Read more
complained of lips tingling; observed additional 15 minutes; still had some tingling in lips but no other reactions.
57 2021-02-08 swollen tongue, mouth tingling Post second COVID vaccination, started feeling a tingling sensation in her mouth and felt light-hea... Read more
Post second COVID vaccination, started feeling a tingling sensation in her mouth and felt light-headed. Reports that the first vaccine caused some "slight flushing". She was laid flat on a cot. VSS. Reported that her tongue was starting to swell. Rapid Response code was called and she was transported to the ED.
57 2021-02-09 mouth tingling, tongue disorder 1452 feeling "thick tongue" flushed tingling lips BP 187/101 HR 94 Benadryl 50mg po provided 1456 BP... Read more
1452 feeling "thick tongue" flushed tingling lips BP 187/101 HR 94 Benadryl 50mg po provided 1456 BP 146/90 HR 91 RR 20 Sats 98 1500 BP 133/91 HR 86 RR 18 Sats 98
57 2021-02-09 ringing in ears sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (pr... Read more
sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (prexisisting but markedly amplified-still; chills (no fever, 3 days for real, now fading); mild nausea/loss of appetite (largely resolved.); mild nausea/loss of appetite (largely resolved.); This is a spontaneous report from a contactable Physician reported for herself. This 57-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 09Jan2021 09:00 AM on Arm left at single dose (Lot # EK9231) for covid-19 immunisation. Medical history included Pacemaker, Insomnia, and some preexisting hearing loss, due to effusion. No known allergies. No covid prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 16:45 PM on Left arm at single dose (Lot # EH9899) for covid-19 immunisation. Covid test after #1 (December) due to sore arm, chills, aches and malaise. Was negative. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. The patient experienced pulsing tinnitus, eased off now, also sore arm (briefer than with #1), malaise/fatigue (still but better), bad headache (persisting but markedly amplified-still, chills (no fever, 3 days for real, now fading), mild nausea/loss of appetite (largely resolved.) Events all on 10Jan2021 06:00 AM. Lab data included covid test (Nasal Swab) on 22Dec2020: negative. No treatments were received for the events. Outcome of events mild nausea/loss of appetite, malaise, fatigue was recovering. Outcome of the event chills (no fever, 3 days for real, now fading) was recovered. Outcome of the events was unknown.
57 2021-02-10 loss of taste, loss of smell Tiredness, chills, sinus congestion, chest congestion, no sense of taste or smell, body aches, no ap... Read more
Tiredness, chills, sinus congestion, chest congestion, no sense of taste or smell, body aches, no appetite. Stayed home and the symptoms got better after 4 days.
57 2021-02-10 taste impairment, smell distorsion Within in minutes I had a strong metallic taste in mouth and order in nasal passages. Heart racing a... Read more
Within in minutes I had a strong metallic taste in mouth and order in nasal passages. Heart racing and lightheaded. I was given water, observed, and told to call for a ride. Felt better in 15 - 20 min. was tired rest of the day.
57 2021-02-10 pain in jaw 12/22 vaccination 12/27 8AM started feeling going on with TMJ. Had appt with audiologist. Wondering ... Read more
12/22 vaccination 12/27 8AM started feeling going on with TMJ. Had appt with audiologist. Wondering if it was in ear. Ran along facial nerve. 12/30 pain increased tremendously, exploded. Weird, yucky lesions on face and mouth. My husband asked if could be shingles; positive. 1/12 Neurology. 2/7/2021 Major pain has subsided. Still recovering from Shingles. *2nd vaccination 1/12/2021 7:30 R arm
57 2021-02-10 mouth tingling, mouth numbness numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness... Read more
numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness and tingling in mouth and cheek on left side; numbness and tingling in mouth and cheek on left side; This is a spontaneous report from contactable nurses. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left deltoid on 27Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, hypothyroidism, and hypertension. There were no concomitant medications. Patient previously took lisinopril. On 27Jan2021, two minutes after receiving the vaccine, the patient experienced numbness and tingling in mouth and cheek on left side on the same side that she got the vaccine on, so she took 50mg diphenhydramine (BENADRYL), it went away and she slept all night. She then woke up and felt fine, with the exception of a little spot on the lip of numbness on 28Jan2021, so then she took 25mg Benadryl at 11:00 and it was gone all day. In the last 15 minutes her numbness was back and so she took another 25mg Benadryl at 17:00. Patient stated that she knows if this kept continuing she will have to go to the emergency room. In detail, patient had tingling on lips and mouth. The tingling traveled up her left side of the face to the bottom of her nose. Took 50mg of diphenhydramine after she got home. Woke up morning of 28Jan2021 with tingling on her lip, so she took 25 mg at that time. The tingling came back the afternoon and she took another 25mg and another dose before bed. She reports a small area of tingling on her lip remains as of 29Jan2021. She has not take any more diphenhydramine. She does not think it was Bell's Palsy.The reporter considered the event medically significant. Patient inquired if she can take the second dose of the vaccine and that she has done that before with lisinopril (not further clarified). Patient was to receive the second dose on 18Fe2021 or later. Patient did not have anything just right before the vaccine, has had no positive Covid or antibody test prior to the vaccine and no issues with vaccines in the past. The patient has recovered from the events, numbness and tingling in mouth and cheek on 28Jan2021 and outcome of the event, little spot on the lip of numbness was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-02-10 mouth tingling lip tingling, dizziness, heart racing had hives 24-48 hours after 1st dose
57 2021-02-11 taste impairment Within a few minutes after receiving the vaccine, the patient's heart started to race, a strong meta... Read more
Within a few minutes after receiving the vaccine, the patient's heart started to race, a strong metallic taste in her mouth and sinuses appeared, and she felt dizzy. Patient were taken to the observation area to sit down. Patient was taken from the observation area to the gymnasium where the patient was placed in a wheelchair and then taken to a lounge for private for observation. Patient was given water to drink and stayed seated in the wheelchair. Patient was observed for approximately 40 minutes and had to have someone come and get her to driver her home. It took 15 minutes before the symptoms started to subside, but patient still felt some of the mild symptoms. Patient was very aware of where she was and what was going on.
57 2021-02-14 lacrimation increased Within 3 hours of dose #1 administration I had a runny nose, watering eyes, chills and sneezing. By... Read more
Within 3 hours of dose #1 administration I had a runny nose, watering eyes, chills and sneezing. By evening the chills got worse, low-grade fever and fatigue. Unable to do anything except bundle up and sleep it off. Still fatigue, chills, runny nose the next day but no fever. Better by 2nd day after vaccine.
57 2021-02-15 mouth tingling, eye discomfort, visual impairment, mouth numbness With initial vaccine on 20 Dec 2020 I had immediate tingling and numbness of left upper and lower li... Read more
With initial vaccine on 20 Dec 2020 I had immediate tingling and numbness of left upper and lower lip. I went home and took a 60 mg Allegra and 1 Aleve. It subsided. I woke in the morning and the numbness returned so I took 1/2 60 mg Allegra and it subsided. No additional problems from 1st dose. I received 2nd dose on 12 Feb 2021. I felt fine initially. I woke the following day and had completely lost far vision. I could see up close but could not see far and my eyes felt very swollen. I also had right sided headache. The symptoms resolved later that day on 13 Feb 2021 at 5 pm.
57 2021-02-17 dry eye, dry mouth, dry throat At 3:00 AM on 1/18/21 she was awoken from sleep with shoulder pain, hip girdle pain, long bones of t... Read more
At 3:00 AM on 1/18/21 she was awoken from sleep with shoulder pain, hip girdle pain, long bones of the thighs, could not raise arms above head, neuropathy of the palms, pain in wrist, tingling, numbness, stiffness of wrists, stiff fingers, hurt to bend fingers with pulsing capillaries. Started more centrally then extended down to extremities, did have some pain in ankles, neuropathy to the feet. Much worsening of the mucosal dryness of her eyes, mouth, lips, throat to the point that she was hoarse, and also her vaginal mucosa started to dry up as well. She took Acetaminophen, etc. She then was given some narcotics, which did not help the pain symptoms either. Her doctor had no answers, and did not prescribe her anything. Her eyes and throat dryness has waned somewhat. She is still having pain in her shoulder girdle. Does have the neuropathy pain, still hard to bend fingers. She had a very severe reaction this past weekend where she could not eat from Saturday to Wednesday due to nausea. She did get an order for Zofran on Monday, 2/15/21. She is still taking the Acetaminophen and Naprosyn, not taking the Norco due to constipation. Started taking her Synthroid again, but low dose. She is an RN and not able to work due to this condition. She also become leukopenic, her WBC's were lower than normal at 2.9, and her neutrophils dropped to a suboptimal level as well. She is now immunocompromised, and another reason for her not going to work as she works in an overflow unit for COVID patient's.
57 2021-02-17 lip swelling, eye swelling Lips puffy, puffy above eye and puffy at throat
57 2021-02-17 pain in jaw, eye strain, toothache, tongue disorder, hearing loss R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; ... Read more
R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-02-19 ear pain Severe body aches, headache, left earache pain, unable to sleep entire night, diarrhea, itching, sto... Read more
Severe body aches, headache, left earache pain, unable to sleep entire night, diarrhea, itching, stomachache.
57 2021-02-19 lip swelling Received 2nd Covid vaccination on 1/6/2021 0830. On 1/9/2021 upon waking up I noticed lips swollen (... Read more
Received 2nd Covid vaccination on 1/6/2021 0830. On 1/9/2021 upon waking up I noticed lips swollen (right upper and left lower) seemed like fluid filled pockets but later lips were completely swollen, the next day my chin became very hard and swollen, no tongue edema noted, no other swelling of face noted. It is now 6 weeks later and I continue to have lip and chin edema. Have been on high dose steroids but rebound within 48 hours. I am currently on antihistamine regimen of Allegra, Singulair, Pepcid and Atarax x one week with continued swelling, although it does lessen throughout the day but every morning I am very swollen despite medication regimen.
57 2021-02-19 sensitivity to light, vision blurred Photo / light sensitivity, blurry vision .
57 2021-02-20 ear pain She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness... Read more
She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury
57 2021-02-22 vision blurred Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1... Read more
Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1.5 days. But the fields in question 21 would not allow me to enter the information when I checked Hospitalization. I received the vaccination at the Stadium in which was a State run POD.
57 2021-02-23 bloodshot eyes, eye swelling Both eyes very bloodshot with redness in skin around eyes and slightly swollen , resolved by next da... Read more
Both eyes very bloodshot with redness in skin around eyes and slightly swollen , resolved by next day. I never get bloodshot eyes.
57 2021-02-23 vision blurred, burning mouth syndrome I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere;... Read more
I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.
57 2021-02-25 visual impairment Dizziness, vision changes, cleared by EMS
57 2021-02-27 loss of smell, mouth pain, eye pain, loss of taste Three hours after vaccine, I started to get body aches, stiff neck and fatigue. Starting around 12 a... Read more
Three hours after vaccine, I started to get body aches, stiff neck and fatigue. Starting around 12 after vaccine I developed chills, headache, fever and extreme weakness which lasted for 10+ hrs. The weakness improved slightly, but continued. Starting 4 days after vaccine, I started to get stinging eyes, nose and mouth, increased nasal congestion and burning in my sinuses. These symptoms are debilitating and are the same ones I had when I was at my sickest with Covid. Whatever sense of smell or taste I had regained disappeared. These symptoms continues to the present.
57 2021-02-27 mouth numbness Patient reports feeling "sides" of tongue numbness for 2nd dose; tongue felt numb in front of tongu... Read more
Patient reports feeling "sides" of tongue numbness for 2nd dose; tongue felt numb in front of tongue for 1st dose. C/o dizziness. Checked and monitored by EMT until no further symptoms.
57 2021-02-28 taste impairment side effect of a metallic taste in her mouth, back of throat, and nose; This is a spontaneous report... Read more
side effect of a metallic taste in her mouth, back of throat, and nose; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced side effect of a metallic taste in her mouth, back of throat, and nose on 27Jan2021. The patient wants more information on this. Outcome of the event was unknown. Information on the lot/batch number has been requested.
57 2021-03-03 mouth tingling tingling all over, tingling lips. Evaluated by EMS-Cleared
57 2021-03-04 eye itchiness Patient received vaccine at 12:01, she stated that approximately 12:30 she noticed her right palm f... Read more
Patient received vaccine at 12:01, she stated that approximately 12:30 she noticed her right palm felt itchy and she noticed red bumps on the inside of her right wrist. She reported the symptoms to the onsite paramedics. She stated that she was placed on a stretcher and given 60 mg of liquid benadryl by the paramedics. She stated she started feeling dizzy, but after 3 minutes the dizziness resolved. She stated that soon after that the itchy right palm resolved, and the red spots on her right wrist diminished. She stated the paramedics took her blood pressure, 150/100 and placed her on oxygen. She stated she was monitored until 1:30 pm, then was discharged, at the time of discharge she had no dizziness, no itching, and only slight red bumps on her wrist. When she got home she stated her eyes felt itchy at about 5:30 pm, she took 2 OTC benadryl tablets, the symptoms resolved. She has been asymptomatic since that time.
57 2021-03-04 hearing loss Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Un... Read more
Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 57-year-old female patient received first dose of bnt162b2 (BNT162B2,COVID 19, brand: Pfizer BioNTech, lot number: EL3247), via an unspecified route of administration on 17Feb2021 15:45 on Left arm at single dose for covid-19 immunisation. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin, zinc, ascorbic acid (VITAMINS C), ergocalciferol (VIT D), fish oil and Occuv. The patient experienced unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing (medically significant) on 20Feb2021 11:45AM with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown. She is not pregnant. Facility type vaccine was workplace clinic. No other vaccine in four weeks. Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. Known allergies was none.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported auditory hallucinations cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-03-04 oropharyngeal discomfort Flu like symptoms. Body aches, head ache, stuffy, runny nose. Swollen raw throat to the point I coul... Read more
Flu like symptoms. Body aches, head ache, stuffy, runny nose. Swollen raw throat to the point I could not talk. Vaccinated at 3:18 AM current time is 3:34 PM symptoms are current and ongoing.
57 2021-03-05 hearing loss, ringing in ears Headache, ear ringing, muffled hearing, fingers oh left side of head
57 2021-03-06 tongue disorder Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left delt... Read more
Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left deltoid and, was escorted to the 15 minute observation area. She noted feeling burning sensation in her chest and bilateral arms after a few minutes. Patient brought to EMS for evaluation. EMS obtained several sets of vital signs, notable for hypertension (170's/90's). Patient placed on stretcher. She was flushed, had a dry/thick tongue, developed rash on bilateral arms, began shaking and shivering but stated she was not cold only nervous. She was given 50 mg benadryl IM, 18 g IV started in her right antecubital. She declined solumedrol due to past experience with steroids. Her flushing and rash began to resolve, patient stated her tongue felt better. Patient was transported by EMS for evaluation. She had her phone with her, but her husband took her other belongings and will meet her there.
57 2021-03-07 ear discomfort, mouth tingling, mouth numbness Tongue began tingling and became numb for about an hour. Sneezing, full feeling in ears.
57 2021-03-07 mouth numbness Numbness/tingling in both checks, lips, tip of tongue approximately 30 mins after vaccine, improved... Read more
Numbness/tingling in both checks, lips, tip of tongue approximately 30 mins after vaccine, improved with Benadryl 50 mg, similar symptoms 4 hours later which again improved with Benadryl
57 2021-03-07 swollen tongue, eye twitching Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tong... Read more
Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tongue started to feel bigger and to itch at the back, throat also started to feel tight. Monitored by EMTs in parking lot. Given oral Benadyl. Was not transported to hospital. Husband came to pick her up. Stated a few hours later felt pressure in windpipe at level of clavicles & had difficulty breathing. Stated sleep the rest of the day. Denies HA, fever, or chills. Stated throat felt better the next day though still feels pressure at base of throat. Also complaining of occasional "brain zap" (zing in brain that then causes eye to twitch). States that since tongue started feeling big she has had trouble talking--words coming out funny. States that is still happening.
57 2021-03-08 loss of taste, loss of smell hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, ... Read more
hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain, vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and taste, tingly limbs gone but severe pain behind right knee, ruled out blood clot, smell back, taste not all the way returned, pain continuous
57 2021-03-08 mouth numbness My lips and tongue became number 30 minutes after the shot. They stayed numb about 6 hours.
57 2021-03-08 pupils dilated According to onsite fire company client symptoms, 8:38 am-alert to name but couldn't recall year and... Read more
According to onsite fire company client symptoms, 8:38 am-alert to name but couldn't recall year and date, confused, slow to react, slow speech, dilated pupils. 8:40 am-BP 145/78, pulse 78, O2 Sat 97%,. 8:42 am-Client verbalized feeling nauseous and dizzy but she was okay, pupils semi dilated, able to follow command. 8:43 am-Per paramedic client needs further evaluation. 8:45 am-BP 142/80, pulse 79, O2 sat 100%, Blood glucose 79. 9:01 am-rescue crew arrived on scene. 9:08 am-Client transfer to hospital for further evaluation due to in and out periods of confusion.
57 2021-03-08 thirst Body aches. Joint pain. Fever. Chills. headache. Skin sensitivity. Thirst. Started about 7:00 pm an... Read more
Body aches. Joint pain. Fever. Chills. headache. Skin sensitivity. Thirst. Started about 7:00 pm and pain and symptoms lasted about 24 hrs
57 2021-03-09 dry mouth Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/... Read more
Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/p-158/90. I was lightheaded and thought I was going to pass out. My blood pressure has never been that high. Nor have I ever had a HR like that. My body was shaking so much that I couldn't hold on to the water bottle they gave me( d/t developing a very dry mouth.) This lasted about 8 min and then my HR started to go back down.
57 2021-03-10 ringing in ears, deafness Within minutes of receiving second dose of the vaccine, I had a severe pain in the right side of my ... Read more
Within minutes of receiving second dose of the vaccine, I had a severe pain in the right side of my neck. I waited 15 minutes, but felt I could not leave as I was diaphoretic and dizzy when I stood up. I waiting up to 45 minutes until I could manage to leave after receiving bottled water and orange juice. About 5 days later, I experienced tinnitus in my left ear (swooshing sound 24/7 that beat to my pulse.) I went to an ENT appointment several weeks after and was examined. Anatomically there was no findings. The audiology report showed moderate hearing loss in my left ear. High dose steroids were prescribed. I am on day 9 of the Prednisone without any relief of the tinnitus or improvement in my hearing.
57 2021-03-11 swelling around the eyes Day 4 after shot - both eyelids were sensitive to touch. Severe pain in both knees. Day 5 both eyel... Read more
Day 4 after shot - both eyelids were sensitive to touch. Severe pain in both knees. Day 5 both eyelids were puffy and swollen. Severe pain in both knees. Day 7 - both issues had subsided but still discomfort
57 2021-03-12 mouth numbness As soon as I received the vaccine , I felt the same as if I were stung by a bee. I felt warm and I... Read more
As soon as I received the vaccine , I felt the same as if I were stung by a bee. I felt warm and I could feel my tongue getting numb. I told the pharmacist & after about 15 minutes I asked if I could take my Benadryl. So it sort of slowed it down but I still had the tingling and numbing . It?s been 3 days and I?m still experiencing the numbing of my tongue .
57 2021-03-13 swollen tongue Patient presents today from the vaccine clinic with concerns for tongue swelling. She states she got... Read more
Patient presents today from the vaccine clinic with concerns for tongue swelling. She states she got her first dose of the Pfizer COVID vaccine today and shortly after developed some swelling in her tongue. She was given a dose of 25 mg of benadryl. She feels much better now that she is at the clinic and wonders if her tongue was just dry.
57 2021-03-14 ear pain 99 fever, chills, headache, double ear ache, fatigue
57 2021-03-14 eye pain . Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (... Read more
. Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (took Tylenol); Day 3: 3/11/21 - debilitating headache. Couldn't work. Eyes hurt. Headache felt like hammers hitting the side of my head. I was so concerned I wanted to go to the hospital. The headache stopped around 2pm on March 11. Day 5: 3/14/21 - face has welts on my left cheek (shot was in the left arm).
57 2021-03-14 mouth numbness, mouth tingling, tongue disorder 11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizzin... Read more
11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizziness, she denied any SOB or breathing difficulty. Assisted Pt. back to sitting in chair. 11:50 AM ? Client states she had her vaccine at 11:20 AM and stayed for 30 min at which time she started to experience the numbness and tingling of lips. B/P 150/70, Pt had own O2 Sat monitor which included pulse, O2 sat was 96%, pulse 92, no respiratory distress noted. 11:51 AM- 12.5mg Benadryl given P.O. Pt states she gets very tired with ?full dose?. Pt states she is ?queasy?, light-headed, dizzy and has vasovagal responses to vaccines. She carries an Epi-pen for various food allergies, an O2 sat monitor and emesis bags in case she has a vagal response which she states this is what she feels like. 12:00 PM ? B/P 156/90, HR ? 92, O2 sat 97%, RR ? 20, No swelling, redness or irritation at Right Deltoid injection site. 12:06 ? Pt denies any dizziness or lightheadedness at this time but continues with tingling at lips and thick front of tongue, numbness B/P 152/92, HR 76, o2 sat 95%, RR- 20, cool cloth applied to back of neck, lower legs elevated on chair. Pt wearing compression hose. 12:20 PM ? Consult with Pharmacist who stated another dose of Benadryl would not be recommended and suggested lying down on stretcher and possible anxiety reaction. Pt refuses to lie down on stretcher and states is fine sitting with legs elevated. 12:24 PM B/P 146/90, P ? 64, RR ? 20, O2 sat 97%, Pt has flushed face and states her cheeks feel tight. She states she has Rosecea but her cheeks aren?t usually very flushed. She c/o warmth on cheeks and numbness in front area of tongue. No difficulties noted with swallowing water. Daughter arrived. Site director consulted to determine next steps and decision made to transfer to ED. Discussed transfer to ED with pt who verbalized agreement. 12:34 PM Pt states dizziness resolved however she now has a H/A and possible onset of a migraine. 12:35 PM B/P 162/90 P- 80, RR-20, O2 sat 98%. Pt denies any respiratory distress, refuses food due to many food allergies. Continues to tolerate water without swallowing difficulty or emesis. 12:40 PM Assisted Pt to wheelchair and transferred to Emergency Department for further evaluation and observation. Dtr present and verbal report given to ED RN.
57 2021-03-14 pupils dilated Patient received 2nd Covid vaccine on 2/19/2021, shortly after patient states she did not feel well,... Read more
Patient received 2nd Covid vaccine on 2/19/2021, shortly after patient states she did not feel well, like she was going to faint. Patient became pale, diaphoretic, pupils dilated and was unresponsive. I stayed with patient and supported her head/airway as she was seated in a chair. Dr. arrived, ED staff arrived and stretcher arrived, patient started to wake up and we assisted her to sit on the stretcher. Patient was alert , talkative and her color was better. She had a small emesis x2. Patient then laid down on the stretcher and stated she was feeling better. Patient was taken to the ED via stretcher, she was alert and responsive.
57 2021-03-14 mouth itchiness Approximately 15 minutes after receiving injection, patient complained of itching around her mouth. ... Read more
Approximately 15 minutes after receiving injection, patient complained of itching around her mouth. She told nurse that she had a shellfish allergy, although no allergies were listed on her consent form. Diphenhydramine 50mg was administered. Patient waited 10 minutes after receiving diphenhydramine before leaving.
57 2021-03-14 swollen tongue, ear itchiness Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives... Read more
Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse. Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed. Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
57 2021-03-15 hearing loss, ringing in ears Blocked/muffled hearing in left ear; loud, constant ringing (tinnitus) in left ear; loud ringing pro... Read more
Blocked/muffled hearing in left ear; loud, constant ringing (tinnitus) in left ear; loud ringing progressed to right ear; tinnitus is so loud that it wakes me up at night and makes falling asleep difficult
57 2021-03-15 swollen tongue, tongue itchiness Developed itching and swelling of face and tongue, confirmed SOB.
57 2021-03-15 swollen tongue Pt received 1st dose of Pfizer vaccine at Convention Center vaccination site and about 10 minutes a... Read more
Pt received 1st dose of Pfizer vaccine at Convention Center vaccination site and about 10 minutes after receiving the vaccine she began to complain of dizziness, scratchy throat and mild tongue swelling. Pt reports that she has multiple allergies (especially tree nuts). BP 138/80. EMS on scene. Pt was administered 25 mg IM Benadryl and EMS transported pt to Hospital ED.
57 2021-03-16 mouth tingling Had tingling in the tongue and numbness in right side pf the face, around eyelid, down the cheek and... Read more
Had tingling in the tongue and numbness in right side pf the face, around eyelid, down the cheek and to side of the nose. It lasted until I went to bed. Symptoms had disappeared by the time I woke up the next day
57 2021-03-16 ringing in ears Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days af... Read more
Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days after vaccine. Pain in right leg calf muscle
57 2021-03-18 oropharyngeal discomfort 10:45 patient complained itchy uncomfortable feeling in her throat. Was able to swallow and move air... Read more
10:45 patient complained itchy uncomfortable feeling in her throat. Was able to swallow and move air. She stated she did not come to clinic with this complaint. Benadryl 25mg given PO with 16 Oz of water. Observation per NP and EMS. vs 10:47 190/106/ SAT on RA 99%. 10:55 BP 200/113, HR 75; SAT 99 RA. Lungs clear, moving air, no SOB, no stridor or wheezing. Moved patient on stretcher to more private area with husband. 11:35 - No further complaints of itchy throat. BP 163/93;HR 75; R 20. Erythema noted on posterior pharynx. Uvula midline. Discharged home 11:35.
57 2021-03-18 ringing in ears, eye itchiness Itchy face, red inflamed and itchy hands, ringing of the ears
57 2021-03-18 ringing in ears headache for 3 days left ear rang for 5 days (shot in left arm) both ears ring since (normal tinnitu... Read more
headache for 3 days left ear rang for 5 days (shot in left arm) both ears ring since (normal tinnitus not loud and different sound than sound after shot)
57 2021-03-18 tongue itchiness Patient with history of anaphylaxis to previous vaccines and food/medication had immediate sensation... Read more
Patient with history of anaphylaxis to previous vaccines and food/medication had immediate sensation of tongue itching and reported "tightness in throat" post vaccine. EMS administered 50 mg Benadryl IM, recommended transportation to hospital which patient declined.
57 2021-03-19 taste disorder, mouth tingling, oropharyngeal discomfort tingling in tongue & then having bad taste in mouth; not swelling in lips or tongue; scratchy throat
57 2021-03-20 ringing in ears Tinnitus Ongoing, high pitched ringing in both ears. Sometimes with 2 tones, one higher, one lower.
57 2021-03-21 oropharyngeal discomfort 57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left... Read more
57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left arm. She states that it feels as though something small got stuck in her throat and is causing mild discomfort. She reports associated injection site pain, body cramps, and headache. She denies itching, difficulty breathing, shortness of breath, chest pain, palpitations, blurry vision, presyncope, difficulty swallowing water, or lip/tongue swelling. She reports no change in symptoms after 40min. post-injection. Physical Exam: Heart Rate 66bpm, Blood Pressure 115/74, Repeat Blood Pressure at 40min post-injection 120/80 Cardiac: regular rate and rhythm Lungs: unlabored breathing, clear to auscultation bilaterally Skin: no injection site erythema or swelling. No rash. No lip/tongue swelling or narrowing of oropharynx. Plan: Patient reports that her symptoms have improved at 1hr post-injection and would like to leave. I advised her that she should wait until all of her symptoms have resolved as throat tightness is a concerning adverse reaction. I provided her with options including contacting EMS right now to take her for observation at the hospital, however, the patient declined and said she would not go in the ambulance. She insisted that she wanted to go home and that her husband was driving and would take her to the emergency room if her symptoms worsen. Patient was well-appearing when she left the vaccination site.
57 2021-03-21 oropharyngeal discomfort Patient was sat out in lobby after vaccine, around 11:05am patients spouse grabbed provider patient... Read more
Patient was sat out in lobby after vaccine, around 11:05am patients spouse grabbed provider patient was complaining of chest tightness, throat closing sensation, "weird" feeling over body.
57 2021-03-21 mouth tingling About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a... Read more
About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a short time she experienced tingling in lips. We moved her to the floor and laid her flat with head raised as she began to experience uncontrolled movements in arms and legs (seizures?) I administered epinephrine for tightness in chest and tingling lips and 911 was called. Rescue squad arrived stabilized her and transported to hospital.
57 2021-03-21 swollen tongue Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, so... Read more
Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, soon was unable to walk due to vertigo, then chills and extreme nausea like I would vomit but I did not.
57 2021-03-21 ringing in ears Intense ringing in left ear post vaccine Chronic nausea Fatigue muscle weakness low grade headache a... Read more
Intense ringing in left ear post vaccine Chronic nausea Fatigue muscle weakness low grade headache at times Treatment: Tylenol, Excedrin migraine
57 2021-03-21 ringing in ears Ringing in the ears (both), began within hours of my second dose and still happening 4 days later Le... Read more
Ringing in the ears (both), began within hours of my second dose and still happening 4 days later Legs ached the day of the shot and the day after but ok now
57 2021-03-21 ringing in ears Saturday, within 6-8 hours started with fatigue. Then later that evening chills, headache, fever, a... Read more
Saturday, within 6-8 hours started with fatigue. Then later that evening chills, headache, fever, and aches. During the first night my ear started kind of ringing and feeling in a funnel or clogged or something (different from anything experienced before). Sunday, continued with fatigue, headache, fever, body aches, generally not feeling well, and ear continued to get worse with some hearing loss. Now today (Monday) I can't hear as well in my left ear and it's a type of ringing and still feeling clogged or in tunnel or something like that. Hard to describe... but I can't hear as well in that ear.
57 2021-03-22 lip swelling, mouth tingling My tongue felt tingly when I was sitting for the 1st 15 minutes but I figured that was nerves. Aroun... Read more
My tongue felt tingly when I was sitting for the 1st 15 minutes but I figured that was nerves. Around 2 hours later I felt the inside of my lips started mildly swelling. It is the same now no better no worse.
57 2021-03-22 mouth discomfort Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tin... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tingling in arms and lips burning/numb, no difficulty breathing was monitored in store for 1 hour, no epipen needed, advised to take benadryl
57 2021-03-23 mouth tingling Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vac... Read more
Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vaccine. Within 1 hour the feeling was almost gone. Next few days left lower side of face still felt different. 10:00 pm (29 hours after vaccine) started with chills and body aches. Next morning 6:00am was very tired and felt the same. Took 2 Ibuprofen. Dozed on and off in morning. Felt better in afternoon. Around 6pm started feeling chills and achy. Took 2 more ibuprofen. Arm was sore. Next morning, had to work. Felt tired and brain fog all day. Slight achy. Next day, felt about 90% back to normal.
57 2021-03-23 tongue disorder, mouth numbness Patient reports disoriented, cold feeling to chest, Heart Palpitations, numbness in fingers, tongue ... Read more
Patient reports disoriented, cold feeling to chest, Heart Palpitations, numbness in fingers, tongue thickness, "feels weird". Macular Rash mid sternum noted by on site physician. No respiratory distress noted. No epinephrine administered.
57 2021-03-24 ear discomfort Adverse Events: Throat grab (immediate), Throat swelling, ears popping, difficulty swallowing Treatm... Read more
Adverse Events: Throat grab (immediate), Throat swelling, ears popping, difficulty swallowing Treatment: Resident "self-medicated" and took 40mg prednisone, 50 mg Benadryl, 1 inhaler of Albudiral Outcomes: Parked at hospital, waited for reaction to subdue. Resident left the vaccine site unauthorized before her 15 minute waiting period.
57 2021-03-24 swollen tongue, lip swelling A few minutes after my Pfizer COVID vaccine injection in my left arm, while in the observation area,... Read more
A few minutes after my Pfizer COVID vaccine injection in my left arm, while in the observation area, I felt an itching sensation on my left forearm which was followed by the same itching feeling on my neck. Then a couple of minutes later my lips felt slightly swollen and my throat was a little scratchy. I told a nurse and she moved me to a chair closest to an oxygen tank. I?m a retired paramedic so I knew I was having a mild allergic reaction. There was never any wheezing. I also had a headache and felt lightheaded. The nurses monitored me 15 minutes longer than the required 15 minutes. I asked them if I should take some Benadryl for the symptoms. They asked if I was driving and said to take it once I got home. The symptoms continued for an hour with added swollen tongue, red lips and blotchy skin spots on my face and feeling tired. Once I took 50mg of Benadryl the symptoms gradually dissipated over 4 hours. I?m concerned about how I will react with my second dose. My MD recommended 25mg of Benadryl before my second Pfizer vaccine and 25mg after if needed.
57 2021-03-24 ringing in ears tinnitus
57 2021-03-25 taste impairment Pt. stated she got a headache a minute after she got vaccinated. It was a sharp pain at first and t... Read more
Pt. stated she got a headache a minute after she got vaccinated. It was a sharp pain at first and then it was dull. Pt. also reported a metallic taste. Vitals signs taken at 11:45 am: BP 148/69, HR 87, O2 Sat 98%, R 18. At 11:57 am pt. stated she is feeling better, headache is almost gone, she wants to go home. Pt. went home at 12:02 pm.
57 2021-03-25 mouth tingling erythematous hives around neck, tongue tingling.
57 2021-03-25 swollen tongue Tongue redness and swelling
57 2021-03-25 ringing in ears Increase in tinnitus
57 2021-03-25 ringing in ears Loud ringing in my ears
57 2021-03-26 swollen tongue Swollen tongue, scratching throat, eruption of psoriasis
57 2021-03-27 eye pain Stiff neck muscles, especially at base of skull accompanied by pain at the base of skull traveling u... Read more
Stiff neck muscles, especially at base of skull accompanied by pain at the base of skull traveling up both sides of head into temples. Painful temples when touched. Headache was constant throughout the day (1-2) and would flare up 3-4 times a day (6-7). Sometimes relived by Tylenol. Often caused eye pain when severe.
57 2021-03-27 eye pain FEVER, CHILLS, HEADACHE, MUSCLE ACHES, DENTAL IMPLANT HURTS, EYES HURT
57 2021-03-28 loss of taste Loss of taste.
57 2021-03-28 taste impairment Strong taste of metal in mouth, began approx. 4 hrs after shot received. Eating and drinking has not... Read more
Strong taste of metal in mouth, began approx. 4 hrs after shot received. Eating and drinking has not helped.
57 2021-03-28 mouth numbness Felt shaky after about 5 minutes , not right pain travel from shoulder up back of neck facial numbne... Read more
Felt shaky after about 5 minutes , not right pain travel from shoulder up back of neck facial numbness almost half way across mouth up to eye area on same side as injection
57 2021-03-28 mouth tingling Itching from head to tops of feet, this includes neck, back arms, buttocks, and other areas of the b... Read more
Itching from head to tops of feet, this includes neck, back arms, buttocks, and other areas of the body, stiff neck, tingly tongue
57 2021-03-28 swollen tongue Patient with onset of facial tingling and sensation of facial swelling and tongue swelling approxima... Read more
Patient with onset of facial tingling and sensation of facial swelling and tongue swelling approximately 10 min after receiving the second dose of her COVID-19 vaccine. This persisted throughout evaluation. She received the first dose of her COVID-19 vaccine 3 weeks prior, without adverse effects. She had progression of symptoms during her evaluation, with some chest pressure, described as a sensation of a brick sitting on her chest, duration approximately 10 min at the time of evaluation, continual, approximately 3/10 on pain scale, persisting chest pressure worse with deep breathing. Oxygen saturations were stable at 95%, anterior breath sounds clear with good air exchange, distant heart sounds. Good peripheral pulses, perfusion difficult to assess since fingertips were cold due to cold external air temperatures. She was transferred from private vehicle to ambulance and oxygen was placed and EKG obtained as below. She was then transferred to hospital for further evaluation. Of note, the patient reported that during the day prior to receiving the second dose of her vaccine, she had worsening shortness of breath with need for supplemental oxygen, 2L by nasal cannula, with activity and at rest. Onset prior to her evaluation after her vaccination. This is above her baseline of nocturnal oxygen use. She was feeling poorly prior to presenting for the vaccine. She had been hospitalized with intubation for CHF exacerbation in the week prior to 2nd dose COVID-19 vaccine administration.
57 2021-03-28 swollen tongue Vaccine recieved at 8:10am. At 11:00 am noticed hives on neck and red. Throat felt tight so looked... Read more
Vaccine recieved at 8:10am. At 11:00 am noticed hives on neck and red. Throat felt tight so looked in mirror. Tongue was 3 times typical size! Ears hot and itching. Airway compromised. Tongue continued to enlarge and throat tighter. Hives on face.
57 2021-03-29 inability to speak, swollen tongue 35 minutes after vaccine tongue started to swell, subsided after 9 hours Slight diarrhea Slight diz... Read more
35 minutes after vaccine tongue started to swell, subsided after 9 hours Slight diarrhea Slight dizzy spell Cough Sore throat Runny nose Nausea next morning Losing voice next morning
57 2021-03-29 swollen lips, lip swelling Lower lip swollen with a multitude of sores on lip and on inside of lip. Only a few sores on the in... Read more
Lower lip swollen with a multitude of sores on lip and on inside of lip. Only a few sores on the inside of the top lip. A few sores inside the mouth on both sides by the back teeth. Teeth and gums extremely sore so much so that I did not eat anything that needed to be chewed for several days.Fflossing teeth was extremely painful. Doctor prescribed Cephalexin 500 mg three times a day Quantity 30 and Acyclovir Ointnent 5% every 3 hours for 7 days. After 7 days teeth and gums almost 100% good. Only some minor soreness on the front lower teeth. Sores on lips 99% better only one minor sore left. Sores on the inside of mouth gone.
57 2021-03-29 deafness first dose of BNT162B2:19Dec2020 ; second dose of BNT162B2: 05Jan2021; first dose of BNT162B2:19Dec2... Read more
first dose of BNT162B2:19Dec2020 ; second dose of BNT162B2: 05Jan2021; first dose of BNT162B2:19Dec2020 ; second dose of BNT162B2: 05Jan2021; hearing loss; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686), via unspecified route of administration on 05Jan2021 (at the age of 57 years) at a single dose in the left arm for COVID-19 immunization. Medical history included 'hypothyroid'. Concomitant medication included levothyroxine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 19Dec2020 at 11:00 AM (age: 57-years) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 at 16:00, the patient had hearing loss. The event resulted to physician office visit. The patient received steroids as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
57 2021-03-29 lacrimation increased About 20 minutes after receiving the vaccination, my left side became numb, especially my face and h... Read more
About 20 minutes after receiving the vaccination, my left side became numb, especially my face and head. And my left eye was watering.
57 2021-03-29 pupils dilated, vision blurred Eyes dilated, blurring within 5 mins. of vaccine administration. 12:45pm 12:46pm End of 15 min med a... Read more
Eyes dilated, blurring within 5 mins. of vaccine administration. 12:45pm 12:46pm End of 15 min med administration 12:55pm Patient report of feeling better-left site.
57 2021-03-29 swollen tongue Vaccine was administered in a drive through event held at the Health Office. During the waiting peri... Read more
Vaccine was administered in a drive through event held at the Health Office. During the waiting period, the patient reported lightheadedness, shortness of breath, and swelling of the tongue. She was assessed and in no acute distress, and normal vitals with oxygen saturation 97%. 80mg of Depo Medrol IM was administered. She was monitored closely for 45 minutes and she symptomatically improved. She was dismissed to home with instructions to monitor carefully for any other symptoms and if severe to seek immediate medical attention.
57 2021-03-29 ringing in ears Strong dizziness for three days. Then intermittent dizziness and unwell feeling in head for the next... Read more
Strong dizziness for three days. Then intermittent dizziness and unwell feeling in head for the next five weeks up to present. Unwell feeling in head interferes with mental processing. Noticed faint ringing in ears approximately a few weeks ago. Then two days ago 3/28 (1 1/2 weeks following 2nd shot on 3/19), tinnitus became very noticeable. Volume was 4/10. And last couple days has ranged in volume between two and four. Have contacted doctor, but not been seen.
57 2021-03-30 taste impairment Metallic taste; This is a spontaneous report from a contactable consumer. A 57-years-old female pati... Read more
Metallic taste; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 16:30 (Batch/Lot Number: EK9231) as single dose for an Covid-19 immunization.The patient had none medical his-tory There were no concomitant medications.Calling about the Covid-19 Vaccine she states that she got her 1st dose yesterday, 28Jan2021. About 15 minutes after, she got an odd metallic taste in her mouth that she still has. she enquired that this is not a side effect that was listed.Vaccination Facility type is Hospital.The outcome was not recovered.
57 2021-03-30 tongue disorder temp 103.8; severe chills; muscle aches; nausea; diarrhea; sinus congestion; mouth/tongue sores; mou... Read more
temp 103.8; severe chills; muscle aches; nausea; diarrhea; sinus congestion; mouth/tongue sores; mouth/tongue sores; sore throat; headache; This is a spontaneous report from a contactable other hcp. A 57-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EN5318), dose 2 intramuscular, administered in Arm Right on 28Jan2021 12:00 as SINGLE DOSE for covid-19 immunisation. Medical history included narcolepsy from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing HTN, thyroid disorder from an unknown date and unknown if ongoing thyroid disease, obesity from an unknown date and unknown if ongoing. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; pitolisant hydrochloride (WAKIX) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication, start and stop date were not reported. On 29Jan2021 02:00, the patient experienced temp 103.8, severe chills, muscle aches, nausea, diarrhea, sinus congestion, mouth/tongue sores, mouth/tongue sores, sore throat, headache. The patient underwent lab tests and procedures which included body temperature: 103.8 on 29Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was recovering.
57 2021-03-31 eye irritation Participant c/o nausea, light-headedness and 'eyes burning'. B/P 160/102; stated "feeling funny". ... Read more
Participant c/o nausea, light-headedness and 'eyes burning'. B/P 160/102; stated "feeling funny". EMS called - arrived at 0835, BS 133. Continued with symptoms; initially refused to go to E.D., but then agreed to be transported to ER at 0848.
57 2021-03-31 mouth discomfort After receiving her vaccine, client stated that she has shortness of breath and a burning feeling in... Read more
After receiving her vaccine, client stated that she has shortness of breath and a burning feeling inside her mouth. Vital signs obtained by EMT: BP 132/84, HR 75, O2 Sat 98%. Client states she feels better. Client discharged home by EMT.
57 2021-03-31 mouth tingling, tongue disorder 3:39 client reported being dizzy ps02 100% b/p 170/82 pulse 86 water given and monitored. Then re... Read more
3:39 client reported being dizzy ps02 100% b/p 170/82 pulse 86 water given and monitored. Then reported that her tongue was thick and lips tingling. 3:42 b/p 218/90 pulse 120 skin pink warm and dry. Respirations even and unlabored, placed in wheel chair and at 3:52 exited the building to ER
57 2021-04-01 taste impairment, dry mouth ASSESSMENT: 57 y.o. female with PMHx of HTN who presented today to the Vaccine site for her second C... Read more
ASSESSMENT: 57 y.o. female with PMHx of HTN who presented today to the Vaccine site for her second COVID vaccine. She c/o only a sore arm for 1-2 days after her first vaccine but otherwise tolerated it well. NKDA. She states that about 5-10 min after the vaccine she developed rhinorrhea so she went to the bathroom and blew her nose and it improved some but did not resolve. She did not inform us of this until her 15 min timer went off so I completed an evaluation. I am the physician assistant on site at the vaccine clinic who monitors the patients and is there for emergencies. If a patient feels they are having a reaction I complete an exam on the patient. She states the rhinorrhea was still there but was better than it was. Associated with a sensation of "oil in my throat, like eating some butter" but denies throat itching or tightness. Associated with intermittent dry cough and throat clearing. Denies difficulty breathing, wheezing, tongue/lip swelling, mucosal or skin itching, hives, palpitations, lightheadedness, dizziness, SOB, headache, nausea, vomiting, diarrhea, abdominal pain. She has experienced similar rhinorrhea and dry cough in the past with certain medical masks like the one we provided her today. She also experiences this with her seasonal allergies. Her allergies have not been flaring up the last 2 weeks or so but they were before that. She states she has dry mouth and has to drink a lot of water or she will develop a dry cough and throat clearing like she has today. Reports she has never had an allergy to any vaccine or injectable medication in the past. ROS: Constitutional: Negative for chills, fatigue, fever, diaphoresis and weakness. Eyes: Negative for blurred vision, photophobia, vision loss and visual disturbance. E/N/T: Positive for rhinorrhea. Negative for hearing loss, ENT Pain, ear pain, nasal pain, sore throat and hoarseness. Cardiovascular: Negative for chest pain, palpitations, tachycardia, edema, dyspnea on exertion, irregular heartbeat and near-syncope. Respiratory: Positive for cough (dry, intermittent, associated with PND). Negative for shortness of breath, wheezing and sputum production. Gastrointestinal: Negative for abdominal pain, diarrhea, stool changes, nausea and vomiting. Musculoskeletal: Negative for myalgias. Integumentary: Negative for pruritus, rashes, color change and flushing. Neurological: Negative for dizziness, headaches, paresthesias, weakness, difficulty with concentration, disturbances in coordination, focal weakness, light-headedness, loss of balance and vertigo. Allergic/Immunologic: Positive for allergies and environmental allergies. Negative for frequent illnesses, urticaria, hives and persistent infections. Psychiatric/Behavioral: Negative for anxiety and depression. OBJECTIVE: Vitals: 15 min after vaccination B/P: 140/88 Pulse: 70 Temp: 98.2 Resp: 12 SpO2: 99% Vitals: 25 min after vaccination B/P: 148/90 Pulse: 68 Resp: 14 SpO2: 98% Vitals: 40 min after vaccination B/P: 150/92 Pulse: 67 Resp: 12 SpO2: 99% Vitals: 70 min after vaccination B/P: 142/82 Pulse: 70 Resp: 12 SpO2: 99% PHYSICAL EXAM CONSTITUTIONAL Vitals reviewed. GENERAL APPEARANCE: Well-developed. GROOMING: Well groomed. LEVEL OF DISTRESS: The patient is not distressed, nervous/anxious, diaphoretic or tearful. She appears to be well. The patient is not lethargic or toxic. The patient does not appear tired. EYES: LIDS/CONJUCTIVA: Lids and conjunctiva are normal. PUPILS/IRIS: extraocular movement intact. ENT EXTERNAL EARS/NOSE: External ears and nose are normal. SEPTUM/MUCOSA: Negative for sinus tenderness. LIPS/TEETH/GUMS: Normal lips, teeth and gums. No lip edema. OROPHARYNX:Mucosa: Mucosa appears normal. No edema of lips, face, tongue, oropharynx or posterior pharynx NECK: Neck normal. RESPIRATORY EFFORT AND PATTERN: Effort normal. No tachypnea, intercostal retractions, accessory muscle usage, hypopnea and irregular rate. AUSCULTATION: Normal breath sounds with no rales, rhonchi, wheezes or rubs. No coarse breath sounds or decreased breath sounds. CARDIOVASCULAR AUSCULTATION: Rate: Is normal. Rhythm: regular. Heart sounds: S1 is normal. S2 is normal. S3/S4 not present. With no murmurs heard. EDEMA/VARICOSITIES: No edema or varicosities. RADIAL: radial pulses normal bilaterally PEDAL PULSE: Normal bilateral posterior tibal pulses. LYMPHATIC OTHER NODES: No neck adenopathy. MUSCULOSKELETAL STABILITY: Normal stability. INTEGUMENTARY SKIN INSPECTION: Normal. PALPATION: Normal. No diaphoresis, no flushing, no urticaria Injection site is unremarkable, no swelling or erythema NEUROLOGICAL GAIT, COORDINATION, REFLEXES Gait: normal PSYCHIATRIC ORIENTATION: She is alert and oriented to person, place and time. MOOD/AFFECT: Normal mood and affect. INSIGHT/JUDGEMENT: Normal insight/judgement. The patient has good insight with good judgment. ASSESSMENT/PLAN: Rhinorrhea - Airway remained clear, breathing was normal, circulation was good and mentation was good. - She was monitored for 60 min after the rhinorrhea began, vitals remained stable and WNL (despite slightly elevated BP). She drank 1.5 bottles of water which improved her dry cough. She stated she was feeling back to normal before she left the clinic. - Warned her that she likely was having a mild allergic reaction to the vaccine and warned that it is possible for allergic reactions to worsen. Reviewed signs and symptoms of anaphylaxis in detail and gave strict ER warnings if any develop, especially difficulty breathing, throat/facial swelling or any worsening symptoms occur. Warned her while driving to work (15 min drive) she keep an eye on her symptoms and pull over and call 911 if any signs or symptoms of anaphylaxis develop. - Advised she take a non-sedating antihistamine like Claritin on her way to work. I advised she let her colleagues at work now to keep a close eye on her at work. - She expressed understanding and stated she was feeling well and wanted to go to work - All questions were answered. I informed her PCP and sent them my note. I called 4 hours after the vaccine to follow up but had to leave a voicemail,. I spoke with her the following day on 3/31/21 and she stated she felt great besides localized soreness at the injection site. Otherwise she felt well. The rhinorrhea, cough and throat clearing had completely resolved after taking 1 claritin. Denied shortness of breath, difficulty breathing, wheezing, fever, chills, n/v/d, chest pain, hives, itching, palpitations, dizziness, syncope, neear syncope or headache. She did not require any further treatment and did not need to have a visit with her PCP and did not need to go to the ER or hospital.
57 2021-04-01 pain in jaw, taste impairment Patient reported metallic taste in mouth, requested orange juice, reported vague feeling of nausea. ... Read more
Patient reported metallic taste in mouth, requested orange juice, reported vague feeling of nausea. Patient reported history of asthma and self administered Albuterol inhaler. After sitting for a few more minutes, patient reported jaw pain #6/10. Patient also reported back pain #9/10. Reported history of open heart surgery in November 2020. Discussed ED evaluation with patient. Patient agreed and writer called Team for evaluation in ED. Oxygen saturation 96% on room air, heart rate 80. Patient transported to ED for further work up.
57 2021-04-01 taste disorder My taste has changed in the past few days. Some items have become very salty all of a sudden For exa... Read more
My taste has changed in the past few days. Some items have become very salty all of a sudden For example, humus (that I snack on every day) now tastes too salty to eat. The same with salami that I ate last week and couldn't eat more than one slice yesterday because of the suddenly too salty taste. Orange juice doesn't taste particularly sweet. I made tacos last night and the flavors were dulled. Wine (same brand I always drink) now tastes sour; I've been craving cola instead. I looked on line to see if this was a a reported reaction to the Pfizer vaccine and saw that a "metallic" taste change was reported; I wouldn't call my taste change "metallic".
57 2021-04-01 ringing in ears Tinnitus
57 2021-04-02 ear discomfort Immediate pain in left arm upon injection, Burning sensation in ears, face, neck and shoulder within... Read more
Immediate pain in left arm upon injection, Burning sensation in ears, face, neck and shoulder within minutes of injection. Redness and blotchiness apparent on skin. Fever of 100.9 within an hour of injection. Fever continued for two days. general fatigue and muscle and joint soreness. Stayed in bed for two days. Administered Benadryl and Tylenol as needed as suggested by the pharmacist at location
57 2021-04-02 feeling of choking, mouth tingling I woke up at approx. 2:30 am the next morning with my mouth (tongue and lips), eyes, and inside of ... Read more
I woke up at approx. 2:30 am the next morning with my mouth (tongue and lips), eyes, and inside of nose on fire, as if dipped in hot sauce. Anywhere I touched burned. It felt like it was coming out of my pores, and I jumped into the shower to rinse off, spreading "it" everywhere. The redness and blisters would migrate every hour or so. One minute it was my tongue, then it would show up on my chest. I called the advice nurse who instructed me to take a Benedryl. My tongue and throat were tingling. The Benedryl helped, and I was able to go back to bed but woke up four hours later worse than before. I called again and my PCP was alerted. via email. She prescribed a run of Prednisone and that stopped it, however after the run was over, it started again. A second run of Prednisone was taken. Upon completion, my throat started to tingle again, then stopped. I have pictures of the hives, swelling, and blisters on my tongue, lips, eye, and chest, I cannot take the second dose, per PCP.
57 2021-04-02 feeling of choking Initially reported tingling in throat, then became concerned about severity. She used her inhaler a... Read more
Initially reported tingling in throat, then became concerned about severity. She used her inhaler and c/o sob, throat tightness. 11:05 Benedryl 11:08 151/96, P 80. 02 98 11:18 174/108 P 84 02 98% 11:20 Epinephrine 0.3IM transfer to EMS
57 2021-04-02 ringing in ears Ringing in right ear
57 2021-04-03 taste impairment Can't stop shivering with chills even in hot tub with heater on in room, headache, sore arm, metalli... Read more
Can't stop shivering with chills even in hot tub with heater on in room, headache, sore arm, metallic nasty taste mouth, cough, fatigue
57 2021-04-03 ringing in ears Tinnitus
57 2021-04-03 ringing in ears I have had very mild tinnitus for many years, but about the second day after the first COVID vaccine... Read more
I have had very mild tinnitus for many years, but about the second day after the first COVID vaccine, the tinnitus has about doubled in intensity and I have a slight fullness in my right ear when lying on that side for more than a few minutes. No pain, nothing like that. I am now almost three weeks out from the initial shot and tinnitus is still heightened.
57 2021-04-04 oropharyngeal discomfort 0955Pt reported "thickness on her throat" denied SOB, no other symptoms. BP 137/79, P-75, Spo2 96% R... Read more
0955Pt reported "thickness on her throat" denied SOB, no other symptoms. BP 137/79, P-75, Spo2 96% RA. 1007 Pt reported feeling much better, P- 69, Spo2 98%. Pt instructed to watch for SOB, difficulty swallowing and call her doctor/911 for emergencies. Pt was evaluated by EMT's. Pt left at 1008, RN.
57 2021-04-04 pain in jaw 1) Sore arm that went up into my shoulder blade 2) Chills 3) Fever 4) Headache 5) Pain in joints &... Read more
1) Sore arm that went up into my shoulder blade 2) Chills 3) Fever 4) Headache 5) Pain in joints & jaw 6) Exhaustion 7) Red face 8) Simply don?t feel good at all This this Monday 4/5/21... the symptoms lasted all weekend. This morning the pain in arm and joints has gone down but is still there; this is the first morning I woke without a fever but low grade fever returned this afternoon as did the redness in my face & headaches.
57 2021-04-04 mouth tingling, lip swelling, dry mouth waited the 15 min - only thing was my arm hurt from the time I got the needle until 2 days later (ve... Read more
waited the 15 min - only thing was my arm hurt from the time I got the needle until 2 days later (very painful entire time but could slowly move arm). While driving home after waiting 15 min my mouth went dry and lips were tingling felt like they were swelling. Got home, drank some water. Took about 2 hrs for the dryness to go away. The tingling went away after about 20 min.
57 2021-04-04 tongue itchiness, swollen tongue Shot received around 12:35 pm, started experiencing itching and swelling of the tongue immediately ... Read more
Shot received around 12:35 pm, started experiencing itching and swelling of the tongue immediately and a tightness in the throat started right after. Alerted EMTS by 12:50pm. EMT's administered benadryl on site and monitored. Blood pressure became extremely high and caused extra concern. It was advised to consider going to hospital but stated would go if it became worse. 1:15 Benadryl started to take hold and some relief was received. Called Dr from the car on the way home (about 1:45pm) and was advised to monitor closely and if it became worse to go to the hospital. Itching and sensitivity to items continued for 3 to 4 days after the shot.
57 2021-04-05 loss of smell, loss of taste Day # 2: pain at injection site 2-21: itchy throat with cough (mostly dry with lite phlegm) hacking ... Read more
Day # 2: pain at injection site 2-21: itchy throat with cough (mostly dry with lite phlegm) hacking and severe choking at times 2-21: shortness of breath, at times complete loss when coughing/choking 3-7: malaise, sleepy 3-7: muscle aches, especially legs with calve spasms 7-21: sinusitis 7-21: upset stomach, gassy, gurgling, loose stools, heartburn 8-12: losing sense of taste 12-16: complete loss of taste 16-21: taste returning, but still "off"
57 2021-04-05 toothache On 3/25/2021, started seeing rash, hive and feeling itchy, got worse thru the night when it started ... Read more
On 3/25/2021, started seeing rash, hive and feeling itchy, got worse thru the night when it started throughout my body and feeling throat stuck, chest pain. Next day, allergic reaction started spread to my face, ear and eyelids. Went to urgent care immediately. The doctor immediately gave me steroid, Zyrtec, Benadryl tablets to calm down the allergic reaction and instructed that I continue to take them for 5 days. After 5 days, I still experiencing lingering and minor rash, itchy sporadically on my body mainly hands, arms, ankle and bottom of feat. Consulted gastroenterologist and allergist, inconclusive of the root cause. Was on prescribed Omeprazole 40mg, Vitamine De+K2, Probiotics prior the vaccination. Also took half of Advil tablet for 3 days to relieve tooth ache prior to the allergic event. Have stopped since then.
57 2021-04-05 visual impairment, eye floaters, light flashes or floaters in the eye After the first vaccine, l experienced swollen right lymph node. After the second dose, I see severe... Read more
After the first vaccine, l experienced swollen right lymph node. After the second dose, I see severe flashing of lights and floaters in the right eye. It happened 3 hours after the 2nd vaccine.. l went to see a retina opthlamalogist. He has referred me to a nueroopthalmologist. He thinks the optic nerve is inflamed. This is a reaction to the vaccine. I can barely see out of the right eye and l have 20/20 vision.
57 2021-04-06 extreme sound sensitivity About 6 hours later flu like symptoms, body aches, fever. The next day having tinnitus type symptom... Read more
About 6 hours later flu like symptoms, body aches, fever. The next day having tinnitus type symptoms and sensitivity to sounds. That lasted about another day and seemed to go away. Then the same hearing symptoms came back on April 5. I went to my Ear, nose and throat doctor and they said I had moderate sudden hearing loss in my left ear. I have gone before and they had a baseline test to compare it to. They have prescribed a steroid, prednisone to try to help. They said there is a possibility the hearing loss could be permanent.
57 2021-04-06 mouth numbness Extreme stiffness that was from shoulder up into neck. Extreme nausea dizziness chills extreme head... Read more
Extreme stiffness that was from shoulder up into neck. Extreme nausea dizziness chills extreme headache and fatigue. for 7 days. Would never go completly go away and would intensify and start again severely making it impossible to leave the house. On day 7 and 8 still nausea with diarhea. The heaasche dizziness and brain fog were from days 4-7 Shaking and delayed movement of legs numbness around lips and tongue on day7 Was told noone knew what to do and just drink water. Awful to be this sick for one week.
57 2021-04-06 oropharyngeal discomfort, taste impairment, vision blurred 1100 vaccine was given 1125: Patient feels headache, metal taste in her mouth. She feels some dizzin... Read more
1100 vaccine was given 1125: Patient feels headache, metal taste in her mouth. She feels some dizziness, vision feels blurred. She is breathing with her mouth open and feels out of sorts. After 15 minutes she had a "funny feeling in her throat" Transferred to the ED at 1140, first responder team was called
57 2021-04-06 ringing in ears have had chronic tendonitis started 2 days after injection and tinnitus that started about 10 days ... Read more
have had chronic tendonitis started 2 days after injection and tinnitus that started about 10 days after injection
57 2021-04-07 mouth tingling I started to pass out and had tingling on the back of my tongue and the tips of my fingers. My hear... Read more
I started to pass out and had tingling on the back of my tongue and the tips of my fingers. My heart rate went over 120 and then my BP shot to 218/110. I was taken to the ER and was given epinephrine and fluids in an IV. It took a few hours for my BP to get to within normal range. I had no other effects after being dismissed from the ER other than fatigue and a rapid heart rate off and on for a few days. My oxygen rate always stayed high throughout.
57 2021-04-07 ringing in ears tinnitus - ongoing
57 2021-04-08 swollen tongue Angioedema (swelling to tongue and side of neck) that started 4 days after vaccination. Swelling imp... Read more
Angioedema (swelling to tongue and side of neck) that started 4 days after vaccination. Swelling improved with steroids, epi, Benadryl and observation. Patient is on lisinopril (has been on for some time) and this is likely precipitated the event.
57 2021-04-08 swollen tongue Swelling of the tongue and throat
57 2021-04-08 tunnel vision Client received first dose @12:18 pm, felt flushed with tunnel vision @12:54 pm. Client's vital si... Read more
Client received first dose @12:18 pm, felt flushed with tunnel vision @12:54 pm. Client's vital signs stable, no symptoms by 1:04 pm. Able to go home by 1:14 pm.
57 2021-04-09 eye itchiness Extreme fatigue, itchy eyes, headache
57 2021-04-09 lacrimation increased Within 15 min of receiving vaccine, patient reported watery eyes and slight SOB. Patient was still a... Read more
Within 15 min of receiving vaccine, patient reported watery eyes and slight SOB. Patient was still able to talk and was given 50mg of diphenhydramine. After approx 20 min. patient reported being better and left pharmacy
57 2021-04-10 loss of taste, ringing in ears Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symp... Read more
Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symptoms: lack of taste, muscle pains in lower extremities/back/arm, ringing ear, itching, throat narrowing/shortness of breath, weight loss, extreme fatigue and weakness for several days; brain fog, dizziness, difficulty swallowing/sleeping.
57 2021-04-10 vision blurred 6 minutes after administration patient displayed symptoms of labored breathing, pale skin pallor, an... Read more
6 minutes after administration patient displayed symptoms of labored breathing, pale skin pallor, and was no longer verbally responding. Patient was slumping in their seat and eyes were not focused. One dose of auto-injector epi-pen was administered 1-2 minutes after symptoms presented. 1-2 minutes after epinephrine administration patient's mental status was back to normal. Monitored patient until paramedics arrived. Patient was allowed to go home following paramedics' assessment.
57 2021-04-11 taste impairment Body aches, chills, nausea, headache, metallic taste
57 2021-04-11 oropharyngeal discomfort Throat fullness with no rash or shortness of breath noted. Pt got IM Benadryl and felt much better i... Read more
Throat fullness with no rash or shortness of breath noted. Pt got IM Benadryl and felt much better in the car and was observed and DC home. BP 160/84 P 95 Sat 98%. BP went down to 146/89
57 2021-04-11 mouth tingling, mouth numbness c/o heavy tongue and numbness in the lips
57 2021-04-11 mouth tingling, lip swelling Tingling and slight swelling of lips started 1 hour after injection. This the fifth day and still e... Read more
Tingling and slight swelling of lips started 1 hour after injection. This the fifth day and still experiencing symptons, started to take Benadryl for the past 5 days. Diarrhea for 5 days and no appetite. Take acid reducing meds.
57 2021-04-11 taste disorder Injection site pain Extreme tiredeness Severe chills entire night after injection Nausea 2 days aft... Read more
Injection site pain Extreme tiredeness Severe chills entire night after injection Nausea 2 days after injection Bad taste in mouth Feeling unwell Getting better, not fully recovered at time of this writing
57 2021-04-12 dry mouth Headache-immediately lasting 4-7 days intermittently Fever-4 days Nausea (Weakness and Dizziness) M... Read more
Headache-immediately lasting 4-7 days intermittently Fever-4 days Nausea (Weakness and Dizziness) Muscle spasms and joint pain Fever -4 days Chills Fast heartbeat Cotton mouth/tightness in throat Chest tightening Tiredness Injection site pain, swelling of arm glands/nodes
57 2021-04-13 loss of taste, loss of smell Patient received Pfizer COVID vaccine on 2/15/2021 and 1/27/2021. On 4/8/2021 developed fever, head... Read more
Patient received Pfizer COVID vaccine on 2/15/2021 and 1/27/2021. On 4/8/2021 developed fever, headache, loss of taste/smell, and sore throat. Tested positive for COVID.
57 2021-04-13 oropharyngeal discomfort, drooling Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Ex... Read more
Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Excess saliva. As the pain persisted the pain radiated to the left arm/shoulder. We sought help at our local emergency department where she was found to be in new onset atrial fibrillation. A battery of tests were ordered including a troponin which was noted to be: 1.48. She was transported via ambulance to the hospital to be admitted and undergo left heart cardiac catheterization with the presumptive diagnosis of NSTEMI.
57 2021-04-13 eye floaters, light flashes or floaters in the eye Pfizer-BioNTech COVID-19 Vaccine EUA The most troubling of the side effects, if it is a side effect,... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA The most troubling of the side effects, if it is a side effect, is that I had an "eye flasher" for the first time on 4/12/2021. I went to the doctor on 4/13/2021, and the doctor confirmed that this is what it was. I do not know if it is related, but coming so soon after the vaccination, I thought it is possible and wanted to report it. (I also had more common symptoms the day after the shot (the day after being 4/8/2021), with those symptoms being tiredness and fever of 101.2. Those symptoms lasted about a day.)
57 2021-04-14 mouth numbness, mouth tingling After 30 mins, my lower lip started tingling and became numb. In 15 mins, my left side of my face ... Read more
After 30 mins, my lower lip started tingling and became numb. In 15 mins, my left side of my face was numb and tingling. It then spread to the right side. My throat started itching and then my ears began itching. I then got a headache. I contacted my primary dr office. They would not see me because they didn't give the shot. I text my allergy office. They told me to take Benadryl and keep my epi pen close. I did. After an hour and a half, the symptoms didn't improve so I decided to go to the Urgent Care. By this time, the numbing/ tingling feeling was going down my arms and back. They said my blood pressure was a little high and I had a slight fever, 99,8. I felt awful. The urgent care said there wasn't anything they could do but recommend continual use of benadryl and ibeprophen. I went home and rested. The numbness and tingling lasted until around 5:00. The itchy throat/ears and bad headache continued until I went to sleep around 9:30. I slept through the night. All symptoms were gone except for a sore arm, in the morning.
57 2021-04-14 mouth numbness, mouth tingling Dizziness, tingling and numbness in lips Patient left Site
57 2021-04-14 mouth numbness 09:16 Pt states her throat was "closing in" and was feeling slightly dizzy. A couple of minutes late... Read more
09:16 Pt states her throat was "closing in" and was feeling slightly dizzy. A couple of minutes later she reports numbness to her tongue and mouth. VS otherwise stable BP 141/72 98% on RA HR 70, in no acute distress, speaking in full sentences. Drinking water without difficulty. Benadryl 2Pt states her throat was "closing in" and was feeling slightly dizzy. A couple of minutes later she reports numbness to her tongue and mouth. VS otherwise stable BP 141/72 98% on RA HR 70, in no acute distress, speaking in full sentences. Drinking water without difficulty. Benadryl 25mg was given orally at 09:18. Symptoms gradually resolved. Pt continued to be observed until complete resolution of symptoms. Pt left observation area at 09:40. Pt reports swelling and erythema at injection site within 24 hours after the first dose.5mg was given orally at 09:18. Symptoms gradually resolved. Pt continued to be observed until complete resolution of symptoms. Pt left observation area at 09:40. Pt reports swelling and erythema at injection site within 24 hours after the first dose.
57 2021-04-14 visual impairment, vision blurred On the fourth day after the injection, I experienced blurry vision that was relatively mild over the... Read more
On the fourth day after the injection, I experienced blurry vision that was relatively mild over the course of maybe an hour. The next day, the same thing. The following day, March 25 (vaccine was 3/19) I experienced transitory vision field impairment in the left eye which came in from the left periphery. This came and went over the course of about 1-1/2 hour, including throughout the visit to my doctor. Prior to this, both my 21 year old daughter (who was vaccinated the same time as I was), experienced sudden migraines at the same time. On Saturday 3/27 I began to experience a twitch/pulse which is still happening intermittently in my left cheek. I received the second dose of the vaccine April 9th. The twitching continues. Additionally, I had sharp pain across the length of the sole of my foot that was brief. It recurred three times. I've had a thorough workout which does not indicate the source of the problem. I've begun taking baby aspirin, but experience minor bleeding if I take it more than once weekly.
57 2021-04-15 eye pain, mouth pain, dry throat Symptoms first occurred approximately 26 hours after injection (4:30 pm following day). Initial sym... Read more
Symptoms first occurred approximately 26 hours after injection (4:30 pm following day). Initial symptom was mild headache progressively increasing in severity with pain between the eyes and at top of left eyeball. Pain in both shoulder joints, swollen fingers, inability to sleep, dry throat, abdominal pain in liver & spleen, pain in mouth, nausea, vomiting. Symptoms lasted approximately 14 hours until 6 am.
57 2021-04-15 lacrimation increased Early morning after second dose: severe pain in left side of neck progressing up to forehead causing... Read more
Early morning after second dose: severe pain in left side of neck progressing up to forehead causing severe headache, dry hacking cough, difficulty breathing. Saw PCP, Dr that day and was prescribed steroids to assist with breathing and cough syrup. Next day same side effects but meds helping, nervous energy. Note: had nervous energy after first dose on first few days as well. April 10, 2021, four days after second dose: phlegm building up in head and chest, coughing with little phlegm, so thick it causes choking with eyes and nose running, leading to loss of breath and almost loss of consciousness, severe headaches, continued neck pain with swelling appears to have radiated from left arm injection site, continued difficulty breathing, severe nausea and stomach cramping, body aches especially in legs, hot flashes mixed with chills (back and forth.) No fever, however. Contacted PCP. As of April 16, 2021, side effects continue with weakness in limbs, extreme lethargy and sleepiness, but restless sleep that's interupted by coughing/choking.
57 2021-04-16 taste impairment Approximately seven minutes after my injection, I tasted a metallic taste in my mouth and I began ... Read more
Approximately seven minutes after my injection, I tasted a metallic taste in my mouth and I began experiencing extreme rapid heartbeat , extreme shakiness and extreme panic and anxiety.. I quickly alerted a nurse who had me lay down and took my vitals and gave me something to eat and drink. They observed me for an additional half hour and then released me as I was feeling mostly better but still shaking a little.
57 2021-04-16 taste impairment Metallic taste in mouth. Starting to abate. No breathing or severe allergic reaction.
57 2021-04-16 lacrimation increased Violent itching, injection site side and face. Extreme eyes watering, nose running excessively. Face... Read more
Violent itching, injection site side and face. Extreme eyes watering, nose running excessively. Face beet red. BP 140/80 Sent home told to take Benadryl. Glands swollen and sore scratchy throat at home. Took Benadryl. Slept. Now 6 hours later glands swelling and extreme itchiness returning. Watery eyes
57 2021-04-16 bloodshot eyes, lacrimation increased At 0902, RRT activated when client (57 y/o F) called recovery nurse c/o feeling itchiness all over h... Read more
At 0902, RRT activated when client (57 y/o F) called recovery nurse c/o feeling itchiness all over her body, and she started turning red all throughout her upper extremities including face. Teary eyed and redness in eyes noted. Vaccinated at 0839 on the L arm. Has had severe anaphylaxis in the past for PCN. BP ? 140/80, HR ? 82, RR ? 22, Pain ? 0/0. Head to toe assessment completed. No PMH. Did not take any medications today. During monitoring period, client?s condition improved. Stated ?feeling much better? after 5 minutes, redness and tearing of eyes subsided. At the end of observation period, client was not experiencing what was experienced initially. Client remained in the post-vaccination area an extra 15 minutes per client?s request. She left the vaccination clinic at 0930 ambulatory, in stable condition.
57 2021-04-16 ringing in ears Left ear intermittent Low pitch sound Right ear intermittent pulsation/ swishing sound
57 2021-04-17 taste impairment Right after first shot I had a metallic tast so strong it made me sick to my stomach. My daughter al... Read more
Right after first shot I had a metallic tast so strong it made me sick to my stomach. My daughter also had this reaction. Mine went away three days after my daughters lasted a day.
57 2021-04-17 eye pain fever, chills, headache, eyes hurt, location of dental implant hurt, body hurts; fever, chills, head... Read more
fever, chills, headache, eyes hurt, location of dental implant hurt, body hurts; fever, chills, headache, eyes hurt, location of dental implant hurt, body hurts; fever, chills, headache, eyes hurt, location of dental implant hurt, body hurts; fever, chills, headache, eyes hurt, location of dental implant hurt, body hurts; fever, chills, headache, eyes hurt, location of dental implant hurt, body hurts; fever, chills, headache, eyes hurt, location of dental implant hurt, body hurts; This is a spontaneous report from a contactable consumer. A 57-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 26Mar2021 18:30 (Batch/Lot Number: ER8732) as single dose for covid-19 immunisation. Medical history included, Biaxin allergies. Concomitant medication(s) included vitamin d3 (VITAMIN D3). The patient previously took bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 18:30 as single dose for COVID-19 immunization. The patient experienced fever, chills, headache, eyes hurt, location of dental implant hurt, body hurts 27Mar2021 10:15. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
57 2021-04-17 eye discomfort breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started q... Read more
breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started quivering and twitching; swelling sensation on her left side of her face; left cheek area felt swollen and tingly; pressure around the eye sockets; Could this be a sign of Bell's Palsy, and is it likely that she develop Bell's Palsy?; This is a spontaneous report from a contactable consumer (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in left arm on 30Mar2021 14:00 at a single dose for covid-19 immunization. Medical history included has back issues, but nothing serious probably for about 7 years and patient stated that she had a Pilates injury and after that her back has never been the same; and patient stated that she was pretty healthy, adding that she was allergic to sulfa, cow's milk, wheat, and almond. Family medical history relevant to events reported included mom has osteoporosis, and severe dry eye syndrome. The patient's concomitant medications were reported as she doesn't take any regular medicines but she does take regular supplements and herbs and stated that she was very lucky. Patient stated that Pfizer COVID-19 vaccine was the he one she trusted the most and she doesn't want to die from COVID if she gets it. Patient received her dose in her left arm, at the time of administration, on 30Mar2021 14:00, she was breathing out, then her "cheeks, lips, and mouth started quivering/trembling and it was definitely noticeable". Patient further stated that while it was being administered her cheeks, mouth and lips started quivering and twitching. She also reported that immediately afterward (30Mar2021), she experienced a swelling sensation on her left side of her face, "kind of how it feels when you have novocaine, but no visible signs of swelling or drooping". Her left cheek area felt swollen and tingly. She stated that it felt swollen but it didn't look swollen, like when you go to the dentist. She also experienced pressure around the eye sockets. She added that both areas under eye sockets felt a little bit weird, tight or something but not like a pain, hard to describe. All of these symptoms resolved within a few hours, and 24 hours later she's "pretty much back to normal". The pressure around eye socket, lasted for a few hours; while trembling and quivering only happened when the shot was being administered, and 24 hours later, she was pretty much back to normal. Patient asked if this has this been reported before and if she should she get her second dose. Patient stated if this could this be a sign of Bell's Palsy, and was it likely that she develop Bell's Palsy (30Mar2021). Patient stated that all her family have all received their doses and no one had this kind of reaction. She wanted to take the second vaccine, just doesn't want to have a stroke or heart attack or anything like that. She stated that all of her events are completely gone except she still has a little bit of swollen feeling left in her cheek on a scale of 1-5 with 5 being the worst, she would say it is a 1, its pretty much gone, the swollen feeling. She stated that provider was aware of the events because she called and told her yesterday. Her family got their vaccines either moderna or Pfizer and have had no issues, other than typical ones such as forearm, a little bit of nausea, or fever but nothing like what the caller has experienced. She was the only one in her family that has had this issue. She did not have any kind of rash, no fever nausea or headache, and stated it was just like getting her flu shot. The patient did not require emergency room and physician office visit. The event swelling sensation on her left side of her face was recovering. The outcome of the other events reported was recovered on 31Mar2021.
57 2021-04-17 sensitivity to light, vision blurred April 1: loss of small patch of corneal epithelium in left eye, upper temporal region. Eye pain. P... Read more
April 1: loss of small patch of corneal epithelium in left eye, upper temporal region. Eye pain. Prophylactically treated with Olfloxacin 3x/day for 2 days, and recovered. Resumed contact lens use 24 hr later. April 9 eye pain left eye again, seen by optometric April 10, loss of corneal epithelium upper nasal eye resgion, start Ofloxacin again. Monday 4/12 pain, light sensitivity, saw optometrist again, now has turned into a corneal ulcer, switched to Moxifloxacin 3x/day. Tuesday 4/13 pain, light sensitivity and vision blurred, increase Moxifloxacin to 4x daily. Thursday 4/15, corneal ulcer still painful but changed in appearance saw ophthalmologist, increase Moxifloxacin to once per hour. Fri 4/16 extreme dizziness, imbalance soon after getting out of bed and fell down. mild dizziness continues next 2 days. Not sure if any of these related to the vaccine but since they started soon after the vaccine thought I should mention it.
57 2021-04-17 visual impairment Patient received her vaccine and during the 15 minute observation period, her husband called us over... Read more
Patient received her vaccine and during the 15 minute observation period, her husband called us over. She was extremely sweaty, had clammy hands, eyes were fading in and out, and appeared as if she was about to pass out twice. No reports of trouble breathing. Called 911, stayed with patient until the paramedics came who then escorted her.
57 2021-04-17 visual impairment tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ... Read more
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
57 2021-04-18 loss of smell ? tiredness ? headache ? muscle pain ? chills ? injection site redness ? feeling unwell above sympt... Read more
? tiredness ? headache ? muscle pain ? chills ? injection site redness ? feeling unwell above symptoms were disappeared at third day but still lost sense of smell
57 2021-04-18 eye movement disorder, gaze palsy Patient told check-in staff that she had pre-medicated for anxiety prior to coming for first COVID-1... Read more
Patient told check-in staff that she had pre-medicated for anxiety prior to coming for first COVID-19 vaccine. Prior to vaccine, patient told vaccinator she was anxious. She shared that she had a history of laryngospasm triggered by some smells. Vaccinator approached writer asking if arm could be cleansed with soap and water prior to vaccination instead of alcohol wipe although patient stated she felt she would be ok with alcohol wipe being used. Writer advised that vaccine site was not equipped with supplies to cleanse arm in that fashion. Advised vaccinator to offer additional mask to patient to cover hers to prevent odors and to turn head while arm being cleansed. (continued on next page)
57 2021-04-18 feeling of choking Throat tingling-congestion. said "Filling up w/fluid-feels like." Had same reaction with Cipro + wa... Read more
Throat tingling-congestion. said "Filling up w/fluid-feels like." Had same reaction with Cipro + was hospitalized. Seen by EMTs-Transported to hospital.
57 2021-04-19 eye pain, loss of taste, ringing in ears, loss of smell Fever up to 101.8, runny nose, cough, covid headache, loss of taste and smell, tinnitus, eye socket ... Read more
Fever up to 101.8, runny nose, cough, covid headache, loss of taste and smell, tinnitus, eye socket pain, boxy aches, bone pain in femurs, nausea, diarrhea - the exact same symptoms I had when I had covid in December, and most had continued off and on for three months.
57 2021-04-19 mouth itchiness, eye itchiness Mild allergic reaction - itching throat, teeth, mouth, eyes
57 2021-04-19 ringing in ears I had covid19 last March 2020 and after I recovered I developed tinnitus in my right ear that is sti... Read more
I had covid19 last March 2020 and after I recovered I developed tinnitus in my right ear that is still a problem for me today. The ringing level was at a 4-5 range before and immediately after the 1st Pfizer vaccine shot on 4/4/21, the ringing level went to a 9-10 and is still at that current level today after almost 3 weeks. I am not going to get the 2nd shot because of this reaction, and wanted it to be documented,
57 2021-04-19 vision blurred, double vision I experienced double vision and difficulty in focusing. This is not a symptom I've ever experienced... Read more
I experienced double vision and difficulty in focusing. This is not a symptom I've ever experienced before. I was outside walking around when it began. I also had a mild headache. The vision problems ended after around two hours.
57 2021-04-20 eye pain Just after 3:00 am, I was very nauseous, vomiting repeatedly while every bone and muscle ached sever... Read more
Just after 3:00 am, I was very nauseous, vomiting repeatedly while every bone and muscle ached severely. My stomach muscles went into spasms and my head felt like what i imagine a migraine feels like. The pain behind my left eye was severe. My left side of neck felt like there was a knot and it took all my strength to try to massage it felt like no blood was moving. Strangest feeling I have ever had. Went from chills to sweats every 3-4 minute cycles. Did not feel like I had a fever though. I am 0 - blood type if that matters. Day 2 all but body aches are gone.
57 2021-04-20 hearing loss Swollen lymph node under right are, slight tingling in right ear canal, slight tingling of exterior ... Read more
Swollen lymph node under right are, slight tingling in right ear canal, slight tingling of exterior right chin, increased hearing issues in right ear since time of vaccine.
57 2021-04-20 swollen tongue Swollen tongue , difficulty breathing. We gave 1 Epipen and called EMT, she got better and then was ... Read more
Swollen tongue , difficulty breathing. We gave 1 Epipen and called EMT, she got better and then was fine
57 2021-04-20 thirst Palpitations, Nausea, Headache, Tired, weak, cold sweat, stomach ache, thirsty.
57 2021-04-20 thirst On 4/18/21 the day after receiving my second Pfizer vaccine. I awoke fatigued and with a sore right ... Read more
On 4/18/21 the day after receiving my second Pfizer vaccine. I awoke fatigued and with a sore right arm and fever of about 99. The fatigue increased, and then included extreme thirst despite drinking plain water throughout the morning and early afternoon, then I experienced slight nausea, then syncope after attempting to sit for a few moments, after having been resting (in a prone position) around 1 pm. My husband was unable to revive me - he says my eyes were open but I was not responsive so he called 911. I regained consciousness after receiving saline via IV and then was taken to the ER for follow up testing, then released a few hours later - around 4 pm. It it likely relevant to know I had passed out from fever brought on by flu during the very harsh flu season a few years before, at the onset of influenza, although vaccinated that year for flu.
57 2021-04-21 taste impairment Patient had COVID Pfizer vaccines on 1/13/21 and 2/3/21. Known exposure to COVID and had positive CO... Read more
Patient had COVID Pfizer vaccines on 1/13/21 and 2/3/21. Known exposure to COVID and had positive COVID-19 PCR testing on 3/28/21; symptoms of runny nose and dysgeusia.
57 2021-04-21 mouth numbness Patient presents to the ED with chief complaint of dizziness, muscle aches, tongue numbness, and thr... Read more
Patient presents to the ED with chief complaint of dizziness, muscle aches, tongue numbness, and throat tightening starting approximately 1 hour after she received her first COVID-19 Pfizer vaccine at ER and Urgent Care.
57 2021-04-21 smell distorsion Altered sense of smell, 3 months after the second dose.
57 2021-04-22 dry throat Pt. stated "I started feeling a lot of dryness on my throat 10 min. after getting vaccinated. Vital... Read more
Pt. stated "I started feeling a lot of dryness on my throat 10 min. after getting vaccinated. Vital signs taken 147/62, 100% O2Sat, HR 78, R 16. No difficulty breathing or swallowing. At 3:35pm pt. reported feeling better and think she is ready to go home. At 3:40pm pt. went home with family member.
57 2021-04-22 ear pain Upon injection I immediately felt "PINS" stabbing my hands, arms, neck, face and feet. After 30 min... Read more
Upon injection I immediately felt "PINS" stabbing my hands, arms, neck, face and feet. After 30 minutes of injection sudden severe headache (lasted 1 hour) nausea for 1 1/2 days, 1 bout of diarrhea, earaches, sinus aches intermittently for 2-3 days. (Of course the usual side effects of minor arm pain at injection site the day after injection along with chills, low grade fever and lethargy for 2 days.)
57 2021-04-22 eye swelling, lip swelling Hives (neck, chest, back and arms); swollen right upper lip, swollen under eye (right); vice-like... Read more
Hives (neck, chest, back and arms); swollen right upper lip, swollen under eye (right); vice-like headache, fever of 102.8, stiff neck, neck spasms, general aches and pains.
57 2021-04-22 lip blister, mouth discomfort, lip swelling, lip itchiness I had my first vaccination for COVID-19 on March 31, 2021. 14 days after that vaccination, I had a m... Read more
I had my first vaccination for COVID-19 on March 31, 2021. 14 days after that vaccination, I had a minor outbreak of SJS but that cleared prior to my second vaccination. My second vaccination was April 21, 2021 at 2:51pm and I had no reaction for the first 36 hours. I woke up at 3am on Friday, April 23 with swelling, itching, burning lips with blisters which is a symptom of SJS so I can only assume that the vaccination is causing the outbreak. I am currently seeking medical attention from my dermatologist for treatment. I also have blisters on my gums and it is extremely painful. I am reporting the adverse reaction but I do not know if the SJS will continue to escalate as in 2011, I was treated multiple times in the emergency room.
57 2021-04-22 oropharyngeal discomfort C/O dizziness, nausea and sensation of throat closing. Speech clear, A/Ox4, able to drink fluids. De... Read more
C/O dizziness, nausea and sensation of throat closing. Speech clear, A/Ox4, able to drink fluids. Denies chest pain or shortness of breath. States hadn't eaten today and very little oral intake of fluids since yesterday. Medics on scene, care assumed.
57 2021-04-22 mouth tingling Pt. stated, "I started feeling tingling on my upper lip and numbness on my nose, 15 min. after getti... Read more
Pt. stated, "I started feeling tingling on my upper lip and numbness on my nose, 15 min. after getting vaccinated." Vital signs done B/P 164/85, HR 86, O2Sat 97%, R 19. At 12:56pm, pt. stated, "Tingling and numbness is going away." At 1:10pm B/P was 140/78. At 1:14pm pt. reported feeling better. At 1:16pm pt. went home.
57 2021-04-22 taste disorder, taste impairment In addition to the previously reported adverse effects, I have had a metallic, rancid taste in my mo... Read more
In addition to the previously reported adverse effects, I have had a metallic, rancid taste in my mouth that has lasted for over 10 days now.
57 2021-04-22 vision blurred I experienced blurry vision after 1st dose to a mild extent,lasted approx 1-1/2 days. After 2nd dose... Read more
I experienced blurry vision after 1st dose to a mild extent,lasted approx 1-1/2 days. After 2nd dose is much worse, at this point lasted a day, not sure exactly what time it stated. Indicated the symptom to individual giving 2nd dose,she had not heard this as side effect and have not found online. I do wear glasses for far sightedness, astigmatism and reading. Not really adverse as life threatening but did not see it reported as a side effect. Also have many of the other typical side effects.
57 2021-04-23 ear pain Received the first dose of hte Pfizer COVID19 vaccine on 4/8/2021. Developed cold-like symptoms on F... Read more
Received the first dose of hte Pfizer COVID19 vaccine on 4/8/2021. Developed cold-like symptoms on Friday, 4/9/2021, including: congestion, headache and right ear pain. On Saturday, 4/10/2021, had persistent headache, congestion and right ear pain. Also develoepd tingling on the right side of her face. She was evaluated at Urgent Care on 4/10/2021 and recommended supportive care for right ear pain. On Sunday, 4/11/2021, developed complete paralysis of the right side of her face. She was evaluated in office on 4/12/2021 and diagnosed with Bell's Palsy based on exam - patient with complete right sided facial paralysis. She was treated with prendisone taper (prendisone 60 mg for 7 days, then 40 mg for 3 dyas, then 20 mg for 3 days) and Valtrex 1000 mg three times daily for 1 week.
57 2021-04-23 mouth tingling, dry mouth patient experienced lips tingling after 5 min, then dry mouth.. Lip Tingling went away but still had... Read more
patient experienced lips tingling after 5 min, then dry mouth.. Lip Tingling went away but still had dry mouth after 15min.
57 2021-04-23 vision blurred 4.22.21 11:15 - 11:30 AM Injection 11:45 AM - 12:00 PM - Quick onset of Vertigo and Increased Blood... Read more
4.22.21 11:15 - 11:30 AM Injection 11:45 AM - 12:00 PM - Quick onset of Vertigo and Increased Blood Pressure (Quick Rise from normal pressure to elevated blood pressure) 12:15 PM Nausea, Headache and Fuzzy Vision 1:15 PM Blood Pressure checked at a doctor's visit previously scheduled for this time. Systolic increased by 33 points and Diastolic increased by 10-15 points from my normal. 3:00 PM Quick onset of extreme exhaustion, joint and muscle pain 5:00 PM Melancholy 4.23.21 Symptoms Persisted with acute onset of hand pain on side of injection 4.24.21 Blood Pressure Normalized and most symptoms reduced, except fatigue
57 2021-04-24 mouth tingling Within 25 minutes of injection, began having: Tingling in lips and tongue. Redness in lips. Itchines... Read more
Within 25 minutes of injection, began having: Tingling in lips and tongue. Redness in lips. Itchiness in face; later felt in legs. Scratchy throat. Red splotchy areas on both arms. Symptoms continued for over 2 hours. Took a Benadryl (25 mg) around 10:30 am. Most symptoms gradually went away, but continued to feel intermittent skin itchiness in limbs for the rest of the day. Felt bad all day.
57 2021-04-24 thirst possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal p... Read more
possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal pain; temperature spike at 101; unquenchable thirst; sweating; This is a spontaneous report from a contactable consumer (patient) reported for herself that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 08Apr2021 04:00 PM (Lot Number: EW0151) at single dose for covid-19 immunization. Medical history included multiple allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, orthostatic hypotension from an unknown date and unknown if ongoing , traumatic lung injury from an unknown date and unknown if ongoing , metaplasia from an unknown date and unknown if ongoing , hiatus hernia from an unknown date and unknown if ongoing , polyp from an unknown date and unknown if ongoing , diverticulum intestinal from an unknown date and unknown if ongoing , exposure to toxic agent from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine taken for an unspecified indication, start and stop date were not reported; calcium carbonate;soya isoflavones;vitamin d nos taken for an unspecified indication, start and stop date were not reported; ibuprofen;phenylephrine hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously took firs dose of bnt162b2 (BNT162B2) intramuscular, administered in Arm Right on 18Mar2021 04:15 PM(Batch/Lot Number: ER2613) at single dose for covid-19 immunisation. The patient experienced possible seizure on 08Apr2021 20:00 with outcome of recovering , chills on 08Apr2021 with outcome of recovering , headache on 08Apr2021 with outcome of recovering , joint and long bone pain on 08Apr2021 with outcome of recovering , dizziness on 08Apr2021 with outcome of recovering , fainting on 08Apr2021 with outcome of recovering , right abdominal pain on 08Apr2021 with outcome of recovering , temperature spike at 101 on 08Apr2021 with outcome of recovering , unquenchable thirst on 08Apr2021 with outcome of recovering , sweating on 08Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: temperature spike at 101 on 08Apr2021. Therapeutic measures were taken as a result of possible seizure. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical course was reported as follows: 4 hrs post vax: chills, sub normal temperature drop >96 f oral, eat, and airmpit , sub normal low BP, headache, joint and long bone pain, dizziness, 2 episodes of warned fainting (vasovagal); followed by temperature spike at 101 F oral onset @21 hrs. post vax riggors and falls, with warned loss of consciousness & possible seizure, followed by lower right abdominal pain w/rebound tenderness, sweating, unquenchable thirst, until fever broke 30 hrs post onset. At febrile onset 400 mg ibuprofen, followed by 200 mg every 8 hrs until symptom resolution. The adverse event result in any of the following Doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event included Public Health RN telephone consult, ibuprofen see. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products:Yes a long list that does not include PG. Other diagnosed illnesses/medical history/chronic health conditions:IMMUNE SYSTEM: multiple allergies including anaphylaxis; R.A., reactive asthma; CARDIOPULMONARY: reactive asthma, chemical exposure lung injury scaring, COPD, orthostatic hypotension; GI: Barrets esophagial metaplasia, hiatal hernia, colonic polyps adenocarcinoma, diverticula. Follow-up (20APR2021): Follow-up attempts completed. No further information expected.
57 2021-04-24 ringing in ears, deafness, ear discomfort deafness; Tinnitus; ear pressure; This is a spontaneous report from a contactable consumer (patient)... Read more
deafness; Tinnitus; ear pressure; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0105) via an unspecified route of administration into the right arm on 05Apr2021 15:45 (at the age of 57-years-old) as single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, hypothyroidism and asthma. Patient was not pregnant. Concomitant medications included simvastatin (SIMVASTATIN), quetiapine (QUETIAPINE), magnesium (MAGNESIUM), acetylsalicylic acid (ASPIRIN (E.C.))and bepotastine besilate (POTAS). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534) into the right arm on 16Mar2021 01:00 PM (at the age of 57-years-old) for COVID-19 immunization. On 06Apr2021, patient experienced deafness, tinnitus and ear pressure. The patient did not receive treatment for the events reported. Outcome of events recovered on Apr2021.
57 2021-04-24 ringing in ears Sore arm at injection site, tinnitus 2 days after injection in right ear only.
57 2021-04-25 dry throat Pfizer-BioNTech Covid-19 Vaccine EUA Swelling in throat, difficulty breathing, difficulty speaking, ... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA Swelling in throat, difficulty breathing, difficulty speaking, very high blood pressure, dizzy, weakness, all symptoms began within 2 minutes of receiving shot, medical attention immediately on site, transported me to hospital as systems became worse shot me up with benedryl which over a few hours I was able to leave hospital, the systems subsided a bit but persisted with feeling like throat full of cotton for additional 4 days, still not feeling as did prior to shot- still having bouts of shortness of breath but getting better every day. still feel week, slugish, short on breath
57 2021-04-25 ear discomfort, ringing in ears, ear pain I started to experience pain in my right ear. Soon I felt pressure in my ear and sinuses. I felt l... Read more
I started to experience pain in my right ear. Soon I felt pressure in my ear and sinuses. I felt like I needed to unplug my ears but swallowing didn?t help. Additionally, my ears felt warm. At the same time the tinnitus in my right ear, which had been mild for years, became much more pronounced. It was debilitating and I had trouble sleeping. After the second shot, the symptoms continued except I started to feel them in my left ear as well. Now I also have tinnitus in the left ear, although it isn?t as loud as my right.
57 2021-04-25 ear discomfort I spiked a fever, had chills, and then started feeling pressure in my ears. The change in my ears a... Read more
I spiked a fever, had chills, and then started feeling pressure in my ears. The change in my ears and my hearing has not gone away. It's kinda of like when you get off a plane after flying
57 2021-04-25 mouth numbness, dry throat complained of numbness in lips, itchy, dry throat, sharp chest pain and slight shortness of breath. ... Read more
complained of numbness in lips, itchy, dry throat, sharp chest pain and slight shortness of breath. BP- 149/87, p-81, O2sat- 97% Lungs clear, no wheezing, resp even and unlabored, Chest pain 6/10 and sharp. Examined by Doctor. 1700-Patient laying on gurney, BP- 125/71, p-80, O2 sats- 98% EKG- Normal sinus rhythm, with normal t waves and ST waves (read by Doctor). Patient given juice 1705- states feeling better. Chest pain 2/10, no further shortness of breath, no dizziness, Patient's daughter did state that her mother's husband had passed away 11 years ago today and that may have contributed to the symptoms. Released home with her daughter with ER precautions
57 2021-04-25 lip swelling My upper lip is swollen. The swelling started in the upper right area at approximately 6 pm on April... Read more
My upper lip is swollen. The swelling started in the upper right area at approximately 6 pm on April 25. At a 7 am on April 26, my entire upper lip is swollen. Doctor has been notified, but have not spoken directly to physician.
57 2021-04-25 mouth tingling Tingling in lips and left side of face. Started immediately after injection and lasted for 30 minut... Read more
Tingling in lips and left side of face. Started immediately after injection and lasted for 30 minutes.
57 2021-04-25 swollen tongue Patient presented to vaccine clinic. She reported a reaction to a flu vaccine that resembled rheumat... Read more
Patient presented to vaccine clinic. She reported a reaction to a flu vaccine that resembled rheumatoid arthritis several years ago. No other vaccines since that time. Patient had questions regarding immune system and how the body reacts to the vaccine. Reviewed vaccine mechanism and side effects with patient. She proceeded to fill out consent and received her vaccination. After vaccine, she proceeded to the back of the room to wait her 30 minutes. Patient stable and did not alert staff to any symptoms. Afterwards, patient left waiting room and told nursing student that her tongue was swelling and she felt like her throat was closing. Nursing student alerted LPN who walked patient to urgent care. At that time, urgent care took over patient care.
57 2021-04-25 ringing in ears My tinnitus is worse that it was prior to the vaccine. The ringing in my ears is significantly loude... Read more
My tinnitus is worse that it was prior to the vaccine. The ringing in my ears is significantly louder.
57 2021-04-26 lip itchiness, mouth itchiness Itching started in the mouth then spread to lips and face, then progressed to thickening of throat a... Read more
Itching started in the mouth then spread to lips and face, then progressed to thickening of throat and difficulty swallowing.
57 2021-04-26 light flashes or floaters in the eye, eye floaters, visual impairment 12 hours after vaccine, started to have eye flashers in right eye, next day flashers went away, and ... Read more
12 hours after vaccine, started to have eye flashers in right eye, next day flashers went away, and floaters began to form as well as a 'gray screen' - screen lasted about a day. Following day, screen had gone away and floaters remained and still remain today.
57 2021-04-26 vision blurred, visual impairment, eye swelling, eye pain On April 1st lost all eye sight in right eye for a few minutes and wet feeling in right quad all da... Read more
On April 1st lost all eye sight in right eye for a few minutes and wet feeling in right quad all day (thought my leg was wet all day but wasn't). On April 2 woke up to stabbing pains in eye and couldn't see in right eye. Went to (Regular doc) that afternoon (Vision in left eye 20/25, right eye 20/70)she referred me to Opthamologist right then. Opthamologist diagnosed me with Optic Neuritis in right eye (50% loss of brightness and color). Referred to Neurologist, hands and legs going numb, bad vertigo. Neurologist ordered 3 MRIs with and without contrast (Brain, Thoracic spine and cervical spine). All clear. Numbness, vertigo continues. On April 18th woke up with swollen/red cheeks and fluid build up under both eyes.. same place a where filler was injected into face. On April 19, did a wide range of blood work...all normal except CRP was 25.1. Gave me penicillian and steroid shot, and 7 day steroid pack. Vertigo and numbness continued. On April 27th symptoms seem to be a better but everyday this moves around my body with different symptoms like one day my left hand is numb and the next it's my right hand. Eyesight still not normal. Vision in right eye is blurry, compared to left.
57 2021-04-27 taste impairment Head pressure and metallic taste. EMS with the patient.
57 2021-04-27 taste disorder Patient reports medicine taste in her mouth without associated difficulty swallowing, itchiness,sob.... Read more
Patient reports medicine taste in her mouth without associated difficulty swallowing, itchiness,sob. Patient given ER precautions and told to follow-up with pcm if persistent symptoms.
57 2021-04-27 ringing in ears Received the shot on Saturday and was fine until I woke up at 6am Sunday with a fever. By 8am Sunday... Read more
Received the shot on Saturday and was fine until I woke up at 6am Sunday with a fever. By 8am Sunday I had ringing in both ears. It has gotten worse over the next few days. It's consistent and loud. Will be scheduling a Dr. visit although I don't think anything can be done about this. As it stands right now, I regret getting the covid vaccine.
57 2021-04-27 toothache, mouth tingling 4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis,... Read more
4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis, like I was going to die 1:13pm took 2 Benadryl 25mg 5:30pm took 1 Benadryl 25 mg Loose stools all day, stayed home as Benadryl was working 4/25/21 12:30am took 1 Benadryl 25mg (weird feeling in my tongue) 1:25pm took 1 Benadryl 25mg for pain in my cheekbones & teeth and rash on both cheeks below eyes 1:58pm took 1 Benadryl 25mg " " 2:19pm took 1 Benadryl 25mg " " 2:49pm checked into hospital emergency room as allergic reaction would not subside 4:30pm got IV with Benadryl 25mg, Methylprednisolone & Pepcid (throat felt strange) 7:26pm discharged from ER 4/26/21 Medrol 24g 4/27 Medrol 20g
57 2021-04-28 mouth numbness HA, chills, anxiety, tongue and fingers go numb during anxiety attack 4-24-21ER was told she had a p... Read more
HA, chills, anxiety, tongue and fingers go numb during anxiety attack 4-24-21ER was told she had a panic attack
57 2021-04-28 taste disorder Body and muscle pain, joint pain, nausea, headache, taste change, fatigue, body weakness
57 2021-04-28 vision blurred woke up and my left side of my face was numb with blurred vision
57 2021-04-29 loss of smell, loss of taste Cough Headache New loss of taste or smell Congestion or running nose
57 2021-04-29 lip swelling Facial fillers have ballooned up, cheeks and lip really swollen and red
57 2021-05-01 extreme sound sensitivity, ringing in ears worsen both my pulsatile tinnitus and hyperacusis and hasn't subsided
57 2021-05-01 ringing in ears, swelling of eyelid, hearing loss, ear pain Headache, cold, eye lid got big with pain and not closing properly, pain in back of left ear with ri... Read more
Headache, cold, eye lid got big with pain and not closing properly, pain in back of left ear with riggings, left face switch to right side, unable to hear properly, unable to talk properly on 3/4/2021 but left face switch still persiste on 5/2/2021 Treatment with Valacyclovir and prednisone
57 2021-05-04 ringing in ears, extreme sound sensitivity, deafness moderate hearing loss; hyperacusis; tinnitus; This is a spontaneous report from a contactable consum... Read more
moderate hearing loss; hyperacusis; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 10Mar2021 13:00 at single dose for covid-19 immunisation. The patient's medical history included hypertension. The patient was not pregnant at time of vaccination. The patient's concomitant medications included desvenlafaxine, candesartan, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and azelastine. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264) via an unspecified route of administration, administered in Arm Left first dose on 17Feb2021 for covid-19 immunisation. On 11Mar2021 14:00, the patient experienced moderate hearing loss confirmed by doctor hyperacusiss and tinnitus. The patient was treated with oral steroids. The events cause physician office visit. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
57 2021-05-06 eye itchiness, eye swelling, bloodshot eyes 05/04/2021-> MY BOTH EYE STARTED EACHY LITTLE BIT ON SAME DAY OF 1ST DOSE COVID19 VACCINATION . 0... Read more
05/04/2021-> MY BOTH EYE STARTED EACHY LITTLE BIT ON SAME DAY OF 1ST DOSE COVID19 VACCINATION . 05/05/2021-> FEEL BETTER TILL AFTER NOON THEN SLOWLY BECAME MORE RED, MORE EACHY AND I NOTICE MY RIGT EYE HAS SWELLING UNDER EYE BY THE TIME OF 9.30 PM, I TOOK BENADRY FOR RELIVE 05/06/2021-> CONSULT MY PRIMARY DR, SHE HAS PRISCRIBED ME ORAL MEDICINES AND EYE DROP: PREDNISONE 20 MG-TWICE A DAY LORTADINE 10 MG- ONCE A DAY NEOMYCIN-POLYMYXIN-HC DROP-TWICE A DAY
57 2021-05-06 oropharyngeal discomfort anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150... Read more
anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat is starting to close up; trouble swallowing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 14:45 (Batch/Lot Number: EW0162), at the age of 57 year, as single dose for COVID-19 immunization. Medical history included anaphylactic reaction to spider bites, pruritus, ongoing hypersensitivity, ongoing allergy to arthropod sting. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Lortab [hydrocodone bitartrate;paracetamol] and experienced drug hypersensitivity, singulair and experienced drug hypersensitivity. Concomitant medication included neocell super collagen, 6g collagen six per day as supplement. On 17Apr2021 the patient experienced anaphylactic shock, reported as medically significant. The patient reported "I started to pass out. She had tingle in her lip/her tongue was tingling. Her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat was starting to close up, she had trouble swallowing. She went to the hospital straight from the clinic where she received the vaccine. The patient reported the following: she went for shot at 14:30 and they didn't take her in until like 14:45. Patient stated after the shot, she sat down and knew she had to wait for at least 30 minutes because 10 years ago she had a couple events of anaphylactic shock due to spider bites. So patient stated she knew she should wait. Patient stated she started reading her book and had trouble swallowing at 5 minutes later, but she decided to keep reading book. Patient stated that 10 minutes she started to feel a tingle in her lip and then she started paying attention. Patient stated she then went over to the staff and found someone who was not busy and explained to them what was happening. Patient stated that staff member walked her over to the nurses station and at that time her tongue was tingling and this is not even 15 minutes later. The patient stated they gave her 10 ml of Benadryl and at about 15:05 at about 15:20 they had to give her the epinephrine because her throat was starting to close up and they called 911. The patient stated unfortunately the epi didn't; it may have slowed it down but she started to pass out. She don't know what her oxygen level was at that point. The patient recalled that her BP was 150 something over 90, she thinks she heard 159 before they gave her the Benadryl or at the same time. The patient stated once the EMT's showed up they gave her an IV and gave her steroids and that stopped her throat from closing and they gave her oxygen and that made her feel so much better. The patient stated it's like reliving the story here and her throat is starting to close up, patient clarified she is just choking up thinking about it and denied that her throat is actually closing up during call. The patient stated they did a lot of testing after did not show any signs of clotting which was good. Patient stated she did have trouble breathing, and they checked heart and her heart was fine. Patient states her throat, that is the part she needs to talk with her doctor about. Her throat didn't start to completely relax. Patient stated it was still tight on Sunday and Monday and that was a little concerning for her, but as far as lab work, no. Patient stated she was not admitted to the hospital, she spent 5 hours in the emergency room (ER) for observation and got sent home with an epi pen which she is not going to get and steroids which she finished yesterday. Patient stated she is not going to get the EpiPen because she does not foresee any need for it due to the amount of money it costs. Patient stated it costs $232 dollars and that is just too much, not to mention the amount of money she will have to give to hospital for the bill due to this event. Patient stated she is pretty clear that she won't or shouldn't get the next shot. The clinical outcome of Anaphylactic shock was recovered on 20Apr2021. The clinical outcome of her throat is starting to close up was not recovered. The clinical outcome of the remaining events was unknown.
57 2021-05-09 ringing in ears First 48 hours extreme/severe pain in right shoulder (person who administered dose put shot too high... Read more
First 48 hours extreme/severe pain in right shoulder (person who administered dose put shot too high - almost in tendon - so that could have contributed), severe headache, diarrhea. Next two plus weeks, I felt like someone took a dump inside my body; like my body was a cesspool. I felt gross, ill, uncomfortable, out of sorts, with joint pains which migrated around my body. When that finally seemed to be resolving, I woke on April 14th (3 weeks post vaccine) with LOUD ringing in my right ear (ringing both ears, but right side worse). 2 weeks later I was diagnosed with acute neurological-sensorial hearing loss and was put on prednisone. A week later, my hearing test was back to baseline, but I am still dealing with tinnitus which seems unstable and changing (I guess thankfully, since I hope this will go away). Prior to the second vaccine I'd been feeling better than I had in years due to a new exercise program begun in late January 2021. Was feeling younger, healthier, stronger than I had in years and was pain free. My diet is super healthy (not the typical diet of a typical American) - consisting of whole, unprocessed vegetables, protein and healthy fats.
57 2021-05-10 mouth swelling, mouth tingling Presented to the emergency room 5/3/21 after the development of multiple symptoms after her second C... Read more
Presented to the emergency room 5/3/21 after the development of multiple symptoms after her second COVID vaccine on Friday. Symptoms consisted of perioral tingling, some possible oral swelling, and then subsequent shortness of breath with labored breathing. Initial treatments in the emergency room did result in some symptomatic benefit, however, the patient continued to have an oxygen requirement and demonstrated persistent symptoms of anaphylaxis. She was then admitted to the intensive care unit for higher level intervention.
57 2021-05-12 ringing in ears developed Tinnitus 3/5/21
57 2021-05-13 ringing in ears vertigo , ringing in ears , nausea
57 2021-05-17 ear pain, swelling of eyelid Evening after afternoon 2nd shot was worse than my worst allergy episode plus body aches Next day I ... Read more
Evening after afternoon 2nd shot was worse than my worst allergy episode plus body aches Next day I had swollen throat, ear ache, headache behind eyes (Sinus?) 2nd day after eye lids and throat still swollen, shoulders and back ached 3rd day (today) was back to normal 1st shot left bad bruise feeling at injection site
57 2021-05-18 eye irritation, eye disorder, bloodshot eyes Bell's palsy; eyes pretty red; runny nose: second dose; eyes started bothering her, the right eye: s... Read more
Bell's palsy; eyes pretty red; runny nose: second dose; eyes started bothering her, the right eye: second dose; her eye had a little burning sensation and was irritated; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 11:30 (Batch/Lot Number: EW0151) as single dose for covid-19 immunization. The patient's medical history included she was a breast cancer survivor, its been 10 years, all she had was radiation and she also had Tamoxifen for 5 years, had a colonoscopy a couple of months, she had seasonal allergies, adverse event following prior vaccinations: when she was young, she would get vaccines and would always get a light fever and her arm would swell and turn red. The patient's concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: ER8733) in left arm on 24Mar2021 10:45 for covid-19 immunization and experienced fainted for just a few seconds, heart rate was very fast and headache, wasn't feeling well and lost consciousness. The patient experienced bell's palsy on 01May2021, eyes started bothering her, the right eye, her eye had a little burning sensation and was irritated on 29Apr2021, on the 30Apr2021 eye was pretty red, runny nose on 30Apr2021. The clinical course as following: This past Wednesday was two weeks and then Thursday, her eyes started bothering her, the right eye. She thought it was seasonal allergies, because she has those, that kept bothering her and and she had a very runny nose. Saturday she woke up she felt like her face was kind of numb. She called the nurse and they told her she should go to the emergency room. She was diagnosed with bells palsy and so they gave her treatment and they explained to her what it was all about. She had been working out in the yard and she came in and her eye had a little burning sensation and was irritated. She thought it was because she was outside. She also had a runny nose. She says again, she thought it was seasonal allergies because she has that. Felt weird around her mouth, felt kind of numb: second dose: This past Saturday, she woke up and stated she felt weird around her mouth, it felt kind of numb, it was hard for her to drink, she couldn't smile correctly, her smile was lopsided, one side was droopy. Caller states this began 01May2021. She went to the emergency room that same day and they diagnosed her with bells palsy. She was discharged from the emergency room because this time the lady doctor gave her the procedure with a stroke. The doctor could tell that it was not a stroke because of the eye, the doctor did something with her finger, they say can you see my finger, can you touch your nose. The doctor told her what she had is bells palsy and prescribed some medication. The eye is worse, but she doesn't have a runny nose anymore. With her eye, she can raise the left one, but the right one not as much. They gave her a patch for the right eye. She has to wear it in the evening, because it doesn't close anymore. She has to wear it to sleep with and during the day she has to wear glasses and if she goes outside, she has to wear sunglasses. Her eye is not really irritated, just kind of stiff, it does not really do much, she did some exercises to try to stimulate the muscles. The eye is just there, it doesn't really blink, it is beginning to blink a little bit but when she tries to close both eyes, she can close the left but it's like she can't completely close the right, she has no control of that part of the face, it's numb. She clarifies her eye started on Thursday 29 Apr because it was the first day she was outside. on the 30 Apr it was pretty red but she kept working. On Saturday morning she worked and she had a runny nose then too. Caller states they gave her some medicine at the emergency room. That night, she took Acyclovir and after she took the first one, she didn't have a runny nose anymore. Her eye is a different kind of bother now, it doesn't burn, its just there. They told her to get artificial tears and put the patch on. When asked if her eye is improved, persisted or worsened, she says the eye is not burning anymore, it's just kind of stiff. Bell's palsy: Caller states it's ongoing, when she smiles its the same. Caller states it's lopsided and when she raises her eyebrows, she can raise the left one, but the right one only goes up a little bit, but not as much. Caller states it's persisting, it's not getting worse, not getting better. Caller states she just started the medicine yesterday. Acyclovir: It was 400mg 5 times a day by mouth, one tablet for 10 days. Methylprednisolone: the other thing they prescribed me was Methylprednisolone. She tried taking both the Acyclovir and the Methylprednisolone yesterday, but she had a really bad stomach ache and couldn't eat anymore. She had no appetite and her doctor, she told him she couldn't take both it is too much, so he just said she should continue the Acyclovir so she is not going to take the Methylprednisolone. The Methylprednisolone is a 4mg dose pack, 6 day thing. Yesterday she was supposed to take two before breakfast, 1 after lunch, 1 after supper and 2 before bedtime. She couldn't take all of that, it was too much. Today would have been different, it tapers off. The emergency room visit on 01May2021, they didn't do any testing, she just had observation. the doctor did this thing with her finger where she could see her finger and she pushed back and held onto the doctor's hands and showed her strength. she raised her eyes, closed her eyes, smiled, but no other testing was done. she had her second emergency room visit on 01May2021. Therapeutic measures were taken as a result of bell's palsy included Acyclovir and Methylprednisolone, for events of 'eyes started bothering her, the right eye', 'her eye had a little burning sensation and was irritated', and 'eyes pretty red' included artificial tears and put the patch on, no treatment received for runny nose. The outcome of the event Bell's palsy was not recovered, the outcome of the event runny nose was recovered on 01May2021, the outcome of the other events was recovered on an unknown date.
57 2021-05-23 deafness unilateral Sudden Loss of hearing in Left ear. Unable to hear when talking on phone with left ear. Can hear pe... Read more
Sudden Loss of hearing in Left ear. Unable to hear when talking on phone with left ear. Can hear perfectly fine with right ear. Thought it may be allergies but had been taking allergy meds, started flonase for allergies without relief. Started on antibiotic in April for 10 days no relief. Referred to ENT. Appointment on May 21. Confirmed hearing loss in Left ear.
57 2021-05-23 ear discomfort, ear swelling, ear pain 29 days after I received my first Pfizer vaccine dose, I developed pain and inflammation of the ri... Read more
29 days after I received my first Pfizer vaccine dose, I developed pain and inflammation of the right eardrum and had to go to the doctor to get prescribed eardrops called Ciprofoxacin and used it for 7 days, after which the pain subsided but the plugged up ears and heaviness in that ear remains. After I received my second vaccine dose 32 days later, my other left ear developed the same symptoms of ear pain/inflammation of my eardrum three days after receiving the second vaccine dose. I used Ciprofloxacin in that ear as well and the pain went away but the fullness and plugged-in ears remain.
57 2021-05-24 mouth discomfort 48 hours after first covid vaccine, severe burning in mouth, gums, lips, and throat, roof of mouth a... Read more
48 hours after first covid vaccine, severe burning in mouth, gums, lips, and throat, roof of mouth advised to get 2nd dose. 45 hours after 2nd dose increased much more severe burning mouth, gums lips, throat, roof of mouth, tongue raw, inflamed and with with horrible looking spots and also 24/7 nausea.
57 2021-05-24 swelling of eyelid Dilation swelling in throat minutes after vaccination. Also became nauseated and light headed minute... Read more
Dilation swelling in throat minutes after vaccination. Also became nauseated and light headed minutes afterward. Had to lie down at home. About 2 to 3 hours later. Right side of face flushed/light rash and right eye drooped and almost closed. Stayed this way for about 3 hours before eye started to resume to normal. Didn't affect left side of body.
57 2021-05-24 ringing in ears Severe Vertigo with vomiting, fever, chills, sweating, nausea, muscle pain headache, and ringing ear... Read more
Severe Vertigo with vomiting, fever, chills, sweating, nausea, muscle pain headache, and ringing ears.
57 2021-05-25 eye disorder Facial numbness and slight drooping of eyes occurred about an hour after receiving the vaccine. It h... Read more
Facial numbness and slight drooping of eyes occurred about an hour after receiving the vaccine. It has gone almost back to normal as of today 5/26/21.
57 2021-05-25 ringing in ears Tinnitus profoundly worse a few days after first dose of Pfizer vaccine
57 2021-05-25 toothache legs feel heavy; Pain at injection site; Body aches; Chills; Teeth hurt; Headache; Very tired; This ... Read more
legs feel heavy; Pain at injection site; Body aches; Chills; Teeth hurt; Headache; Very tired; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown, Dose number: 1) via an unspecified route of administration in the left arm on 15Mar2021, 13:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient medical history includes hereditary sensory neuropathy, Hashimotos thyroiditis. The patient concomitant medications include Levothyroxine, Bit D, Immunity vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced Headache, very tired, teeth hurt, legs feel heavy, body aches, chills, vaccination site pain. The patient was not treated for the adverse events. The clinical outcome of the events Headache, very tired, teeth hurt, legs feel heavy, body aches, chills, vaccination site pain was resolving at the time of the report. Information about lot/batch number cannot be obtained. No further information is expected.
57 2021-05-26 eye discomfort, vision blurred Pressure and blurry vision in my right eye; Pressure and blurry vision in my right eye; This is a sp... Read more
Pressure and blurry vision in my right eye; Pressure and blurry vision in my right eye; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female (no pregnant) patient received the first dose of BNT162B2 via an unspecified routed of administration on the right arm on 17Apr2021 at 13:15 (Lot Number: EW0250) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. Known allergies is sulfa. The patient was not diagnosed with COVID-19 prior vaccination. The patient had not been tested for COVID-19 post vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included hydroxychloroquine (PLAQUENIL). On 21Apr2021 at 12:00, the patient experienced pressure and blurry vision in right eye. The treatment was not received. The adverse event result in doctor or other healthcare professional office/clinic visit. The outcome of events was both not recovered. No follow-up attempts are possible. No further information is expected.
57 2021-05-26 ringing in ears, pain in jaw It started with a headache the next day and pain in my jaw Then overtime this progressed to numbnes... Read more
It started with a headache the next day and pain in my jaw Then overtime this progressed to numbness in the right side of my face and tinnitus, Which then progressed to Jaw locking, pain and pressure in my face, and feeling like the nerves in my face are on fire Over a month later I still have the symptoms and the jaw walking has only gotten worse
57 2021-05-27 loss of smell, loss of taste mouth no taste or smell; mouth no taste or smell; Mouth appears to be inflamed and beet red; Mouth a... Read more
mouth no taste or smell; mouth no taste or smell; Mouth appears to be inflamed and beet red; Mouth appears to be inflamed and beet red; cold symptoms/Worst cold she has had in her life; sneezy; headache; foggy; Woke up in the morning not feeling well; This is a spontaneous report from a contactable nurse (patient) reported that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), via an unspecified route of administration, administered in arm left on 04May2021 10:30 (at the age of 57-years-old) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10May2021, the patient had cold symptoms and described as the worst cold she has had in her life, and experienced sneezy, headache and foggy. On 12May2021, the patient experienced mouth no taste or smell, and was concerned about her mouth appears to be inflamed and beet red. It was also reported that the patient woke up in the morning not feeling well on May2021. Therapeutic measures were taken as a result of the events as patient was treated with Claritin. The outcome of the cold symptom/worst cold she has had in her life, mouth no taste or smell and mouth appears to be inflamed and beet red was not recovered; outcome of sneezy, headache, foggy and woke up in the morning not feeling well was unknown. The events did not require a visit to emergency room or physician office. Reporter seriousness for the events was medically significant. Relatedness of drug to reactions/events: Reaction assessed: cold symptoms, mouth appears to be inflamed and beet red and no taste or smell. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), to reported events is possible based on temporal association and known profile of the product.
57 2021-05-31 eye discomfort Eye pressure; Light headed dizzy; Limbs feel like jello and wobbly; Felt like I was floating as if I... Read more
Eye pressure; Light headed dizzy; Limbs feel like jello and wobbly; Felt like I was floating as if I was 10 feet tall; Sugar bottomed out to 80; Fast heartbeat; Shaky hands and legs; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 57-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Feb2021, 07:30 AM (Batch/Lot Number: EL9261) as 1st dose, single for covid-19 immunization. The patient's medical history included Diabetes mellitus type 2, Fibromyalgia, Hypothyroidism, Osteoarthritis, allergies to Penicillin from an unknown date. The patient received other medications within 2 weeks of vaccination. On 02Feb2021 at 11:30 am, 4 hours after the vaccination the patient experienced Eye pressure, Lightheaded dizzy, Limbs feel like jello and wobbly, felt like she was floating as if I was 10 feet tall, Sugar bottomed out to 80, Fast heartbeat and Shaky hands, and legs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was Recovering. Follow-up attempts are completed. No further information is expected.
57 2021-05-31 mouth tingling Tongue tingling, numbness, ?mild swelling - self-resolving.
57 2021-06-01 eye pain, blindness, eye disorder, ear pain she sees something like she's blind; her eyes feel like she put some lemon inside her eyes; pain in ... Read more
she sees something like she's blind; her eyes feel like she put some lemon inside her eyes; pain in her eyes after the second dose; headache/painful in her head; can't take her arms in one position, she has to move around; pain in her arms is getting worse; pain in her ears; pain all over her body; muscle pain; lost her appetite; tired in the beginning, sleeping all day; tired in the beginning, sleeping all day; right side of her head, neck, back, all her arm tingles on her right; worsened when she received her second dose; right-sided back/neck/shoulder pain; right-sided back/neck/shoulder pain; right-sided back/neck/shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12May2021 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. The patient medical history was none. Concomitant medications included colecalciferol (VITAMIN D 3); zinc; ascorbic acid (VITAMIN C ACID); ascorbic acid/ergocalciferol/nicotinamide/retinol palmitate/riboflavin/thiamine mononitrate (MULTIVITAMIN 6) from an unspecified date and ongoing (been taking them her whole life). The patient previously received BNT162B2, dose 1 administered in arm left (injection) on 05Apr2021 (Batch/Lot Number: EW0158) for COVID-19 immunization and experienced painful, tired, headache, sleep all day because she wasn't sleeping good, hard for her to look back to the right side, arm was getting painful on her shoulder/back, numb and pain came on more strong in back. The patient experienced saw something like she's blind on 15May2021 with outcome of not recovered; her eyes feel like she put some lemon inside her eyes on 15May2021 with outcome of not recovered; pain in her eyes after the second dose on an unspecified date in May2021 with outcome of unknown; headache/painful in her head on an unspecified date in May2021 with outcome of not recovered; couldn't take her arms in one position, she has to move around on an unspecified date in May2021 with outcome of not recovered; pain in her arms was getting worse on an unspecified date in May2021 with outcome of not recovered; pain in her ears on an unspecified date in May2021 with outcome of not recovered; pain all over her body on an unspecified date in May2021 with outcome of not recovered; muscle pain on an unspecified date in May2021with outcome of unknown; lost her appetite on an unspecified date in May2021 with outcome of unknown; tired in the beginning, sleeping all day on an unspecified date in May2021 with outcome of not recovered; right side of her head, neck, back, all her arm tingles on her right on an unspecified date in May2021 with outcome of unknown, right-sided back/neck/shoulder pain on an unspecified date in May2021 with outcome of unknown, all reported as worsened. Clinical course reported as follow: Patient was calling to ask if taking ibuprofen (ADVIL) or naproxen sodium (ALEVE) to treat side effects was better than taking paracetamol (TYLENOL), which was what she has been taking. Patient received her first dose of the Pfizer BioNTech COVID-19 vaccine and experienced side effects that were worse after receiving the second dose. Patient reported pain in her eyes after the second dose. Patient was very concerned about the shot she has gotten. She was in such painful. She stated the whole right side of her head, neck, her back and all her arm tingles on her right. She stated the one she got, the second one, it made her have a headache. When she got the second shot, her arm, she couldn't take her arms in one position, like when she's driving, she has to move around or something. Patient stated but something she's really concerned about was about three days ago, after she take that shot, she had such a headache, the pain in her arms was getting worse. She felt a pain in her ears, its painful/sound in her ear and stated they were painful, not all day, but sometimes, but it was getting really strong. The most concern was her eyes, when she has such a headache, it's like needles in her head, and her eyes were feeling like she put some lemon inside her eyes (11:00 in the morning), it really hurts. She closed her eyes because she couldn't leave it open. When she opens her eyes, she saw something like she's blind and was really concerned, the first time it started was Saturday, 15May2021. Yesterday and Sunday, it happened three times, today two times already. It was ongoing, persisting, and was happening more often. It's getting worse since yesterday. Patient already talked to the doctor in the hospital, but they gave her prescriptions because they said for the pain all over her body that it was the symptoms for the shot, so they gave her prescription for the muscle pain and they said it was gonna be gone like a couple of days, and it was still there for more than two weeks, so it was too much. Patient stated another thing that concerns her was she has lost her appetite. She still took her vitamins, but she didn't know what the pain was from. Patient confirmed all symptoms have gotten worse since they began. Patient then decided she would like to be transferred to facility because she has pain now and would like to speak to someone. Patient reported of right-sided back/neck/shoulder/arm pain that began after her first Pfizer COVID vaccine and worsened when she received her second dose. Patient stated the doctor sent her some medicine, like anti-inflammatory and muscle pain relievers, but it didn't help. No family medical history relevant to AEs. No relevant tests. AEs did not require a visit to emergency room and physician office, just talked to physician on the phone. Follow-up attempts are needed. Information about lot/batch number is available.
57 2021-06-01 eye pain, vision blurred, eye irritation, blindness half of face is paralyzed; vision blurry and can't see; eyes hurt and are burning; eyes hurt and are... Read more
half of face is paralyzed; vision blurry and can't see; eyes hurt and are burning; eyes hurt and are burning; vision blurry and can't see; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 (Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation (reported as does not want to die) in Pharmacy. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Lot number: W0L61 or W0161) at age of 57 years old on 18Apr2021 at right arm for Covid-19 immunization. Caller state she received the first and second shot Covid. Clarified that she is referring to the Pfizer Covid vaccine. She got the shot last Sunday, a week ago. Patient experienced half of face is parlayzed: States that it is the left side or the right, she doesn't even know any more. It started the same day she got the vaccine, last Sunday 09May2021. It is getting worse. No treatment (nothing) for it. Also reported hard to read (lot number) because her eyes hurt and are burning. Caller states that she cannot see and that her eyes hurt very bad and they are burning. She cannot see and her vision is blurry (all on 09May2021). Wanted to know what to do. Outcome of the events was not recovered.
57 2021-06-01 mouth numbness, lip swelling swelling and numbness in lip and chin area of face. fingers on right hand numb, tingling sensation... Read more
swelling and numbness in lip and chin area of face. fingers on right hand numb, tingling sensation, and swelling. symptoms have lessened since this morning but still prevalent.
57 2021-06-01 mouth tingling Tingling lower lip, itching for 3 days after the vaccine took Benadryl at home
57 2021-06-01 ringing in ears My existing tinnitus got worse. Before the 1st dose of the Pfizer Covid-19 vaccine, the tinnitus wou... Read more
My existing tinnitus got worse. Before the 1st dose of the Pfizer Covid-19 vaccine, the tinnitus would basically on intrude on my notice when I was 'quiet' (going to sleep, sitting quietly outside, etc). That evening, as I was watching the news, I noticed my tinnitus was intruding - I could 'hear' it over the TV news, and it has remained so ever since! My tinnitus now intrudes all the time, and has become quite a nuisance. I can see that this was/has become a known issue, and I am quite concerned there is no warning. As you may know, there is no cure, and no remedy for tinnitus. I am quite upset that NO ONE mentioned this before I received the vaccine. I have talked to my Dr. about this, but have not had an official appt., and I fear this is permanent.
57 2021-06-02 mouth tingling, dry mouth, mouth numbness red rash wrist, itching, about a 3-4 inch area; red rash wrist, itching, about a 3-4 inch area; Jaw ... Read more
red rash wrist, itching, about a 3-4 inch area; red rash wrist, itching, about a 3-4 inch area; Jaw up to ear, under eye, eye lid, down her neck, left side of windpipe, back of neck, shoulder and left side of forehead lost sensation, lost sensation in part of arm above elbow.; tingling sensation in mouth, tingling lip; upper lip went numb; tingling half face; Headache; left arm swelled up; Elevated Heart Rate; Brain fog; dry mouth; funny sensation in her mouth; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0158, Expiration Date: 31Jul2021), via an unspecified date of administration in left arm on 14May2021 at 09:35 (at the age of 57-year-old) at first dose, single for COVID-19 immunization. The vaccine was administered at hospital. The patient did not receive other vaccine within four weeks prior to the first administration date of the COVID-19 vaccine. Relevant medical history included dental work to left upper molar done on 11May2021. She was given anesthesia and stated all this resolved. She had the procedure at 10:00. The patient was not receiving concomitant medications. On 14May2021 within 10 minutes of receiving shot the patient experienced tingling sensation in mouth, tingling lip, half face, and upper lip went numb. Her jaw up to ear, under eye, eye lid, down neck, left side of windpipe, back of neck, shoulder and left side of forehead lost sensation. Left arm swelled up and lost sensation in part of arm above elbow. The patient went to the emergency room for these symptoms and she was monitored there. The patient stated she is about 90% resolved of these symptoms, but they are not completely gone. On 14May2021 had headache that has resolved but she keeps having a sensation like she is about to get a headache on the left side of her forehead and also had elevated heart rate. She stated that her heart rate was elevated for many hours. It was still higher than normal for her when she left the emergency room. On 17May2021 had right red (rash), very itchy area on right wrist. Came on all of the sudden and was fire red and very itchy, was about a 3-4 inch area. Dissipated within an hour. She is still experiencing brain fog since an unspecified date in May2021, it is improving; but she had to take a half a day off of work the day before reporting to rest. Dry mouth and a funny sensation in her mouth are still lingering since an unspecified date in May2021. The patient stated that she called her doctor's office the day before and is awaiting a call back. She says the emergency room doctor told her to follow-up with her doctor and that the emergency room doctor also advised her not to get the second vaccine. They stated that she could potentially have a long-lasting vaccine effect. The patient asked what are the risks of her getting the second shot since she had such a severe reaction that is taking so long to resolve. Rash resolved on 17May2021, headache resolved on 14May2021, final outcome of heart rate increased was unknown, dry mouth and a funny sensation in her mouth had not resolved, while all the remaining events were resolving.
57 2021-06-02 ringing in ears Initially, after the first shot, I felt fatigued. Ten days later, I woke to neck and face tremor wit... Read more
Initially, after the first shot, I felt fatigued. Ten days later, I woke to neck and face tremor with shaking in lip on 5/17/2021. Each night since I have have tingling and electrical sensations in neck, mainly on the left but have noticed it on my right a couple of times as well. I woke to a tremor sound in my left ear another night. Face sensations and lip shaking on two additional occasions and the other nights, a tingly, electrical current type tremor. These last only a short moment but it's scary. I have never had any health issues. I also have mild twitching at night in legs and arms. Maybe I am more sensitive and attuned now but I think that is also related to these other symptoms.
57 2021-06-03 ear discomfort, ringing in ears On 4/14/21 experienced increased ringing in left ear & a hard hit of dizziness. Slowly improved over... Read more
On 4/14/21 experienced increased ringing in left ear & a hard hit of dizziness. Slowly improved over days. On 4/20, had right ear (my good ear) sudden loss of hearing along with a feeling of pressure & fullness. Thought it was a cold, treated w/some improvement w/decongestant. Hearing dropped out one more time before recovering. About 6 days later had a short course of antibiotics for a slight sinus infection (ears looked fine) . On 5/10/21 - had constipation & was pushing on the toilet & got another (worst one yet) hit of dizziness. I have had my PPPD for 9 years including tinnitus in left ear & occasional sinus infections and I have NEVER had anywhere near the amount of issues that I experienced after my 2nd shot including the increase in tinnitus. Since 5/10 I have had an unprecedented amount of near dizziness and off balance issues & am embarking on a course of supplements to improve gut/mucosal health; immune support.
57 2021-06-03 tongue discomfort, oropharyngeal discomfort I feel some weird in my mouth like on my tongue; now on my tongue, on the inside of my mouth, in my ... Read more
I feel some weird in my mouth like on my tongue; now on my tongue, on the inside of my mouth, in my throat it is like troubling; I feel some weird in my mouth like on my tongue; now on my tongue, on the inside of my mouth, in my throat it is like troubling; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection), via an unspecified route of administration, administered in arm left on 27May2021 (Batch/Lot Number: Patient reported that "EW971, it looks like. consumer was not very sure about E but it look like E", Expiration Date: unknown) (at the age of 57-year-old) single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that, "I just took the vaccination of Pfizer (confirmed as Covid19 vaccine) and on an unspecified date I feel some weird in my mouth, like on my tongue. It's something weird, you know, I want to get normal. It's on my teeth and everything that's why I wanted to call you, my mouth is weird like something like hot something in my tongue and full mouth, my lips. Like around 6 we have appointment around 6:30 and we stayed till 7:00 to see any side effect but patient did not know its feel like weird when patient was coming home did you recommend anything or something." The patient reported that "the main reason why she called was because she was worried because now on her tongue, on the inside of her mouth, in her throat it was like troubling." The patient did not receive any treatment for the events. The outcome of the events was unknown. Information about batch/Lot number has been requested.
57 2021-06-08 lip blister, mouth discomfort, lip itchiness, lip swelling swollen, burning, itching lips with blisters and blisters on my gums; swollen, burning, itching lips... Read more
swollen, burning, itching lips with blisters and blisters on my gums; swollen, burning, itching lips with blisters and blisters on my gums; swollen, burning, itching lips with blisters and blisters on my gums; continue to have burning, itching, blistering and swelling of both lips; This is extremely painful; blister on her gums; This is a spontaneous report from a contactable consumer (Patient, self-reported) and a physician. A 57-year-old female non pregnant patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0161 and expiration date: Not reported), via an unknown route of administration, administered in arm left on 21Apr2021 14:45 at age of 57 years old as single dose for covid-19 immunisation. Medical history included chronic pain, stevens-johnson syndrome, Hep C, drug allergy to sofusbuvir. Concomitant medications included hydrocodone bitartrate/paracetamol (NORCO); valaciclovir; calcium and multivitamin. The patient historical vaccine include took First dose of BNT162B2, (lot number:ER8737), via intramuscular, in Arm Left on 31Mar2021 14:45 at age of 57 years old as single dose for covid-19 immunisation, Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient had not been tested for COVID-19, post vaccination. Reportedly, patient had a minor outbreak of SJS (Stevens-Johnson Syndrome) 14 days after the first vaccination but that cleared before the second vaccination. thirty-six hours after the second vaccination, Patient had swollen, burning, itching lips with blisters and blisters on her gums. This was a symptom of SJS, patient currently seeking medical treatment/assistance from dermatologist. Patient was waiting on her doctors office to call back. On 23Apr2021 03:00, the patient experienced swollen, burning, itching lips with blisters and blisters on gums, continue to have burning, itching, blistering and swelling of both lips and this was extremely painful. Patient visited physician office for adverse events. Therapeutic measures were taken (lidocaine, Clobetasol, getting a biopsy on 5/17, topical steroids) as a result of swollen, burning, itching lips with blisters and blisters on my gums, continue to have burning, itching, blistering and swelling of both lips, this was extremely painful. Outcome of event lip swelling, blisters was recovering. Outcome of other events was not recovered. The patient provided information to physician regarding the reported adverse events lip swelling, blisters with the use of the product, and physician considered vaccine had a casual effect to the adverse event. No follow-up attempts are needed. No further information is expected. Follow-up (24May2021): New information from a contactable physician in response to HCP letter includes: Medical history (add hep-c); Reaction data (outcome of event swelling, blisters was recovering). Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between the events and suspect drug BNT162B2 Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
57 2021-06-08 mouth tingling Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat t... Read more
Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; felt sensation of lacking oxygen to brain similar to high altitude sickness; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; muscle aching in legs, hips and lower back; off balance; room spinning; Headache; throat swelling; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 57-year-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0151 and Expiration date was not provided), via an unspecified route of administration in Arm Left on 16Apr2021 08:30 (age at vaccination 57-year-old) as 1st dose, single dose for COVID-19 immunization. The patient was not pregnant. Medical history included spondylosis, hypothyroidism, diverticulitis, Allergies to medications, food, or other products penicillin, arithamyacin and tetracycline. Concomitant medications included tizanidine (TIZANIDINE); sulindac (SULINDAC); thyroid (ARMOUR THYROID). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The adverse event result in any of the following Emergency room/department or urgent care. On 16Apr2021 09:30, the patient experienced numbness in face from bridge of nose, across cheek bones, below chin. Numbness tingling tongue. throat tightening. muscle aches thighs of legs, worse on left leg. stumbling while walking. chills, sore arm, fatigue, confusion, felt sensation of lacking oxygen to brain similar to high altitude sickness, muscle aching in legs, hips and lower back, off, room spinning, headache, throat swelling. Therapeutic measures were taken with Intravenous Benadryl and Pepcid. The outcome of events was Recovered/Resolved with Sequel on an unspecified date in Apr2021. Follow-up attempts are needed. further information is expected.
57 2021-06-08 ringing in ears Rumbling started in left ear and chirping in right ear. It happens 24 hours a day. Never stops. On M... Read more
Rumbling started in left ear and chirping in right ear. It happens 24 hours a day. Never stops. On May 10 the volume increased. On May 27 volume increased again making it hard to sleep. Diagnosed myself that it's tinnitus.
57 2021-06-08 vision blurred, deafness Irregular high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of... Read more
Irregular high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization. Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering. Information about batch/lot has been requested.
57 2021-06-09 deafness unilateral could not hear anything from her right ear/lost hearing in right ear; something annoying her in righ... Read more
could not hear anything from her right ear/lost hearing in right ear; something annoying her in right ear; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 12Apr2021 as 1st dose, single dose for COVID-19 immunization. Family medical history included mother is almost 90 and her hearing is bad, thinks it is age related. Her mother does not have total loss of hearing, her mother needed hearing aids after age 70 or 75. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks and no events prior to vaccination. The patient previously received an unspecified flu shot on Oct2020 at 56 years old for immunization. On 19Apr2021 21:00, the patient had something annoying her in right ear. She didn't pay too much attention to it because she could still hear. Then, she went to sleep. First thing in the morning when she woke up on 20Apr2021 07:00, she could not hear anything from her right ear. She suddenly lost her right ear hearing. She went to urgent care. Urgent care transferred her to the ear doctor. There, she got a hearing test at the ENT department. The ear doctor was suspicious because she had gotten her vaccine a week ago. Doctor was thinking it was probably a side effect so she would like to report this. She clarifies she doesn't know if it's a side effect. Right now she is still under treatment. ENT Doctor did a check, clarified as the inside of ear, and it's all normal. She had a hearing test on 20Apr2021 and no hearing at all from right ear. The doctor didn't know what happened so he ordered an MRI. She took the MRI test on 28Apr2021, the results were all normal. In the meantime, she took prednisone pills for the hearing loss. She explains the Prednisone did not help. She took the Prednisone about two weeks. Doctor said to come back and see him in two weeks after finishing the prescription of the Prednisone. The first 5 days, she was supposed to take 3 tablets daily. Then the second 5 days, she was supposed to take 2 tablets daily. Then the last 5 days, she was supposed to take 1 tablet daily. On 03May2021, she went back to see the doctor and he gave her a injection in her ear since he had the MRI results and determined nothing was wrong on the inside of her ear. She clarifies it was a injection in her ear, still like Prednisone or a steroid, she thinks. The injection was to be for once a week for 3 weeks. She clarifies further she had the steroid injection 3 times total. After her second injection, she could hear a little bit of sound, it's a little bit, only some. Only sounds, not speech. She can hear a little bit of sounds if she covers her left ear. The patient had another hearing test on 21May2021 and hearing still really bad from right ear. She thinks the steroid injection shot in her ear really helped her and that's why she can hear a little bit of sound. Before, she could hear nothing. She thinks the name of the injection is Prednisone, she is not sure the name of it. She was supposed to get her second dose on 05May2021. On 03May2021, when she saw her doctor and asked the question whether or not she could get the second dose, the doctor said not to get second dose of the COVID vaccine yet. The outcome of the event could not hear anything from her right ear was recovering while for the event had something annoying her in right ear was unknown. Information on the lot/batch number has been requested.
57 2021-06-09 vision blurred, deafness loss of balance 4/11/21 dizziness / unsteady walking 4/11 lightheaded / near falling to ground 4/24 ... Read more
loss of balance 4/11/21 dizziness / unsteady walking 4/11 lightheaded / near falling to ground 4/24 vertigo 4/28 - ER and hospialized for 2 days (4/28-4/30) Increased blood pressure Increased hear rate blurred vision, trouble concentrating, brain fog, short term memory impacted nystagmus hearing loss inflamation of 7th and 8th nerves, face twitching itchy head, tinglingly pain / burning in feet, achy hands joints,
57 2021-06-09 vision blurred Patient received in RN observation area, post-COVID vaccination administration, as recommended per C... Read more
Patient received in RN observation area, post-COVID vaccination administration, as recommended per CDC guidelines and policy on post-vaccination RN monitoring. Patient ambulating in door way and grabbed the door, stating, "I'm dizzy, I feel like I'm going to pass out". Patient helped to bench outside and then to the gurney. Patient reporting lightheadedness, dizziness, and blurred vision. Denies Hx of anaphylactic reaction to first vaccine. Patient denies adverse reactions to vaccinations in past. Medical history as stated in patients chart. Patient does report diabetes. Last Blood glucose was 189 per patient at 0630 on 6/10/2021. 09:19 : Vitals: BP: 143/76, P: 86, Resp: 18, SpO2: 98%. RRT called at 09:20, and responded promptly, RRT, Dr. Almond and nurse leader updated on patient status. 09:23 Patient reported chest tightness, and a "massive headache". Vitals at that time were: BP 133/78, Pulse: 82, SpO2: 99%. Patient transported to ER with RRT with all belongings.
58 2021-01-01 mouth tingling Peri-oral tingling, shortness of breath, nausea immediately after injection
58 2021-01-03 deafness unilateral I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous repor... Read more
I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number number EJ1685, expiration date Mar2021, on 25Dec2020 09:30 at single dose on left arm for Covid-19 vaccination. Medical history and concomitant medications were none. The patient had not received other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient received her first Covid-19 vaccination on Christmas morning. She worked at a medical center. Within an hour of when she got home, she lost hearing in one ear and also had some numbness on the same side of her face, She was wondering if that was something she should be concerned and she still didn't have hearing in her right ear. Treatment received for the events included Tylenol. The outcome of the events was not resolved.
58 2021-01-03 ear discomfort S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my ... Read more
S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my body". The following day she experienced nausea and moderate joint pain. She then also experienced redness on forehead, ears and "felt like they were on fire." B: Covid vaccination on 12/28/20. Employee contacted advice nurse and was instructed to report to ACC A: Employee reported to ACC on 12/29/20 and received solumedrol shot R: Reporting for tracking purposes
58 2021-01-03 mouth numbness, mouth tingling Tingling, numbness lips and tongue, tightness in throat. Benadryl taken
58 2021-01-05 dry eye, dry mouth Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to s... Read more
Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D). The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.
58 2021-01-05 taste impairment Metallic taste; injection site pain Narrative:
58 2021-01-06 permanent deafness, ringing in ears, deafness unilateral Within an hour of receiving the injection I lost 100% of my hearing in my right ear. Starting with ... Read more
Within an hour of receiving the injection I lost 100% of my hearing in my right ear. Starting with some ringing, vertigo and then just silence. I called the Pfizer hotline, and they took down some information and then directed me to call the COVID hotline which resulted in pretty much the same. As it was Christmas day and the weekend, I waited to contact my Primary Physician on 12/30/20. She saw me immediately and sent me to a Specialist the next day to see Dr. for my hearing loss. There I was given an audiological assessment where my right ear was found to have moderately severe to profound sensorineural hearing loss in the right ear.
58 2021-01-06 mouth numbness tongue felt numb, denied shortness of breath. Benadryl 25mg given po, no rash, patient left after 20... Read more
tongue felt numb, denied shortness of breath. Benadryl 25mg given po, no rash, patient left after 20 minute observation after Benadryl given.
58 2021-01-07 taste impairment, ringing in ears Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in... Read more
Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in right side headache with right ear tinnitus, sometimes cough, runny nose and metal taste in mouth.
58 2021-01-07 lip swelling Difficulty swallowing. Sensation of lip swelling. Immediate Care response activated. IV Benadryl, So... Read more
Difficulty swallowing. Sensation of lip swelling. Immediate Care response activated. IV Benadryl, Solumedrol and Pepcid given. Patient taken to Care Center for observation and further care.
58 2021-01-07 mouth tingling Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling ton... Read more
Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling tongue and fingers; This is a spontaneous report from a contactable physician (patient). A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 02Jan2021 at 09:45 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, migraines. Concomitant medication included losartan 100mg/d, ergocalciferol (VIT D) 4000u/day, ascorbic acid (VIT C) 1000 /day. The patient experienced blotchy rash on chest, neck, shoulders and arms on 02Jan2021 at 10:05, mild tingling tongue and fingers in Jan2021. No urticarial lesions. Rash noted 20 minutes post injection. Took 25mg Benadryl and rash resolved. The outcome of the events was resolved in Jan2021. There was no other vaccine in four weeks. The patient was not diagnosed with COVID 19 prior vaccination, and was not tested for COVID 19 post vaccination. This case was reported as non-serious by reporter.
58 2021-01-07 swollen tongue Swelling of the tongue, feeling "not right", tightening of the airway (all mild and short duration)
58 2021-01-07 swollen tongue Felt "not right", minor 'thickness of my tongue', tightness of airway (all minor in severity)
58 2021-01-07 vision blurred Bad headache, dizzy, very tired, nausea, blurred vision.
58 2021-01-08 taste impairment, mouth tingling Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, mya... Read more
Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia Narrative: tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia
58 2021-01-08 eye pain On the day of taking the vaccines had joint pains all over mainly involving the arms but they subsid... Read more
On the day of taking the vaccines had joint pains all over mainly involving the arms but they subsided. On the next day noticed redness and pain in the left eye. On 1/6/21 noticed diminished vision and blurriness in the left eye. Called opthalmology ED and was seen the next day on 1/7/2021 morning . Was diagnosed with left uveitis. I was seen by the on call doctor. There are many doctors involved in my care. My previous episodes of uveitis have been mostly in the right eye and the vision was not affected, The doctors involved in my care are not sure if this was just a coincidence, was an exacerbation of the preexisting pathology or was something new. I have asked to put the eye drops every hourly but the vision has not completely improved. I don't use the eye drops in the night and when I get up in the morning it is still very hard to read. It is an unusual episode of uveitis as typically my left eye is not involved and I have never had this much diminished vision , I am supposed to put the drops every one hourly until 1/11/2021. I have informed my PCP, Rheumatologist, regular eye doctor. I will inform my ID doctor Dr .
58 2021-01-08 lip swelling Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow.... Read more
Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow. At 5:34 pm when 15 min wait was done told staff what was happening. Was triaged by NP and MD on standby along w/EMT treated w/50 Benadryl/20 Pepcid/125 Solumedrol IVP. Waited in onsite Immediate Care and was given 1L 0.9 NS bolus. Transferred by ambulance to ER at 6:45 pm after experiencing tingling to chest and dizziness. Tingling changed to warmth in route to ER. Observed in ER and discharged home at 9 pm.
58 2021-01-08 swelling of eyelid, lip swelling 1/1/21 minor lip swelling. Took 1 dose of Benadryl and it resolved within 2 hours. 1/2/21 minor eye... Read more
1/1/21 minor lip swelling. Took 1 dose of Benadryl and it resolved within 2 hours. 1/2/21 minor eyelid swelling . Took 1dose of Benadryl and condition resolved overnight. 1/4/21 significant lip swelling. Took 3 doses of Benadryl. Condition resolved in 24 hours.
58 2021-01-08 vision blurred Bad headache, dizzy, blurred vision, nausea, very tired. vomiting.
58 2021-01-10 lacrimation increased Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye an... Read more
Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye and nose on the right. Fatigue, cough
58 2021-01-10 mouth swelling, swollen tongue Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to... Read more
Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to the ED with hives that went into her mount & swollen tongue - resolved as of 1/11/2021
58 2021-01-11 loss of smell, loss of taste tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste a... Read more
tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; excruciating headache; runny nose; congestion; shortness of breath when she started talking; having aches and pains; lightheaded, experienced dizziness; tied; This is a spontaneous report from a contactable consumer(patient). The 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, intramuscular injection ), intramuscularly in left arm on 23Dec2020 at single dose for COVID-19 vaccination in nursing home. Medical history included she had a right knee injury so she had some inflammation, She had stomach issues in the past- Barrett's syndrome, H. pylori(Helicobacter infection), GERD(Gastrooesophageal reflux disease), so, Pantoprazole is just a maintenance medicine, she was stable right now. She had a Vitamin D deficiency at one point. Ongoing concomitant medication included meloxicam for inflammation, thyroid for thyroid(Thyroid disorder), pantoprazole for stomach issues, colecalciferol (VITAMIN D 3) for supplementation therapy. There was no vaccination within 4 weeks. She received her first vaccine on 23Dec2020. There no other vaccine received in the same day. By 26Dec2020, she started with symptoms and then she tested positive for COVID-19 on 29Dec2020. She felt horrible with an excruciating headache and was wondering if she was going to die now. She can really feel for the residents she works with who get it. Right now, she was hopefully going back to work next week, but she was wondering about the second vaccine. People are saying she got COVID-19 because of receiving the first vaccine and she was hoping it was not the case. Is it going to be an issue getting the second vaccine after testing positive? The caller declines to include her healthcare professional for this report, stating she has been talking with her doctors over the week. Her symptoms included runny nose, congestion, and what seemed like shortness of breath when she started talking. She started having aches and pains over the weekend. By Monday, 28Dec2020, there was loss of taste and smell, it was totally gone. She also was lightheaded, experienced dizziness, was tied. She went through a lot of symptoms which was shocking to her. She clarified these symptoms first began the morning of the 26Dec2020. Christmas she was fine, and then she to go out to get snow off of her car and do some running around on 26Dec2020 and she noticed she started having symptoms. When probed for outcome, the caller state she was most definitely feeling better. She was having some excruciating headaches and she has worked with her doctor on what they needed to do. She is still working with the doctor on her lightheadedness. She has set up a follow-up appointment, but she was feeling better. There was no emergency room nor physician office. Relevant test was none. It was also reported lot number was either EJ1685 or EJ1085, she can't tell. Outcome of loss of taste and smell was recovered, of dizziness was not recovered, of other events was recovering.
58 2021-01-11 hearing loss, ringing in ears Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. ... Read more
Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. A few days later, I felt like my head, on the side of my right ear, had a great deal of pressure in it and it felt "funny " but it did not really hurt. It was uncomfortable and distracting. I waited to see if it would go away. I noticed my hearing was decreased . On 01/06/20 when I woke up, my hearing was completely gone in my right ear. I could hear nothing out of that ear. I had a noise in my head. Just a loud roaring noise. I had severe vertigo and could not walk across the room. I describe this as I felt like I was on a merry-go-round and someone was spinning me really fast. (continue) Additional information for Item 18: Vaccine Adverse Event Reporting System, continued: I also experienced severe vomiting and could not stop. My husband took me to the doctor. Since I could not get in to my regular doctor that day, we went to an ear doctor I had visited a couple of years ago because that was the only person I could find to see me on short notice. I had regular hearing test in the past and my hearing was normal last time he checked it. After doing a hearing test, he verified my Hearing was severely decreased in my right ear. I explained to him, I also feel "foggy" and I have problems concentrating, was having vertigo, and vomiting. I am not sure if that is because of the constant sound in my ear that distracts me but it is a definite problem and interferes with my work. I cannot concentrate. He started me on Steroids (Prednisone) 60 mg a day for 7 days, then 40 mg for 3 days, then 20 mg for three days, Antivert 12.5 mg three times a day as needed, and Zofran for the vomiting if I needed that. I have not experienced anymore vomiting and the Vertigo has been very limited. Mostly when I lay down now instead of when I stand up. My blood pressure has also been slightly elevated, but it could be from the Steroids. I was scheduled to take the 2nd Pfizer Vaccine on 01/09/21. Since I was receiving the high doses of Steroids, I was concerned that the vaccine would not be effective or may interact with the steroids so I went to my family doctor 01/08/21, for a visit. He said he would check and let me know if it was contraindicated for me to take the Vaccine on high doses of steroids. When I did not hear from him, because I had to take the vaccine the next day, I called the Pharmacy and talked to someone there and they told me the agency was still recommending you take the Vaccine even if you are on the steroids. I received the second Pfizer Vaccine on 01/09/21. My hearing is now coming and going but I can hardly hear anything out of that right ear. . There is a constant noise, like a roaring, in my head and I still have problems concentrating. I have had no more vomiting and my vertigo has hot been as severe but I have experienced some at times. I reported to the Pharmacy the day I received my vaccine, 01/09/21, about the things I had experienced this since my first vaccine. They took my information and said they would call me but today is 01/12/21 and I have not heard from them yet so I thought I would go ahead and report this. I am concerned this was an adverse reaction to the vaccine. I return to the doctor 01/20/21 for a repeat hearing exam. The Doctor expressed this condition could be a permanent and disabling issue but currently being treated and will follow up with more testing. I am also concerned about how the second vaccine affected me because I was receiving the high doses of Steroids at the time I received it. I am sending this from a work email so if you reply, please reply to personal email.
58 2021-01-11 mouth numbness immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe... Read more
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
58 2021-01-11 eye discomfort Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grad... Read more
Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grade fever, chills, muscle/body aches, nausea, vertigo, primarily muscle/body aches. My symptoms resolved aprox. 36 hours later. Aprox. 60 hours later, I had a couple of episodes of diarrhea, and was just feeling a little "spacey" and slightly tender behind my eyes.
58 2021-01-11 ringing in ears Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By We... Read more
Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By Wed evening had chills and low grade fever 99.4. Called out of work Thursday. Felt terrible. Thursday morning lower abdominal cramping consistent and pain scale between 4-5 with occasional spikes to 8. Also felt terrible. Had body aches, could only lay on couch. Called my gastroenterologist. Office returned call late afternoon and stated probably from vaccine and if it worsens or fever to call primary and to fill out VAERS form. Thursday evening had temp of 100.4 and started with a cough where it felt I couldn't take deep breaths. Only lasted a few hours. Abdominal pain persisted. Friday morning woke up and now have headache, but abdominal pain is now down to a 2 and I feel achy, but feeling a bit better. Had to call out of work still too sick to go in. No cough. No fever. Since I was feeling better my hope was since it was vaccine related that I would wake on Saturday and be totally fine, unfortunately, not the case. Saturday morning abdominal pain same at a 2 and headache was on and off through the day into the night. Still pretty much rested all day into the night. Sunday morning much better. Headache gone and abdominal pain down to a 1 and sometimes just vague. Although I'm feeling better my head feels out of sorts, kind of like my brain can't keep up with my eyes? And new symptoms? right ear crackling and teeth on right side feel sensitive also, pain under left armpit. It's tender and lasts through the day. Monday still feeling a bit lightheaded and fatigued and armpit pain still there but not worse and feel able to go to work to see if I can. Tooth sensitivity also still there but ear pain gone. Called primary doctor she suggests getting Covid test and have appointment for phone conference for Tuesday with doctor, also had Covid test today at work (was Covid tested last Monday also for work and negative) into Monday night head is still feeling "off". Tuesday armpit pain still same and dizzy head feeling same, mild abdominal pain comes and goes - Not bad enough to stop daily activity. Spoke with primary doctor and she said side effects could possibly last this long and let her know when yesterday's Covid test comes in.........
58 2021-01-13 mouth tingling, taste impairment Pt voiced metallic taste in mouth and lips tingling. Voiced initial compliant @ 1350. Left observa... Read more
Pt voiced metallic taste in mouth and lips tingling. Voiced initial compliant @ 1350. Left observation @ 1415, denies any s/s of distress not trouble w/ SOB or breathing.
58 2021-01-13 ringing in ears Arm soreness, headache , body aches, dizzy, ears ringing
58 2021-01-17 deafness Within 1 hour MILD light headiness, passing headache, chills, sweating, Within 3 hours LEFT EAR HEA... Read more
Within 1 hour MILD light headiness, passing headache, chills, sweating, Within 3 hours LEFT EAR HEARING LOSS about 25% to 50% have not yet resolved & ENT office recommends PCP prescribe prednisone rapid taper pack ASAP
58 2021-01-17 eye swelling Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on... Read more
Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on 1/11/2021 was seen in the ED for bilateral eye swelling, right side greater than left.
58 2021-01-17 lip swelling, swollen tongue, mouth tingling Patient developed tongue tingling 30 minutes after receiving first dose of Pfizer covid vaccine. Pat... Read more
Patient developed tongue tingling 30 minutes after receiving first dose of Pfizer covid vaccine. Patient also reports that she experienced tongue swelling, lip swelling, difficulty swallowing and rash on her back that developed 1 hour after vaccine. Patient did not seek immediate medical treatment and will receive treatment at Occupational Health.
58 2021-01-17 mouth tingling Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour afte... Read more
Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour after vaccine, felt fatigued the day of the vaccine for about an hour after, On 1/14 at 0530 woke up with a horrible right calf cramp was relieved by massage. Sat at side of bed began feeling extremely nauseated, diaphoretic then syncopal episode that lasted approximately 5 seconds.
58 2021-01-18 mouth tingling, dry mouth Late Entry 0952: Patient not feeling well. Reports shortness of breath, tongue tingling and has a ra... Read more
Late Entry 0952: Patient not feeling well. Reports shortness of breath, tongue tingling and has a rash to left upper arm. 0954: O2 sats 99%, HR 130 bpm, BP 150/90. Offered PO Benadryl per vaccine standing orders for adverse reactions. Patient refused PO Benadryl. O2 at 2L/NC applied at this time. EMS notified and in route. 1000: Patient remains very anxious and complains of dry mouth, dizzyness and tingling tongue. Attempted to administer EpiPen per vaccine standing orders for adverse reaction. Patient refused EpiPen. 1002: EMS on site. Patient continues to refuse EpiPen. O2 sats 99% on 2L/NC, HR 123 bpm, and BP 137/76. Patient ambulated with EMS personnel outside. After ambulating with EMS personnel, patient stated she felt better and refused to be transported to the hospital. Returned inside for follow up and monitoring. Late Entry 1025: Patient waiting to sign AMA form and had another episode in the hallway. Patient stated she did not feel right and squatted in the hallway. Staff assisted her to a chair. EMS notified and in route. Dr. notified. 1028: O2 sats 99%, HR 94 bpm and BP 138/102. Patient refused EpiPen at this time. Patient complains of feeling dizzy and short of breath. O2 at 2L/NC applied for comfort. 1032: O2 sats 98% on 2L/NC, HR 88 bpm, and BP 128/84. 1035: Dr. at bedside assessing patient. 1040: EMS here. Patient agreed to be transported to the local hospital for evaluation. O2 sats 98% on 2L/NC, HR 86 bpm, and BP 140/81.
58 2021-01-18 vision blurred Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath,... Read more
Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath, itching, severe chills alternating with fever, chest pain, facial nerve numbness, blurry vision, sore throat, nausea, diarrhea. Treatment was a Medrol Dose pack for 6 days. Outcome was severe symptoms decreased after 4 hours of taking first dose (6 tabs) of prednisone. As the prednisone dose decreases each day there is increased muscle pain and shortness of breath/lung tightness with activity, and severe fatigue
58 2021-01-19 eye movement disorder I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w... Read more
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-01-19 mouth numbness I started out with an itchy chin. The itch then went to my forehead, scalp, cheeks and left ear pin... Read more
I started out with an itchy chin. The itch then went to my forehead, scalp, cheeks and left ear pinna. The tip of my tongue also became numb. Symptoms lasted for 45 minutes.
58 2021-01-20 mouth numbness, mouth tingling, taste impairment, tongue discomfort Around 2pm the day of the vaccine, my tongue started to feel like it was burned, rough , and someon... Read more
Around 2pm the day of the vaccine, my tongue started to feel like it was burned, rough , and someone spilled novacaine on the surface of it. My throat also started to hurt, which lasted until about 6pm. The day after the vaccine, (today) my tongue still feels the same, and i have a metallic taste in my mouth when I eat.
58 2021-01-20 mouth numbness, thirst Right after she received the vaccination she felt dizzy and very thirsty. Her tongue was also numb f... Read more
Right after she received the vaccination she felt dizzy and very thirsty. Her tongue was also numb for 3 days.
58 2021-01-20 mouth numbness Shortly after the injection she was dizzy and very thirsty. She had itching and her tongue was numb ... Read more
Shortly after the injection she was dizzy and very thirsty. She had itching and her tongue was numb for 3 days.
58 2021-01-20 mouth tingling, lip swelling Complained of tingling and swelling in the lips about 10 minutes after receiving vaccine
58 2021-01-20 swollen tongue Nausea, headache, chills, sweats, swelling to the tongue, SOB, loss of appetite, shakiness,
58 2021-01-20 taste disorder I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throa... Read more
I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throat get bad; I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe; I started hyperventilating because I was scared; I started hyperventilating because I was scared; I felt strange but not sick or anything like that, it hit me like with a ton of bricks; I was shaking so bad I couldn't even hold anything; I was aching all the way from head to toe; I got my first Pfizer BioNTech COVID 19 Vaccine on 22Dec/And then I had my second one on 08Jan; I have residual like I am sill aching in my back; I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally; I had sort of a cough but not like I urge to cough but it was not like chronic; Muscle soreness; still tired; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient received the second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on right deltoid on 08Jan2021 08:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on left deltoid on 22Dec2020 at single dose for covid-19 immunisation. The patient stated she got her first Pfizer BioNTech COVID 19 Vaccine on 22Dec2020 and had no issues really with that one. And then she had second one on 08Jan2021. The first she got in her left deltoid and the second one she had on 08Jan2021, she had in her right deltoid. It's towards 8:30 in the morning roughly is when she had it. So, during the day went on 08Jan2021, she felt strange but not sick or anything like that. And the day went on to eat something and then came home. And then she'd say at around 7:30 it hit her like with a ton of bricks. She was shaking so bad, she couldn't even hold anything. And then she was aching all the way from head to toe. And she was like she will get her tooth brush at least. So, she brushed her teeth and then all of a sudden her throat closed up on 08Jan2021 around 7:30 pm and she couldn't breathe. And she stated she was like "oh my gosh and then it sort of opened up enough for me to scream for my husband, I yell for him to come and then it did it again, it closed up again. And when he came, I started hyperventilating because I was scared. And he calmed me down and rub my back and everything, and it went away. But it scared me. But the shaking lasted probably all through night maybe till 3 in the morning because I tried not to take anything and I probably took 2 Advil. And now I have residual like I am sill aching in my back. And it's weird, in morning I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally. And then I had sort of a cough but not like I urge to cough but it was not like chronic. Not a lot but it's there like if you urge to cough, it doesn't happen a lot. " The patient stated "It started on 08Jan2021 around 7:30 pm, when my throat get bad. I have muscle soreness specially in my back and I don't know in the taste in the morning the food doesn't taste right but then like it's fine towards the afternoon. And I am still tired and a slight like cough. But the cough isn't really anything, if I get urge to cough. It's not all day, it's not chronic at all." The patient started to took Advil as a treatment and stated "Well I started to because it was like 3:30 in the morning, or 2 or 3 in the morning I did take 2 Advil. And they helped with that pain." The outcome of the event taste abnormality was recovered, outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
58 2021-01-21 eye swelling On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen ... Read more
On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen - slight headache. On 1/21 3:45am right eye swollen, (but not swollen shut) a little ache -slight headache.
58 2021-01-21 mouth itchiness Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy bu... Read more
Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy but that resolved quickly . Over the next few minutes she also developed erythroderma of bilateral forearms and hands, slight swelling of hands, reddened palms. We assessed her vital signs below, kept her in observation over the next 40 minutes. She denied difficulty breathing, she questioned if her voice was different, but was not detectable to 2 observors. Lungs remained clear, no stridor, no capillary refill delay. Gradually symptoms improved, erythroderma and hand swelling resolved over about 15 minutes. Pt. then noted possible tongue swelling, on the sides at 25 minutes post vaccine but again, no difficulty with breathing or swallowing. Vital signs continued to improve, pt. then stated itching was gone and tongue felt better so she was released and advised to return to E.R. in event of change. Pt. is a phyician.
58 2021-01-21 ringing in ears, mouth numbness, swollen tongue, vision blurred, lip swelling Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation s... Read more
Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation spreading on the top of my head. Since I was recovering from a severe allergic reaction to the Covid vaccine (numb, swollen lips, face, tongue), I initially thought it may be a recurrence. However, by the morning of Tuesday, 1/19/2021, the numbness was complete from the tops of my eyebrows, over my scalp, my ears and down the center of my back to my buttocks. The numbness was bilateral. Alarmed, I went to the Emergency Room. (I am a hospital pharmacist there.) The ER consulted Neurologist. After MRI results, diagnosis was Post-Vaccination Paresthesia. I was released from work by the ER through 1/21/2021. The height of the paresthesia was 1/21/2021. This included some auditory buzzing and mild blurred vision. Today, 1/22/2021, I am beginning to regain feeling on my back and forehead. I estimate that I have regained about 50% feeling on my scalp.
58 2021-01-21 vision blurred Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, v... Read more
Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, vomiting, chills, drop in body temp to 96F. Onset 10 mins post injection, increasing over the subsequent hour, subsiding x 1 hr then peaking 5 hrs later, resolved after 12 hours.
58 2021-01-22 ringing in ears Continuous tinnitus started the day after my second vaccine administration. No treatment taken. Has ... Read more
Continuous tinnitus started the day after my second vaccine administration. No treatment taken. Has not gone away.
58 2021-01-24 lip swelling Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours sev... Read more
Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours severe vertigo with this for 2 days, vertigo is still happening on 3rd day but has lessened did not seek medical attention: took benadryl 1st day only and it took care of the symptoms except vertigo Started Meclizine 25 mg over the counter on day2 and it makes vertigo tolerable but still persitant at this point
58 2021-01-25 taste impairment Foul taste. Everything tastes like it was slathered in old butter. Nothing tastes right; This is a s... Read more
Foul taste. Everything tastes like it was slathered in old butter. Nothing tastes right; This is a spontaneous report from a contactable nurse reporting for herself. A 58-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL3246, expiry date: not reported), via an unspecified route of administration, on 06Jan2021 04:30 PM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient was not pregnant at the time of vaccination. Medical history included asthma and hypothyroidism. The patient had no known allergies. Concomitant medications included unspecified medications. It was reported that the patient received other medications within 2 weeks of vaccination. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: not reported), via an unspecified route of administration, on 16Dec2020 11:00 AM at a single dose on the right arm for COVID-19 immunization. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 04:30 AM, the patient experienced "Foul taste, everything tastes like it was slathered in old butter, nothing tastes right." The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any treatment for the reported adverse event. Outcome of the event was not recovered.
58 2021-01-25 mouth tingling, mouth numbness muscle aches; significant stomach pain; felt numbness and tingling around the mouth; tingling around... Read more
muscle aches; significant stomach pain; felt numbness and tingling around the mouth; tingling around the mouth; This is a spontaneous report from a contactable other HCP(Patient). A 58-year-old female patient received second dose BNT162B2(lot number EK9231), via an unspecified route of administration at Arm Left on 12Jan2021 11:45 at 58 years old at single dose for COVID-19 immunization. The patient medical history was Graves' disease and COVID-19. Concomitant medication included ibuprofen(MOTRIN) and diclofenac sodium. The patient previously took Percocet and Darvocet, both experienced Drug Allergy. The Historical Vaccine was first dose BNT162B2(lot number EJ1685) received on 22Dec202011:45 at 58 years old at Left arm and experienced body ache, muscle aches, feeling like coming down with the flu. While receiving the product the patient felt numbness and tingling around the mouth that went away in about 30 minutes on 12Jan2021 then the next day 13Jan2021 02:30 muscle aches and rather significant stomach pain. There was no treatment received for all the events. There was no covid tested post vaccination. There was no other vaccine in four weeks. The outcome of events numbness and tingling around the mouth was recovered on 12Jan2021 , the events muscle aches and stomach pain was recovering.
58 2021-01-25 mouth tingling PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAI... Read more
PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAIR AND VITALS WERE TAKEN. ALLERGIST CONTACTED AND ADVISED THE PT TO TAKE ZYRTEC NOW AND BID FOR THE NEXT 3 DAYS,. PT TOOK THE DOSE AND UNDERSTOOD THE INSTRUCTIONS. VITALS IMPROVED AND HER ITCHING SUBSIDED. HER ONLY REMAINING SYMPTOM WAS A HEADACHE THAT DEVELOPED AFTER TAKING THE ZYRTEC. SHE WAS GIVEN ICE PACK FOR HER HEAD AND ENCOURAGED TO DRINK FLUIDS. PT STATED SHE FELT FINE AND WANTED TO LEAVE TO RETURN TO HER UNIT SO SHE LEFT OBSERVATION AT 1:31PM.
58 2021-01-25 feeling of choking tingling / burning sensation in throat about ~12 minutes after vaccine. Did not progress to airway c... Read more
tingling / burning sensation in throat about ~12 minutes after vaccine. Did not progress to airway compromise. Sensation changed to a numbness but did not worsen. Patient given Benadryl and Pepcid, monitored. Improvement in symptoms noted, discharged home.
58 2021-01-26 ear pain Until 12/26/20 no symptoms whatsoever, and I started feeling congested on the 26th early evening aro... Read more
Until 12/26/20 no symptoms whatsoever, and I started feeling congested on the 26th early evening around 6-7PM. The next evening I was actually talking to my sister and I coughed and she brought to my attention about my cough. It was late around 7PM. The next morning, around 4AM I woke up with a terrible ear ache. I called my doctor on the 28th and he suggested a COVID test at his office. On Thursday 12/31/20 in the morning he called me giving me positive results for COVID.
58 2021-01-26 ringing in ears 15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud... Read more
15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud. She also reports her parkinson symptoms are increasing. Shaking of arms and legs were observed. Patient also reported nausea.
58 2021-01-27 ear discomfort, deafness, ringing in ears Sudden onset right sensorineural hearing loss day 5 after vaccine. Bilateral worsened tinnitus and a... Read more
Sudden onset right sensorineural hearing loss day 5 after vaccine. Bilateral worsened tinnitus and aural fullness starting 2 days after vaccine, mildly for a few days after 1st dose of vaccine, then more intensely after second dose. Transtempanic steroid injection seems to be helping hearing loss but increase bilateral tinnitus continues to be more intense than baseline.
58 2021-01-27 pain in jaw, mouth pain The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphore... Read more
The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphoretic, pain to entire right side; right side teeth and jaw pain; general malaise. I took 2 -650mg Tylenol before bed. Pain in the right arm from neck to elbow lasted for 1 week, used 2-650mg Tylenol to tx
58 2021-01-27 mouth tingling, taste impairment After getting vaccine, pt. had tingling in her lips and a metallic taste in her mouth. This resolve... Read more
After getting vaccine, pt. had tingling in her lips and a metallic taste in her mouth. This resolved after Benadryl.
58 2021-01-27 mouth tingling, mouth numbness "I just wanted to follow up with information about what I experienced from the second COVID 19 vacci... Read more
"I just wanted to follow up with information about what I experienced from the second COVID 19 vaccine from Pfizer. I stayed 30 minutes after the second vaccine was given and felt fine. However within another 10-15 minutes (so 45 minutes later) I experienced both my lips and tongue tingling and feeling numb. I reported it through the CDC given to us: It lasted approximately 45 minutes with no other symptoms that day."
58 2021-01-28 loss of smell, loss of taste After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, ... Read more
After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, and shedding an excessive amount when brushing. She started noticing this about 1-2 weeks after her first vaccine, and it got worse after the second vaccine on 1/7/21 (Pfizer Lot#EK9231). It is an even thinning, no patches of hair loss. She was diagnosed with COVID on 10/7/20 which resulted in hospitalization. Reporting fatigue, continued loss of sense of taste and smell, decreased appetite, and hair loss. Experiencing fatigue and decreased energy, worse in the evening, falls asleep easily when she gets home after work, started when she got COVID.
58 2021-01-28 ear pain pt is having ear pain bilaterally, back pain, sob, fatigue
58 2021-01-28 thirst, dry mouth Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the... Read more
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
58 2021-01-30 pain in jaw Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immedia... Read more
Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immediately after injection. They sent me to doc on site and applied ice. After 29 minutes symptoms started to subside. By the evening pain moved across back of shoulders blades. Increased headache with chills and alternating fever. Could not sleep due to pain. Next morning,today. Had abdominal pain cramping and diarrhea. Unable to sit up or walk much due to weakness and feel will pass out.
58 2021-01-31 ear pain She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Dia... Read more
She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.
58 2021-01-31 lip swelling, swollen tongue, taste impairment Metalic taste in throat Burning in chest lips swelling tongue swelling with swallow difficulty
58 2021-01-31 mouth tingling Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administratio... Read more
Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administration the patient developed itching and a flushed feeling, tingling lips, racing heart rate, and headache. Patient reports these symptoms lasted several hours and then resolved.
58 2021-01-31 visual impairment Increased fluid in left eye with significant decreased vision started 1 week post immunization; and ... Read more
Increased fluid in left eye with significant decreased vision started 1 week post immunization; and shingles started 1/29/2021
58 2021-02-01 thirst felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and... Read more
felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and speech slowing; Mild cognitive and speech slowing; Felt strange sensation on top of head; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 14Jan2021 04:00 PM (vaccine location: right arm) at single dose for COVID-19 immunisation.The patient's medical history included hashimotos, fibromyalgia, known allergies to sulfa drugs and extreme shellfish. There is no other vaccine in four weeks. The concomitant drug included levothyroxine sodium (SYNTHROID), Amitriptyline, Valsartan, Vitamin D. After about 12 mins from shot on 14Jan2021 04:15 PM, patient felt extremely thirsty. Then spouse noted facial flushing and called an advanced registered nurse practitioner (ARNP) on site to eval. Mild hives on face neck and upper chest developed then. Then increase flushing on face. Mild cognitive and speech slowing. Felt strange sensation on top of head. Self medicated with 50 mg Benadryl capsule. Emergency medical technician (EMT) and ARNP insisted should go to emergency room (ER), in ambulance not with spouse. Other treatment included OTC ongoing Benadryl and Pepcid. The outcome of events was recovered in Jan2021. Information on the batch number has been requested.
58 2021-02-03 eye itchiness severe itching, especially eyes, ears and throat
58 2021-02-03 oropharyngeal discomfort @0825am received Dose #2 of Pfizer, resting/lying on the gurney. (due to the experience/adverse rea... Read more
@0825am received Dose #2 of Pfizer, resting/lying on the gurney. (due to the experience/adverse reaction from Dose #1), water offered. @0835am pt C/o HA, ice pack offered w/ mild relief. still lying on the gurney. @0845am noted pt's voice changed, + coarse/weak, + episode of dry coughing, + "weird feeling inside throat but breathing fine", + HA, + severe fatigue, but denies Dizzniess/N/V/epigastric pain. VS: 36.8(o), 85, 151/95, 20. 99%RA, no s/s of resp distress/swelling/rash noted. pt continue to resting/lying on gurney @0900am pt 's voice slowing returning, coughing less, + HA, continue to deny N/V,dizziness,epigastric pain. pt states "feeling a bit better but very tiring". VS: 36.8(o), 79,140/93, 20, 99%RA, no s/s of resp distress/swelling/rash noted. pt continue to rest on gurney. @0915am pt asleep, no coughing noted. no s/s of resp distress/swelling/rash noted. VS: 77, 139/93,18,98%RA @0930am pt asleep, no coughing noted. no s/s of resp distress/swelling/rash noted. VS: 76, 138/91,20,97%RA @0945am pt asleep, no coughing noted. no s/s of resp distress/swelling/rash noted. VS: 79, 130/90,20,98%RA @10am pt woke up and claimed feeling a lot better, no more HA, no more weird feeling inside throat. + tiredness, but much better. VS: 78, 138/92, 20, 98%RA RN recommends pt to rest at home. strict return precaution explained and discussed.
58 2021-02-07 lacrimation increased Allergies and nasal drip in back of throat and sneezing; Allergies and nasal drip in back of throat ... Read more
Allergies and nasal drip in back of throat and sneezing; Allergies and nasal drip in back of throat and sneezing; Allergies and nasal drip in back of throat and sneezing; Eyes watering; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 20Jan2021 at 08:40 at 0.3 mL, single on arm left for covid-19 immunisation. Medical history included high blood pressure diagnosed for a while. Historical vaccine included flu shot for immunization and experienced allergies. Concomitant medication included hydrochlorothiazide/lisinopril and ascorbic acid/ betacarotene/ biotin/ calcium/ chromium/ colecalciferol/ copper/ folic acid/ iodine/ iron/ lycopene/ magnesium/ manganese/ nicotinamide/ pantothenic acid/ phosphorus/ phytomenadione/ potassium/ pyridoxine hydrochloride/ retinol/ riboflavin/ selenium/ vitamin b1 nos/ vitamin b12 nos/ vitamin e nos/ xantofyl/ zinc (CENTRUM SILVER). Patient had the first Pfizer vaccine on Wednesday, 20Jan2021 at about 8:40AM, yesterday (22Jan2021) she started with allergies and nasal drip in back of throat, eyes watering and sneezing around 10 AM. Stated that this was normal for her to have these allergies this time of the year. Caller reports Temperature of 99.8, "not feverish", no nausea. Caller wanted to know if she was contagious because of the vaccine, if it was possible the vaccine triggered her allergies. States she was just wanting to know if she was able to go to work tomorrow. Caller said "the first time i got the flu shot, it triggered my allergies real bad". Patient was treated symptoms with diphenhydramine hydrochloride (BENADRYL) and stated it got better with the diphenhydramine hydrochloride. Outcome of the events was resolving.
58 2021-02-07 ringing in ears The 1st shot I had terrible arm pain, this time I took 2 Aleve and didn't have all that pain. What I... Read more
The 1st shot I had terrible arm pain, this time I took 2 Aleve and didn't have all that pain. What I had the 1st time was a ringing/buzzing in my ears/head. I again have the same thing this time.; This is a spontaneous report from a contactable healthcare professional who is also the patient. A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EL3249), intramuscularly, on 11Jan2021 at 06:45 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history includes status as pre-diabetic. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EL1284) on 21Dec2020 at 04:45 in the left arm. The patient is allergic to epinephrine, norethindrone and Comtrex. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as "none." Prior to the vaccination the patient had not received any other vaccination within the last four weeks. On an unspecified date after the second vaccination, the patient experienced ringing/buzzing in her ears/head. She explained that after the first shot she had ringing/buzzing in her ears/head (AER 2020508246) and she again has the same thing this time. She commented that it never really went away before having this second shot. She also said that she only really hears the buzzing when things are quiet. As treatment for the event ringing and buzzing in the head, the patient's primary care physician told her to take "Ginkgo" which she says helps somewhat. The clinical outcomes of the ringing/buzzing in the ear was reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
58 2021-02-08 mouth tingling, lip itchiness 58 yo female 2nd dose Pfizer. Pre-medicated with antihistamine 30 minutes prior to inoculation. Appr... Read more
58 yo female 2nd dose Pfizer. Pre-medicated with antihistamine 30 minutes prior to inoculation. Approximately 15 minutes post-inoculation she complained of tingling on the roof of her mouth and a mild itching sensation on lips. Observed for 30 minutes without intervention. Discharged to home.
58 2021-02-09 hearing loss, taste impairment Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost abi... Read more
Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost ability to walk without a walker, severe weakness, fatigue, dizzy, distortion in hearing, metellic taste, body aches and joint pain, intermittent headache and nausea. No fever no cough.
58 2021-02-10 permanent deafness, ringing in ears, deafness unilateral Right sensory neural hearing loss; Bilateral increased auditory fullness; Tinnitus; This is a sponta... Read more
Right sensory neural hearing loss; Bilateral increased auditory fullness; Tinnitus; This is a spontaneous report from a contactable physician (patient herself). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL8982 and expiry date unknown) intramuscular at the left arm on 21Jan2021 15:00PM at a single dose for COVID-19 immunization. The patient's medical history included osteoarthritis and exercise-induced asthma, both from an unknown date and unknown if ongoing. Concomitant medications included celecoxib, paracetamol (TYLENOL), and Vitamin D (NOS); the patient received these medications within 2 weeks of vaccination. The patient is not pregnant at the time of vaccination. She received the first dose of BNT162B2 (lot number: EK9231, expiry date unknown) intramuscular at the left arm on 30Dec2020, 8:30AM at a single dose for COVID-19 immunization. The patient previously took metronidazole from an unknown date and had allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Five days after the second vaccine, on 26Jan2021, 6:00AM, the patient had a sudden onset of right sensory neural hearing loss. Leading up to the sudden loss of hearing, bilateral increased auditory fullness and tinnitus began one to two days after vaccine. The patient received intratympanic steroid injection as treatment for the adverse events. Outcome of the events was not recovered. The case report was assessed as Serious since the events were reported as disabling/incapacitating.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be fully excluded based on the temporal relationship. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-02-10 double vision, vision blurred Double Vision. Unable to focus far away . Blurry up close. Urgent care. Primary Dr. 2 eye drs prim... Read more
Double Vision. Unable to focus far away . Blurry up close. Urgent care. Primary Dr. 2 eye drs primary care three times . Out of work vision issue is on going
58 2021-02-10 mouth tingling, taste impairment, dry mouth Tingling in the side of her mouth; her tongue started tingling; she had dry mouth then it turned int... Read more
Tingling in the side of her mouth; her tongue started tingling; she had dry mouth then it turned into a metallic taste; Her blood pressure was elevated; she had dry mouth then it turned into a metallic taste; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left Arm on 26Jan2021 at 1:04PM as a single dose for COVID-19 immunisation, lot number: EL8982, expiration date: 31May2021. Medical history included penicillin allergy (she was diagnosed as a child) and high blood pressure. Concomitant medication included diltiazem (CARDIZEM) from 2011 and ongoing for high blood pressure. Patient did not receive other vaccine in four weeks prior to the COVID vaccine and did not receive additional vaccines on same date of the COVID vaccine. Patient got the vaccine on 26Jan2021 (yesterday) and after ten minutes of having the vaccine she started getting tingling on the sides of her mouth. Five minutes later she had dry mouth then it turned into a metallic taste. Later her tongue started tingling. They monitored her there for about an hour. Her blood pressure was elevated. Eventually the tingling stated to go down after an hour. They said it was a minor reaction and they were not going to report it. She is kind of freaking out. She knows there have been limited cases of Bell's palsy and sometimes tingling is how it starts. Her tongue started tingling about 30 minutes after the vaccine. Then about two hours it seemed to subside. Last night it started coming back. It started coming back around 09pm, so eight hours after getting the vaccine. The tongue, the sides of her mouth, and lips were tingling. Initially it was on both sides of her mouth that she is tingling. Last night it was more on left side, which is the side the vaccine was given on. When she woke up the morning of the report it was gone. Patient recovered on 27Jan2021 from tingling in the side of her mouth and tingling tongue, while outcome of the other mentioned events was unknown.
58 2021-02-11 swollen tongue facial/ tongue swelling, hives, shortness of breath, trouble swallowing
58 2021-02-12 eye irritation Sore arm, headaches, body aches, chills, fever, acidity, burning of eyes
58 2021-02-15 taste impairment, mouth tingling Ten minutes after getting the vaccine I experienced tingling on both sides of my mouth and my tongue... Read more
Ten minutes after getting the vaccine I experienced tingling on both sides of my mouth and my tongue. About 5 minutes after that, I had a metallic taste in my mouth. I was monitored and my blood pressure was elevated. My pulse was normal. They monitored me for 1 hour and then let me go home. The tingling continued through the night. Around 8 hours after the vaccine, the tingling was only on the left side of my mouth and tongue. Two days after the vaccine, my heart began to race. My blood pressure remained high for approx. 2 1/2 weeks. My heart beat continues to race at times. I followed up with my PCP and cardiologist who both took EKGs which were normal.
58 2021-02-16 mouth tingling Lip tingling
58 2021-02-17 double vision The Department came to the work place to give COVID19 vaccines. Approximately 4 hours after receivin... Read more
The Department came to the work place to give COVID19 vaccines. Approximately 4 hours after receiving the 1st dose of the COVID vaccine, the patient/staff c/o feeling dizzy / double vision/ headache . her Blood pressure was high / blood sugar wnl she was becoming sluggish lungs were clear she was sent out to ED via EMS . She reported to this RN after the event that she was kept in the hospital until just before 2:00 am where they had her on IV fluids to bring her BP down.
58 2021-02-18 ringing in ears, deafness Hearing loss, Tinnitus, Headache
58 2021-02-19 thirst Wednesday evening Feb. 17th diarrhea, nausea accompanied with intestinal pain. Feb. 18th am, diarrh... Read more
Wednesday evening Feb. 17th diarrhea, nausea accompanied with intestinal pain. Feb. 18th am, diarrhea, nausea, intestinal pain and a strange pain in the urethra area. Feb. 18th 4:30 pm, 100.5 Fahrenheit, severe headache, body aches, slight cough, dizzy and thirst. 1 325 mg Aspirin at 9 pm. Feb. 19th-mild headache and a little dizzy in am. Feb. 20th appetite recovered, a little tired still.
58 2021-02-21 mouth tingling Reported tingling tongue. Took own benadryl, monitored for 15 mins, noted resolution of symptoms and... Read more
Reported tingling tongue. Took own benadryl, monitored for 15 mins, noted resolution of symptoms and d/c home,
58 2021-02-22 ear itchiness, tongue itchiness began having itching inside ears and tongue, without tongue swelling; intermit cough within about 5 ... Read more
began having itching inside ears and tongue, without tongue swelling; intermit cough within about 5 minutes after administered. Pt took 25mg of personal benadryl. Pt continually monitored for 30 minutes following benadryl administration. Cough resolved after 10 minutes, other symptoms remain unchanged. 25 minutes following benadryl, patient stated symptoms resolved. Pt monitored another 5 minutes, vital signs rechecked. Pt sent home with spouse in stable condition.
58 2021-02-23 lip swelling lips swelling; This is a spontaneous report from a contactable consumer reported for herself. A 5... Read more
lips swelling; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot number #EL9267on 14Feb2021 09:00 AM (at 58 year old) at single dose via unspecified route at the left arm, for COVID-19 immunization. Medical history included Anaphylactic reaction to the Capsaicin Family, thyroid and High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID), lisinopril, verapamil and loratadine (CLARITIN). The patient was not pregnant. No COVID prior vaccination. The patient had not been tested for COVID since the vaccination. On 14Feb2021 09:15 AM the patient experienced lips swelling. The outcome of the event was unknown. The patient visited Emergency room for the event and treatment was received, steroid shot and prednisone for 5 days.
58 2021-02-23 oropharyngeal discomfort Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort wi... Read more
Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort with swallowing. I took 1 Benadryl and then another 15 minutes later, then drove home once rxn seemed to stabilize. Took 2 more Benadryl through the course of the evening as flushing stopped but still had throat discomfort and new headache. Also took Tylenol. In AM, allergic symptoms were resolved, but had significant arm pain (upper arm around site was very firm and warm to the touch), mild headache, moderate fatigue, and diarrhea. This continued for another 24 hours. Took Tylenol 3 times. Felt fine by Wednesday (2 days after vaccination).
58 2021-02-24 ear itchiness 1435- Received vaccine 1437- Pt developed ear and lower leg itching, no other symptoms 1440- Pt was ... Read more
1435- Received vaccine 1437- Pt developed ear and lower leg itching, no other symptoms 1440- Pt was brought back to assessment area. Vitals checked 1450- 142/82 1506- 133/90 Recommend diphenhydramine for symptoms- Pt refused treatment recommendation. Emergency Response Team called to discuss with Pt. Pt signed recommendation refusal form and left clinic.
58 2021-02-24 vision blurred 1st vaccination -Head ache, muscle ache, fever, fatigued- lasting 2 days Ibuprofen and Tylenol be... Read more
1st vaccination -Head ache, muscle ache, fever, fatigued- lasting 2 days Ibuprofen and Tylenol bedrest 2nd vaccination- Head ache, muscle ache, joint pain, blurry vision, fever fatigued - lasting 3 days Ibuprofen and Tylenol and bedrest
58 2021-02-25 mouth tingling, tongue discomfort Progress Notes (Nurse Practitioner) - - Family Medicine Attempt to call patient for follow up vi... Read more
Progress Notes (Nurse Practitioner) - - Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes APRN (Nurse Practitioner) - - Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Patient: Date: 2/24/2021 MRN: 1356120 Subjective Patient is a 58 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience tip of tongue tingling/burning. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to drooling, rapid progression of symptoms, respiratory distress, tongue swelling and vomiting. Pt reports that she may have burned the tip of her tongue this am after eating hot oatmeal. She wanted to be evaluated to be sure if that was the issue and not an allergic reaction. PMH includes HTN: takes 10 mg of Lisinopril ALLERGY REVIEW OF SYSTEMS: Patient denies chills, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, cysts, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 0912 02/24/21 0920 02/24/21 0927 BP: (!) 144/79 126/82 132/71 Pulse: 75 67 SpO2: 99% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: No visible burn noted to tip of tongue. No swelling or discoloration noted. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Encouraged to monitor symptoms at home. She is aware of f/up care with ED if she does progress in symptoms of allergic reaction. This time I think she has the burnt tip of her tongue sensation. F/up with pcp otherwise. APRN Electronically Signed 2/24/2021 9:40 AM
58 2021-02-28 mouth tingling This was second injection. She did have worse reaction to first shot and was sent to ED and also cle... Read more
This was second injection. She did have worse reaction to first shot and was sent to ED and also cleared by her PCP. This time she has tingling of the tongue. She immediately took Benadryl. Issues subsided and sent home with instructions to call PCP or go to ED if symptoms returned.
58 2021-03-01 loss of smell Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it fel... Read more
Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it felt I was having knee surgery without anthesis nothing helped with the pain. General aches through out whole body settling in the joints. Fatigue, migraine headache, loss of smell on and off through day. Loss of appetite on and off. Injection site has a large redden area warm to touch approximate size of a silver dollar if not bigger, lymph node under left arm pit is swollen and sensitive to the touch, movement aggravates the arm pit. Evening time body breaks down in an allergic rash.
58 2021-03-02 burning mouth syndrome, swollen tongue, mouth tingling Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper bac... Read more
Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper back within 5-10 minutes of injection 1-2 days after, continued tingling, pain, and swelling in tongue, hives/rash on face with itching and difficulty swallowing Benadryl was administered at the testing site. Continued Benadryl with Zyrtec and Pepcid daily for adverse reaction through 3/3/21. Called PCP?have appt 3/4/21.
58 2021-03-02 lip swelling lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of... Read more
lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of both hands. unable to grasp with both hands, dark spot in middle of hand.
58 2021-03-03 lip swelling Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom... Read more
Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom; the sores are underneath the lip by the cheek on top and bottom/sores being white on top and real red where the bump is, but on top of it, it's really white; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 30Jan2021 11:30 at a single dose for COVID-19 Immunization. Medical history included Hashimoto's thyroiditis and acid reflux. Concomitant medication included levothyroxine for Hashimoto's thyroiditis and pantoprazole for acid reflux. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL1283; expiration date: Apr2021) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 09Jan2021 at a single dose for COVID-19 Immunization. The patient reported that she got her second shot on Saturday 30Jan2021 and yesterday (01Feb2021), her lips were swollen, and she has sores inside the mouth, the sores are underneath the lip by the cheek on top and bottom. She further reported that swelling was on both top and bottom lips, it occurred yesterday 01Feb2021, she noticed it as soon as woke. The sores in the mouth also started at the same time. She added that the lips swelling is ongoing but getting better. The Sores in the mouth, she thinks that they are getting better but it does bother her more when she is eating, but it is getting better, she only experiences pain on the sores when she is eating but other than that there is no pain. She has not used anything to treat the swelling and sores. The sores are sensitive to touch. She described the sores being white on top and real red where the bump is, but on top of it, it's really white. She has had no positive COVID Test prior to the first dose. She has had no issues with vaccines in the past. She also added that she did have chills and body aches on Saturday (30Jan2021) and Sunday (31Jan2021), she thought she was doing great, but then on Monday the sores showed up. She wanted to report this because no one said to her that would happen. She clarified that she experienced the chills on the same day of getting the second dose on 30Jan2021, then the body aches came Sunday 31Jan2021. The outcome of the events chill and ache were unknown while the outcome of the other events was recovering.
58 2021-03-04 loss of taste, loss of smell, taste impairment Taking Aleve and drinking lots of Water
58 2021-03-04 pupils dilated History of HTN, left-arm numbness, and ipsilateral dilated (blown) pupil about 2 minutes post vaccin... Read more
History of HTN, left-arm numbness, and ipsilateral dilated (blown) pupil about 2 minutes post vaccine. Transported to ED. Patient left the ED without treatment.
58 2021-03-05 vision blurred Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, ... Read more
Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, difficulty focusing eyes. Aches started at 6:30 am. High heart rate noted at 10:00 am. The rest came on in the afternoon. Took my vitals when I got home from work (7 pm). Chills, cold extremities through the night. By 5am, temp down to 100. By noon next day, BP and HR normal. Dizziness still comes and goes.
58 2021-03-06 dry mouth, thirst Extreme dry mouth, sinuses and lips. Very thirsty.
58 2021-03-06 eye pain, bloodshot eyes Yes got very painful at night and upon wakening. In the morning they were very puzzled and red. Pu... Read more
Yes got very painful at night and upon wakening. In the morning they were very puzzled and red. Put Systane eye drops in a couple of time during the day and also put ice pack on eyes which helped. Definitely something going on with my eyes. I never use eye drops or have to put ice on my eyes. Hopefully will be better soon but wanted it noted.
58 2021-03-07 swollen lips, eye irritation, lip swelling swollen and irritated lips and eyes, started 24 hours after vaccine 3/5, took over the counter Benad... Read more
swollen and irritated lips and eyes, started 24 hours after vaccine 3/5, took over the counter Benadryl and called my primary care's office on Monday 3/8
58 2021-03-07 sensitivity to light, extreme sound sensitivity felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Simila... Read more
felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time. These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering. Information on the lot/batch number has been requested.
58 2021-03-07 taste disorder Just 12 hours later experienced severe headache that woke me up in the middle of the night. Fever ... Read more
Just 12 hours later experienced severe headache that woke me up in the middle of the night. Fever (100), chills, all over body aches, sore throat, alteration of taste, heaviness in chest, nausea. The headache lasted a few days .... each morning for the next 4 days I awaoke with headaches
58 2021-03-08 taste impairment client waiting in post-vaccination area and started to have difficulty breathing. Post-vaccination n... Read more
client waiting in post-vaccination area and started to have difficulty breathing. Post-vaccination nurse notified Vaccination Team Lead. After 1 minute, difficulty breathing did not decrease, client also reported a metallic taste in mouth. Reaction at 9:32, EAMS called 9:33, Epinephrine administered at 9:34 in right arm, IM. 0.5mL administered per protocol. EMS arrived 9:37. Client placed on stretcher and transfer of care to EMS at 9:43.
58 2021-03-08 eye itchiness, eye pain, eye floaters I developed severe headache for two to three days after getting the 2nd dose of the Covid-19 vaccin... Read more
I developed severe headache for two to three days after getting the 2nd dose of the Covid-19 vaccine starting approx. 3 hours after the vaccine. I took Celebrex as the head aches were quite severe(7-8/10) with difficulties in focusing due to the pain. I received my first Covid-19 vaccination shot on 12/16/2020 and did not have any significant side effects besides mild pain in my left arm at the injection site the next day and it resolved with no intervention. Then on 01/14/2021 I developed floaters in my right eye that was very sudden around early afternoon that progressed to large black spots obscuring my vision. It was associated with headache and deep eye itching and pain. I was unable to look at the computer and that is when I called my eye doctor and was told to come to see her right away. She then diagnosed me with Posterior Vitreous Detachment and referred me right away to see Dr. retinal specialist.
58 2021-03-08 swelling around the eyes My skin around my eyes swelled about 45 mins after vaccine. I had a prickly itchy sensation on my ba... Read more
My skin around my eyes swelled about 45 mins after vaccine. I had a prickly itchy sensation on my back, the back of my neck & under my right arm pit. My throat felt itchy. I took benadryl & the swelling around my eyes went down considerably within a few hours. The itchiness persisted until my 2nd dose of benadryl. When I woke up this morning, I was fine.
58 2021-03-08 swollen tongue Patient received second dose of Covid 19, Pfizer, at 8:10 am. Stated she was doing fine and left the... Read more
Patient received second dose of Covid 19, Pfizer, at 8:10 am. Stated she was doing fine and left the Clinic. At approx. 8:14 ambulance was called to truck stop. Patient was having weakness, shortness of breath and tongue swelling. Patient brought to Emergency Room. See enclosed notes.
58 2021-03-08 vision blurred, double vision double vision; blurred/double vision; This is a spontaneous report from a contactable nurse. A 58-ye... Read more
double vision; blurred/double vision; This is a spontaneous report from a contactable nurse. A 58-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date: unknown), via an unspecified route of administration on the left arm on 22Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history included elevated B/P. Patient was not pregnant at the time of vaccination. Unspecified medications were received within 2 weeks of vaccination. The patient experienced blurred/double vision on 25Jan2021. Patient had urgent/ emergency care visit for which she was given antibiotics and steroids. She had 2 eye doctors and been to primary doctors twice. Outcome of the events was not recovered. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination on 27Jan2021 (nasal swab: negative).
58 2021-03-09 dry eye, mouth numbness, dry mouth Numbness in center of face numbness tongue dry eyes dry mouth restless leg
58 2021-03-10 taste impairment, mouth numbness 15 minute waiting period I had no events, but 20 minutes after receiving vaccine I had metal taste i... Read more
15 minute waiting period I had no events, but 20 minutes after receiving vaccine I had metal taste in mouth on right side along with numbness on right side of face, right jawline, ear area, and small portion of tongue. No pain. No swelling. The metal taste dissipated in approximately 1/2 hour but numbness lasted until evening. By next morning, all symptoms were gone.
58 2021-03-10 mouth numbness Tremors, Itching, Tongue feeling numb,
58 2021-03-13 sensitivity to light, eye irritation Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, naus... Read more
Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, nausea, all over muscle and joint pain, weakness. By mid day, eyes were irritated and sensitive to light. By 5:00, fever, chills, muscle aches, headache, joint pain, nausea, rapid pulse rate when walking. Symptoms lasted 3 days. On 4th day, no fever or chills but still painful headache and some muscle/joint pain and weakness.
58 2021-03-14 lip swelling I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vacc... Read more
I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vaccine at approx. 12:00 Noon on 13MAR2021. I experienced minor lower lip swelling at 9:30 PM (the lower lip, left side only). Went to bed approx. 10:30 PM and experienced mild chills. I woke up at ~3:30 AM with full facial swelling (forehead, brow, eyes, under eyes, facial lines, jowls and full lower lip only - now right side engaged and more pronounced than the left side) and mild full body hives. I took a Zyrtec. The itching of hives subsided in approx. 30 minutes. The facial swelling and lower lip swelling subsided in approx. 12-hours. I took and have photos of my face and lips.
58 2021-03-15 vision blurred -1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chip... Read more
-1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chips,- ended up treating with ondansetron 2- 5 mg doses-no appetite for at least 4 days and resultant weight loss of 6-8 lbs -balance impaired, vision blurred about 12 hours after-lasting 12 hours -confusion from about 12 hours post vaccine until 24 hours post vaccine -weakness, and hand and leg diskinesia about 12 hours after -lasting 12 hours -sore throat, phlegm 48 hours after for 12 hours -hyper alertness and unable to sleep almost 48 hours -twitching during sleep (throughout body, arms and legs) and in evenings which lasted 6 days, slowly abating over time -headache -multiple hot flashes 3-4/hour first 2 days mostly at night, way more than I normally have (I usually have 2-3 a night and 1-2 during the day-4 days/week) Shot on 2/8/21 and finally felt back to normal, resumed all normal activities including exercise 2/14/2021
58 2021-03-16 eye pain Severe eye pain - began day after vaccine (went to emergency at Hospital three days after vaccine be... Read more
Severe eye pain - began day after vaccine (went to emergency at Hospital three days after vaccine because pain continued - diagnosed with cornea abrasion but said pain was in a different area - I?m unaware of how it could have occurred); severe pain in both shoulders with difficulty lifting both without pain- I have degenerative disc disease in my cervical spine so I assumed it was associated. However, the pain I?m experiencing is unusual and it?s never occurred like this. This pain also began the day after the vaccine. I used the V-Safe system, but didn?t report either problem because I assumed they weren?t related to the vaccine. But the timing, severity, and unusual nature have me very concerned about a connection to the vaccine.
58 2021-03-16 mouth numbness facial and tongue numbness for 1 full day and still feeling it at this time
58 2021-03-16 mouth numbness Numbness in face, neck and mouth. Red Rash on face and neck. Dizzy.
58 2021-03-16 mouth tingling, mouth numbness Patient presented with numbness/tingling in mouth, a slight cough. Progressed to become nauseated wi... Read more
Patient presented with numbness/tingling in mouth, a slight cough. Progressed to become nauseated with tingling down arms and legs. Blood pressures in the 150/90s, HR 86, 98% O2 saturation, and alert/oriented. Patient was placed in a supine position and monitored. EMS was called as symptoms persisted and increased.
58 2021-03-17 eye swelling, swelling around the eyes Within 10 minutes of taking shot, I had an allergy attack - my nose became stuffy and was hard to br... Read more
Within 10 minutes of taking shot, I had an allergy attack - my nose became stuffy and was hard to breathe. Medic came to my car to assist. Told me to keep window down and take deep slow breathes. This worked, but maybe to minutes later it happened again. My blood pressure and oxygen level was taken. I was given a banana to eat. I ended up calling my husband to pick me up. On the evening of Sunday 3/14, I noticed a red patch on my chest. Monday, 3/15 when I woke up, red patches were on my arms, hands , neck and face. Tuesday, 3/16 the red patches had spread up my arm and my eyes were puffy. I went back to the vaccination site and reported it to a medic. I was told to take Benadryl. Wednesday, 3/17 my right eye was swollen more and puffiness under my eye. My left eye was swollen but not as much. I went to clinic and was given Benadryl and prednisone, and told to go to the emergency room if it gets worse. Today 3/18 blotches still on arms, hands, neck and chest. Swelling on right eye lid has gone down some.
58 2021-03-17 burning mouth syndrome A few hours after injection my tongue started to feel sore, almost as if I had scorched it. The fol... Read more
A few hours after injection my tongue started to feel sore, almost as if I had scorched it. The following day it continued to be sore but only on the side the injection was given (right), it also developed a purplish blister in the area where it is sore. I had my injection on 03/16/2021 today is 03/18/2021 and the blister and soreness is still there. I can still eat and drink normally, it is just uncomfortable to do so.
58 2021-03-17 mouth numbness Approximately 30 minutes after receiving vaccine patient experienced numbness on the left side of he... Read more
Approximately 30 minutes after receiving vaccine patient experienced numbness on the left side of her tongue and cheek. This lasted about one hour, but the numbness progressed to her left jaw and left cheek and then her whole head. The next morning the numbness was at the base of her skull and lasted most of the day. All symptoms resolved within 48 hours of the vaccine. On 3/16/2021 patient reported slight numbness of her whole head during the day. This resolved within a few hours.
58 2021-03-18 mouth numbness, lip swelling hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, prog... Read more
hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, progressed by evening of that day, lips swelled and were numb feeling, felt like a lump in my throat, throat felt swollen but no pain or difficulty breathing. Took 2 Benadyl(generic) at 9:30pm and again at 3:30am
58 2021-03-18 mouth numbness, mouth tingling Numbness and tingling in lips and tongue, no visible swelling, lasting for about two hours. After nu... Read more
Numbness and tingling in lips and tongue, no visible swelling, lasting for about two hours. After numbness and tingling had nearly subsided, I took two Benadryl tablets just in case and went to sleep. Upon waking there was no more numbness or tingling. 9. Continued: multivitamin, vitamin D3, melatonin when needed for sleep, Tylenol, probiotics
58 2021-03-18 mouth numbness tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, an... Read more
tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 58-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on Left arm on 03Feb2021 15:59 at single dose for covid-19 immunisation administered at state facility. Medical history included Asthma (diagnosed about 5 or 6 years ago, states she has probably had it all her life) and Fibromyalgia (diagnosed about 20 years ago). Historical vaccine includes Shingrix shot on an unspecified date, she did not feel well for a day, she felt sick but then it resolved it. The patient's concomitant medications includes pregabalin (LYRICA) at 250 mg (It is a 50mg capsule, she takes 100mg in the morning and 150mg in the evening) for Fibromyalgia; budesonide, formoterol fumarate (SYMBICORT) at 2x/day (two puffs twice a day) for Asthma and montelukast sodium (SINGULAIR) at 20 mg, 1x/day (once a day). The patient reported that she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. 45-60 minutes after, she felt the tip of her tongue, lips and part of her cheek become numb. She said this went away after 30 minutes. Consumer wants to know what reactions can she expect after she receives the 2nd dose, and if it would be worse than her reaction with the 1st dose. Asking if she should take Benadryl before the second dose. She is asking if she would have more of a problem. States she is an allergic person. She stayed at the facility for 30 minutes. Event occurred while she was driving, she thought if it got worse, she would go to the hospital but then it went away. The patient took covid vaccine for preventive action. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events resolved. Information on the lot/batch number has been requested.
58 2021-03-18 mouth numbness Patient returned to vaccine clinic approximately 2 hrs after receiving Pfizer vaccine. She waited i... Read more
Patient returned to vaccine clinic approximately 2 hrs after receiving Pfizer vaccine. She waited in vaccine clinic waiting area 15 minutes, then sat in hospital waiting area an additional hour (her own decision) then started feeling numb around her lips and part of her tongue, as well as heartburn symptoms. By the time she reported back to vaccine clinic, she said she was mostly better, but still had some circumoral numbness and the tip of her tongue was numb. Patient evaluated by RN and MD working in vaccine clinic; no swelling noted. Lips and tongue normal in appearance. Pt. denied any shortness of breath. VSS (139/63, HR 100, 95% O2sat). Pt declined to go to ED and discharged home without any other known complications. Patient received second Pfizer vaccine on 3/2 (lot# EN6198) without known complications.
58 2021-03-18 mouth tingling, mouth numbness C/o tongue heeling heavy and big. No resp. distress noted. Resp. even and reg. (20). C/o numbness... Read more
C/o tongue heeling heavy and big. No resp. distress noted. Resp. even and reg. (20). C/o numbness in tongue. BP 134/77, Hr 66, O2 sat 100%\ 10:10 am client stated tongue continues to feel somewhat swollen but better, sensation remains. Tongue observed and did not appear swollen by Paramedics.
58 2021-03-18 mouth tingling, swollen tongue, mouth numbness Pt. c/o tongue swelling. Numbness and tingling. Vital signs: 2:10pm 135/105 82 17 O2 96% 2:25pm 12... Read more
Pt. c/o tongue swelling. Numbness and tingling. Vital signs: 2:10pm 135/105 82 17 O2 96% 2:25pm 125/100 75 16 O2 94%; 2:40pm 130/82 75 16. Given 20ml of Diphenhydramine by mouth @ 2:30pm.
58 2021-03-18 swollen tongue, mouth numbness Patient started with teeth numbness, tongue numbness, became nauseated. Tongue started swelling, fin... Read more
Patient started with teeth numbness, tongue numbness, became nauseated. Tongue started swelling, finger numbness. Benadryl was given at 1046.u
58 2021-03-19 hearing loss, ringing in ears, ear discomfort Very loud worsening of Tinnitus that interfered with hearing and very weird feeling ears. I went to ... Read more
Very loud worsening of Tinnitus that interfered with hearing and very weird feeling ears. I went to the doctor and was prescribed Flonase, Sudafed, and an antihistamine. Using those improved the symptoms after about a week.
58 2021-03-20 mouth tingling lip tingling and throat tightness started minutes after vaccine was given. Vitals unremarkable. Brea... Read more
lip tingling and throat tightness started minutes after vaccine was given. Vitals unremarkable. Breath sound clear, no post oropharyngeal edema, no angioedema on exam. No urticaria or skin changes. Suspected anxiety vs. mild allergic reaction, offered Benadryl, which pt accepted, was given Benadryl and observed for 30 minutes, at whichpoint she felt symptoms had nearly resolved completely
58 2021-03-21 double vision, vision blurred Third Nerve Palsy; vision was double; vision problems which was like little blurry; Myasthenia gravi... Read more
Third Nerve Palsy; vision was double; vision problems which was like little blurry; Myasthenia gravis; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported), at the age of 58-year-old, as SINGLE DOSE for covid-19 immunisation. Medical history included thyroid disease and asthma. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of the vaccine on 12Jan2021 and developed Covid symptoms and on 18Jan2021, the patient was tested positive, was sick from all and had fever (stopped at end). On an unspecified date, the patient stated she was just at the hospital on Tuesday, in emergency room and they told me that she should report possible side effects from the Covid vaccine. The patient have the Third Nerve Palsy they think this might be connected to the vaccine they are not sure. When paraphrased the concern, consumer stated, "They said I should just report that there was a reaction and they don't know if the Third Nerve Palsy is due to the vaccine or just something freak that I got." When probed if patient was a Health Care Professional, consumer stated, "I am not, I am a manager." The patient also added, "Can I give you the Path Gram, on the 9th I had my first shot on the 12Jan, I developed Covid symptoms and on 18Jan I was tested positive, I was sick from all and finally got tested on the 18 and was Positive and finally stopped my fever at end, I think may be 01Feb, and they told me to get my second shot I got my second shot on 05Feb and on 15 I started having vision problems which was like little blurry and I went to my eye doctor and they didn't think anything else he said that it could be something from Covid like what they called continuing symptoms but not having Covid, I don't know what the terminology is or it could have been from vaccine then that was the 15, the following Monday I went to my Primary because my vision was double at this point in my right eye and they thought it might be sinus related I had a CT done came back normal they told me that they thought it was Third nerve palsy and I had a MRI in the meantime they told me to go back to my Ophthalmologist which I did on Tuesday as soon as he see my he sent me to emergency room cause he thought it was an Aneurysm, so I was in the Emergency room being examined in hospital in (withheld) when I spoke to the Doctor they said I should advise Pfizer that they can't prove but it's vaccine related." When the patient was asked about teatment: she stated, "Well right now what they are doing is they had an had a MRI to be sure it was not Aneurysm or brain tumor which thank God came back negative and they did blood work so they are assuming it's third Nerve Palsy at this point but I have to see in 4 weeks it clears up or it could be Myasthenia gravis." The outcome of the events was unknown.
58 2021-03-21 eye swelling, swelling around the eyes As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotc... Read more
As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotchy and my eyes started to swell. I took benedryl and applied a cool pack. Redness and swelling around mybeyes lasted for 2+ days. Still not feeling well and have scheduled a doctor appointment for tomorrow.
58 2021-03-21 mouth tingling, lip swelling 3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfiz... Read more
3/19/21 Patient called Health Department to report an allergic reaction to her vaccination with Pfizer COVID vaccine on 3/17/21. She attended the Vaccination Clinic. Her appointment was at 1:35 PM. She states she had no symptoms that day. However, she woke up on 3/18/21 with two small hives in groin area which were itchy. By late afternoon her lips became tingly and she developed itchy hives on her arms which then spread to her trunk. By evening her lips with swollen. She took 2 tabs of Benadryl at 9:30 PM and went to bed. She woke up at 3:00 AM with her lips doubled in size and she felt like there was something stuck in her throat. She took two more tabs of Benadryl and went back to bed. She woke up on 3/20/21 with her throat feeling better and no more swelling of the lips. However, the hives remained spread over her arms and trunk. She called her PCP (who she had not seen in eight years) to report her allergic response and they did not want to see her in the office but encouraged her to go to ER or Urgent Care. Patient stated that she felt better by then and did not go to ER or Urgent Care. RN encouraged patient to go to Urgent Care due to seriousness of the original allergic response. Patient instructed to go to ER if symptoms such as the swollen lips or difficulty swallowing resume as they are more severe allergic signs and may require more urgent medical care. Patient verbalized understanding. Patient also encouraged to follow up with PCP and get a referral for allergy testing as appropriate. Patient states she will follow up with physician prior to her next dose of the Pfizer vaccine in 21 days. Patient also states that she has filled out a VAERS report of her own (Report # 366931).
58 2021-03-21 swollen tongue, mouth numbness Swelling tongue, swelling throat, numbness on face, lips, headache nausea, numbness feet, numbness ... Read more
Swelling tongue, swelling throat, numbness on face, lips, headache nausea, numbness feet, numbness hands
58 2021-03-21 visual impairment Sat down, grabbed phone and couldnt see it, told husband to get somebody, escorted to cot via wheelc... Read more
Sat down, grabbed phone and couldnt see it, told husband to get somebody, escorted to cot via wheelchair due to feeling light headed and nauseous. Pt continuously monitored until 10:40 when she was escorted out via wheelchair and accompanied by RN and patient husband.
58 2021-03-22 taste impairment, mouth tingling I became flushed and it lasted a few days. it feels like a sunburn from the inside out and it was fr... Read more
I became flushed and it lasted a few days. it feels like a sunburn from the inside out and it was from the neck up. then I had a tingly tongue and a metallic taste in my mouth. it did NOT swell, it just didn't feel right. has resolved by today 03/23
58 2021-03-22 mouth numbness tongue numbness
58 2021-03-22 mouth tingling Patient had shortness of breath, nausea, dizziness, and their tongue tingled soon after receiving th... Read more
Patient had shortness of breath, nausea, dizziness, and their tongue tingled soon after receiving the Pfizer vaccine. EMT onsite evaluated patient and called 911. Ambulance Service arrived, evaluated the patient, and transported the patient to the hospital.
58 2021-03-22 vision blurred faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a co... Read more
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events. Information on the batch/lot number has been requested.
58 2021-03-23 taste disorder Patient received the Covid-19 vaccine. She reports symptoms of lightlessness, taste in mouth. Pt sta... Read more
Patient received the Covid-19 vaccine. She reports symptoms of lightlessness, taste in mouth. Pt stated she is unsure if she had a seizure since she has a hx of seizure disorders. Pt did take medications this morning. Pt does not have any facial swelling. Pt started feeling unwell at 11:02am Vitals: B/P: 110/74 HR: 110, 105, 100 02: 87 11:20: Vitals: B/P: 112/74 HR: 98, 86 02: 97 11:32am: BP: 116/76 HR: 86 02: 97 11:45am: B/P:112/72 02: 97 HR: 86 Pt stated she feels ok now, husband is here with pt and is driving her home. Pt aware to mention this to health care provider, pt verbalized understanding
58 2021-03-23 ringing in ears, loss of taste ringing in the ears and lost of taste
58 2021-03-24 taste impairment Chemical taste in mouth was the first sign, then inability to swallow for approximately 1-2 minutes.... Read more
Chemical taste in mouth was the first sign, then inability to swallow for approximately 1-2 minutes. Resolved by itself and no further problems.
58 2021-03-24 mouth numbness Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: ... Read more
Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: @ 0815 TEAM ALERT was called to covid vaccine clinic. This RN arrived @ 0818 to find pt sitting in chair in observation room. Received report from RN, pt received covid vaccine #2 and began experiencing cough, clearing throat, runny nose, and chills. Benadryl 25mg PO given @ 0810. Overall discomfort 1/10. 0818: VS: BP 132/98. HR 63. R 14. O2 Sat 98%. Pt c/o clearing throat, chills, coughing, itchy throat, itchy chest. Pt alert & oriented. 0820: overall discomfort 3/10. 0828: VS: BP 124/92. HR 63. O2 Sat 100%. Still experiencing above symptoms plus dizzines, lip numbness and discomfort in diaphragm region. "feels like it won't go down. Like something is stuck there." pt moved to gurney in hallway. 0842: VS: BP 122/86. HR 63. O2 Sat 100%. Pt still feeling diaphragm discomfort. States other symptoms are resolving. Noted pt no longer clearing throat. States lip numbness improved and diaphragm discomfort improving. Pt alert & oriented. 0855: Manager, spoke to pt. Advised pt she may go home when she feels okay. Pt states she feels well enough to go home. This RN advised pt to go home and relax for the remainder of the day, benadryl will make her feel sleepy. Advised pt to watch for symptoms of shortness of breath, difficulty breathing, and chest pain and go to ED if she experiences any of those symptoms. Pt verbalized understanding. VS: BP 118/72. HR 63. O2 Sat 100%. 0857: Pt left covid vaccine clinic ambulatory in stable condition. COVID Vaccine Worksheet 1. Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)? Yes 2. Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol? No 3. Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause? No 4. Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine? No Assessment: Pt had reaction to covid vaccine. Pt reported previous reaction to first dose with similar symptoms. After close observation and benadryl 25mg PO pt symptoms resolved and pt was able to leave clinic ambulatory in stable condition.
58 2021-03-24 mouth numbness Tongue numbness. Referred to EMS. No transport.
58 2021-03-24 swollen tongue tongue swollen and irritated by my teeth on each side of my mouth
58 2021-03-24 toothache Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day ... Read more
Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day one
58 2021-03-24 visual impairment I was hospitalized with visual disturbances which lasted about 30 minutes and transient aphasia that... Read more
I was hospitalized with visual disturbances which lasted about 30 minutes and transient aphasia that lasted about 1.5 hours and blood pressure of 190/85.
58 2021-03-25 ear pain Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on l... Read more
Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on left arm injection site
58 2021-03-25 ear pain Fever 102+, headache, stomache ache, ear ache, body and muscle pain, skin hurt, chills, muscle pain
58 2021-03-25 feeling of choking, mouth numbness, mouth tingling Within a minute or receiving the COVID 19 vaccine I began experiencing tingling and numbness in my l... Read more
Within a minute or receiving the COVID 19 vaccine I began experiencing tingling and numbness in my lips, tongue, mouth and throat. My throat felt like it was closing or tightening and I had difficulty swallowing. I was administered Benadryl at the vaccine site and then transported by ambulance to the Hospital. There I was given an IV with peptide, steroid and benadryl. After a couple of hours, my symptoms began to improve and I was released. I continued to experience irritation of my tongue and mouth and a sore throat until the next day.
58 2021-03-27 taste impairment Metallic taste in mouth about five minutes after getting shot. Tongue was white looked like it had ... Read more
Metallic taste in mouth about five minutes after getting shot. Tongue was white looked like it had thrush
58 2021-03-27 pain in jaw Headache, 101 fever, dizzy, chills, heart race, jaws hurt, fatigue, sore throat, cough. This is 1st ... Read more
Headache, 101 fever, dizzy, chills, heart race, jaws hurt, fatigue, sore throat, cough. This is 1st day.
58 2021-03-28 loss of taste First dose was only pain at the injection site. During the 2nd dose injection, the needle became di... Read more
First dose was only pain at the injection site. During the 2nd dose injection, the needle became disattached from the syringe during the injection process. The needle stayed in my arm and had to be pulled out manually. There was no way to note how much of the vaccine was actually delivered. I am, however confident that I received enough of the dosage to cause me some uncomfortable side effects starting within 12 hours. I had a low grade fever, chills and a pretty significant headache that lasted about 18 hours. After that point, I took an alleve and the symptoms resolved within an hour. These are all typical side effects so I wasn't going to fill this form out, but I have noticed something unusual that I haven't seen much about. My taste is way off. I am now 5 days out from my 2nd vaccine and still nothing tastes right. Not bad or like anything specifically, it's just that nothing has any flavor. I can still smell just fine and can minimally taste my food but it just doesn't taste normal.
58 2021-03-28 mouth numbness Pt received vaccine 0927. 0940 Pt c/o numbness to lips and lower face, slight pinkness noted to b ch... Read more
Pt received vaccine 0927. 0940 Pt c/o numbness to lips and lower face, slight pinkness noted to b cheeks and neck. Pt initially stated swelling in neck, but symptom resolved and pt denies now. Pt given Benadryl 25mg PO, additional OBS x 30 min. Pt co-worker picked her up and left @ 0955 with pt stating she felt better. RN
58 2021-03-28 lip swelling pt states that her ears started itching and became red. She noticed her back, legs, and arms were r... Read more
pt states that her ears started itching and became red. She noticed her back, legs, and arms were red and very itchy. She says her skins is raised like a rash. Her voice became strange and she lips were swollen. She went to bed and when she got up her lips were more swollen. She took Benadryl for her symptoms and went back to bed. She says she has some itching but feels like she seems to be improving.
58 2021-03-28 mouth tingling, vision blurred Pfizer-BioNTech COVID-19 Vaccine EUA No reaction during 30 minutes of wait time after shot 1 hour af... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA No reaction during 30 minutes of wait time after shot 1 hour after shot: blurry vision for about 30 minutes 3 hours after shot: itchiness on left side of neck and around hairline 4 hours after shot: minor outbreak of hives on left side of neck and in/around hairline, slight tingling of tongue. Treated with 2 TBSP of liquid children's Benadryl, no further outbreak of hives and tongue stopped tingling. Had slight scratchy throat for 2-3 days afterwards. No additional liquid Benadryl required.
58 2021-03-28 swelling of eyelid, mouth numbness Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and chee... Read more
Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and cheeks were swollen, syncope, dysphagia occurred. As of today, only has numbness in lower lip. Recommended for her to see provider right away. Patient says she does not have insurance. Recommended some income based clinics but call was disconnected, called back but no answer.
58 2021-03-28 ringing in ears 2nd vac on 3/27/21. On 3/29/21 called Vacination site to report having tinnitus occuring approxima... Read more
2nd vac on 3/27/21. On 3/29/21 called Vacination site to report having tinnitus occuring approximately 24 hours after rec 2 dose vacination. No hx of tinnitus, no immediate reaction reported day of vac. No complaints from 1st dose 3 weeks prior. Pt reported symptoms have diminished but not completely gone. Advised to call primary if symptoms worsen. Provided reassurance. No other complaints. Advised about V-Safe site.
58 2021-03-28 ringing in ears Injection site soreness (including lymph nodes under that arm), low grade fever, chills, headache, n... Read more
Injection site soreness (including lymph nodes under that arm), low grade fever, chills, headache, nausea, body/joint aches as well increased tinnitus symptoms/volume (both ears). All symptoms EXCEPT the increased tinnitus symptoms were gone by noon the next day, Saturday, March 27th. As of today, the tinnitus continues to be almost unbearable it has increased in volume so much.
58 2021-03-29 ringing in ears Patient with no prior otologic history notes onset of bilateral hearing loss ~ 10 days after first d... Read more
Patient with no prior otologic history notes onset of bilateral hearing loss ~ 10 days after first dose of vaccine. She notes associated non-pulsatile tinnitus and aural fullness AU. Currently treated with oral steroids
58 2021-03-30 eye bleeding Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet ... Read more
Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet and legs bleeding in left eye conjunctiva hemorrhage I was tested by blood urine and CT of Aorta and nothing was found to be the cause of the pain or bleeding except the blood pressure was elevated. I told Doctor I had the covid shot and began experiencing the symptoms the next day. I took all my medications and did not have a problem with the pressure. She could find no physical outside of covid cause and sent me home the next morning.Symptoms began 3/27/21 and I was in the ER by 6pm on 3/29/21 and stayed until 3/30/21.
58 2021-03-31 mouth numbness client complained of numbness to lip after receiving the 1st COVID (lot # EW 0150, exp. 4/3/21) at... Read more
client complained of numbness to lip after receiving the 1st COVID (lot # EW 0150, exp. 4/3/21) at 1150. Client signaled PHN and informed her she was starting to feel her left lip going numb, pressure to her lower base of the head and palpitations. First set of vitals:blood pressure 140/80, pulse 80, oxygen 98%. Client alert and oriented with flushed skin. Client denied shortness of breath , chest pain, no swelling at this time. PHN offered client Benadryl, per client would call friend first if medication was given so she could be picked up. History of anxiety and hypertension, per client had an allergic reaction to flu shot in the past. Current medication: losartan. At 1200 client stated numb sensation was radiating to left cheek PHN offered client Benadryl again and client accepted. 50 mg/IM Benadryl administered to right deltoid at 1203. Client informed we would keep her for further observation and would take vitals every 5mins. Vitals at 1205: pulse 94, blood pressure 180/95 oxygen 97%. Numbness to lip and face same, pressure to head same, palpitations same. Alert and oriented. Vitals 1210: blood pressure 120/80, pulse 81, oxygen 100%. Per client previous complaints improving. Client stated could feel cheek again. Vitals 1215: blood pressure 140/80, pulse 102, oxygen 99%. Client stated feeling nausea, emesis bag given and water. Per client also starting to feel drowsy. Palpitations improving and more sensation to lip area. At 1219 client stated having chills, palpitations returning. Per client was not sure if it was her anxiety. PHN offered 911, get paramedics for further assessment and to transfer to hospital for higher level care. Client refused, she felt benadryl was helping at this time. Vitals 1221: blood pressure 140/80, pulse 87, oxygen 99. Client stated all complaints improving. Vitals 1228: blood pressure 142/80, pulse 80, oxygen 100%. Vitals 1234: blood pressure 140/90, pulse 78, oxygen 99%. Per client lip and cheek no longer numb, normal sensation. Nausea had resolved and palpitations improving. 1241 vitals: blood pressure 140/90, pulse 80, oxygen 97%. Vitals 1247: blood pressure 130/90, pulse 75, oxygen 100%. Client stated feeling good. All complaints had resolved. Per client just tired feeling. 1257 vitals: 130/90, pulse 78, oxygen 96. No complaints. Client advised to speak with primary doctor prior to second dose. ER precautions given. Friend arrived at 1300 and would drive client home. last set of vitals 1305: blood pressure 130/90, pulse 75, oxygen 98. All symptoms resolved. Client left facility with a steady gait at 1307
58 2021-03-31 swollen tongue, lip swelling Note from epic: lip, tongue and throat swelling.
58 2021-03-31 vision blurred, visual impairment Patient received dose at noon and was counselled to stay in waiting area for 15 minutes to monitor f... Read more
Patient received dose at noon and was counselled to stay in waiting area for 15 minutes to monitor for symptoms. Shortly after, within 5 minutes) patient began feeling "it in her stomach" and it began rising up. Patient began turning red in face, sweating, felt as if her throat was closing, tachycardic (upon pharmacist palpitation, but HR was coming down) and vision became spotty and blurry. Immediately gave patient first two liquid caps of benadryl and had epi-pen on hand while technicians called EMS.
58 2021-04-01 ear discomfort Right ear had odd sensation, headache that became migraine, difficulty breathing, lightheadedness/fa... Read more
Right ear had odd sensation, headache that became migraine, difficulty breathing, lightheadedness/faintness, numbness on right side. Also had flu like symptoms.
58 2021-04-01 mouth discomfort Patient stood up and was immediately dizzy. Patient stated "i'm dizzy and my mouth feels funny". Abl... Read more
Patient stood up and was immediately dizzy. Patient stated "i'm dizzy and my mouth feels funny". Able to speak full sentences. heart rate 88, respiratory rate 18, able to swallow, skin warm and dry. Patient was assisted to wheelchair and escorted to the emergency department. Report given to ER nurse.
58 2021-04-01 mouth tingling Tingling lips Itchy face Rash on neck
58 2021-04-02 taste impairment, ringing in ears, mouth numbness Tingling in area above breast and heart then Heart rate and blood pressure increased. Metal taste i... Read more
Tingling in area above breast and heart then Heart rate and blood pressure increased. Metal taste in mout. Face and lips went numb. Ears ringing loud. Dr at vaccination site. Stayed I was having an antihistamine reaction and she needed to cool my body and the blood to my brain down. She iced my jugular on both sides of my neck for 20 minutes in vehicle with the window down and the ac on high. It was quite cool. Heart rate downed and Metal taste disappeared. Face got some feeling back. Lips still were particularly numb. She released me to go home after 3:45pm. Tired, headache that night. Next day 4/2 tired, headache and diarrhea all day. Ears ringing 4/3 slight headache , ears better. Diarrhea gone
58 2021-04-02 eye swelling Pfizer-BioNTech COVID-19 Vaccine EUA Swollen eyes 24 hours after vaccination. Diagnosed with conjun... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Swollen eyes 24 hours after vaccination. Diagnosed with conjunctivitis 4 days after vaccination. RX TobraDex ST - 1 drop each eye 4 times daily until 4/15/21 or until systoms are gone. Was given a RX
58 2021-04-03 ear itchiness allergic reaction; Face went numb; Hard to swallow; Voice got hoarse; Inside of her ears got very it... Read more
allergic reaction; Face went numb; Hard to swallow; Voice got hoarse; Inside of her ears got very itchy; Scalp also got itchy; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 24Feb2021 (Batch/Lot Number: EM9809) (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma since many years ago, but it was under control and fibromyalgia since many years ago. Concomitant medications included pregabalin at 250mg daily (100 mg once a day and 150 mg second part of the day) for fibromyalgia, budesonide, formoterol fumarate (SYMBICORT) inhalation powder, at 2 inhalations twice a day for asthma, escitalopram at 20mg tablet once a day for asthma, rosuvastatin calcium at 5mg tablet once a day for an unspecified indication, venlafaxine hcl at 50mg tablet twice a day for an unspecified indication, montelukast sodium at 10mg once a day for an unspecified indication and ciclosporin (RESTASIS) eye drops at one drop in each eye, twice a day for an unspecified indication. The patient was previously received the first dose of BNT162b2 (Lot number: EL9262), via an unspecified route of administration on the left arm on 03Feb2021 15:59 (at the age of 58-years-old) as a single dose for COVID-19 immunization and experienced tip of her tongue, lips, and part of cheek close to her mouth went numb on 03Feb2021, 45-60 minutes after the shot and the patient was recovered from the events on 03Feb2021 as they went away. Within 5 minutes after getting the vaccine shot on 24Feb2021, the patient had a much bigger allergic reaction and she experienced face went numb, it was hard to swallow, her voice got hoarse, the inside of her ears got very itchy and her scalp also got itchy. The patient was treated with diphenhydramine (BENADRYL) at 25mg tablet that night. The outcome of events, allergic reaction, face went numb, hard to swallow, voice got hoarse, inside of her ears got very itchy and scalp also got itchy was recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122392 first dose
58 2021-04-04 hearing loss First injection on 3/2/21 I developed Eustachian tube dysfunction with significant hearing loss in b... Read more
First injection on 3/2/21 I developed Eustachian tube dysfunction with significant hearing loss in bilateral ears. Treated with Rx ear drops. No infection noted on exam findings. Symptoms nearly resolved w/in 2 weeks. Second injection on 3/23/21, I did not have any reaction or adverse symptoms until 2 days after. The ETD restarted. I was treated with Prednisone with a positive response w/in 2-3 after treatment, while tapering the Prednisone my ETD got more severe. I am scheduled for an ENT visit on 4/6/21. My symptoms are progressing to the point of inability to tolerate hearing my voice or any other noises.
58 2021-04-04 mouth tingling about 20 minutes after receiving the vaccination patient developed a sore and itchy throat along wit... Read more
about 20 minutes after receiving the vaccination patient developed a sore and itchy throat along with tingling of her lips. Patient was given benadryl 50mg PO and observed for 30 minutes. At the end of her observation period patient stated that her symptoms have resolved. Her vitals remained stable throughout her stay in the observation area.
58 2021-04-04 mouth tingling "After 10 minutes of getting the vaccine, patient c/o of throat scratchiness and lip tingling. No c/... Read more
"After 10 minutes of getting the vaccine, patient c/o of throat scratchiness and lip tingling. No c/o of shortness of breath, chest heaviness or generalized urticaria. 25mg of Benadryl PO given. Throat scratchiness resolved in 20 minutes, but continued to have lip tingling. An additional 25mg of Benadryl given. Lip tingling resolved in 10 minutes Recommended that she speak with her PCP about receiving the second vaccine.
58 2021-04-04 swollen tongue Shortness of breath, throat swelling or chest pain. Complaints of tongue swelling.
58 2021-04-04 ringing in ears Tinnitus, has not resolved 4 days later.
58 2021-04-05 dry throat STARTED TO FEEL SOME ITCHING IN BOTH EARS,THROAT GOT DRY AND WAS NOT ABLE TO SWALLOW WITH 20 MINUTES... Read more
STARTED TO FEEL SOME ITCHING IN BOTH EARS,THROAT GOT DRY AND WAS NOT ABLE TO SWALLOW WITH 20 MINUTES OF THE VACCINE. i WAS INJECTEWD WITH AN EPIPEN , WAS GIVEN BENARYL AND STEROID AND WAS CARRIED BY AN AMBULACE.
58 2021-04-05 mouth numbness 40min after receiving her second Pfizer vaccine, pt reported numbness on left side of tongue, down n... Read more
40min after receiving her second Pfizer vaccine, pt reported numbness on left side of tongue, down next and into upper chest.
58 2021-04-05 mouth numbness pt states that she got a strange feeling in the left side of her face. She had a hot streak across ... Read more
pt states that she got a strange feeling in the left side of her face. She had a hot streak across her ear and her face. She had some heat that she felt was moving through the left side of her body. Her left arm is numb from her elbow to her fingertips. Her left foot became numb. Her right foot has also become numb. She says it feels like her lips and her mouth are numb. Pt went to bed and when she woke up the numbness was getting worse. She contacted her PCP that instructed to go to the ER. She went to Medical Center ER on 4/1 /2021 where they treated her as a stroke patient. She was given MRI, CT, blood work. All tests were negative for stroke. She spent the night and then released to go home to FU w/ Neuro Dr. Pt saw Dr. and will do more blood work. She was told these symptoms would probably dissipate. Pt says she still has some numbness at this time.
58 2021-04-05 lip swelling, swollen tongue, mouth tingling Patient describes subjective tingling/swelling around lips and tongue. No difficulties with breathi... Read more
Patient describes subjective tingling/swelling around lips and tongue. No difficulties with breathing. States this is similar to how she reacts when exposed to seafood. Patient was transferred to Urgent Care. She was given a single IV dose of diphenhydramine. No further complications or evolution of symptoms; ultimately discharged in stable condition.
58 2021-04-06 deafness unilateral woke up on 4/7/2021 unable to hear at all in right ear, after having NO symptoms since original vacc... Read more
woke up on 4/7/2021 unable to hear at all in right ear, after having NO symptoms since original vaccine on 3/11/2021 except for a dull headache on most days, which subsided on 4/3/2021. There were no prior indication that hearing loss was imminent, such as pain, ringing in the ear, redness, itching, fever, crackling, popping, muffled hearing, etc. I saw my primary doctor on 4/7/2021 to rule out ear wax or infection. She started me on Prednisone and referred me to ENT. Appointment with ENT is on 4/8/2021 for his evaluation.
58 2021-04-06 deafness Pt presented to clinic for eval for severe vertigo, nausea, vomiting, diarrhea, dizziness, hearing l... Read more
Pt presented to clinic for eval for severe vertigo, nausea, vomiting, diarrhea, dizziness, hearing loss, loss of balance. Symptoms started the evening of 3/31/21 and she presented to the clinic for eval on morning of 4/1/21. Was diagnosed with labyrinthitis by ENT.
58 2021-04-06 lip swelling r 1356 Pt c/o lips swelling, denies SOB or other s/s reaction. Benadryl given po. BP 130/76 P92 r18... Read more
r 1356 Pt c/o lips swelling, denies SOB or other s/s reaction. Benadryl given po. BP 130/76 P92 r185a029. Released Lungs clear, mild edema iulips. MM pink. Normal respiratory effort p 1409 Pt states feels fine and needs to go to her doctor's appt. BP 120//80 p 88 r 18 1411 released stable condition go directly to pcp office
58 2021-04-06 mouth itchiness Pt received Pfizer vaccination 1st dose at 1125. Pt was in observation area and complained of an itc... Read more
Pt received Pfizer vaccination 1st dose at 1125. Pt was in observation area and complained of an itchy throat, mouth, arms and legs at 1138. No facial swelling noted. No hives or rash noted. VS at 1125: BP 96/60,HR 72, O2 sat 98%, RR 14. VS remained stable. Given Benadryl 25mg PO at 1154. At 1214 pt stated that her throat stopped itching, her mouth still itched. Her arms no longer itched and her legs still itched. NP assessed pt at 1220. Pt voluntarily left at 1223. Had history of seasonal allergies (did not take allergy medicaitons prior to vaccination appt)
58 2021-04-06 mouth tingling, feeling of choking tingling sensation around the face, lips and throat--sensation of swelling of cheek--no swelling of ... Read more
tingling sensation around the face, lips and throat--sensation of swelling of cheek--no swelling of tongue, no CP or SOB IM 50mg Benadryl given and observed in medical tent for 60 minutes. Vitals stable, improved symptoms during the observation time.
58 2021-04-06 drooling, lip swelling Approximately 20 minutes after dose I experienced numbing and swelling of lips. Increased salivatio... Read more
Approximately 20 minutes after dose I experienced numbing and swelling of lips. Increased salivation and nausea and dizziness. I took a Benadryl and went to bed. When I woke the swelling had left. I felt great, almost "high" for the next 24 hrs. The following 24 hours after that i experienced extreme fatigue. My lips still feel a little odd. I had no other side effects, not even a sore arm.
58 2021-04-06 ringing in ears Intermittent ringing & loud buzzing of Left ear; This is a spontaneous report received from a contac... Read more
Intermittent ringing & loud buzzing of Left ear; This is a spontaneous report received from a contactable other Health care professional. A 58-Year-old non-pregnant female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Mar2021 at 16:00 as single dose in arm left for covid-19 immunization. Relevant medical history included Allergies to medications, food, or other products: Sulfa. Concomitant medications included an unspecified medication. Past drugs included Amoxicillin with allergies to amoxicillin, Vicodin with allergies to vicodin, Codeine with allergies to codeine. On 08Mar2021 at 11:00, the patient experienced Intermittent ringing & loud buzzing of Left ear. The patient did not take any treatment for the event. The outcome of the event was not resolved. Information on the lot/batch number has been requested.
58 2021-04-06 tongue itchiness Fifteen minutes post vaccine patient to feel itchy on her face & tongue. Given PO diphenhydramine 2... Read more
Fifteen minutes post vaccine patient to feel itchy on her face & tongue. Given PO diphenhydramine 25 mg once
58 2021-04-06 vision blurred Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went t... Read more
Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went to see eye doctor a few days later, was recommended to come to pcp due to eye findings, pt went home and checked sugar which glucometer read HI, which prompted her to go to er because this has never happened to her before
58 2021-04-07 extreme sound sensitivity, smell distorsion, sensitivity to light Woke up with a migraine. Am on Aimovig but it broke through. Extreme head pain, sinus pain, light... Read more
Woke up with a migraine. Am on Aimovig but it broke through. Extreme head pain, sinus pain, light sensitivity, sound sensitivity, scent sensitivity. Took one Butal-ASA-Caff-CAP and 2 Sinus Pressure and Pain pills. It took about 12 hours for it and symptoms to go completely away.
58 2021-04-07 extreme sound sensitivity, ringing in ears Tinnitus in the left ear. Permanent loud hissing noise.
58 2021-04-07 ringing in ears, ear discomfort Soreness in upper arm started at 6 PM. Warm rush of feeling starting from arm to neck and rising to ... Read more
Soreness in upper arm started at 6 PM. Warm rush of feeling starting from arm to neck and rising to the head. Not uncomfortable just notably not usual for me. Left ear started ringing and lasted for 10 minutes and just went away. The left side of my face feels slightly numb but OK. The strangest thing was I thought someone was just standing next to me and sticking something in my ear as a joke. I only live with my mother of 87 so this idea is preposterous but the feeling of something swimming and moving and going inside my ear was so strong I actually used a Q Tip to make sure there wasn't a bug going in there. it stopped after 5 minutes but it was the weirdest thing ever. It reminded me of when you get your ears cleaned and the doc puts something (cleanser - peroxide for instance) in it. GOD I'm glad it stopped because there is NO WAY I would be able to sleep with that. Now its fine. I hope it never comes back.
58 2021-04-08 eye pain immediate sinus nose and rear eye pain, immediate slight breathing problem, all subsiding within 15 ... Read more
immediate sinus nose and rear eye pain, immediate slight breathing problem, all subsiding within 15 minutes. Next morning - slept over 10 hours, after 9:15 am experienced chills, nausea, headache, joint and muscle pain, severe injection site pain, lightheadedness with swaying when walking, lethargic, sneezing, slight lower lung heaviness. Some symptoms went away by 3:00pm. Still subsiding now at 3:32pm.
58 2021-04-08 drooping eyelid My right eye has a drooping eyelid
58 2021-04-08 mouth discomfort, vision blurred, tongue discomfort, swollen tongue, mouth numbness, taste impairment First started with headache, nausea, then had chills, shakiness swollen tongue, metallic taste, num... Read more
First started with headache, nausea, then had chills, shakiness swollen tongue, metallic taste, numb lips, tongue felt as if it had been burned, blurred vision, SOB, fatigue.
58 2021-04-08 mouth itchiness Body itch; internal mouth itch; This is a spontaneous report from a contactable other hcp (patient).... Read more
Body itch; internal mouth itch; This is a spontaneous report from a contactable other hcp (patient). A 58-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right in Jan2021 at the age of 58 years old (Batch/Lot Number: EL9262) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma , breast cancer, Allergy to all seafood including shellfish and codeine. Prior to and since the vaccination the patient has not been diagnosed with COVID-19. Concomitant medications included exemestane (EXEMESTANE), omeprazole magnesium (PRILOSEC), cetirizine hydrochloride (ZYRTEC). On The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 18:00 the patient experienced body itch and internal mouth itch, the patient took Benadryl and Tagamet as treatment for the events. Outcome of the events was recovered on an unspecified date 2021. Follow-up (29Mar2021): No new information.
58 2021-04-08 mouth tingling, burning mouth syndrome tongue paresthesia Narrative: Immediately following administration of first dose of Pfizer COVID19 ... Read more
tongue paresthesia Narrative: Immediately following administration of first dose of Pfizer COVID19 vaccine, patient reported pruritus, bumps on sides of R then L neck, and tingling/stinging sensation of the R side of her tongue without swelling of tongue/lips elsewhere. Patient took personal supply of diphenhydramine 50mg and was transported to ED for further evaluation. Upon arrival to ED, no additional symptoms reported. She denied any areas of urticaria/hives at that time and stated the neck is the only area of rash she noted, and she currently has pruritus only around the neck area and still notes small bumps. Her tongue felt improved but not normal and she denied any tongue/oral swelling, wheezing, dyspnea, chest pain, syncope, LH, palpitations, confusion, n/v/d/abd pain HA, focal neurological complaints, seizures, or any other acute symptoms. Patient had an extensive history of multiple other allergies. Diagnosis included early angioedema and second dose not recommended by ED provider. Methylprednisolone and famotidine administered in ED. Patient discharged from ED with prednisone and famotidine. Previously prescribed epinephrine for anaphylactic seafood allergy.
58 2021-04-08 feeling of choking, mouth tingling Approx 3 minutes after injection I experienced flushing, tingling in my tongue, throat esophagus and... Read more
Approx 3 minutes after injection I experienced flushing, tingling in my tongue, throat esophagus and stomach. It started in the back of my throat and spread quickly. Through my upper torso. I had no pain, no apparent swelling, no difficulty breathing. Just stinging/tingling throughout my upper torso, throat and mouth. It gradually subsided after about 30 minutes. I had no reaction at all to the first shot. I am now 48 hours out from the second injection and have a very sore arm, headache, body aches and low grade fever. All are relatively mild and are resolved with Tylenol.
58 2021-04-08 swollen tongue, tongue itchiness Had tongue swelling and itching 1 week after vaccination, progressed to total body itching, no hives... Read more
Had tongue swelling and itching 1 week after vaccination, progressed to total body itching, no hives reported. Still having itching, tongue has normalized 3 weeks after.
58 2021-04-08 ringing in ears Existing tinnitus worsened shortly after getting the injection.
58 2021-04-09 hearing loss Lost hearing in right ear. Sounds extremely muffled but also has a very loud 'white noise' sound. It... Read more
Lost hearing in right ear. Sounds extremely muffled but also has a very loud 'white noise' sound. It is constant, never stops. It's very difficult to concentrate and function with this noise constantly in my right ear. A low to medium constant loud hum like of something mechanical or a loud car bass or something. Sometimes has a rythm to it that varies, pulses. Started 14 days after 2nd Pfizer vaccine, now over a week of having this noise. Extra antihistamines don't seem to help.
58 2021-04-10 eye swelling, mouth swelling, mouth tingling, swollen tongue, taste impairment Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of F... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypertension-Mild, Additional Details: pt states heart rate increased, inside of lips swell, exhausted, tip of tongue tingling, taste of chemicals in mouth. it is subsiding now. we were monitoring her for 30 minutes. may need follow up
58 2021-04-10 lip swelling, mouth numbness, swelling of eyelid, swollen tongue About 6 hours after the vaccine, I experienced lip, eyelid and tongue swelling, numbness of lips. I... Read more
About 6 hours after the vaccine, I experienced lip, eyelid and tongue swelling, numbness of lips. Immediately took Benadryl 50 mg. Improved after the Benadryl but did not resolve for 2.5 days. Retook Benadryl a few times in that period. Resolved completely after that.
58 2021-04-10 mouth tingling, vision blurred When I got to the car my face felt hot and flushed, but went away. then about 45 mins later I felt d... Read more
When I got to the car my face felt hot and flushed, but went away. then about 45 mins later I felt dizzy and my feet, hands and tongue were tingling . I kept having dizzy feeling and light headed. The next day I felt nauseated and had blurry vision with not tingling in hands or feet. I felt Anxious and my heart was vibrating, I still felt light head and would have dizzy spells. On the 3rd day after the vaccination I felt like I was having a hard time breathing.
58 2021-04-10 swollen tongue, mouth tingling Patient experienced tingling on the lips after 5-10 mins of the shot, after 25 mins patient was give... Read more
Patient experienced tingling on the lips after 5-10 mins of the shot, after 25 mins patient was given epipen into left thigh and 911 was called. upon arrival patient was given IM benadryl. Patients tounge was swollen and her throat was begining to close up.
58 2021-04-11 swelling around the eyes Day 1&2: Aches,slight fever, headache Day 3: breast tenderness, followed by lymph node under right ... Read more
Day 1&2: Aches,slight fever, headache Day 3: breast tenderness, followed by lymph node under right arm swelling/very painful (12 hours after tenderness began) face swelling under eyes, hand swelling and hand joint pain Days 3/4/5: joint pain spreading throughout body. Some sharp pains in various joints Day 5/6: migraine again, not as severe (responded to my medicine better) day 6 migraine better (didn't take medicine)(zololatriptan) Sharp pain in my lower right side (like the ovarian cyst pain I had when I was ovulating)
58 2021-04-11 toothache, eye swelling 2 Events: Evening following 2nd injection, I went from having no dental issues to having severe toot... Read more
2 Events: Evening following 2nd injection, I went from having no dental issues to having severe tooth pain on lower left jaw, roughly 4-5 teeth in from back molar. Swelling began within hours accompanied by intense pain and sensitivity. By that Sunday evening, swelling had extended up to left eye, over to bottom of ear, and down neck to baseline and half way to center jaw line. Bruising present. Throbbing was constant. Made emergency dental appointment for Monday, but by that Sunday night, I could not stand it any longer and was afraid the swelling would extend to my throat. Went to ER, who diagnosed an abcess under the tooth root. Perscribed pain pills and antibiotics. Saw dentist Monday, who scheduled me for an emergency root canal on Tuesday. Got root canal on a tooth I never had problems with before, although there certainly could have been an issue brewing but not yet pronounced. Anyway, he also drained what he called an unbelievable amount of infection fluid (pus) after making an incision in my gum line and basically squeezing my face to get as much out as he could. Said he never saw anything like it. And for me to go from 0 to that in a matter of days was incredible. I thought perhaps it was an immune response? At the same time that I was experiencing the dental issue, I started to develop a strong dry cough. I have a light former smokers cough, and have had pneumonia many times, but this cough was different. Every day it has gotten strongly, but is very much intermittent. I now go into fits of coughing that last one to two minutes and so strong and to the point where I have either fractured my rib directly beneath my right breast, or something else is going on. These fits can last minutes, but never result in expulsion of phlegm. The coughing fits also occur if I take a deeper breath, walk too far, laugh, or talk too long. Very strange. I am very fatigued and have been since the onset of the dental issue reported above. While the dental issue is gone since the absess was drained, the cough is still present, and wakes me up every single night too with coughing fits. The cough has loosened up a bit. I would go to the doctor, but I am in the middle of a move from MO to AZ, and just arrived in AZ after a 3 day drive. So, first off, I am reporting this issue. And next, I will seek a new doctor in Arizona if this cough continues.
58 2021-04-11 visual impairment Patient called on 4/12/21 and reported that starting 2 days after her second dose she experienced ch... Read more
Patient called on 4/12/21 and reported that starting 2 days after her second dose she experienced changes in vision, She said she feels like her distance vision has changed significantly. She was directed to vsafe as we were uncertain whether this was a reported side effect. I told her I would report the issue for documenting purposes.
58 2021-04-12 mouth numbness Immediately afterwards developed tingling to the corner of her left eye. Patient states over the cou... Read more
Immediately afterwards developed tingling to the corner of her left eye. Patient states over the course of the day she developed numbness to the left corner of her lip and ear fullness. Patient states once in a while she will experience tingling to thenar eminence of her left hand. Symptoms have improved over the course of 24 hours. Patient is in stable condition and offers no additional complaints at this time. Informed patient that tingling has been a reported side effect of the vaccine, but it's unclear whether her symptoms are due to the vaccination. Patient wishes to go home. Discussed with patient diagnostic results and differential diagnosis. Patient advised to return to the ED for new or worsening symptoms. Patient is agreeable with plan for discharge.
58 2021-04-12 mouth tingling, dry mouth 1. severe pain left arm, hand numb and tingling. chest little tight, tongue felt funny, felt like s... Read more
1. severe pain left arm, hand numb and tingling. chest little tight, tongue felt funny, felt like something in back of throat. Had a rush of heat from chest to head like a flush feeling. Happened 10 minutes after leaving facility after my 15 wait period. Left went to vehicle sitting in vehicle going over grocery list and that is when the pain started in arm and rest followed went back in facility they made me sit in the back for while. Had real bad cotton mouth. Left after about half hour on way home had severe pain in lower back kidney area on the left. The pain subsided in kidney area to a dull ache that lasted all day on the 10th and little on the 11th. Had the cotton mouth for 3 days.
58 2021-04-12 ringing in ears the morning after my first dose of the PfizerCovid-19 vaccine I noticed a much louder then normal ri... Read more
the morning after my first dose of the PfizerCovid-19 vaccine I noticed a much louder then normal ringing. I have had tinnitus for about 8 years with ringing mainly in the left ear with occasional swooshing/pounding sounds in both left and right ears but its been in the background and manageable. The morning after the vaccine the ringing increased by about 40-50%, is now a constant 24/7 high pitch ringing in both ears that has moved front and center and no longer is in the background. I advised my doctor of the increase and am scheduling an appointment with an audiologist.
58 2021-04-12 ringing in ears Immediately following vaccine on Saturday, I experienced arm pain that increased over the day and ev... Read more
Immediately following vaccine on Saturday, I experienced arm pain that increased over the day and evening. In the evening I was somewhat more fatigued. On Monday, two days after receiving vaccine, I experienced repeated episodes of tinnitus, shakiness, and light-headiness. On Tuesday, the third day following vaccine, I again experienced repeated incidence of tinnitus. On both Monday and Tuesday, the tinnitus was worse when I was upright and better when reclining. On Tuesday I also experienced a flu-like feeling along with loose bowels, nausea, headache, and increased emotional lability.
58 2021-04-13 swollen tongue, taste disorder Within several minutes of the injection, I noticed a strange taste in my mouth. A few minutes later... Read more
Within several minutes of the injection, I noticed a strange taste in my mouth. A few minutes later my tongue became swollen. Shortly after that I noticed that swallowing was different than normal. I was still able to breathe normally but thought I should tell someone. I notified the person who have me the shot and she told me a nurse practitioner would come talk with me. I told the NP about the strange taste and that I felt like my tongue was swelling up and that swallowing was more difficult than usual. She asked me a bunch of questions and then told me she would give me a Zyrtec tablet to take home with me in case I needed it later. I stayed for another 20 minutes and since it didn't get any worse, I told them I thought I was okay to leave. I took the Zyrtec when I got out to the car and about an hour later the swelling was gone and swallowing was normal again. On Monday I notified my PCP of what happened and asked her if I should get the second dose in 3 weeks. She told me should would consult with an allergist and get back to me.
58 2021-04-13 ringing in ears I have tinnitus in both ears since about 1-1/2 weeks after my first dose of the Pfizer vaccine which... Read more
I have tinnitus in both ears since about 1-1/2 weeks after my first dose of the Pfizer vaccine which I received on 3/5/2021.
58 2021-04-14 deafness Sudden hearing loss in left ear, occurred within 24 hours after first COVID vaccine received. Not su... Read more
Sudden hearing loss in left ear, occurred within 24 hours after first COVID vaccine received. Not sure if conidence or if an adverse reaction. Treated by Dr and had two audiology test preformed. Currently wearing hearing aid's.
58 2021-04-14 mouth discomfort, mouth itchiness Pt completed 15 minute observation, returned to car, then started a reaction. Pt's husband requested... Read more
Pt completed 15 minute observation, returned to car, then started a reaction. Pt's husband requested assistance from police office in parking lot. Pt was found on passenger side of care, diaphoretic, reports buringing and pruritis of mouth and throat, and difficulty breathing. EMS called, epinephrine administered, and pt transported to hospital.
58 2021-04-14 ringing in ears After about 2 hours I had vertigo and everything began swirling around me and making me feel sick to... Read more
After about 2 hours I had vertigo and everything began swirling around me and making me feel sick to my stomach. This has improved although it's difficult to watch fast moving objects such as traffic or things on tv. After about 4 days, my left ear started ringing and making weird low humming sounds. I still have this now and it isn't improving and has become very loud. It sometimes wakes me up in the night. In addition, my legs still ache, even after taking Advil and I just feel a bit off.
58 2021-04-15 ringing in ears Severe loud tinnitus all day every day
58 2021-04-15 ringing in ears Tinnitus in both ears worsens at night
58 2021-04-15 visual impairment Within 7 minutes of receiving shot, my vision was slightly impaired (darkening ) cold sweating, hea... Read more
Within 7 minutes of receiving shot, my vision was slightly impaired (darkening ) cold sweating, heart racing, head pressure and feeling I was going to faint. Emt?s and nurse assisted me. My blood pressure spiked to 176/100 and my legs and hands were shaking uncontrollably. Someone mentioned a hypertensive crisis and I was getting frightened. I requested an anti anxiety pill from my purse, which they let me have. It didn?t help me at all. I was taken to an ambulance and waited for a relative to come pick up my disabled daughter who was with me getting her covid shot as well. I asked if they were taking me to the hospital, and was told ? you don?t want to go there? after an hour, bp came down to 146/90? ..which is still too high and not typical for me.This was NOT brought on by an anxiety attack.i was not remotely anxious and was simply sitting and speaking with my daughter when I was striken. The next 3 days my heart was racing. I wear a Fitbit to bed and my heart rate recorded spikes of 116 while I was asleep. Had bouts of bad stomach pain and diarrhea the next two days. Followed up with my GP 4 days later . Still having palpitations and following up with cardiologist.
58 2021-04-16 ringing in ears developed tinnitus and vertigo within one week of vaccination
58 2021-04-17 mouth tingling, mouth numbness Almost immediately after vaccination, pt felt like her tongue and lips were numb and tingling, also ... Read more
Almost immediately after vaccination, pt felt like her tongue and lips were numb and tingling, also happened with first dose of Pfizer vaccine, but never progressed, eventually went away. VS 150/88 60 99%RA, EMS evaluated for visible swelling or difficulties breathing, none noted. Pt remained stable, numbness disappeared and pt released by EMS after 40 minutes, husband drove
58 2021-04-17 ringing in ears, ear discomfort shaky inside my body; Felt like passing out; ears feel clogged; had a hard time falling asleep; unse... Read more
shaky inside my body; Felt like passing out; ears feel clogged; had a hard time falling asleep; unsettled stomach ( a little queasy).; Felt pressure with slight headache; Felt pressure with slight headache/felt pressure in my head; Loud Ringing in both ears; dizzy/dizzy spell; nauseated/unsettled stomach ( a little queasy)/sick to my stomach; body felt uneasy like it was fighting something inside; pain at injection site and side of left neck; pain at injection site and side of left neck; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Mar2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included vitiligo and known allergies. The patient had no COVID prior to vaccination. There were no concomitant medications. The patient has no other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 22Mar2021, the patient got the shot and later (at 18:00) had pain at injection site and side of left neck. On 23Mar2021 10:30, the patient experienced loud ringing in both ears, felt dizzy and nauseated, and body felt uneasy like it was fighting something inside. On 24Mar2021, the patient was still having ringing in both ears, feel nauseated on and of lasting at least 30 seconds or so. From 25Mar2021 to 29Mar2021, ringing in ears sometimes get louder than other times, he also felt pressure with slight headache. On 30Mar2021, ringing in ears intensified and had a hard time falling asleep. The patient felt pressure in her head. She also had slight headache and an unsettled stomach (a little queasy). On 31Mar2021, ringing seems lower today; ears feel clogged. She still has pressure in head with slight headache and had one episode of dizzy spell for a few seconds only. At night, ringing in ears intensified. On 01Apr2021, lower ringing in ears noted. On 02Apr2021, the patient had pressure in head, clogged ears, sick to her stomach, shaky inside her body, and felt like passing out. Ringing was intensified at night. On 03Apr2021, headache and pressure in head were noted. The events resulted in doctor or other healthcare professional office/clinic visit but were not treated. The outcome of the events was not recovered. No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
58 2021-04-17 ringing in ears, ear pain A few days after my first dose of the Pfizer vaccine, I began having a high pitch ringing sound in m... Read more
A few days after my first dose of the Pfizer vaccine, I began having a high pitch ringing sound in my ear. I began unplugging appliances in my home trying to figure out what was causing it. I finally went outside and realized the sound was in my head. It wasn't as noticeable when there were other sounds going on in my background. After the second shot, I began to have a terrible earache on the side my injection was given and now my ears are ringing even louder. I am scheduling an appointment with an ENT this week. My gut told me not to get this vaccine. I wish I would have listen to it. I am beyond sad because everything I've read so far is that it doesn't go away. Shame on you all for pushing this so fast on to the public.
58 2021-04-18 oral mucosal blistering The day after the vaccine, I noticed the following: (1) A blister had grown on the left side of my m... Read more
The day after the vaccine, I noticed the following: (1) A blister had grown on the left side of my mouth overnight (took a picture). (2) Three red under-the-skin, semi-circle 'brusies' on my right upper arm. The bruises were NOT raised. I thought that I'd taken a picture of this too, but I must have deleted if for I currently cannot find a picture. I did, however, mention these on my weekly check-in call regarding the vaccine. (3) I've had a sore throat and, periodically, a shortness of breathe since that week of the vaccine.
58 2021-04-18 mouth tingling, mouth numbness Tingling and numbness in three left toes of left foot; tingling in pinkie/ring fingers of left hand;... Read more
Tingling and numbness in three left toes of left foot; tingling in pinkie/ring fingers of left hand; random "pings" (nerve-related) around body; mild tingling/numbness in lips. These symptoms concern me because I was hospitalized for Guillain-Barre Syndrome in July, 2020 and numbness/tingling in the feet was one of the initial symptoms of GBS. GBS is an auto-immune condition which can cause temporary paralysis and, depending upon its severity, death. It is is usually self-limiting but can take months or years to resolve. In early stages it can be treated with IV immunoglobulin to replace "bad" antibodies with "good" ones and that is the five day treatment I had at Hospital over the summer. I am very nervous that the Pfizer vaccine may be triggering another GBS episode though everything I have read says that there have been reported instances of this happening. Still, I thought it concerning enough to contact my primary care physician and website because GBS is no joke.
58 2021-04-18 mouth tingling At 11:06AM shortly after vaccine was administered, patient experienced numbness and tingly arms. She... Read more
At 11:06AM shortly after vaccine was administered, patient experienced numbness and tingly arms. She was lightheaded and vitals were BP 138/88 mmHg, HR 58 beats per minute, PO2 98%, and temp 97.6 degrees Fahrenheit. At 11:15AM vitals: BP 168/110 mmHg, PO2 98%. Patient is dizzy, legs tingly/heavy, and experiencing hot and cold flashes. At 11:30AM upper lip tingly, patient denies difficulty breathing or swallowing. 12.5 mg Benadryl given at 11:30AM and second dose of Benadryl 12.5 mg given at 11:40AM. At 11:45AM EMS called. Vitals: BP 151/85 mmHg, HR 83 beats per minute. Patient states tongue is tingly and experiencing full body chills. Upon EMS arrival, patient transported to Hospital.
58 2021-04-19 lacrimation increased, bloodshot eyes, eye irritation rash on face,neck & upper chest. eyes red, burning. watery. slight headache, lower back pain. Goin... Read more
rash on face,neck & upper chest. eyes red, burning. watery. slight headache, lower back pain. Going away slowing almost gone have not gone back on xeljanz. seeing rheumatologist on 4-22
58 2021-04-19 taste disorder I felt an intense sensation of heat throughout my body, a strange sensation in my mouth and an odd t... Read more
I felt an intense sensation of heat throughout my body, a strange sensation in my mouth and an odd taste. A lump formed in my throat with phlegm that caused me to need to cough to clear my throat. I felt very jittery. Staff at the clinic reported I felt clammy to touch and that I became pale. I was given oral Benadryl and staff reset the clock. I experienced several of these intense body-wide heat waves while at the clinic. Staff told me I was not having an allergic reaction but that my "body was reacting to a foreign substance introduced into my body." I was told to return for the 2nd shot on 5/5/21 and staff will premedicate me with Benadryl.
58 2021-04-19 ringing in ears Developed tinnitus (ringing in the ears) within 3 days of 2nd shot.
58 2021-04-19 tongue disorder Angry red bumps on the back of my tongue still there but not as bright red now just pink and not nea... Read more
Angry red bumps on the back of my tongue still there but not as bright red now just pink and not nearly as big now. I've been rinsing with antiseptic. Please note that I was on an antibiotic when I got my vaccine
58 2021-04-20 blindness I got a Mighty sore arm about 4 hours after injection. 30 hours later I began to feel agitated and g... Read more
I got a Mighty sore arm about 4 hours after injection. 30 hours later I began to feel agitated and grouchy. I woke up about 44 hours after vaccine with a painful and swollen left thumb joint. I felt strangely tired. While walking a couple of hours later I felt drunk and dislocated from my body. 48 hours after receiving the vaccine, I felt a shocking jolt to my entire body. Immediately my left arm began a deep painful tingling from my shoulder to my fingertips, then began to feel numb and tingling and as if it were swelling. I lost my vision, felt like I was going to pass out, turned extremely pale, broke out in a cold sweat, then my shins and feet began to tingle. I felt as though I couldn?t breathe. My vision came back but my body felt dislocated and my head a cinder block. It took great concentration to move my limbs and speak. I couldn?t find the words I wanted. This lasted for about 15 minutes just like a complete shock to my nervous system. I was very irritable and exhausted for 4 days following.
58 2021-04-20 eye swelling, swelling around the eyes Hives on body, in mouth; facial swelling, swelling around eyes. New reactivity to soaps, shampoos, ... Read more
Hives on body, in mouth; facial swelling, swelling around eyes. New reactivity to soaps, shampoos, makeup, - seems to be things containing PEG and palm oil and coconut. Also reacted with mouth hives from avocado. Hives still present as of today 4/21/2021, but reducing in frequency and severity. Some hives present after first vaccine, and did contact physician . They remained up until 2nd dose at which time they increased in frequency and amount. Had throat swelling, swollen eyes and hives around eyes after ingesting salmon post 2nd vaccine. Not a previous food allergy. Shortness of breath was exacerbated after first dose of Pfizer, with significant increase in shortness of breath and accompanying throat tightness after 2nd dose.
58 2021-04-20 mouth numbness 4/21/2021 was observed post Covid-19 immunization for 15 minutes . During the observation period, s... Read more
4/21/2021 was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: numbing of lips and tongue and left arm. Assessment : Time of assessment 1314. Alert and oriented and numbing to left arm, lips, and tongue. Actions taken: Vitals sign taken EMS called at 1334. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 1338. VS at 1334- BP- 133/88, P- 88, O2- 97%, recheck at 1345- BP- 120/82, P- 74, O2- 98% Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1314 and 1319. Administered by RN. Disposition:Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 1338. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 12:42 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc
58 2021-04-20 lip swelling Swelling of lower lip and under lip, extreme itching on chest, headache
58 2021-04-21 eye pain 2.24 - Received 1st dose of vaccine at 2 pm Pfizer EN6202. Left arm. Had a little soreness in arm ... Read more
2.24 - Received 1st dose of vaccine at 2 pm Pfizer EN6202. Left arm. Had a little soreness in arm next day and several days later a little bruise. 2.27 - Noticed around 6 little pimples on my scalp. Just scratched them, they scabbed, thought it was odd. 2.28 Noticed little pustules on my legs. In the coming days they appeared all over my torso and some on my arms as well. Also a few spots on hands, inside ears was scaly and very dry skin on sides of nose where it connects with face. 3.9 Contacted Dr. Rhuemotology, about bumps thinking they might be an reaction to Humira which was started in the fall. She didnt think it was Humira and suggested dermatologist. Contacted Nurse bVie as well. She didnt think it was the Humira. 3.17 Appointment with Dr. Dermatology, She did a punch biopsy on left leg and took a bacterial culture from pustules under left breast. Notes said after pustules on head appeared on legs, axillae, under breasts, genital area. Papules. Pustules w/ erythema 3.20 Started having issues with left eye, dry and a bit painful. Felt like it was perhaps scratched. 3.22 Dr. prescribed Triamcinolone Cream. Result of biopsy, etc. was that it was not an infection, not psoriasis. It was spongiotic dermatitis which is an eczema rash or reaction to a medicine. 3.22 - Vaccine Received 2nd vaccine dose, same place, 2 pm. Pfizer EN6206 Left arm Did not have soreness, redness, etc. at injection site. 3.22 Left eye very painful. Ophthamology, 3.24 Dr. diagnosed epithelial basement membrane dystrophy. Protocol was Besivance (besifloxacin ophthalmic suspension, 0.6%) 1 drop 3x/day for 3 days Genteal gel 4x a day Muro 5% ointment (sodium chloride hypertonicity ophthalmic ointment, 5%), 1 application at bedtime 3.29 Follow up with Dr. She noticed rash on my face that wasn't there before ? under left eye and on eye lids of both eyes. Issue had healed 80%. 3.31 Contacted Dr. about RA flare. 4.1 Was prescribed Methylprednisolone 4 mg dosepk. Took immediately and started to feel better within hours. Elbow swelling went down, energy overall went up. 4.2 Elbow pain greatly reduced, body pustules and bumps going away. 4.10 Elbow pain back, flexibility compromised. 4.22 First day without noticing any new pustules. Elbow pain diminished. Most of elbow flexibility has returned. Left eye issue may
58 2021-04-21 ringing in ears, ear discomfort inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Deve... Read more
inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Developed tinnitus in left ear(same side as shot) on day 5 and had plugged ear. Have never had tinnitus in the past. Blood pressure went up by 30 points. Have generally not felt well since vaccine. Doctors called it an adverse immune reaction. Week 3-thyroid swelled and am now dealing with that. Went for ultrasound today
58 2021-04-21 visual impairment, toothache, ear pain Woke up with bad headache next day went to work and left at 12 felt so bad. No fever, just severe h... Read more
Woke up with bad headache next day went to work and left at 12 felt so bad. No fever, just severe headache, full like symptoms, freezing, body aches, ear ache, jaw ache, teeth hurt, also my eyes were weird like not clear in seeing. I also have woken up with my body completely wet but not sweating g or cold. So weird. This has happened each night after second shot. I had lower back pain and that started after first shot but I didn?t realize that it was from the 1sr shot done on 03/30/2021.
58 2021-04-22 eye swelling, mouth numbness, lip swelling, eye itchiness Immediate chest tightness. 10 minutes in severe burning at on upper arm and pain. At same time entir... Read more
Immediate chest tightness. 10 minutes in severe burning at on upper arm and pain. At same time entire stomach area, abdomen began with intense itching. No hives, swelling or redness. Tachycardia present 139. sPO2 97, respiration?s 22. Stayed in observation for 30 minutes, when outside and in car left eyelid itching and now swollen. When home Dyspnea began and itching and prickling sensation began systemically all over body. Took 25 mg. Diphenhydramine and 20 mg. Famotidine. 20 minutes later worse and now upper lip swollen and numb, facial puffiness, nose extremely swollen and red, neck swollen and upper chest red. Got Epi Pen and drove 25 minutes to ED. No issues with breathing, or swelling of throat, tongue or uvula. BP 151/91, HR 112, respiration?s 18 at triage taken into ED and given 60 mg. po of Prednisone observed 4 hours. At 2 hours symptoms began to return to baseline, tachycardia resolved now 87. Discharged with 50 mg. Prednisone daily for 4 days, Diphenhydramine 50 mg. q6h for 13 doses and Famotidine 20 mg. bid x3 days. Referred to immunologist.,
58 2021-04-22 mouth swelling, swollen tongue, oral mucosal blistering, eye swelling Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec... Read more
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Severe, Additional Details: Blistering in mouth, urgern diagnosed with infection in arm. Severe redness/sweliing at injection site, more than six inches surrounding site. TPrescribed cephalexin 500 mg (as needed if arm swelling continues, pt did not take) and valtrex 1 gram for fever blisters
58 2021-04-22 mouth tingling 20 minutes after the shot, my jaw and tongue felt tingly, my voice felt hoarse, An hour after shot I... Read more
20 minutes after the shot, my jaw and tongue felt tingly, my voice felt hoarse, An hour after shot I had the shakes. Within 2 hours all these symptoms were gone. Arm continued to be sore at injection site for two days.
58 2021-04-23 ringing in ears severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, seve... Read more
severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, severe brain fog, weakness - all running for 8 days since I was vaccinated! What is the point of getting sick for 8 days and running?? Its like having covid again!!
58 2021-04-24 inability to speak 8 hours after receiving injection, started having a sore throat. 48 hours after injection noticed a... Read more
8 hours after receiving injection, started having a sore throat. 48 hours after injection noticed a small grape size lump/knot close to collar bone (lymph node?) on left side which is the injection side. 72 hours after injection, I had lost my voice, not totally. Sounds like I'm whispering when I talk. I also had the normal reported sore arm, but was quite bothersome for 3+ days. I have also noticed some shortness of breath and still quite tired after doing several small chores. I am currently on day 11 after injection, and have another smaller lump/knot beside the first one that appeared by my left collar bone. The only side effect that has dissipated is the sore arm, I still am having fatigue, shortness of breath, lumps near collarbone and loss of voice. I have not seeked medical treatment since I have no health insurance. I felt like these would subside, but have not so far. I am really hesitant to receive my 2nd dose since claims are that it is worse that the first, regarding side effects. I feel that my body has not recuperated from trying to build up my immunity. As stated above, my side effects have not subsided as of today's date, 11 days after receiving the 1st dose injection.
58 2021-04-24 ear discomfort, ringing in ears First shot 3/6/21 totally fine after. Second shot, 3/27/21 started feeling fullness in my left ear t... Read more
First shot 3/6/21 totally fine after. Second shot, 3/27/21 started feeling fullness in my left ear two days later. Felt I had an ear infection. On 4/1/21 I started getting loud Tinnitus in both ears. It is still here today. It is awful.
58 2021-04-24 mouth numbness numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; ... Read more
numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; tongue has been numb; really feel weird on her face; burning sensation that shot across the top of her left ear and nose/burning sensation down the left side of her body; left side of her face started to feel hot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left, at the age of 58-year-old, on 31Mar2021 18:45 as SINGLE DOSE for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 31Mar2021, a half an hour later, as the patient was driving home, the left side of her face started to feel hot and she kept putting her right hand on it to cool it off. The patient got a burning sensation that shot across the top of her left ear and nose. Once at home, she started to really feel weird on her face, and she had a burning sensation down the left side of her body. Her face felt strange for 1 hour and then declined. The patient went to bed at 09:30P.M. and she noticed numbness in her left leg. The next morning, the numbness in her left leg was much worse and she had numbness in her left arm down to fingers. States she called the doctor when they opened at 09:00 A.M. and they said to go to the ER right away because of all the numbness. The ER treated her like a stroke patient, and wanted to make sure she didn't have a stroke so she had a full MRI, Cat Scan, and Bloodwork done that all came back normal. The patient was in the ER on 01Apr2021 morning and she was admitted for observation and she came out of the hospital 02Apr2021 before 5:00P.M. The doctor ordered more bloodwork and a CT with contrast was ordered for her spine to see if she has any spinal damage. The patient saw a neurologist on 05Apr2021, she has had more numbness on the right side. Clarified that her right foot feels numb intermittently along with the right side of her face. Her tongue has been numb on 31Mar2021, like a line across it, most of the time. The numbness ebbs and flows and where she feels it, moves around. It is not as strong as a week ago but it moves around. No treatment was given in response to the events. She stated the neurologist and no one has recommendations on if she should receive the second dose. Outcome of left side of her face started to feel hot, really feel weird on her face was recovering; tongue has been numb was not recovered;Burning sensation recovered on 31Mar2021, numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-04-24 mouth numbness numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on th... Read more
numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (lot number: ER8727), via unspecified route of administration in left arm on 26Mar2021 11:45 AM at single dose for COVID-19 immunisation. The patient's medical history included primary central nervous system lymphoma and seizure. The patient had allergies to tree nuts. The patient's concomitant medications included vitamins, fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received levetiracetam (KEPPRA) (anti-seizure medication) that she had stopped in end of Jan2021. Approximately 21 hours after injection of vaccine, the patient experienced numbing on the left side of face - eye, cheek, mouth - and left fingers, thumb to pinky. Lasted about 10 minutes and feeling came back. Same thing happened 15 minutes later and then stopped. Events onset date reported as 27Mar2021 09:15 AM. The event resulted in doctor or other healthcare professional office/clinic visit. The patient contacted her oncologist, she resumed taking levetiracetam and will continue until 2 weeks after next shot (if decide to get it). The patient had routine brain MRI and all clear. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-04-24 swollen tongue She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my... Read more
She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
58 2021-04-24 ringing in ears, ear pain Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Moment... Read more
Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Momentary buzzing sound in left ear; Vertigo at night; Feeling foggy; Autoimmune fluid response (injection left arm); Left eye felt inflamed; Face felt swollen/fluid; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in the left arm, on 30Mar2021 at 14:00 (Batch/Lot Number: 8733), at the age of 58 years old, as a single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, Crohn's disease, and asymptomatic mild thrombocytopenia. The patient had allergy to penicillin, sulfa, preservatives, azithromycin (ZPACK), dust, mold, and sulfites; she also had seasonal allergies. Additionally, allergy to food included wheat, rye, oats, barley, quinoa, tomato, potato, celery, peas, banana, cantaloupe, strawberries, chocolate, tea, beef, and caffeine. In 1982 the patient reacted to an unspecified allergy shot with anaphylaxis and 4-day delayed reaction of serum sickness including liver dysfunction, swelling, rash, nausea, not being able to keep food or liquid down, treated with hydroxyzine (ATRAX) (started at day 5 of serum sickness which helped clear it up). The patient had not had COVID-19 prior to vaccination withy BNT162b2. Concomitant medications included mesalazine (LIALDA), cetirizine hydrochloride (ZYRTEC), mometasone furoate (ASMANEX), fluticasone propionate (FLONASE), and vitamin D. The patient had not received any other vaccines during the 4 weeks prior to BNT162b2 administration. The patient stated that 20 minutes after vaccination her left eye felt inflamed and 3 hours after vaccination her face felt swollen/fluid. The patient stated waking-up on 04Apr2021 at 06:00 AM with momentary buzzing sound in the left ear, ear ache/inflammation, sinuses feeling congested, lightheaded/dizziness all day, vertigo at night and on the following morning when lying on the left side, and feeling dizzy/lightheaded for 3 more days. The patient also reported feeling foggy, feeling like her left side of head was congested, and autoimmune fluid response (injection left arm) (as reported), all on 04Apr2021. Due to the events, the patient consulted a doctor or other healthcare professional office/clinic visit. No treatment was required for the events. The patient was not tested for COVID-19 after vaccination. The patient was recovering from all reported events with the exception of buzzing year which resolved on 04Apr2021.
58 2021-04-24 ringing in ears Dramatic increase of ringing in ears, loudest in right ear. Loud enough to affect daily life, mental... Read more
Dramatic increase of ringing in ears, loudest in right ear. Loud enough to affect daily life, mental health. High pitch sound with no cessation in 3 weeks.
58 2021-04-25 lip swelling No symptoms after 1st shot - Symptoms started after 2nd shot on 4/20 & some of the symptoms lasted f... Read more
No symptoms after 1st shot - Symptoms started after 2nd shot on 4/20 & some of the symptoms lasted for days - Sore left arm - Massive Headache - Body Aches - Nauseous - Felt like ice cold poison was racing thru my veins - chills like I have never had before, could not warm up - Hives - Bottom lip swelled up - Low Blood Pressure (90/59, 108/65, 115/66, 112/70 - Extreme fatigue
58 2021-04-25 oropharyngeal discomfort developed throat fullness and tightness on left side of throat - sent to emergency department for ev... Read more
developed throat fullness and tightness on left side of throat - sent to emergency department for evaluation
58 2021-04-25 pain in jaw About a week after the second dose, the right side of my jaw swelled up. It is very tender and painf... Read more
About a week after the second dose, the right side of my jaw swelled up. It is very tender and painful, like a huge swollen gland on my jawline. Aspiririn and ibuprophin do not help vert much.
58 2021-04-25 mouth tingling, oropharyngeal discomfort Minutes after tingling in lips. After 10-15 minutes tongue felt swollen and throat felt weird. All ... Read more
Minutes after tingling in lips. After 10-15 minutes tongue felt swollen and throat felt weird. All symptoms were gone after 35 minutes. Allergist advised to pass on shot 2
58 2021-04-25 taste disorder Within minutes (possibly 5) of the injection I tasted medicine in the back of my throat. I parked ou... Read more
Within minutes (possibly 5) of the injection I tasted medicine in the back of my throat. I parked outside of the facility to wait. Within 15 minutes I had difficulty swallowing, tingling in my arms, and my face feeling numb. I got out of my car to breathe in colder air. At around 15 minutes the difficulty in swallowing started to subside so I left the facility. At around 20 minutes my face felt like I had a shot of Novocain that was wearing off. I took a picture of my face in the car (approx 1/2 hour after the shot) because it felt so weird. It appears as if the left side of my face is drooping slightly. This drooping has appeared since then so possibly something I never noticed before or related to the shot, I don't know. I purchased Benedryl and took a dose at approx. 40 minutes after the shot. Symptoms did not reappear.
58 2021-04-25 vision blurred Pt. developed a reaction to 1st dose of covid-19 vaccine. Symptoms described as having a heavy che... Read more
Pt. developed a reaction to 1st dose of covid-19 vaccine. Symptoms described as having a heavy chest, blurred vision, and fatigue. Pt currently does not have HCP. States that she has elevated readings daily for her blood sugar, alsostates that she takes a non prescribed medication that she gets from other persons, not HCP or any other healthcare professional. Vitals: 142/102, 100%, blood sugar 36 mg dl. Pt. verbalizes that symptoms are still present. Additional EMS called for transportation to Hospital. Pt. requested to be transferredto hospital by EMS.
58 2021-04-25 vision blurred Patient had the second Pfizer COVID vaccine on 4/20/21 in her left arm. Within 2-3 days, she noticed... Read more
Patient had the second Pfizer COVID vaccine on 4/20/21 in her left arm. Within 2-3 days, she noticed left facial swelling, left facial droop, left ear sensitivity, left eye blurriness. She had a HA for 5 days. She took NSAIDs as needed. States symptoms are persisting.
58 2021-04-26 ear pain positive COVID test 2/16/2021 after 2 Pfizer doses; patient asymptomatic other than ear pain which s... Read more
positive COVID test 2/16/2021 after 2 Pfizer doses; patient asymptomatic other than ear pain which she presented to the ED for on the same day (ED presentation was not for COVID symptoms although she was positive at time of presentation)
58 2021-04-26 hearing loss, ringing in ears Onset of tinnitus between the first and second dose. Hearing test showed minimal hearing loss. No t... Read more
Onset of tinnitus between the first and second dose. Hearing test showed minimal hearing loss. No treatment given yet.
58 2021-04-26 lacrimation increased, swelling of eyelid, eye itchiness, eye swelling I RECEIVED MY VACCINE AT APPROX 9:45 AM AT THE vaccination site. I WAITED IN THE HIGH RISK AREA ... Read more
I RECEIVED MY VACCINE AT APPROX 9:45 AM AT THE vaccination site. I WAITED IN THE HIGH RISK AREA FOR APPROX 45 MINUTES UNTIL 10:30 A.M. APPROX 15 MINUTES AFTER LEAVING THE vaccination site HIGH RISK WAITING AREA, THE REACTION SYMPTONS STARTED (APPROX 10:45 A.M.) THE SYMPTONS STARTED AS WATERY AND ITCHY EYES AND THEN SWELLING - MY RIGHT EYE WAS COMLETELY SHUT WITHIN APPROX 30 MINUTES OF ONSET SYMPTOMS. MY LEFT EYE DID NOT SWELL COMPLETELY SHUT.
58 2021-04-26 mouth itchiness Immediately after the patients 2nd dose of her covid 19 Pfizer vaccine she began to feel "itchy" and... Read more
Immediately after the patients 2nd dose of her covid 19 Pfizer vaccine she began to feel "itchy" and had a palm size red area on her right shoulder. She also complained of and "itchy mouth". She was assessed by an RN and PA and given 50 mg of liquid Benadryl and monitored for 30 minutes.
58 2021-04-27 eye irritation, dry eye, bloodshot eyes, eye itchiness the evening of the vaccine both eyes were itchy and dry. friend noticed at about 2pm the next day th... Read more
the evening of the vaccine both eyes were itchy and dry. friend noticed at about 2pm the next day that right eye very bright and almost solid red on the entre outer half of the white area and inner eye lid (looks bloody); also looks to have some bumps in the red area. I had not looked at myself in the mirror, but I guess it was like that since earlier in the day since my eye felt irritated. I have not used contacts since removing them before bed the night of the vaccine (4/27) Also experiencing fever of 101.2, and body and head aches, and fatigue
58 2021-04-27 vision blurred Patient reports sudden onset blurry vision in distance with a headache in back of head. Describes ... Read more
Patient reports sudden onset blurry vision in distance with a headache in back of head. Describes dizziness upon standing.
58 2021-04-28 vision blurred BP 224/99 P99, patient c/o CP, SOB, and feeling hot, nausea, blurred vision. Started to sweat, MD a... Read more
BP 224/99 P99, patient c/o CP, SOB, and feeling hot, nausea, blurred vision. Started to sweat, MD alerted, patient send out to ED at 1415 via amb.
58 2021-04-29 eye pain Vaccine date Fri 4/23/21 Starting at 5pm I had a low grade Fever 99.1 and Chills lasted until appro... Read more
Vaccine date Fri 4/23/21 Starting at 5pm I had a low grade Fever 99.1 and Chills lasted until approx 9pm and then went away. Sat 4/24/21 woke up with Sore L. Arm at site of Vaccine, but felt better. Sun. 4/25/21 woke up at 7:30am and didn't feel well, nausea, chills, needed to lay down, about 8:00am severe Headache at my Sinuses, Behind my Eyes, Forehead, and Back of Head at Base of Neck through 10pm. I took Speedy Release Tylenol, 3 hrs later Headache was returning I took 2 Ibuprofen and slept. Slept most of the day until 9pm when I felt I could tolerate Chicken Noodle Soup. I woke up Mon. 4/26/21 w/mild Headache just behind my Eyes.
58 2021-04-29 hearing loss This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose ... Read more
This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose Pfizer on 4/27/21 (Lot# EW0151). Of note, the patient was in a motor vehicle accident on 4/12/21 with a diagnosis of concussion and cervical/thoracic strain/sprain (see history under patient information). On 4/29/21, the patient's sister contacted the patient's primary care clinic with the following documented concern: "Pt's sister calling to report that two days ago pt got 2nd dose Pfizer vaccine and has been sick. This morning they found her passed out against the her bedroom door. Pt reports that she can't remember much other than going to the bathroom. Pt's sister states that patient totaled her car a week ago, and that it was determined she had a concussion. "She hasn't been herself since the wreck and I am very concerned." This caller recommenced the Ed or UC but caller denied stating that either needs to see her today. This writer is reaching out to nurse to see if they can advise from here." A RN assessed the patient virtually with the following documentation: "RN note: Call transferred from patient's sister. Pt noted to be found on her floor this morning. Pt unsure if she hit her head. Spoke to patient. She reports body aches, and feeling weak. Pt is slow to answer questions, and had a lot of difficulty hearing me (sister did not have any difficulty hearing me). Pt is noted to have more rapid breathing, and some slight wheezing. Speech is clear when she is speaking. Sister gave patient water to drink. She drank out of bottle and was able to hold on her own (though had difficulty with this at first). Sister noted some water dripping down face, but was able to swallow okay. Sister also noted that patient's lips seem to be pursed. Plan: Given recent concussion, and patients change in behavior per sister (pt more irritable, speaking more slowly, moving slowly, breathing faster, and wheezing), recommended patient be taken to the ED today--recommended ambulance since it took 2 men to help patient back to bed this morning. Sister states patient is not agreeable to going to ED at this time. Advised to try to encourage her to drink more fluids, and continue to monitor her sxs, and if any worsening, to call for ambulance transport. Sister agreeable to plan, and will discuss with sister, and recommend ED visit today." On 4/30/21, the patient's sister contacted the clinic to inform them that the patient was found dead that morning. The medical examiner is completing the further investigation. If additional information is needed from the primary care physician for this patient.
58 2021-04-29 ringing in ears Tinnitus
58 2021-04-29 visual impairment, vision blurred Light headed, blurred vision, foggy headed & felt medicated, balance off, weakness and dizzy. Starte... Read more
Light headed, blurred vision, foggy headed & felt medicated, balance off, weakness and dizzy. Started after woke up and progressed to the point of having to call husband home because of fall risk. Then fever came. Most concerning and alarming are the symptoms of vision change like smog in front of my eye sight, feeling weak, light headed and dizzy like walking on a rocking ship. Such a medicated feeling, this all progressed from between 7:30 am to about 10:30, had fever come 100.1 dizziness and weakness and vision gradually got better around 11:30. But when fever spiked again in the evening dizziness came back for a hour or more. Next day a milder episode of dizzy and that passed. These are the most concerning symptoms and Doctor advised I do not get second dose. I had many other symptoms and still have some.
58 2021-05-02 ear pain 1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlarge... Read more
1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlargement. 3rd day after vaccine left ear pain, difficulty swallowing, but could breath, fever,migraine, chills, ,fatigue, tender breast, breast enlargement. My primary said not to get second dose. Also rash on right arm.
58 2021-05-03 ear pain 4/25 Pt presented to urgent care with complaint of HA and earache. Her pulse ox was in the 80's and ... Read more
4/25 Pt presented to urgent care with complaint of HA and earache. Her pulse ox was in the 80's and she was sent to the ED for further evaluation and admission. D/C summary from 4/26 : Patient is a 58 y.o. female patient of, DO with history of OSA cannot tolerate CPAP, depression, rheumatoid arthritis, chronic pain syndrome, obesity, diabetes type 2, CAD, hypertension, hyperlipidemia, TIA who presents with shortness of breath. Patient was placed on 4 L NC but quickly weaned off. She tested positive for covid on 4/25. She was started on dexamethasone and covid cocktail for 10 days. Her CTPA and venous duplexes were negative for blood clots. There was bronchitis on CTPA so pt was placed on albuterol, mucinex and advised to use IS. Her Cr was elevated to 1.52 and improved to 1.25 this morning. Her hydrochlorothiazide was held. Her AST was 186, ALT 245 previously normal. Her atorvastatin and metformin were held. She was tolerating po and her VS were stable so she was discharged home. She was advised to have repeat labs with her PCP in 1 week and if at that time her Cr, AST, ALT improved, then her hydrochlorothiazide, atorvastatin, metformin could be resumed at her PCP's discretion. She was at home for one day and presented to another ED with CP and SOB. Admitted 4/27-5/1 D/C Summary :Clinical Summary Patient is a 58 y.o. female with a history of positive covid test 4/25/21, CKD, CAD s/p PCI, depression OSA rheumatoid arthritis morbid obesity, HTN and DM2 who just discharged from hospital 4/26/21 after diagnosis of COVID and starting on dexamethasone. She presented to hospital 4/27/2021 with chest pain and shortness of breath. CXR negative 4/27/21, CTPA negative 4/26/21, LEVD negative 4/26/21 labs stable from last admission. 1. COVID 19 Pneumonia: Suspected re-infection. Husband reported was positive mid - January. Continued dexamethasone to complete 10 days (started 4/25/2021). Remdesivir not started with LFT elevation on admit. 2. Acute hypoxic respiratory failure: with increasing O2 requirement 4/28/2021. CXR 4/28/2021 with underaeration of lungs. ABG 4/28/2021 without hypoxemia. Likely d/t COVID, resolved 3. Chest pain: Suspect in setting of COVID infection and component of costochondritis. CTPA and LEVD negative 4/26/21. Troponins stable from last admission in setting of CKD, ekg without acute findings on admit. 4. Elevated LFT: on admit AST 186, ALT 245, total bilirubin 0.2. likely d/t COVID. Improving, AST 93, ALT 163 4/30/202.1. will need outpatient repeat in 1-2 weeks with PCP 5. CKD3: Baseline creat 1.2-1.5. Cr on admit 1.52, improved 0.99 4/30/2021. Repeat chem in 1-2 weeks 6. T2DM: Per history, on Januvia at home (held on admit). A1C 8 1/29/21. Hyperglycemia on admission, improved with SSI, discussed continuing on discharge while on steroids and following up with PCP in next week
58 2021-05-03 oropharyngeal discomfort The patient received her second dose of the Pfizer COVID vaccine around 8 a.m. on 5/3/21 in one of o... Read more
The patient received her second dose of the Pfizer COVID vaccine around 8 a.m. on 5/3/21 in one of our outpatient clinics. She reported no reaction after her first dose of Pfizer vaccine. Within 20 minutes of receiving the dose, she had some numbness, tingling and uncontrollable jerking movements. She also had some blueish discoloration of toenails. Patient was reportedly weak and had to have assistance getting up onto stretcher prior to transport to hospital ER. Patient also reported "full" feeling in her throat that resolved after being given benadryl IM prior to arrival of EMS. She denied Shortness of breath. Patient was transported to ER and was noted to have dystonia. Patient was given benadryl and cogentin injection for jerking movements. Dystonia improved some, but patient was admitted to hospital for observation. After 24 hours, patient reports dystonia is better but is having some cerebellar issues probably due to medications that were given to stop the dystonia. MRI is to be done and neurology will be consulted.
58 2021-05-04 deafness unilateral, ringing in ears Severe Vertigo, profusely sweating, vomiting, severe dizziness, hearing loss (left), tinnitus.
58 2021-05-05 loss of taste Fever Fatigue Body/muscle aches Loss of taste Nausea heavy chest pressure Pneumonia due to COVID-19 ... Read more
Fever Fatigue Body/muscle aches Loss of taste Nausea heavy chest pressure Pneumonia due to COVID-19 increase hydration, Tylenol, Motrin as needed. Finger pulse oximeter dispensed.
58 2021-05-06 deafness unilateral, ringing in ears Tinnitus both ears one week post injection. Audiology exam and ENT exam 2 1/2 weeks post injection t... Read more
Tinnitus both ears one week post injection. Audiology exam and ENT exam 2 1/2 weeks post injection to determine other illness or injury. None detected.
58 2021-05-10 lip swelling Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips ... Read more
Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips started to swell; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; Then my body would jerk and I groaned; Then my body would jerk and I groaned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0169) at left arm on 24Apr2021 09:45 AM at second dose, single for COVID-19 immunisation. Medical history included chronic rhinitis and Lyme disease. Patient previously received Morphine, cefzil and grass. Patient previously received the first dose of BNT162B2 on 03Apr2021 09:45 AM (lot number: EP7533) on Left arm for Covid-19 Immunization. Concomitant medication included loratadine, astaxanthin (BIOASTIN), spirulina spp. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 5 hours after the second shot (also reported as 24Apr2021 22:00), her lips started to swell. she took her allergy medicine and she felt better. Twelve hours after the second shot, she had convulsions. she had a pain that started in her left armpit, shot down to her inner elbow, and caused her whole arm to get rigid. Then her body would jerk and she groaned. It stopped and started in intervals, with calm in between. It was unknown prior to vaccination, if the patient diagnosed with COVID-19. Not tested for COVID-19. Outcome of the events was recovering. Follow-up information requested.
58 2021-05-15 double vision, ear pain, vision blurred, ringing in ears Tinnitus, brain fog, blurred vision/double vision, ear pain, ear congestion, fatigue, fever, body ac... Read more
Tinnitus, brain fog, blurred vision/double vision, ear pain, ear congestion, fatigue, fever, body aches
58 2021-05-17 mouth numbness This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patien... Read more
This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:45 (Batch/Lot Number: EN0161) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took lisinopril and experienced allergy. After getting shot about 1/2 hr later tongue on right side started going numb and right side of face started to swell on 16Apr2021 17:30. Therapeutic measures were taken included steriods and antihistamine. Patient visited doctor or other healthcare professional office/clinic visit for events. Outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
58 2021-05-21 ringing in ears fainted; feeling horrible; dizzy; ringing in ears; nausea; chills; fever; This is a spontaneous repo... Read more
fainted; feeling horrible; dizzy; ringing in ears; nausea; chills; fever; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Left on 04May2021 09:45 (58-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. Facility where the most recent COVID-19 vaccine was administered was Clinic (Public Health Clinic/Veterans Administration facility). Concomitant medication included levothyroxine sodium (SYNTHYROID) and multivitamin. The patient previously took first dose of bnt162b2 (lot number: EW0164) , on 13Apr2021 01:30 PM at 58-years-old, on Left arm for COVID-19 immunization. The patient was fine until 17 hours after the second dose. She woke up around 3 am feeling horrible, got up to go to bathroom. She was very dizzy, had ringing in ears, nausea, then fainted. She had chills and fever for the next ~ 12 hours. Events started on 05May2021 03:15. No treatment was given. The outcome of the events was recovered.
58 2021-05-23 vision blurred I waited 30 minutes after the shot, then left the building to head home. About 10 minutes after that... Read more
I waited 30 minutes after the shot, then left the building to head home. About 10 minutes after that, I developed hives on face, neck, chest & arms. I had a very bad headache, swollen glands, stiff neck and some upper back and abdominal pains, slightly blurry vision. I went back to the facility and was checked out there. Was advised "not to worry" and sent home. I took Benedryl that I had brought from home which helped with the hives. Took Tylenol after coming home.
58 2021-05-23 visual impairment, eye floaters, vision blurred Blurred vision suddenly onset. Right eye diagnosed with posterior vitreous detachment and left eye l... Read more
Blurred vision suddenly onset. Right eye diagnosed with posterior vitreous detachment and left eye liquefaction. Both eyes have floater with right eye very significant visual disturbance. No safe treatment (surgical) so it is wait and see to determine if retinal will be affected
58 2021-05-23 visual impairment Viterous Detachment; Unable to clearly see out of right eye.
58 2021-05-24 ear discomfort After the second injection on April 16th, 2021 at hospital (vaccine site), about 3-4 hours later sta... Read more
After the second injection on April 16th, 2021 at hospital (vaccine site), about 3-4 hours later started with symptoms. Initially started with headache, fatigue. Then changed to vestibular. Such as left ear pressure, dizziness, nausea at times, (vestibular). The symptoms have NOT stopped and increasing! Huge medical workup. Also had new cardiac symptom (possible short run of svt) went to ER, overnight, 2 week home monitor which is now completed. But the vestibular symptoms are increasing, including bilateral facial paresthesias, now moving into my hands at times. Balance at times affected now and more. I walked in ok and now a medical nightmare.
58 2021-05-25 loss of taste Loss of taste; This is a spontaneous report from a contactable other hcp. A 58-years-old no pregnant... Read more
Loss of taste; This is a spontaneous report from a contactable other hcp. A 58-years-old no pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Feb2021 08:00 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation. Medical history included asthma, meniere's, hypoactive thyroid, syncope, allergies: Penicillin. There were no concomitant medications. No covid prior vaccination, no covid tested post vaccination. The patient experienced loss of taste (non-serious) on 20Feb2021 07:00 with outcome of not recovered. The case is non serious. Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
58 2021-05-25 ear pain pain in arm from point of injection and shooting up the arm-shoulder-collarbone-neck to my ear, whic... Read more
pain in arm from point of injection and shooting up the arm-shoulder-collarbone-neck to my ear, which continued for periodically throughout the day mostly from the collarbone up my neck to my ear until May 2021 at which time just dull pains and sometimes sharp pains
58 2021-05-25 lacrimation increased APPROXIMATELY 22 MIN. AFTER RECEIVING VACCINE, CLIENT BECAME LIGHT HEADED, DIZZY, SHORT OF BREATH, T... Read more
APPROXIMATELY 22 MIN. AFTER RECEIVING VACCINE, CLIENT BECAME LIGHT HEADED, DIZZY, SHORT OF BREATH, THROAT SWELLING, EYES WATERING, BLOOD PRESSURE DROPPED, TIGHTNESS IN CHEST. 911 CALLED. PARAMEDICS GAVE IV EPI. AND TRANSPORTED CLIENT TO HOSPITAL ER. MD DIAGNOSED ANAPHYLAXIS DUE TO COVID VACCINE. IN ER, CLIENT WAS GIVEN PREDNISOLONE AND ALBUTEROL TREATMENT. CLIENT RESTED IN ER WHILE BEING MONITORED. CLIENT THEN RELEASED TO GO HOME.
58 2021-05-25 swollen tongue 2nd dose received. AFter a few minutes, patietn reporting "fuzzy lip" sensation. No swelling, angioe... Read more
2nd dose received. AFter a few minutes, patietn reporting "fuzzy lip" sensation. No swelling, angioedema, chest pain, shortness of breath, tongue swelling, airway obstruction or difficulty speaking or diaphoresis. No issues with 1st dose. Monitored for 30 minutes. Symptoms improved/resolved and patient was discharged from clinic.
58 2021-05-26 lip swelling during 30 min observation period, patient developed swelling of lips and chest tightness. given dip... Read more
during 30 min observation period, patient developed swelling of lips and chest tightness. given diphenhydramine 50mg. Felt better.
58 2021-05-27 eye bleeding broken blood vessel in left eye/It might have happened after the 1st dose too; This is a spontaneous... Read more
broken blood vessel in left eye/It might have happened after the 1st dose too; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had a broken blood vessel in left eye and stated that it was not going away. The outcome of event was not resolved. Information about batch/lot number has been requested. Further information was expected.
58 2021-05-27 lip swelling Severe vomiting; Severe diarrhea; fever; pain in left ankle and foot; extreme cold hands and feet, f... Read more
Severe vomiting; Severe diarrhea; fever; pain in left ankle and foot; extreme cold hands and feet, fever on and off,; pain in left ankle and foot; extreme abdominal pain; dehydrated; lip started swelling; This is a spontaneous report from a contactable consumer. A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06May2021 14:45 (Batch/Lot Number: EW0172) as 2nd dose, single (at the age of 58 years old) for COVID-19 immunisation. Medical history included high heart rate, bp and prediabetic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), hydrochlorothiazide, triamterene (MAXZIDE) and duloxetine hydrochloride (CYMBALTA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took VALIUM and experienced allergies; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1, (lot number: EW0158) 14Apr2021 at 10:15 AM on left arm for COVID-19 immunisation and experienced lip swelling, bnt162b2 for covid-19 immunisation and experienced lower lip and chin swelling, Itchy chest, bumps, unable to walk and left knee severe joint pain. The patient experienced 15 minutes after shot, lip started swelling on 06May2021 15:00. Severe vomiting, severe diarrhea, fever, extreme abdominal pain, extreme cold hands and feet, fever on and off, pain in left ankle and foot on 07May2021 12:30. The patient went to emergency room (er) 3 days after vaccine (dehydrated, extreme abdominal pain) 6 days later still have abdominal pain, diarrhea, vomiting and fever. The patient received IV(intravenous fluids), potassium, abdominal CAT (computerized tomography) scan, Troponi (unknown drug). Prior to vaccination, was the patient not diagnosed with COVID-19 and been tested for COVID-19 (nasal swab) on 09May2021 and the result was negative. The outcome of the events were not recovered.
58 2021-05-27 ringing in ears Tinnitus in both ears
58 2021-05-28 eye bleeding broken blood vessel in left eye; This is a spontaneous report from a contactable consumer (patient).... Read more
broken blood vessel in left eye; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 19Apr2021 (Batch/Lot Number: EW0151) as 1st dose, single for covid-19 immunisation. Medical history included ongoing high blood pressure. Concomitant medication included metoprolol taken for hypertension. Patient has had this condition for 3 years, but it is not that high; it is very mild. The patient received second dose of COVID vaccine (Lot Number: EW0167) on 10May2021 at the age of 58-years-old in the right arm for Covid-19 immunization. The patient experienced broken blood vessel in left eye on 19Apr2021. It went away few days later, maybe 5 days later. After receiving second dose, the patient again noticed broken blood vessel in left eye and now it looks like worse than ever. The patient added that it was getting a little better, got worse, and at the time of the report was still there. The patient went to the doctor's office on16May2021 and will consult at the time of the report to an eye doctor. The patient added that she also went to one right after, a week ago. She says she wants different opinions and she think it might be a broken blood vessel. The outcome of the event was recovered on unspecified date in Apr2021.
58 2021-05-28 mouth numbness Toes turned purple; Large purple circle on my arm below the injection site; numbness in my lower lef... Read more
Toes turned purple; Large purple circle on my arm below the injection site; numbness in my lower left lip which spread to my chin and lower cheek the following day.; numbness in my lower left lip which spread to my chin and lower cheek; This is a spontaneous report from a contactable patient. A 58-year-old non-pregnant female patient received second single dose (Pfizer -BioNTech Covid-19 mRNA Vaccine,) via an unspecified route of administration on the right arm on 24Feb2021 for COVID-19 immunisation. Her medical history included hypothyroidism. She has no allergies to medications, food, or other products. Prior to vaccination, she was not diagnosed with COVID- 19 and has not tested for COVID-19, since the vaccination. Furthermore, she has not received other vaccines within 4 weeks prior to the COVID vaccine. She received concomitant medications within 2 weeks of vaccination were multivitamin, atorvastatin (LIPITOR 20mg) and levothyroxine (SYNTHROID 112 mg). Her past vaccination history included (Pfizer -BioNTech Covid-19 mRNA Vaccine) first single dose via unspecified route administered on right arm on 04Feb2021 for COVID-19 immunisation. On 24Feb2021 (the same day of vaccination), she had large purple circle on her arm below the injection site. On 25Feb2021, the patient toes turned purple but cleared quickly. On an unreported date (9 days post vaccination on an unknown date in 2021), she experienced some numbness in her lower left lip which spread to chin and lower cheek the following day. She felt better after a couple of days but still felt a slight numbness in her lower lip. It was reported that she did not receive any treatment for the events. At the time of the report, she has recovered from toes turned purple and was recovering from numbness in face and lips however the clinical outcome of large purple circle on my arm below the injection site was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-05-29 mouth numbness Patient tongue and cheek were numb. patient felt it was a mild allergic reaction. Patient was given ... Read more
Patient tongue and cheek were numb. patient felt it was a mild allergic reaction. Patient was given OTC benadryl to take for the evening, and told if problem breathing should contact physician
58 2021-05-31 ear pain Right arm pain into shoulder, neck and ehind righ ear
58 2021-05-31 ringing in ears I have always had Tinnitus but it has greatly intensified since my second vaccine. Not medical atten... Read more
I have always had Tinnitus but it has greatly intensified since my second vaccine. Not medical attention required at this time. I developed Hypnic Jerks at night prior to sleeping that last for up to an hour on some nights and can be quite strong in nature always stemming from my lower back. I went to the doctor in April and he told me it's just stress and to keep an eye on it. I have an appointment scheduled with a Chriropractor to see if they can help on 6/7.
58 2021-06-01 taste impairment metallic taste in my mouth, chest pain, nausea, throat closed up. went to the ER via ambulance. migr... Read more
metallic taste in my mouth, chest pain, nausea, throat closed up. went to the ER via ambulance. migraines, brain fog , fatigue
58 2021-06-01 taste impairment metallic taste in mouth about 45min after receiving the shot
58 2021-06-01 ringing in ears Ringing in left ear. I'm not worried about it. I just thought someone would want to know.
58 2021-06-02 vision blurred, visual impairment stroke like symptoms/minor stroke; high/extremely high blood pressure; blood sugar numbers were very... Read more
stroke like symptoms/minor stroke; high/extremely high blood pressure; blood sugar numbers were very high in the 700s; face on the left side felt paralyzed like she couldn't feel if something was in her mouth; trouble seeing on the side of her eye/can only see straight on the left side; Blurry vision; fall; splintered hand; losing her balance; numbness in her arm; Soreness/sharp pain on her arm; dizzy spells; fatigue; This is a spontaneous report from a contactable consumer (daughter). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 17Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke in 2012 (first stroke was from a heart attack), heart attack in 2012, stroke in 2017, stroke in Dec2020, high blood pressure from 2012 and ongoing, diabetes from 2013 and ongoing, glaucoma from 2009 and ongoing, ongoing at risk for heart failure, ongoing tumor in her stomach (23 years, benign and hasn't been surgically removed due to other issues and not harming her), ulcers (3 ulcers in the past and none currently), broken ankle in 2014, preeclampsia attack in 1990, baby being strangled during birth in 1994, broke her pelvis during birth in 1996, and complicated birth in 1996 (which she was in a coma for). The patient had no family history. Concomitant medications included labetalol (MANUFACTURER UNKNOWN) taken for heart condition from Dec2020 and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for stroke from 2012 and ongoing; furosemide (MANUFACTURER UNKNOWN) from an unspecified date and ongoing; atorvastatin (MANUFACTURER UNKNOWN) taken for stroke from an unspecified date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nicotinic acid, pantothenic acid, phosphorus, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin B12, vitamin D, vitamin E, vitamin K, zinc (CENTRUM WOMEN 50+) from an unspecified date and ongoing, and unspecified eye drops for glaucoma from an unspecified date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced stroke like symptoms/minor stroke, high/extremely high blood pressure, blood sugar numbers were very high in the 700s, face on the left side felt paralyzed like she couldn't feel if something was in her mouth, trouble seeing on the side of her eye/can only see straight on the left side, and blurry vision on 08Apr2021, which all required hospitalization from Apr2021 to Apr2021 for 4 days. The patient also experienced losing her balance, numbness in her arm, soreness/sharp pain on her arm, dizzy spells, and fatigue on 08Apr2021 and fall and splintered hand on 30Apr2021. The clinical course was reported as follows: It was reported that the patient had stroke like symptoms, which were reported to be not a result of the vaccine as the patient had a lot of health issues. The patient had the vaccine and was completely fine and then right around the time she was supposed to get her second dose she was showing signs that could have been a minor stroke. She just had high blood pressure and her blood sugar numbers were very high in the 700s on 08Apr2021. It affected her face. It was not a full on stroke, she got to the hospital in time. The patient had strokes before. They thought it was better to stabilize her blood pressure and blood sugar before getting the next shot. She was in the hospital for 4 days. They gave it time to stabilize and come to a normal number. When it did and they went back to the pharmacy, they said they did not feel comfortable administering the second shot after 42 days. Now it was pushing more than 42 days. The reporter stated she would not necessarily call it a stroke. Her mother had symptoms leading up to a stroke but not a full on stroke. She had numbness of her arm and blurry vision, but not a full on stroke. She was in the hospital the week of 07Apr2021. She was supposed to have the second shot on 14Apr2021. She was discharged from the hospital the week of 12Apr2021, either that Monday or Tuesday. She had trouble seeing on the side of her eye. She can only see straight on the left side. Her face on the left side felt paralyzed, like she couldn't feel if something was in her mouth. She has been losing her balance. Her blood pressure was through the roof on 08Apr2021, as well as her blood sugar. She did a video chat with the doctor the night before going to the emergency room (ER). They monitored her symptoms, and they started within the first 72 hours before going to the hospital. She had a blind spot in her left eye. The other one she can see just not as great as before. Before this instance she did not have a blind spot, and now she does. The patient walked with a cane now. If she is outside, she is held with someone and cannot just walk along because she does not see well by herself. She had to sit at a certain angle to see clearly. Her vision is not well. The numbness in her arm comes and goes. Sometimes it is a sharp pain and sometimes it is numb. It was definitely worse when she was at the hospital. The numbness and sharpness level goes hand in hand with when her blood pressure is too high and fluctuates with her blood sugar and blood pressure. With her face feeling paralyzed, her left eye socket is closed a little bit. She has more mobility than when it happened. She has been working on it with physical therapy trying to get it back. Her balance was off when she wasn't seeing well and was unassisted. She would get dizzy spells and fall. Now she is more aware of when she will feel dizzy and will let them know. The cane helps her balance. The dizzy spells came at the same time as the other symptoms. They fluctuate. They have stabilized over time. When it first happened, they were a lot more frequent. Now they almost never happen. The patient underwent lab tests and procedures, all in 2021, which included bloodwork: unknown results, computerised tomogram (CAT) scan: unknown results, and x-ray: unknown results (on her hand when she broke it in the past 2 weeks). The clinical outcome of stroke like symptoms/minor stroke, soreness/sharp pain on her arm, fatigue, fall, and splintered hand was unknown; high/extremely high blood pressure, blood sugar numbers were very high in the 700s, face on the left side felt paralyzed like she couldn't feel if something was in her mouth, losing her balance, numbness in her arm, and dizzy spells was recovering; and trouble seeing on the side of her eye/can only see straight on the left side and blurry vision was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
58 2021-06-03 ear pain elevated BP for 24 hours; pain in the ear; low grade fever; chills; pain in the joints; sharp shooti... Read more
elevated BP for 24 hours; pain in the ear; low grade fever; chills; pain in the joints; sharp shooting pain in the crown of the head; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old female patient received unknown dose of BNT162B2 (Pfizer -BioNTech Covid-19 mRNA Vaccine, lot number: EL3247), via an unspecified route of administration on 15Mar2021 (at the age of 58-years-old), as a single dose for COVID-19 immunisation . Medical history included hypothyroidism and autoimmune disease. Concomitant medications were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient experienced low grade fever, chills, pain in the joints, ear, sharp shooting pain in the crown of the head and elevated BP for 24 hours. No therapeutic measures were taken for the events. The clinical outcome of the low grade fever, chills, pain in the joints, ear, sharp shooting pain in the crown of the head was recovering and for elevated BP for 24 hours it was recovered on 17Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
58 2021-06-03 pain in jaw, toothache The 3rd day after my 2nd Pfizer shot, I got sharp dental nerve pain in several teeth on the right si... Read more
The 3rd day after my 2nd Pfizer shot, I got sharp dental nerve pain in several teeth on the right side to the midline. Since it is only on one side, it does not seem to be teeth grinding at night. Since it is both upper & lower jaws, it does not seem to be related to seasonal allergies/sinuses. (upper jaw) The pain intensity varies day-to-day and tooth-to-tooth. Pain occurs without eating/chewing. Upper right - teeth #5,4,3 and roof of the mouth near those teeth. Sometime between teeth #8 & 9. Lower right - teeth #29 & 30, with pain under the right jaw near those teeth. Sometimes between #25 & 24. There is also new dental sensitivity to chewing and food temperatures on the right side. I have been treating the sharp dental nerve pain with OTC aspirin and Aleve every day. Today (6/4/21) is the the first morning when the pain is dull enough that I have not taken an OTC pain medication ... yet.
58 2021-06-03 sensitivity to light Fever; Muscle aches; Pains; Sensitivity to light; Nausea; Chills; Sweats; Overall lethargy; Irregula... Read more
Fever; Muscle aches; Pains; Sensitivity to light; Nausea; Chills; Sweats; Overall lethargy; Irregular heart rate; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in right arm on 16Mar2021 at 14:30 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefalexin (KELFLEX) and amoxicillin; clavulanic acid (AUGMENTIN) and experienced drug allergy on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 23:45, the patient experienced fever, muscle aches, pains, sensitivity to light, nausea, chills, sweats, overall lethargy, irregular heart rate. The patient did not receive any treatment for the reported events. The clinical outcome of the fever, muscle aches, pains, sensitivity to light, nausea, chills, sweats, overall lethargy, irregular heart rate was recovering. No follow-up attempts are needed. No further information is expected.
58 2021-06-03 vision blurred Sensation that moved up my jaw to my neck and then to my brain and head then jaw and neck pain ting... Read more
Sensation that moved up my jaw to my neck and then to my brain and head then jaw and neck pain tingling in my whole head and brain with pressure. Blurred vision the the next morning have facial numbness. Dizziness vertigo leg tingling. And pain. While Arm pain in injection side. Pain in side of body with injection Muscle twitching in injection arm throat tightness and swelling me coughing Sinus pain and headache tiredness feeling unwell. Felling hot all over
58 2021-06-04 mouth tingling tingling in the tip of the tongue halfway; redness in face and forehead; This is a spontaneous repor... Read more
tingling in the tip of the tongue halfway; redness in face and forehead; This is a spontaneous report from a contactable consumer reporting for herself. A 58-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 26Feb2021 11:00 as SINGLE DOSE for COVID-19 immunization. The patient had known allergies (unspecified). Concomitant medication(s) included hydrocortisone cream; clobetasol cream 0.05 (unit not reported); and bacitracin zinc, neomycin sulfate, polymyxin B sulfate (NEOSPORIN). The patient did not receive any other vaccine in four weeks prior to COVID vaccination. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that on 26Feb2021 11:00, the patient had tingling in the tip of the tongue halfway, redness in face and forehead. Therapeutic measures were taken as a result of event; treatment included Benadryl. The outcome of the events reported as Recovered with lasting effects (Recovered/Resolved with Sequel). No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
58 2021-06-07 sensitivity to light, visual impairment I was sitting after I got the shot and I started to feel a little off. I felt light headed and wish ... Read more
I was sitting after I got the shot and I started to feel a little off. I felt light headed and wish I would have drank more water before I received the vaccine. I was kind of okay, sitting there waiting, but then I started feeling a weird sensation from the top of my head to the tip of my toes. My skin felt like it was tingling. While I was sitting there I was thinking that I was experiencing anxiety. I received a phone call from my sister that distracted me from my feelings and I felt okay. When I started to leave, I felt light headed and disoriented. I thought I may have been dehydrated. I went to the car and my lips felt like they were swollen, but were physically not. I started feeling like there were pins and needles in my skin. I started to itch in the back of my throat and started experiencing breathing complications. I sat in the parking garage for 40 minutes and debated if I wanted to go back. It was a long walk from my car to the vaccination area. I had my service dog with me and decided to go home. The itchiness went away and I started feeling better for about 24 hours. The next day, I ended up in the ER. I was given Benadryl and in 10 minutes I was fine. Over the next couple of weeks, I started experiencing random heart palpitations. It felt like my heart would skip and jump from time to time. I have not seen anyone yet in regards to my heart. I have had multiple ocular migraines. I still get them now and then after receiving the vaccine. It affects my vision for up to 20 min to an hour after the headache. Bright lights and too much time on my phone and computer causes a problem for my vision.
58 2021-06-08 dry eye Ten days after the first dose vaccine I started to have Stroke like symptoms. I was coming home and ... Read more
Ten days after the first dose vaccine I started to have Stroke like symptoms. I was coming home and my daughter was driving. My daughter asked me why I was stretching my mouth. I did not know this was happening and my daughter said she was taking me to the ER. We called the 24 hour nurse. Two days before I did notice that I got a headache in the evening and it was still there all the next day. I just thought I was coming down with a cold. The headache was still present on the day of the facial symptoms. It was mostly on the left side of my head. The left side of my face is effected by Bells Palsy. I still had mild headaches for two weeks. I still have problems with memory and speech after eight weeks. I feel like I have some good days which are better than others. I have problems with dry eye and balance. The ER doctors diagnosed Bells Palsy. I have been unable to work for eight weeks so far.
58 2021-06-08 ringing in ears Tinnitus....extremely Loud bilateral....left side worse
58 2021-06-09 ear pain immobility in left arm; Headache through the night; Intermittent pain in right ear; Difficulty sleep... Read more
immobility in left arm; Headache through the night; Intermittent pain in right ear; Difficulty sleeping; Lethargy; Nausea leading to a single vomit; Nausea leading to a single vomit; temperature of 101 degrees fahrenheit; Chills; Rash covering entire trunk of body the following evening; This is a spontaneous report from a contactable consumer. This 58-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 11:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation . Medical history included from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 05Apr2021, administered at 11:15 AM on left arm. There were no concomitant medications and no other vaccine in four weeks. It was reported that on 27Apr2021 at 12:00 AM, the patient experienced headache through the night, intermittent pain in right ear, difficulty sleeping, lethargy, nausea leading to a single vomit, temperature of 101 degrees Fahrenheit, chills immobility in left arm, rash covering entire trunk of body the following evening. The outcome of the events was recovered on unknown date. Therapeutic measures were taken as a result of events included Ibuprofen. Patient had no covid infection or tested positive for covid prior to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-06-09 ear itchiness, mouth discomfort, tongue discomfort, mouth numbness I had my 1st vaccine on may 21st about 2:30. I woke up 5:45am May 22nd I was hoarse and wheezing, my... Read more
I had my 1st vaccine on may 21st about 2:30. I woke up 5:45am May 22nd I was hoarse and wheezing, my tongue lips and face felt tingly numb and puffy. my ears were hot and itchy also my body felt like my skin was crawling. taking a lot of allergy meds, My mouth is still numb 3 weeks later.
58 2021-06-09 swollen tongue, mouth swelling, lip swelling About 6 hours post vaccine, I woke up with fever, chills and shaking. I took ibuprofen and Tylenol ... Read more
About 6 hours post vaccine, I woke up with fever, chills and shaking. I took ibuprofen and Tylenol . I could not go to work and stayed home. These symptoms lasted about 48 hours. About a week after the vaccine, I started having angioedema. I notice my tongue started to swell. I also noticed my lips and the inside of my mouth was swelling too. It would start from the left inside of my mouth and migrate to the right side. I took Benadryl. The swelling lasted for about 4 days and started to slowly go away. About a week later, I started getting body rashes on random parts of my body. It had it on my ears, underarms, under my breasts, thighs, hands, legs and trunk. The rash would randomly appear and dissapear and could last from 12 hours to several days. I went to se a doctor and was prescribed Allegra, Zyrtec and steroids. I got another 2nd opinion with Dr and got blood work done. I still am suffering from random rashes and notice it will flare up when I don't take my antihistamine medications. The rash is very red, blotchy, can be raised, itchy, painful and very uncomfortable. I never know when I would get them or how severe it may be.
59 2021-01-01 loss of taste Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore a... Read more
Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore arms, fatigue then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms. I knew then I needed to get swab. Symptoms is still current.
59 2021-01-03 mouth numbness I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (a... Read more
I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (allergy Tablet PO) and monitored for 1 hour, with vital signs being taken.
59 2021-01-03 tongue itchiness TONGUE ITCHING AT 0940; RECEIVED VACCINE AT 0721. REFERRED HER TO HER PCP.
59 2021-01-04 bloodshot eyes Woke up with redness to the left eye.
59 2021-01-04 smell distorsion Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and sh... Read more
Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and she got the head cold in Dec2020; little whooping cough; I had severe headaches and it was just too uncomfortable; my head was so congested; worst headache; it was just too uncomfortable; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female patient received BNT162B2 via an unspecified route of administration on 22Dec2020 at the 59-year-old at single dose for Covid virus. The medical history included Congested, head cold and Covid virus. There was no concomitant medication. The patient work at a hospital and she went for a Covid shot (clarified as Covid 19 vaccine) on 22Dec2020 and she got a very bad reaction from it which bothered her, she had severe headaches in Dec2020 and it was just too uncomfortable and on 24th she was very tired, she didn't had too much of upset stomach in Dec2020 but it was not all that bad by 9 in the clock by morning she was at work and everything and she was told by if she was not feeling well she can walk by a day, but her question and her concern was back on November okay she had called in sick around, she had a funeral that she gone too and people that were at the funeral, unfortunately were smoking outside and smoke bothers me very much, she get congested and she get head cold from it you know and I was thinking it's nothing it's just a cold and somebody told her no (name) you better go get yourself to the employee health office and get checked out and she didn't bother doing that, she said no it's just the cold she will be fine but then it just got worse down the road and she said to herself may be she better just to say she did it, so she called in sick on 24th because she had the cold still and she called and she went to employee health office on 25th she still had the headache and she still had the cold, however when she went to the health office they said to her well stay out of work and we will get back in touch with her and she said okay and she will do that so when they got back in touch with her they said they do have the Covid and she said ohhh she said okay so she stayed out of work and she went to work on the 07Dec so she was wondering whole time, so her confusion was this she was told if you already had the virus in her which at that time, she did not know what it was she just thought it was from cigarette smoke because it got her all congested and she got the head cold in Dec2020 and the whole thing that went along with it and the health employee officer know you had the virus and it's just the virus and she go oh great and that's when they told her to stay out of work and she said okay fine then she just have to that, so in the meantime everybody in the work said hi calling me checking up on her and she said it's so nice of you people, she appreciate it but then she went back to work she was still feeling you know much better than she was but she had little whooping cough in Dec2020 but that was not really that bad, so they said you going to get the shot or not, and she said she don't know she kind of debatable, she don't know if she should get it, because she work in the hospital or she should not get, she said she don't know she was kind of up and some people like she get it sometime your health was not that good but on the other hand everybody that is working here in the hospital working with patients because was work right in the ICU, all over the floor you know spreading right there so she said oh alright so she kicked myself and said go get the shot, get it just over with and get it out of here so that is when she took her shot that was on 22nd and on 24th she was very tired all day no she was tired all day but she was kind of dragging most of the day but she had on the 20th no that was fine on the 20th okay for some reason she guess it was after work that week on 19th, she came home and her head was so congested and she had the worst headache and she felt like a wand had hit her over the head, it was horrible and all she could smell was cigarette smoke, like is her neighbor smoking here so she went down the hall because in live in building that used to be hotel but now they turned that into Condominium and she walk up and down the hall and she was like was somebody smoking or why this or why smell this so strong and the all the lights off in a hallway and she don't want to offend anybody but they had to go to work and somebody elsewhere and she am like she can't stand this smell and they gave this shot and she went for this shot, and they told us to come back she think it was a week or something like that to get the second shot, and she am saying if this going to cost her going to feel this way again, she don't want to get the second shot, she told them that and they told her to call this number and talk to them.The only reason she got it because they encouraged to get it. Even though she had the Covid virus, people said if you already have the virus you don't need to get a shot but people were encouraging because that's she thought well she guess she will get it. But she was mad that she got because it made her sick in Dec2020. And because we already got it they want us to go back and get the second shot and what she was m trying to say to you is, without take and hour 3 hour of conversation here she just want to say she don't want to get back and get the second shot and if it is okay by you guys somehow send her a letter or whatever it is, whoever she have to talk to because she don't want to go back and get the second shot just because of getting sick. She took Excedrin because that works for my headache. She didn't understand why you need all this information history with all this when all she want to say was she didn't want to get a second shot. The outcome of events Head cold and Headache was not recovered, the other events was unknown. Information on the lot/batch number has been requested.
59 2021-01-04 ringing in ears Development of tinnitus/ringing sensation/buzz as a "generalized sensation" that is generally not pl... Read more
Development of tinnitus/ringing sensation/buzz as a "generalized sensation" that is generally not pleasant. Within first 24 hours after administration patient had regular side effects including headache, fever (99.8) , and chills that disappeared after 36-48 hours.
59 2021-01-05 vision blurred Extreme Dizziness, Blurry Vision, Near fainting and Nausea
59 2021-01-05 vision blurred Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness... Read more
Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness, near syncopal episode, blurred vision, chest tightness, tachycardia, weakness, shortness of breath. . Returned to vaccination room, in obvious distress. Ushered by staff to chair. Unable to obtain BP via electronic machine, obtained manual , after about 10 or so minutes NIPB 106/69. Remained in room for 45 more minutes, symptoms slowly resolved. Remained with mild to moderate dizziness x 4 days. Headache, chills, chest tightness, weakness, lethargy, x 7 days..
59 2021-01-06 eye swelling Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the... Read more
Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the following day and symptoms had resolved.
59 2021-01-06 lip swelling Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelli... Read more
Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelling and she went back to sleep and woke up again around 5:30 am and swelling had gone down, and then at 10:30 am patient reports that left facial swelling and left lip swelling completely resolved. Pt. denies taking anything to resolve swelling of left face and lip.
59 2021-01-06 mouth itchiness Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,ho... Read more
Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,hot and swollen after the allergy shot . Itching whole body and also the roof of mouth and the back of throat was itching . Head aches . No new symptoms.
59 2021-01-06 ringing in ears Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also r... Read more
Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also reported worsening tinnitus which started 12/22/2020, prior to the vaccine administration date.
59 2021-01-07 dry mouth Patient developed dry mouth and dificulty swallowing 11 min after vaccination, lasted 30 min. Has li... Read more
Patient developed dry mouth and dificulty swallowing 11 min after vaccination, lasted 30 min. Has lingering post nasal drainage.
59 2021-01-07 mouth numbness, mouth tingling Tingling in mouth, numb tongue and lips; numb tongue and lips; This is a spontaneous report from a c... Read more
Tingling in mouth, numb tongue and lips; numb tongue and lips; This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 04Jan2021 14:30 at single dose at left arm for COVID-19 immunization. There was no medical history reported. Concomitant medication included pravastatin, levothyroxine, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium, glucose oxidase, lactoferrin, lactoperoxidase, lysozyme, sodium fluorophosphate (BIOTENE [GLUCOSE OXIDASE;LACTOFERRIN;LACTOPEROXIDASE;LYSOZYME;SODIUM FLUOROPHOSPHATE]). On 04Jan2021 14:45, within 15 min observation period, the patient experienced tingling in mouth, numb tongue and lips. No throat swelling. The patient was given 25mg diphenhydramine. Therapeutic measures were taken as a result of tingling in mouth, numb tongue and lips. The outcome of the event was recovered in Jan2021.
59 2021-01-07 mouth swelling, lip swelling Bottom lip is not crooked or nothing like it but inside it is kind of little swelled; Mouth is kind ... Read more
Bottom lip is not crooked or nothing like it but inside it is kind of little swelled; Mouth is kind of swollen up; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had the COVID shot on Tuesday (29Dec2020) and thinks her mouth is kind of swollen up. Her bottom lip is not crooked or nothing like it but inside it is kind of a little swelled. The patient started experiencing the adverse events in the morning of 31Dec2020. No treatment was administered for the events, and the patient was advised to contact primary healthcare professional. The outcome of the events was unknown.
59 2021-01-07 mouth tingling Tingling around mouth 6-7 min post vax Observation and fluids Sxs resolved after 5 mins of close mon... Read more
Tingling around mouth 6-7 min post vax Observation and fluids Sxs resolved after 5 mins of close monitoring Allergies: Codeine, Latex, Iodine Contrast, Hydrochlorothiazide. No known food allergies, but consumed two foods new to her (yogurt parfait and Gatorade Zero) just prior to injection
59 2021-01-07 mouth tingling tingling tounge and flushed, monitored until resolution,
59 2021-01-07 mouth tingling tingling LUE, LLE, Left face and left side of tongue/cheek Narrative: condition C called
59 2021-01-08 ear discomfort left side lymph node swelling x3 days, began on 1/3/21, also has fatigue, has been afebrile, no othe... Read more
left side lymph node swelling x3 days, began on 1/3/21, also has fatigue, has been afebrile, no other issues Narrative: Has not required medical attention yet. Today now feels there may be some ear pressure. Advised to f/u with PCP if ear begins to bother her more and update Occ. Health. No known exposures to anyone who has tested positive for COVID-19 infection.
59 2021-01-08 mouth tingling patient complained of tingling in lips & tongue. Vitals taken; airway checked - no signs of swelling... Read more
patient complained of tingling in lips & tongue. Vitals taken; airway checked - no signs of swelling. Onset @ 1235, 8 minutes after injection. Lasted for ~ 10 mins then subsided. No rash/itch. Agree with assessment unlikely to allergic rxn
59 2021-01-10 swelling of eyelid, lip swelling She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsen... Read more
She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.
59 2021-01-11 loss of taste, loss of smell tested positive for Covid-19 after receiving 1st dose; COVID-19 PCR test: positive on 31Dec2020, Cov... Read more
tested positive for Covid-19 after receiving 1st dose; COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020; smell was gone/no sense of smell; no sense of taste; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) via unspecified route of administration in the left arm on 26Dec2020 at single dose for Covid-19 immunization. Medical history included cholesterol, blood pressure (controlled blood pressure), hypothyroidism. Concomitant medications included TELMISARTAN (MICARDIS) for blood pressure and ATORVASTATIN (LIPITOR) for cholesterol; both on unspecified date. The patient was asking if she was able to get the 2nd dose of vaccine, since she was tested positive for Covid-19 (31Dec2020) after receiving 1st dose. The patient was asking information about missing 2nd dose and when can she get it and wanted to know if it was still okay to get the second dose. The patient asked if she needed to have a test negative for covid-19 prior to receiving 2nd dose. The patient experienced no sense of taste and actually realized it on 29Dec2020 that her food was not tasting good. The patient didn't notice her smell was gone until she was cooking the chicken curry, she even tested it out by spraying some perfume, she has no sense of smell on 30Dec2020. The patient informed that both her taste and smell returned 02Jan2021 but was not recovered completely. The patient underwent lab tests and procedures which included A1C: 6.4 on 12Dec2020, COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020. The patient informed that she had no positive test before the Covid-19 vaccine, she took Covid-19 antibody test in Apr2020 and it was negative. The outcome of the events tested positive for Covid-19 after receiving 1st dose was unknown, no sense of taste and smell was gone/no sense of smell was recovered with sequel on 02Jan2021.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use.
59 2021-01-11 vision blurred numbness in right fingers along with tingling. moved to back of neck and side of face. right side ... Read more
numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL01284, expiry date not reported), via an unspecified route of administration in the right arm on 31Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included pituitary tumor/prolactinoma. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Concomitant medications were none. On 31Dec2020 at 10:45, the patient experienced numbness in right fingers along with tingling. The patient moved to back of neck and side of face. The right side of face was completely numb. It began with tingling and then moved to numbness. Her right eye was blurred for short period. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
59 2021-01-11 vision blurred 1/5/2021 at 3am I woke up feeling very lightheaded and dizzy. Went back to sleep and At 7am woke f... Read more
1/5/2021 at 3am I woke up feeling very lightheaded and dizzy. Went back to sleep and At 7am woke feeling same. I took routine vitamins and 2 extra strength Tylenol. Symptoms lasted all day with difficulty walking due to the dizziness. Also had difficulty focusing, blurry vision. 1/6/2021 still a little lightheaded just a little dizzy. Headache ( I have routine headaches). lightheaded and dizziness decreased with each day.
59 2021-01-12 dry mouth 1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter... Read more
1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter 5:30pm Shivering muscle pain temp 101 took motrin 1/9/2021 Felt 80% ok 1/10/2021 and 1/11/2021 95% better Appetite decreased from 1/8/20201-1/11/20201 ( dry mouth, fever, chills, lightheadedness, muscle pain)
59 2021-01-13 ear discomfort Patient began to experience neck pain on the same side she received her injection along with tightne... Read more
Patient began to experience neck pain on the same side she received her injection along with tightness and stiffness. Patient also experienced pressure, popping and burning in and around bilateral ears. Patient expressed she felt hot, and had a headache. Patient verbalized she had a lot of allergies to environmental substances.
59 2021-01-13 eye pain, eye swelling Awoke at 3 am on 1/14/2021 with eye pain and swelling , at 6:30 am eye swelling in right eye was mor... Read more
Awoke at 3 am on 1/14/2021 with eye pain and swelling , at 6:30 am eye swelling in right eye was more prominent, rinsed eyes with cold water multiple times. Swelling still exists 1/14/2021 at 1315, (time of typing this information). Seeing slight improvement.
59 2021-01-13 eye pain wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; h... Read more
wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; headache, muscle spasms in abdomen; headache, muscle spasms in my abdomen; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 02Jan2021 at a single dose in left arm for COVID-19 protection. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 18 or 19 years ago), COVID-19 previously and did not have side effects like this (the patient had COVID 19 last month and did not feel this bad at all. Patient was asymptomatic). Concomitant medication included ongoing liraglutide (VICTOZA), ongoing insulin detemir (LEVEMIR), both started about 2 or 3 years ago for diabetes Type 2. She received the product vial workplace policy, so it was not specifically prescribed to her. The patient received the first dose of the vaccine on 02Jan2021, and starting on 06Jan2021, she started with headaches, and muscle spasms all over her abdomen and back. Headaches was reported as worsened. The headache will not go away and even with Tylenol it still lingers. Muscle spasms all over her abdomen and back was reported as worsened. Her eyes were weak and hurting, started on 08Jan2021. She was so tired, she wanted to sleep. The tiredness, started on 06Jan2021, and it is like in the morning she is okay, but then during the day she just got worse and worse and worse. Her sore throat starting 07Jan2021 night, and this morning it was really bad. Throat was very sore was reported as worsened. She received no other vaccines on the same day at the COVID vaccine. The patient was wondering if those are side effects of the vaccine, because the patient had COVID-19 previously and did not have side effects like this. This is a non-serious report. The outcome of event eyes being weak and hurting, and wanted to sleep was unknown, outcome of the other events was not resolved.
59 2021-01-13 lip swelling The patient developed swelling of left jawline and L side of lips that began 12-14 hours after injec... Read more
The patient developed swelling of left jawline and L side of lips that began 12-14 hours after injection. She denies any other symptoms. Denies itching or pain of area. Denies swelling of tongue or throat. Denies shortness of breath. Was seen by her PCP and symptoms were attributed to angioedema due to ACEi medication.
59 2021-01-13 swollen tongue About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue s... Read more
About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue swelling. Patient was treated with an IM injection of epinephrine and then transported down to the emergency department. Upon arrival to the ED, she felt markedly improved with no symptoms other than some mild nausea. Patient was treated with steroids and ondansetron.
59 2021-01-14 feeling of choking About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my... Read more
About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my blood had turned into lava. About a minute after that I felt a "tickle" in my throat. The same sensation I felt when I had my reaction to Gadolinium. I tried to swallow, and it was a little difficult. I did NOT feel short of breath. I tried to calm down by doing slow concentrated breathing. I continued to take small sips of water to gauge my swallowing ability. After about 2-3 minutes, the flushing sensation subsided, and swallowing started to improve. I had brought my Epinephrine pen with me. About 1-2 min after the flushing sensation had subsided,, it came back and my swallowing ability got much worse, to the point I couldn't swallow a small sip. I was breathing well, and did NOT feel short of breath, but gave myself my Epinephrine injection at that time. A Rapid Response was called at that time, my vitals signs taken, an IV inserted, 911 called. O2 sats were fine mid 90's, heart rate was mid 80's, BP was elevated, I don't remember the exact systolic 170-180, but my diastolic was 116. It took the ambulance approximately 10-15 min to arrive. By the time the ambulance arrived, I was feeling close to my baseline and my BP was improving. I was seen by the ER MD, and feeling fairly well, my throat still felt a tiny bit tight, but no difficulties swallowing. The plan was to complete treatment with IV steroids, Benadryl, and Pepcid, then be observed for a few more hours. This was approximately around 16:30. Not more than 5 min after MD left my room, I got the flushing feeling, and throat closing feeling again. While the medications were being prepared these symptoms increased, ( I could still breath adequately and vital signs were still OK. It took about 10 minutes after meds were given for symptoms to begin to subside ( No epi given) I was observed until 21:30 then discharged. I am taking 50 mg daily x 3 days, 25mg Benadryl q 8hrs x 3 days, and 20mg Pepcid bid x 3 days. I feel fine , no further episodes
59 2021-01-15 mouth tingling, lip swelling Started 5am on 1/16. Upper lip felt tingly. Applied ice and fell asleep. Awoke at 9am to extremely s... Read more
Started 5am on 1/16. Upper lip felt tingly. Applied ice and fell asleep. Awoke at 9am to extremely swollen upper lip. Took Benadryl 25mg at 9:15 am and 1:15 pm. At 6:30 pm, has improved but not completely yet.
59 2021-01-16 loss of smell, loss of taste About 2 hrs post vaccination, developed generalized muscle pain & malaise/fatigue . During the night... Read more
About 2 hrs post vaccination, developed generalized muscle pain & malaise/fatigue . During the night, had mild sweats and chills and moderately severe body pain, especially in legs and back. The next morning had no sense of taste or smell. Body pain and loss of taste improved over the day. ,
59 2021-01-19 dry eye, eye pain TEMPERATURE OF 100.7, BODY ACHES, EYES STINGING AND DRY, HEADACHE
59 2021-01-19 lip swelling, eye discomfort Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minut... Read more
Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minutes. Two hours later, itching began on left leg and arms. Noted red blotches to these areas. Face began to feel very prickly and flushed, felt lower lip swelling and left eye began to feel funny. Observed one hive to cheek. Was able to take a Benadryl 25mg capsule within about 10-15 minutes after this developed. Symptoms began to subside after this. Felt back to normal the next day. Just moderate injection site pain for 1-2 days.
59 2021-01-19 mouth tingling Person receiving the vaccine developed a tingling in her mouth. Not short of breath or itchy, no hiv... Read more
Person receiving the vaccine developed a tingling in her mouth. Not short of breath or itchy, no hives. Vital signs 156/90, Pulse 72, SPO2 97. Gave her water and candy, sat her in recliner with feet up. She remained with us for over 30 minutes. Felt better after water. Vital signs before leaving were 147/90, pulse 73, SPO2 97
59 2021-01-20 ear pain Pfizer-bioNtech COVID-19Vaccine EUA Approximately 2-3 hours after the vaccine was administered, I no... Read more
Pfizer-bioNtech COVID-19Vaccine EUA Approximately 2-3 hours after the vaccine was administered, I noted tingling and a "tight" feeling on the right side of my face. I have had bells palsy before and if felt the exact same way. I noted drooping of the right side of my mouth, stabbing pain in my right ear. This lasted for 24 hours, currently, slight numbness remains at corner of right side of mouth and occasional stabbing pain right ear.
59 2021-01-21 mouth numbness, mouth tingling Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and ting... Read more
Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.
59 2021-01-23 lip swelling, swollen tongue Swollen bottom Lip, tongue, prickly skin, burnining nostril, headache, fatigue
59 2021-01-23 lip swelling 1/21 at 10:45PM-joint/muscle pain & bad chills. 1/22 all day--headache, nausea, slept alot. 1/24--ve... Read more
1/21 at 10:45PM-joint/muscle pain & bad chills. 1/22 all day--headache, nausea, slept alot. 1/24--very sleepy; bad balance--small steps and holding wall/furniture; lips swollen; slow cognition
59 2021-01-24 light flashes or floaters in the eye Less than 24 hours after vaccine started stomach cramps, diarrhea and sore arm, next day ocular migr... Read more
Less than 24 hours after vaccine started stomach cramps, diarrhea and sore arm, next day ocular migraine(never had before) with flashing lights and severe headache, extreme fatigue, sore throat, felt terrible Had vaccine on Friday and by Monday, I felt recovered
59 2021-01-24 swollen tongue, eye swelling Left side of my face became numb. Then my eye, tongue and throat began to swell. I stopped and purch... Read more
Left side of my face became numb. Then my eye, tongue and throat began to swell. I stopped and purchased Benadryl. The swelling started to diminish after about 4 hours, but tingling and slight numbness continued for about 3 days.
59 2021-01-24 tongue disorder hives started 30 minutes after vaccine administered, then she started feeling wheezy and tongue th... Read more
hives started 30 minutes after vaccine administered, then she started feeling wheezy and tongue thickness. Rapid response team notified. Epinephrine given and patient transported to ER
59 2021-01-25 taste impairment Metal taste in mouth directly after administration of vaccine, no airway changes.
59 2021-01-25 ear discomfort ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/hea... Read more
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
59 2021-01-25 vision blurred Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint ... Read more
Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
59 2021-01-26 gaze palsy 14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down,... Read more
14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down, but has joint pain and dull headache.
59 2021-01-26 mouth tingling, lip swelling, mouth numbness My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later i... Read more
My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later it went away. But as it started to go away my lip was tingly and prickly.
59 2021-01-26 swollen tongue Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for al... Read more
Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for almost 2 weeks , headaches, dizziness Completely normal on 1/22/21
59 2021-01-27 mouth numbness numbness in my mouth and around my lips. Numb for 3 days now experiencing numbness on left side of f... Read more
numbness in my mouth and around my lips. Numb for 3 days now experiencing numbness on left side of face, felt like druelling sensation
59 2021-01-27 vision blurred bruising to site, painful, next day very tired with blurry vision, aching pain
59 2021-01-28 inability to speak Initially itching arms, legs, chest Lose of voice Shortness of breath Headache After 12 hours fever... Read more
Initially itching arms, legs, chest Lose of voice Shortness of breath Headache After 12 hours fever and tiredness
59 2021-01-28 extreme sound sensitivity, taste disorder, smell distorsion Dehydration, fever 101, body aches, joint pain, chills, loss of appetite, increased fatigue, headach... Read more
Dehydration, fever 101, body aches, joint pain, chills, loss of appetite, increased fatigue, headache, heightened smell, taste, and hearing
59 2021-01-28 mouth pain Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside... Read more
Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside cheek have white spots on it; it looked red and swollen and it hurt; it looked red and swollen and it hurt; It was more of the cheek inside the mouth, that's painful; It was not open sore but it was just red; Tenderness of lymph nodes/Lymph node is kind of tender; swelling of the lymph node; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: not sure EL3249 or EU3249), via an unspecified route of administration on 11Jan2021 at single dose at left deltoid for covid-19 immunization. Medical history included hypertension, hypothyroidism, heartburn. Concomitant medications included levothyroxine for hypothyroidism, olmesartan, hydrochlorothiazide, amlodipine, omeprazole for heartburn, alprazolam. Patient had the tiredness, mouth sores or something like that in Jan2021. When patient look at her cheek, the gum inside cheek have white spots on it and it looked red and swollen and it hurt, especially the left side and that bothered patient because patient cannot really eat and it hurt. It was more of the cheek inside the mouth, that's painful. It's not open sore but it's just red and like tender. And also patient had a tenderness of lymph nodes on the left neck. For causality, the patient thought so because nothing has changed since before patient got the vaccine. Patient didn't have any of this, especially the sore in the mouth. Patient cannot eat on the left side because it hurt. But the rest of the symptoms which was the tiredness and the swelling of the lymph node, lymph node was kind of tender but it's only on the left side, that's listed as the side effects. But the sores in the mouth was not listed that's why patient was worried about that. Lab work: results were okay. The tiredness, it was like patient got it in the morning, so patient slept. Patient went straight after work, then patient slept. When patient started getting ready for work and the alarm went off, patient was extra tired so I called out sick, but patient was okay. For treatment, patient took naproxen sodium (ALEVE) and then, because patient was at work and yesterday it was really bothering patient because it was hurting. It started hurting really more when the evening was on. Then patient took paracetamol (TYLENOL), then the nystatin solution, patient tried to swish and it helped a little bit with the pain. Due date for the next dose was 08Feb2021. Outcome of events was unknown. Information on the lot/ batch number has been requested.
59 2021-01-28 oropharyngeal discomfort The vaccine was given to me. Within 5 minutes my throat felt strange so I went get water. I went pal... Read more
The vaccine was given to me. Within 5 minutes my throat felt strange so I went get water. I went pale and blood pressure was 205/198 along with tachycardia. Spent hours in E.R.
59 2021-01-29 oropharyngeal discomfort Pfizer COVID- 19 Vaccine EUA Pt received 0.3ml Pfizer-BioNTech(Lot EL3249 exp 5/2021) at 15:25 today... Read more
Pfizer COVID- 19 Vaccine EUA Pt received 0.3ml Pfizer-BioNTech(Lot EL3249 exp 5/2021) at 15:25 today in left deltoid. Pt expressed "scratchy throat" and strange feeling radiating from shoulder to upper rhomboid muscles after 5 minutes. Gave patient drink of ice water with Diphenhydramine 25mg po (Lot 502605 exp 10/31/2021). After 10 minutes reassessed and still experiencing little improvement. Gave second dose Diphenhydramine 25mg po, and observed for next 30 minutes. Patient expressed feeling better and not so scratchy in her throat. Escorted to vehicle after stating that she felt well enough to drive home. Recommended she f/u with her physician and may need to pre-medicate with diphenhydramine 25mg prior to booster.
59 2021-01-30 eye itchiness Patient exhibited red and itchy face and eyes. Was given 50 mg of Benadryl P.O. symptoms decreased a... Read more
Patient exhibited red and itchy face and eyes. Was given 50 mg of Benadryl P.O. symptoms decreased and B/P 180/104. H/R 120. Discharged 170/98 B/P HR 111 bpm. Discharged with her husband driving. Advised to follow up with hospital and to follow up with her PCP before anymore immunizations.
59 2021-02-01 ear pain Couple days later began to feel fatigued again, ear pain, brain fog, 101.4 temp so was sent from wor... Read more
Couple days later began to feel fatigued again, ear pain, brain fog, 101.4 temp so was sent from work to and tested neg for COVID and Flu. I was advised I had fluid on my ears and was advised I may have and Upper Respriatory infection and was given antibiotics and advised if the symptoms didnt get any better to return but I am still taking the antibiotics to date and still experiencing the no taste and smell, brain fog, fatigued and tired but feeling a whole lot better today.
59 2021-02-01 smell distorsion, taste disorder Started with 3 strong jabs. 1 in shoulder, 1 in stomach and 1 in groin. Very stabbing painful jabs... Read more
Started with 3 strong jabs. 1 in shoulder, 1 in stomach and 1 in groin. Very stabbing painful jabs but only lasted 1 second. Chills a few hours later that lasted about 4 hours. Next morning felt stomach sick. Couldn't eat or drink anything but water. Barely make it to the bathroom because joints hurt and just felt sick. Tried toast and coffee, tasted terrible. I am a very strong coffee drinker. Haven't been able to drink it since vaccination because nothing tastes or smells the same. Went to primary yesterday because haven't been able to sleep. Told him weird taste and smell, can't eat anything and I feel like my muscle is very weak. Trouble getting in car yesterday for work.
59 2021-02-01 taste disorder I had covid and didnt know it when I got vaccinated. I went to work and a couple days later I start... Read more
I had covid and didnt know it when I got vaccinated. I went to work and a couple days later I started feeling crappy. I had no taste and smell, very fatigued and slept all the time so I went and got tested for COVID. While there my O2 level was 89 so I was given a steroid injection and was sent home with an antibiotic and was off for the 14 day quarantining and went back to work
59 2021-02-02 tunnel vision 45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilati... Read more
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
59 2021-02-05 eye irritation PATIENT WAS OUT OF WORK DUE TO RACTION TO THE SECOND COVID VACCINE. SYMPTOMS WERE BODY ACHES, NAUSEA... Read more
PATIENT WAS OUT OF WORK DUE TO RACTION TO THE SECOND COVID VACCINE. SYMPTOMS WERE BODY ACHES, NAUSEA AND EYES BURNING.
59 2021-02-06 eye discomfort, eye movement disorder A minute after receiving the Pfizer COVID-19 vaccine, started feeling numbness on the right side of ... Read more
A minute after receiving the Pfizer COVID-19 vaccine, started feeling numbness on the right side of the body starting on my arm, minutes later, the sensation had extended up to my right leg and later to my right foot. Ten minutes after feeling this symptom, my right eye started feeling dizzy and shaking, also a feeling of chest pressure, it was hard to breathe normal, I had hoarseness and my throat was itching at the same time my blood pressure went up to 160/89 and tachycardia at 128. All these symptoms lasted for about one hour. After the hour the blood pressure went down some to 134/89 but the general sensation on my body is not back to 100% normal.
59 2021-02-06 sensitivity to light Pain, swelling (hive), itching, photophobia in Left eye, and pain in injection site Right arm.
59 2021-02-07 mouth numbness Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roo... Read more
Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roof of mouth, and back of throat started approximately 35 minutes later. No Shortness of Breath, Difficulty Breathing, or problems swallowing. Administered 50 mg Benadryl. Symptoms improved slightly, symptoms did not worsen. Observed for an additional 40 minutes. Went home with husband. Instructed to follow-up with 911 if symptoms worsened.
59 2021-02-07 vision blurred Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry.... Read more
Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry. BP 200/130 Pt stated she was feeling better. Medic rechecked BP 247-200/130. Medic rechecked 191/119, HR 68 @ 1310 Pt advised to go to ER. Pt doesn't want to go by squad. States she will call her daughter 1332 RN still monitoring pt. Pt sitting quietly waiting on her daughter to take her to ER as advised by medic. 1337 daughter of pt arrived. Rn supervisor walked pt to meet daughter and advised daughter take her to ER ASAP and to pull over squad if worsen. Pt advised to go to ER by medics & RN due to elevated BP, blurred vision, & dizziness.
59 2021-02-08 loss of taste, ringing in ears, vision blurred Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 day... Read more
Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 days. Ongoing symptoms: waves of being hot/sweating, blurred visions, intermittent loss of taste and false sense of feeling of drowning or suffocating and/or breathing in heavy smoke, which last for a few seconds to a few minutes. diminished appetite, more easily fatigued, loss of energy. On February 8th, these symptoms began: feeling anxious, fatigued,sleepy, head feels spacey, slight headache, somewhat dizzy, intermittent buzzing sound in head, body aches, severe ache and muscle tenderness in left shoulder blade area down left arm, and muscle spasms in left shoulder and arm. Loss of taste again.
59 2021-02-08 mouth tingling Tingling of tongue, facial itching.
59 2021-02-08 light flashes or floaters in the eye, eye floaters Approximately 2 hours after vaccine, I started seeing flashes of light in my left eye, which continu... Read more
Approximately 2 hours after vaccine, I started seeing flashes of light in my left eye, which continued and became worse through the evening with an increase of floaters in my left eye. This morning I only saw the lights a couple of times but more floaters.
59 2021-02-10 loss of smell, loss of taste not had a sense of smell or taste; not had a sense of smell or taste; Headache are off and on; littl... Read more
not had a sense of smell or taste; not had a sense of smell or taste; Headache are off and on; little tired; she cannot think; hoping it is her sinuses; When she gets up and moves around and when up and moving with the mask on, she is lightheaded; nose is stopped up; with her mask on she can hardly breathe; busts out in a sweat; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the left arm on 18Jan2021 07:40 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took cortisone in her both knees and left shoulder from 15Jan2021 for inflammation and could not walk and was making her feel bad. On Friday (22Jan2021), she started having headaches and was a little tired. Everyday, she would take her temperature and she never had a fever. The last couple of days on 24Jan2021, she has not had a sense of smell or taste. She works and sees patients. She cannot think. Headaches are off and on and ongoing. She was hoping it is her sinuses. When she gets up and moves around and when up and moving with the mask on, she is lightheaded and gets tired. When she lays down, she is ok. Her nose is stopped up and she has not gotten up to eat anything today. The patient told it is strange, she hasn't run a fever but if she gets up and moves around with her mask on, she can hardly breathe, she busts out in a sweat, and it gives her a headache and she don't have a taste bud. Therapeutic measures were taken as a result of headache and included treatment with naproxen sodium (ALEVE). Outcome of the intermittent headache, tiredness, loss of smell was not recovered while of the remaining events was unknown.
59 2021-02-10 extreme sound sensitivity, eye pain, vision blurred, ringing in ears, thirst, taste disorder 7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks throug... Read more
7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks through left arm down to fingertips... 8:30- shooting shocks through left arm and starting to throb down through hand ... shooting up through next and base of head 9:00am- random shocks throughout my whole body. shoulder pain. 10:30- shocks stopped somewhat, shoulder and arm still achy, extreme fatigue/weakness, fogginess, blurry vision 11:30- extreme fatigue/weakness, fogginess, kind of blurry vision, severe shaking rt hand, had to sit down. Needed to hang on to things to walk. 12:00pm- continued severe fatigue and brain fogginess & still minor blurry vision, and a few shooting shocks in arm, shoulder , neck, 1:00pm? still great fatigue/weak, body aches-more like shocks than aches Neck is especially sore? back of neck up through head 1:10pm- severe fatigue, eyes hurt, foggy vision and cannot focus? off and on? chest pain for a period of time 1:40pm- twinges through body, still extreme fatigue? fogginess, back of neck is super sore.. Shoulder is slightly sore? 2:00pm- shoulder sore, severe fatigue but other symptoms seem to be getting less?. 2:45pm- shocks in left arm? 4:00pm- went home from work? hard to drive and focus.. severe fogginess, disorientation, 4:20- laid on the couch? slept in between nausea, buzzing in my head, severe arm pain going down into my hand, random shocks throughout my body, could not focus, brain was fuzzy, random severe itching, neck pain, eye pain, extremely irritable, extremely thirsty, bad taste in my mouth, extremely cold, no fever, super sensitive to sound & touch, no appetite, trouble peeing, felt extremely dehydrated. Needed to hang on to things to walk. Fri, Feb 5 6:00am- next day? better, but still buzzing, ringing in my head, extremely exhausted & weak, arm pain radiating to hand, hard to focus, coughing, chest heaviness like an elephant sitting on it, sore, scratchy throat, drainage out of head but not stuffed up?, eyes hurt. Severe nausea & bloating, rt hand shaking badly, no appetite 9:30am- everything is a bit better, coughing & chest discomfort gone, still bad taste in my mouth, slight nausea, bloated, eyes hurt, extremely tired, entire arm sore, buzzing in my head?random twinges or jolts in my limbs? 11:00am- still super tired, still not peeing?... weird for me who pees every 2 hrs or so? Still really bloated? still buzzing in my head, 1:30pm- feeling better, no buzzing, no zinging, super tired and drinking a lot but not much peeing? 4:00pm- home and bed.. hard to sleep because of jolts though my body.. Sat, Feb 6 Normal body aches.. finally able to pee decently, arm and hand on shot side sore (this is my good hand side), shooting pain, and hand aching. Fatigue, This has continued into Monday.. arm and hand pain are off and on. Everything is getting better?
59 2021-02-11 eye bleeding Headache then right eye blood vessels bursted
59 2021-02-11 eye itchiness, swelling of eyelid left eyelid swollen, itchy and a little weepy
59 2021-02-11 mouth pain, swollen tongue, burning mouth syndrome Mouth sores on roof of mouth and cheek (white/very sore) about 1 week after injection. Tongue sores ... Read more
Mouth sores on roof of mouth and cheek (white/very sore) about 1 week after injection. Tongue sores (red/swollen/sore) on both sides and tip of tongue + a fizzing feeling on top of the tongue starting about 10 days after injection. Fizzing feeling on roof of mouth (opposite side to previous sore) at same time as tongue sores. At this date, the roof of mouth and cheek sores are healed, but the tongue sores have spread and make eating and talking challenging. Additional side effects - Increased asthma for 7 days after injection - treated with Albuterol and Dulera. Tiredness and chills within first 2 days of injection Sore upper arm for 2 days, followed by continued soreness in elbow.
59 2021-02-13 mouth numbness Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1130 with symptom onset at 1135. Pt rep... Read more
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1130 with symptom onset at 1135. Pt reported numbness in arm and shoulder of injected site (left), which progressed to the tip of her tongue and lips with a tingling sensation. Benadryl 25mg PO administered at 1155. Symptoms resolved after further observation.
59 2021-02-15 eye twitching Left eye twitching
59 2021-02-15 taste impairment, taste disorder Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing ... Read more
Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing was noisy. and noticeable" States breathing was not difficult but it felt like, "my chest was not right." About 12 hours later back to breathing normally. Tongue looks like all taste buds are gone on one section of tongue. Color is different than rest of tongue. Noticed metal taste on tongue on 02/11/2021 two days after vaccine. Food does not taste the same. Continues to have these concerns. 02/15/2021 chest was "pinkish, lacy redness." This was gone by 02/15/2021
59 2021-02-17 loss of taste, loss of smell This is a spontaneous report from a contactable other health professional. A 59-year-old patient re... Read more
This is a spontaneous report from a contactable other health professional. A 59-year-old patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration in the left arm on 22Jan2021 at 17:00 at 59-years-old at a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included pneumothorax from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing (Prior to vaccination). Concomitant medications included bupropion hydrochloride (WELLBUTRIN), desvenlafaxine succinate (PRISTIQ), meloxicam (MANUFACTURER UNKNOWN); taken for an unspecified indication from an unspecified date to an unspecified date (received within 2 weeks of vaccination). The patient previously took diphenhydramine hydrochloride (BENADRYL) and fluticasone propionate, salmeterol xinafoate (ADVAIR diskus) and experienced allergy from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown) for COVID-19 immunization on an unknown date. On 23Jan2021 at 04:00, the patient experienced: temp 101.7 which held for 28 hrs, then 100.7 for 24 hrs, now at 99.4 (non-serious), severe back pain (non-serious), severe joint swelling in hands (non-serious), severe headache (non-serious), severe body aches and pain (non-serious), right foot felt like bones were broken when walking (non-serious), coughing (non-serious), increased phlegm production (non-serious), loss of taste (non-serious), loss of smell (non-serious); in which no treatment was received. The patient, however, went to a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included temperature: 100.7 in Jan2021 for 24 hrs, temperature: 101.7 on 23Jan2021 held for 28 hrs, temperature: 99.4 on 26Jan2021. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
59 2021-02-17 eye irritation 2nd vaccine - major chills, 101 fever, migraine, joints are super achy, hard to bend my fingers, inj... Read more
2nd vaccine - major chills, 101 fever, migraine, joints are super achy, hard to bend my fingers, injection sight red swollen and warm to touch, eyes burning
59 2021-02-17 lip swelling, mouth numbness This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient (no... Read more
This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient (not pregnant) received the first dose of bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 05Feb2021 08:15 at SINGLE DOSE for Covid-19 immunisation. Medical history included colorectal cancer and thyroid cancer. She had allergies to sulfur. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient experienced her lips felt swollen and numb for about one hour after the dose was administered (non-serious) on 05Feb2021. No treatment was given. The outcome of events was recovered on unspecified date in Feb2021. Information on the lot/batch number has been requested.
59 2021-02-17 mouth itchiness Itching, whole body and mouth.
59 2021-02-17 vision blurred Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blu... Read more
Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
59 2021-02-18 taste disorder, mouth numbness Pfizer-BioNTech COVID-19 Vaccine EUA. Approximately 30 minutes after shot, got a very bad taste in t... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Approximately 30 minutes after shot, got a very bad taste in the mouth, then throat became numb and I could not swallow unless I really forced it. I had to drink to be able to swallow. Again had to really try before I could. Then roof of mouth, back of throat and back of tongue felt number as if I had novocaine. The lack of swallow lasted about 10 minutes of forced swallowing. The numbness continued for about 2 hours but I was able to do everything. The numbness was more of an annoyance.
59 2021-02-19 vision blurred, dry mouth On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations,... Read more
On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations, and I almost passed out at home, my husband had to take me to Er. They wanted to keep me in the hospital but I told him I will follow up with my doctor on Monday, I did not want to stay on the floor with covid patients the test that they had ordered at the hospital were normal they did not order a CMP they only did a basic metabolic panel and that was normal, so I followed up with my doctor on Monday which was January 18th, and she ordered CMP and all the labs, when they threw my blood my liver enzymes were very elevated over the thousands LT ASG and the and others, then the doctor ordered a second set of blood works of CMP just to make sure it wasn't a fluke, they were even more elevated they were over 1,400.
59 2021-02-21 mouth pain, swollen lips, burning mouth syndrome Two days after I got mouth sores that hurt, inside front lip and on tongue (I believe it was two or ... Read more
Two days after I got mouth sores that hurt, inside front lip and on tongue (I believe it was two or three sores, and they lasted about 5 or 6 days.) I share this because I got my second dose 2/17/21 batch EL9266 in left arm and again two days out got sores on my lip and tongue (total of 2 sores that hurt). The one on my tongue has made it hard to swallow, because it is far back on my tongue. I have used a peroxide product to lesson the pain. I am 5 days out from my second vaccine, and the sores are not getting worse and I hope they lesson and go away as the first batch did after about 6 days.
59 2021-02-22 loss of smell, smell distorsion 02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolv... Read more
02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolved on 02/14/2021. 02/15/2021 I developed an altered sense of smell. I smell an medicinal or chemical smell. Husband does not smell this so it is not an environmental odor. Received a covid test on 02/22/2021 which was negative. The altered sense of smell is still persisting. Notified my doctor of it & she asked that I notify the CDC as it may be a potential side effect from covid vaccine.
59 2021-02-24 swollen tongue Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ... Read more
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
59 2021-02-25 taste impairment Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes af... Read more
Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes after she received the vaccine and also started with a weird iron taste in her mouth, and tingling in her hands. She felt like she was going to pass out but got better after 20 minutes. The tingling in her hands continued though and would start and stop periodically.
59 2021-03-01 eye swelling, swelling of eyelid Body aches, fever (101.5), swollen eye lids and beneath eyes, headache, upper back aches, chills
59 2021-03-01 lip swelling, lip itchiness, ear swelling approximately two hours after receiving my vaccination my left ear swelled, a hive came out on my le... Read more
approximately two hours after receiving my vaccination my left ear swelled, a hive came out on my left cheek and my upper lip swelled. The swelling stayed itchy for about 3 hours
59 2021-03-02 mouth numbness 20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Pat... Read more
20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Patient was given 50mg of PO diphenhydramine and was monitored for 60 min. Refused call to 911. Flushing and warmth had abated and left clinic under own volition.
59 2021-03-02 ringing in ears Pain, swollen gland, flu, chills, tinnitus, fatigue
59 2021-03-03 lip swelling, pain in jaw, ear pain right ear was aching; head was ache; jaw was also aching/throbbing; swelling of bottom lip and it wa... Read more
right ear was aching; head was ache; jaw was also aching/throbbing; swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen; felt sick similar to a sinus infection/pressure in front of head, jaw, right ear/sinus pressure/pressure in nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure; dizzy on and off/Dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included sinus problems, allergy, allergy to cow's milk, TMJ (she had her wisdom teeth she was having issues on the right side; after they pulled it out she was fine), and wisdom teeth pulled out at the age of 57 or 58. Concomitant medication included ascorbic acid, biotin, folic acid, iron, manganese, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM FRUITY CHEWABLES). The patient previously took keflex and was allergic to it. The patient received her first dose of COVID-19 vaccine on 19Jan2021. She was okay from Tuesday to Thursday. On Friday (22Jan2021), the patient reported to have felt sick similar to a sinus infection, there were pressure in front of head, jaw, and right ear and was dizzy on and off for a long period. She had a sinus pressure/pressure in her nose and felt like she had a bad sinus infection in whole head. She is not saying she had a sinus infection, but that's what she experienced after receiving the shot. Her right ear was aching, head was ache, and jaw was also aching/throbbing on unspecified dates. The patient mentioned that she had swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen on 07Feb2021 but it went away today (08Feb2021). It was actually her neighbor that noticed the swelling and said it was on the bottom of lip chin area, it also felt hard when touching it. She called her primary care doctor following the events. At first, she did not want to provide these to her primary care, she did not have high blood pressure, high cholesterol or anything, but she did have bad sinuses. She took an antibiotic for sinus and pressure and her doctor told her that these could be side effects of the COVID vaccine as it causes dizziness and pressure. The dizziness must have been from the pressure since it was in her ear, cheek bones, and right ear was throbbing. It took her one month to come back to her normal self. The patient is scheduled to receive the next shot on 09Feb2021 and asked if she need to get the next shot or should she wait another week. The patient recovered from events "felt sick similar to a sinus infection/pressure in front of head, jaw, and right ear/sinus pressure/pressure in her nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure" and dizzy on and off/dizziness on 06Feb2021; recovered from event swelling of bottom lip on 08Feb2021; while unknown outcome for the remaining events. Information on the lot/batch number has been requested.
59 2021-03-06 mouth tingling Tingling in lips and tongue. Scratchiness in neck and facial area (right side). Vitals within normal... Read more
Tingling in lips and tongue. Scratchiness in neck and facial area (right side). Vitals within normal limits; Benadryl 50 mg PO given.
59 2021-03-06 mouth tingling Tingling in upper lip, nose, hairline and right arm. Evaluated by medics-cleared
59 2021-03-06 ringing in ears Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, acros... Read more
Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, across back shoulders, and down right are above elbow from 3/4/2021 at 6:00 pm through current time (3/7/2021 at 10:30 am.). 3/5/2021 at 10:00 am to current time (3/7/2021 at 10:30 am.) Burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones. Overall weakness and tiredness throughout body. Slight headache begins and feeling unwell at 3/5/2021 at 10:00 am. 3/6/2021 at 8:00 a.m. through 3/7/2021 at 8:00 a.m. Dizziness and weakness, tiredness, severe/excursiating headache/ muscle pain/chilles/fever/feeling unwell/severe ringing in ears/unable to get out of bed. No relief from advil pain reliever. 3/6/2021 at 5:00 pm nausea added to all symptoms above last 2 hours. 3/7/2021 at 8:00 am to current time (3/7/2021) Able to get out of bed. Headache managable, dizziness presists, weakness/shakey/, minimal energy/burning underskin is still occurring but reduced in level somewhat. Muscle pain in arms/shoulders/back torso and chills is occurring but at a reduced level.
59 2021-03-07 mouth tingling 5 mins after 1st dose Pfizer, pt c/o cough, SOB, tight chest, tingling of tongue & scratchy throat. ... Read more
5 mins after 1st dose Pfizer, pt c/o cough, SOB, tight chest, tingling of tongue & scratchy throat. EKG NSR. Pt DC home stable condition 11:42
59 2021-03-07 swollen tongue Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest ... Read more
Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest and neck. PB was elevated, dizzy, weak. Symptoms escalated quickly. Immediately flagged help from nearby medic.
59 2021-03-10 eye pain I woke up on Sunday feeling like my eyeballs were being ripped out of my face. Took Tylenol Sinus wh... Read more
I woke up on Sunday feeling like my eyeballs were being ripped out of my face. Took Tylenol Sinus which helped. As the day went by, I began to have body aches, chills, joint pain, nausea. I took my temp at bedtime, it was 101.9. On Monday, things were much worse. My temp was 102.4 upon awakening & the pain level for my head was excruciating. Again, Taking Tylenol Sinus helped w/the headache & fever, not so much for the rest. On Tuesday, I woke & took my temp, it was normal. It is now Thursday, 3/11 & although I have no fever, it still feels as though I have one. Regular Tylenol helps but the head ache, body aches & fatigue remain.
59 2021-03-10 oropharyngeal discomfort I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body ... Read more
I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body aches, joint aches, headache, fatigue, and nausea. The next night I started vomiting. I felt like I had the flu. These symptoms persisted 3-4 days. The sore throat lasted maybe a week or more. No fever at any time. Had the usual arm soreness start the evening of the vaccine, much more than any other vaccine I've received. The arm soreness awakened me at night if I rolled over. FYI: I received the 2nd vaccine 2/4/2021 and only had a sore throat and sore arm.
59 2021-03-10 oropharyngeal discomfort Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pre... Read more
Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pressure/pressing/swelling. I kept swallowing and it didn't feel like my throat, more like between the outside of my throat/esophagus and skin...in the position where a man's Adam's apple would be, or possibly where my thyroid is. I got flushed, but I could breath ok. I felt odd, but I think I may have been panicking, I don't know. I drove home and saw that my face, neck, chest, even my thighs, were slightly flushed. I took my temperature throughout the evening. I am normally a low temperature of 97.6. It went up to 99.9. The second day my temperature was in the low 98s. However, by second day the roof of my mouth where it meets the throat felt odd, like if you burned it by eating something hot. Third day, today, I woke up and my temperature was only 95.2. I kept taking it, and then used my daughter's thermometer as well. It stayed low for several hours. I also had several bouts of diarreah this morning. Temperature came up into the 98s again. None of this is life threatening, but I still feel the weirdness in the front of my neck. I've never heard of that side effect so it upset me and scared me. I can handle the fever also, but the low temperature also scared me.
59 2021-03-11 lip swelling 9 hours after injection, injection site started to swell significantly. after putting a cool towel a... Read more
9 hours after injection, injection site started to swell significantly. after putting a cool towel and then trying to put covered ice pack, started having significant joint and muscle and scar tissue pain in hands knee and feet and hip. Then bicep muscles tensed up in both arms and then relaxed several times, as well as pain in collarbone and tightness up neck as well as swelling of face and top lip. I did not know if I was going to have a stroke and if I needed to go to an emergency room but the symptoms subsided. Some diarrhea next day. I understand from my therapist that multiple people have reported the significant muscle issues and it is not printed anywhere as a side effect which would help.
59 2021-03-11 sensitivity to light Week 1 - headache and light sensitivity Week 2 - Thoracic spine pain and left sided rib pain that e... Read more
Week 1 - headache and light sensitivity Week 2 - Thoracic spine pain and left sided rib pain that escalated to finally resulting in shingles outbreak. Week 3- horrible rash on left torso from t-spine to front of abdomen and excruciating pain. Week 8 - horrible torso pain continues with rash fading. I am currently at week at time of this report.
59 2021-03-11 drooling 3/6/21 ER 59 y.o. female who presents with SHORTNESSS OF BREATH FROM NURSING HOME. EMS STATES THA... Read more
3/6/21 ER 59 y.o. female who presents with SHORTNESSS OF BREATH FROM NURSING HOME. EMS STATES THAT PT HAD COPIOUS ORAL SECRETIONS AND WAS IN REESPIRATORY DISTRESS UPON THEIR ARRIVAL.EMS PRE-ARRIVAL TREATMENT: IV ATTEMPTS UNSUCCESSFUL, PLACED ON BIPAP AND SATS CAME UP TO 98% Presented by EMS from facility with altered mental status confusion Desat 85 on 02 3L NC foaming at the mouth is What nursing home staff reported; EMS unable to get IV access but did apply CPAP at 10 with sat of 99%; patient will wake up with painful stimuli. Nursing Home reports patient wears BIPAP S.T. rate 20/8/10 at night and 2 hours during the Day COVID vaccination Pfizer patient received 1/7/2021 and 1/28/2021 Took insulins this morning and guaifenesin, blood sugar accu check 221 Transferred to higher level of care
59 2021-03-12 taste impairment Metallic Taste immediately after injection. Felt a bit wobbly.
59 2021-03-12 mouth tingling, lip itchiness Macular rash around eyes including eyelids, on cheeks and around mouth. Itching and tingling of lip... Read more
Macular rash around eyes including eyelids, on cheeks and around mouth. Itching and tingling of lips. Treated with Benadryl 25mg x 2 doses. Duration of 1 day.
59 2021-03-14 eye itchiness, bloodshot eyes, lacrimation increased, eye swelling Eyes became extremely itchy, red, watering, swollen. I also began sneezing and runny nose. I took ... Read more
Eyes became extremely itchy, red, watering, swollen. I also began sneezing and runny nose. I took a Benedryl and within 20 minutes was feeling much better. I continued the Benedryl every four hours through the night (set alarms) and was fine in the morning. Reaction started in the afternoon (1:00 p.m.). Took Benedryl at 3:00 p.m., 7:00 p.m., 11:00 p.m., 4:00 a.m. (time changed). I did not need any more at 8:00 a.m.
59 2021-03-14 mouth tingling I have allergies and it feels like allergic hypersensitivity, which I had before when my allergy sho... Read more
I have allergies and it feels like allergic hypersensitivity, which I had before when my allergy shots were missed a year or so ago. Burning and tingling feeling in legs, torso, neck basically where clothes touches or rubs. Some tingling sensation on tongue as well. I stayed after 20 minutes after the vaccine because of I have allergies. After I left and got into my car to drive away I started having the burning feeling in my legs, torso and tingling in lips and tongue. I work for the ED group, so I drove over and stayed by the entrance until I felt like it was not getting any worse. I waited for about an hour. I though the burning sensation would go away, but it has not. I called my allergist and he advised I should contact you and report via this source.
59 2021-03-14 swelling of eyelid left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthca... Read more
left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581 and expiry date unknown), via an unspecified route of administration in the left arm on 10Feb2021 15:00 at a single dose for COVID-19 immunisation. There were no medical history. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Concomitant medications included vitamin D NOS and vitamin C [ascorbic acid]. Patient experienced left eyelid swollen, itchy, and a little weepy on 10Feb2021 18:30. Patient was recovering from the events. No treatment was received for the adverse events. This case was reported as non-serious.
59 2021-03-14 swollen tongue Tongue Swelling - took benadryl
59 2021-03-14 tongue discomfort 1050: Pt in waiting lot after receiving 2nd dose of Pfizer vaccine. Reported to attendant sensation... Read more
1050: Pt in waiting lot after receiving 2nd dose of Pfizer vaccine. Reported to attendant sensation of throat tightening. RN and NG medic responded to vehicle. Pt calm, talking, no appearance of distress. States "feels like my mask is too tight". Also states tongue feels different. Denies itching, denies SOB. 1054: VS stable. 1057: Med Officer contacted. Advised Benadryl 25mg po per s.o./ med administered. MD also instructed pt to take home med of ProAir on arrival home and be sure to take Singulair tonight. Pt advised. No further progression of symptoms. Pt left lot @ 1115. RN f/u with ph call @ 1335. Pt home, reported symptoms have resolved. No further complaints.
59 2021-03-15 swollen tongue Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation ar... Read more
Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation area when she started to experience a racing heart-rate and warmth. The patient was brought water, juice, and tried to relax. Patient was stable but after drinking juice started to feel swelling of the tongue and itching around the neck. Patient was given more water and a diphenhydramine capsule. Tongue swelling and itchiness decreased and the patient went home with her husband after improving. Total course of observed reaction was around 1 hour.
59 2021-03-16 mouth tingling TINGLING IN TONGUE Narrative: Veteran experienced mild tingling in tongue a few minutes after is P... Read more
TINGLING IN TONGUE Narrative: Veteran experienced mild tingling in tongue a few minutes after is Pfizer covid vaccine. Symptoms subsided after 10 minutes of onset. No other symptoms. VS: 137/86, P-76, Temp 98.2, PO2 - 98%. Adverse reaction note entered. Patient released with instructions to seek care with PCP if symptoms return or ED if worse symptoms such as breathing or lightheadedness occur.
59 2021-03-17 mouth numbness Tongue, gums and throat numb for 45 minutes, waves of of tingling numbness from my knees to my throa... Read more
Tongue, gums and throat numb for 45 minutes, waves of of tingling numbness from my knees to my throat every 10 minutes for about 45 minutes.
59 2021-03-17 lip swelling, vision blurred swollen lips, blurry vision, shaky, tingling. Evaluated by EMS- Transported to Emergency room/depart... Read more
swollen lips, blurry vision, shaky, tingling. Evaluated by EMS- Transported to Emergency room/department or urgent care.
59 2021-03-18 loss of smell, loss of taste She was tested on 13Jan2021 and it came back positive the next day 14Jan2021; she was getting a cold... Read more
She was tested on 13Jan2021 and it came back positive the next day 14Jan2021; she was getting a cold; She also had a fever of 99.5; chills; sweats; she had lost smell and taste; she had lost smell and taste; That night she could not lift her arm. It was sore at first; That night she could not lift her arm. It was sore at first/Then she could not lift her arm; tired/she felt extremely tired; terrible left leg pain; leg cramps/more so in the left leg and then it turned into both legs/sporadic leg cramps; full body achiness; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported for herself that a 59-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Jan2021 (at the age of 59-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing prophylactic health. Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81mg; calcium/colecalciferol (CALCIUM +D3) at 600mg; ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+); colecalciferol (D3) at 200 units and elderberry gummies with vitamin c and zinc. All are ongoing and taken for prophylactic health. The patient had her first COVID Vaccine dose on 09Jan2021. She thought she was getting a reaction but ended up testing positive for COVID. She was tested on 13Jan2021 and it came back positive the next day 14Jan2021. She had questions about when and if she should get the second dose. She was referred to speak with her doctor and Pfizer does not have information for that. She got her first dose on 09Jan2021. That afternoon (09Jan2021) her daughter came home, and she had lost smell and taste. That night she could not lift her arm. It was sore at first. She was laying down and her husband asked if she needed anything, and she said no. Then she could not lift her arm. She was sure that was from the vaccine. That lasted until 10Jan2021 and then she was fine and has recovered completely. That same day on 09Jan2021, she felt extremely tired. That lasted about two weeks from the COVID. On 11Jan2021 that Monday, she had also felt like she was getting a cold, but she was not even really stuffy. She also had a fever of 99.5. The chills were setting in even without a fever. She was got, had chills and sweats. That night she went to bed and woke up about an hour later and had terrible left leg pain. Her doctor wanted her to get tested in case it was COVID. She had called him that Monday she thinks, 11Jan2021. He wanted her to go to the ER, not somewhere private, in case she did have COVID, but she did not want to go. She had the leg cramps for 3 days, more so in the left leg and then it turned into both legs. She also had her legs checked out and was negative for any DVTs. It was 3 days of sporadic leg cramps. They were so bad and mainly on her left side. It then turned into full body achiness after that. Caller says overall she was fine. The outcome of the events smell loss, taste loss, pain in arm, mobility decreased recovered on 10Jan2021, all other events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.
59 2021-03-18 dry eye Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. i... Read more
Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. it started off as becoming very tight, then the tingling. it has been over 24 hours and still sum tingling in the check bone and chin area.
59 2021-03-18 taste impairment About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my... Read more
About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine). The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
59 2021-03-18 eye swelling Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on e... Read more
Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on energy for an hour or so; and then all of a sudden I can't even hold my head up; Eyes were swollen; Back to my head very weak; My whole body feels like it is bruised; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9262/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 17:30 (at the age of 59 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included rheumatoid arthritis. Concomitant medication included methotrexate 2.5 mg (8 tablets, once weekly), hydroxychloroquine 200 mg, 2x/day and folic acid UNK, 1x/day(1 tablet). On 12Feb2021 (Friday night), the patient reported that she "don't still feel good". The clinical course was as follows: On 12Feb2021, an hour after the receiving the vaccination, the patient reported "it started with pain in side in my head and within minutes it was like I was jelly. I was felt like fall on to the floor. I slowed down and I was extremely tired. I even left work early. I was off Saturday and Sunday. Today I could not even get work. It is like I have a burst on energy for an hour or so. And then all of a sudden, I can't even hold my head up. My eyes were swollen and back to my head very weak. My whole body feels like it is bruised. Treatment received for the events included ibuprofen. The consumer stated, "I took 4 on Saturday and later on like midday about 4 or 5 O'Clock. That was 200 mg each. It was total of 800mg." The outcome of the events was unknown.
59 2021-03-18 mouth numbness (Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up ar... Read more
(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up around 12 hours after having the vaccine and felt a strange sensation in my head, almost like a helmet of fog over my head, sort of a numb feeling, and I noticed that also my eyes and lips felt numb. I ate a grapefruit as I usually do (not sectioned by myself). I felt extremely lethargic, had joint pain and a weakness. I usually have tea and toast in the morning and as I was at the table buttering my toast, I had an overwhelming nausea come on. I then woke up on the floor. My companion told me I went unconscious and slipped off the chair. Perhaps the whole episode was a maximum of 20 seconds. My first words were "Where am I?" and my companion told me. I rest on the floor, directed my companion to read on the internet about stroke and we ascertained I was okay, so I was thinking completely clearly. In any case, I had the fog in my head the entire day, and also today, but I feel a little better and was able to eat after 4 hours of rest. I wasn't able to fall asleep but I rested the entire day and slept a couple of hours during the night, which is not like me. I usually don't have any problem sleeping.
59 2021-03-18 mouth tingling, lip swelling Swelling to upper lip and around nose. Tongue tingling. Patient given 25mg of liquid Benadryl. Withi... Read more
Swelling to upper lip and around nose. Tongue tingling. Patient given 25mg of liquid Benadryl. Within approximately 20 minutes the patient's swelling began to subside. Patient felt better and tongue was no longer tingling.
59 2021-03-18 ringing in ears, mouth numbness Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l... Read more
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
59 2021-03-19 taste impairment, lip swelling, taste disorder I woke up on 3-19-2021, about 48 hrs after the vaccine, with swollen lips. They also have a light me... Read more
I woke up on 3-19-2021, about 48 hrs after the vaccine, with swollen lips. They also have a light metallic taste. My sense of taste seems to be slightly affected. This is the reaction I have had in the past to antibiotics I am allergic to.
59 2021-03-19 bloodshot eyes sever loss of energy. bloodshot eyes
59 2021-03-19 ringing in ears Approximately 2days after 2nd day of Pfizer I fe leopard a white noise sound in my ears . Went to EN... Read more
Approximately 2days after 2nd day of Pfizer I fe leopard a white noise sound in my ears . Went to ENT and he said it is Tinnitus. I have never had this before and it has been persistent since I received vaccination
59 2021-03-20 taste impairment headache; Asthmatic Cough; Taste metallic/ tongue felt metallic; This is a spontaneous report from a... Read more
headache; Asthmatic Cough; Taste metallic/ tongue felt metallic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 04Feb2021 11:40 (Batch/Lot Number: EL9261) (at 59-year-old) as single dose for COVID-19 immunization. Medical history included Hypertension, Gout, Allergy. She clarified that she is allergic to NSAIDS and as well has environmental and food allergies. She clarifies that her Allergies do change from time to time, she is allergic to fragrances. Wheat bothered her before, but not anymore, thats what she meant by her allergies changes. Concomitant medications was not reported. She did not take any NSAIDS because they made her wheeze. She only had her regular medication that she takes on routine schedule. The patient previously took ibuprofen and allergy. She is Allergic to ibuprofen and had an asthmatic cough after it. The patient had first dose of the Pfizer covid vaccine a week ago Thursday, she has a question. She had that dose, and when she had the injection was fine, she did have a metallic taste in mouth (04Feb2021) but it was no issue. Then she woke up coughing on Friday (05Feb2021) and Saturday (06Feb2021), it was like an asthmatic feeling, she will feel it time to time when having an allergy to something. She had headache on Sunday (07Feb2021). She didnt know if that was an indication to a problem with the vaccine. She wanted to know if it was safe to take the second dose. It was clarified that the metallic taste started 10 minutes after the injections. The Asthmatic Cough started on Friday 05Feb2021, she woke up coughing. She clarified that the metallic taste only last just up to that afternoon. The asthmatic cough subsided Saturday. She experienced a lot of coughing on Friday, then a little on Saturday and that was last day. She was just concerned about it, she did not want it to get worse. She does not normally have metallic taste in her mouth, so she thought it could be related but she really doesn't know. She didn't know if the asthmatic cough is related, it could even be a coincidence, she hasn't experienced something like this in a year. She just wants to know if she should get the second dose. It stated that her second dose is schedule for 25Feb2021 at 11:40AM. The outcome of the event Taste metallic/ tongue felt metallic was recovered on 04Feb2021, Asthmatic Cough was recovered on 06Feb2021, and headache was unknown.
59 2021-03-20 vision blurred, ringing in ears, mouth tingling Ringing in my ears since a day after I got the shot , Have had the condition previously but this has... Read more
Ringing in my ears since a day after I got the shot , Have had the condition previously but this has been exacerbated significantly since the vaccine. Sensation in tip of my tongue. Left eye feels like it is a bit burry . Hands and feet very cold . Has gotten better after the 5th day. Was tired for 5 days after vaccine.
59 2021-03-21 lip swelling On Thursday, March 18th I experience mild itchiness on my scalp. On Friday, March 19th I began to fe... Read more
On Thursday, March 18th I experience mild itchiness on my scalp. On Friday, March 19th I began to feel a lump in my throat and developed large itchy hives all over my body. My lips began to swell up.
59 2021-03-21 swollen tongue On March 5th (day 11 after vaccine) I awoke with red rash/hives on palms of both hands and elbows an... Read more
On March 5th (day 11 after vaccine) I awoke with red rash/hives on palms of both hands and elbows and underside of forearms and upper left thigh. The rash got worse each day spreading all over my body causing me to seek medical treatment first with primary doctor who gave me prednisone pack and injection and then my local emergency room (twice) due to swelling of throat and tongue. I was given prednisone IV treatment and sent home with a high dose of medication for inflammation and hydroxyzine for itch and famotidine for stomach upset. My doctor got me in to see immunologist for tests and treatment. That doctor took blood and diagnosed me as having a moderate to severe delayed allergic reaction post covid vaccination. My liver had elevated levels of bili-rubin my white blood count was over 16,000 and my skin was cover in red, itchy hives and rash from head to bottoms of my feet for over ten days. I was very sick and miserable.
59 2021-03-22 double vision, vision blurred Double vision x 4 days, continued blurred vision
59 2021-03-22 oropharyngeal discomfort Patient received first dose of Pfizer COVID vaccine. 10 minutes after vaccination patient reported ... Read more
Patient received first dose of Pfizer COVID vaccine. 10 minutes after vaccination patient reported mouth felt 'weird' and throat felt 'swollen' although no difficulty swallowing was reported. Assessed by provider Benadryl PO administered. After 20 minutes patient reported symptoms had resolved. Discharged to home with husband.
59 2021-03-23 mouth numbness, mouth tingling I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing... Read more
I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing tingling sensation on the right side of my face and tongue and top of my head. I also felt very jittery or crawling sensation like I had to much coffee. I called the guards to my car twice and was told it was my nerves. I was released even though I wasn't feeling right and felt like was drunk driving on the way home, the worst of it passed within a hour but the fuzzy feeling lingered with numb spots on my face lasted for a few days. Now I'm afraid to get my second shot due April 3rd.
59 2021-03-23 thirst 16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. ... Read more
16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. I asked to go outside and was told no. I moved from back to the front as i felt cold and was swearing. It was sift chsnge and the staff was huddled in a corner and i called for help.2x before taking off my mask amd callinf a thried time. By this point i felt like vomiting and nedded immediate water. The thirst was intrnse. The University of Arizona didn't have anything for me to throw-up into except a half full used large janitorial garbage can. I was given water and that really helped the thirst and nausea. The nurse came and put a monitor on my finger and immediately took me to a back area where rhe cold sweat and chills now covered my whole body and the thirst returned. Tje nurse took my vitals and i remember my heartbeat reading in the 30s and had a very low blood pressure. No one ever experienced what was happening and i asked if i was going to die. The only thing they had to lie down on was an army cot 6" off rhe ground. I wanted to lie down so badly buy it had no sheets, pillow or anything. With all the money they get from the feds they should be able to afford a gurney. I was never told the truth about what had happened to me. I was let go with a very low heart rate of 51. My normal is 68 to 78. No follow up instructions.
59 2021-03-24 ear pain Arm pain for two days, body temperature of 99.7 f Third day: tiredness , chills , 98.5 f, stomach p... Read more
Arm pain for two days, body temperature of 99.7 f Third day: tiredness , chills , 98.5 f, stomach pain Fourth day: tiredness , chills, stomach cramps. Fifth day. Tiredness, stomach pain, chills Sixth day:headache, ear pain, sneezing, sore throat, tachycardia. Seventh day: Headache, ear pain, sneezing, sore throat , tachycardia. Eighth day: Headache, ear pain, sore throat, sneezing, tachycardia. Anxiety. Ninth day: Headache, ear pain , sore throat . Anxiety and bad mood. I take ibuprofen 600mg every day , my vitamins , lots of fluids.
59 2021-03-24 lip swelling Heart pounding, lips swelling (reported). Pt did not appear to be swollen, pt " felt better" soon a... Read more
Heart pounding, lips swelling (reported). Pt did not appear to be swollen, pt " felt better" soon after assessment. Pt refused transport to hospital.
59 2021-03-24 ringing in ears, toothache, ear pain ?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, ... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, possible seizure, tinnitis, pressure in frontal cortex, brain fog, inability to urinate for 1 day, headache, exhaustion-constant sleeping, rapid heart rate, problems speaking-slow and deliberate, dehydration, motor skills slower, sinus's and whole brain feels dry, time going by really fast, ears hurt, teeth hurt, right and left neck hurt, left arm hurt, right shoulder hurt, hot flashes day and night. MEMORY ISSUES SUBSIDED TODAY, still brain fog, still RAPID HEARTBEAT and shaky. If all of this brain fog/rapid heartbeat doesn't subside by Monday March 29, 2021, an EEG will be ordered to look at the brain. I'm on my 2nd weeks bedrest with no exercise and Tylenol every 6 hours, the tylenol every 6 hours seems to help with some of the brain fog and the rapid heart beat, if I forget to take it I am soon reminded as my heart races and the brain fog reappears.
59 2021-03-25 mouth tingling 1100: patient with c/o numbness and tingling of right side of tongue. Physician on duty ordered 25m... Read more
1100: patient with c/o numbness and tingling of right side of tongue. Physician on duty ordered 25mg Po Benadryl to be given. Patient took Benadryl and refused water. 1110: Patient checked on by EMS on Duty with no changes. 1120: No changes to mouth noted still for patient. 1130: Still no changes, EMS on duty cleared patient for discharge home after 30 minutes of observation. Informed patient to seek immediate medical attention if symptoms should worsen. Patient communicated understanding.
59 2021-03-25 ringing in ears I noticed tinnitus in my left ear within 2 hours of receiving the vaccine in my left arm. Today, on... Read more
I noticed tinnitus in my left ear within 2 hours of receiving the vaccine in my left arm. Today, one week later, it continues. It is a high pitched ringing in my left ear. This is not normal for me at all.
59 2021-03-26 double vision Extensive dural venous sinus thrombosis, SAH, acute ischemic thalamic infarct. Headache, lethargy, d... Read more
Extensive dural venous sinus thrombosis, SAH, acute ischemic thalamic infarct. Headache, lethargy, diplopia, right arm weakness
59 2021-03-26 taste impairment 3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light heade... Read more
3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light headed. Got chills. Hot & cold nauseated . It?s three days later I?m still very tired. Headaches , throats feels swollen , glands swollen. I feel like I got the flu! When is this going to end ?
59 2021-03-26 mouth tingling palpitations, tingling over lips, rash
59 2021-03-26 swollen tongue, eye movement disorder, visual impairment Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Dif... Read more
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
59 2021-03-26 ringing in ears Ringing in left ear. New. Never had before in either ear.
59 2021-03-27 bloodshot eyes, eye pain High temp for two days after shot and then low grade temp for three days Headache Nausea Chills Bo... Read more
High temp for two days after shot and then low grade temp for three days Headache Nausea Chills Body aches Joints hurt Left eye became bloodshot and hurt Cold sores inside and outside of mout
59 2021-03-27 swollen tongue SWOLLEN TONGUE AND THROAT, HIGH BLOOD PRESSURE, FAST HEART RATE, TINGLING IN FACE
59 2021-03-28 dry eye, eye pain Dry eyes at 3 AM, feeling run down at 10:30 AM, Injection site really sore, stiff neck, headache, ey... Read more
Dry eyes at 3 AM, feeling run down at 10:30 AM, Injection site really sore, stiff neck, headache, eyeballs feel tender and sore, ice cold feet that will not warm up, Skin on torso tender, nose stuffed up, loss of appetite at 1 PM. Try to nap but cold feet can?t wake me up. Took my temperature at 7:45 PM 100.6, Took a Tylenol and back in bed.
59 2021-03-28 lip swelling Patient experienced swelling of bottom lip first. This was followed by labored breathing. An Epi-P... Read more
Patient experienced swelling of bottom lip first. This was followed by labored breathing. An Epi-Pen (branded generic form) was administered in addition to two diphenhydramine 25mg tablets. Patient was given a bottle of water. Over the course of approximately 7 minutes she consumed about one-half of the bottle. Paramedics were called. Prior to their arrival at 9:47 AM, the patient experienced additional swelling of lips, this time the top, and labored breathing. Another Epi-Pen was administered. Patient reported some elevated heart rate and mild headache, probably as a result of the epinephrine administration. She was transported to hospital at 9:49 AM.
59 2021-03-28 eye discomfort Fever, chills, arm soreness, nausea, headache, eyes hurt, back pain, dizziness, feel bad
59 2021-03-28 oropharyngeal discomfort Released from observation at 10:20am. Walking towards exit my throat felt strange. Employee asked ho... Read more
Released from observation at 10:20am. Walking towards exit my throat felt strange. Employee asked how was my day and I said great but my throat feels funny. Employee immediately escorted me to front of facility and asked me to wait to see how I was feeling however moments later paramedic walked up to me and escorted me to screened medical area. My face and neck were flushed, throat and swallowing were changing. Paramedic gave me Benadryl and antacid tablet with water however Pharmascist arrived at same time and instructed paramedic to administer Benadryl shot as well. BP elevation, itch.
59 2021-03-28 vision blurred Heat through body, Nausea, numbness in left hand, pressure in head, cognitive problems, pressure in ... Read more
Heat through body, Nausea, numbness in left hand, pressure in head, cognitive problems, pressure in head, memory problems, joint pain, right eye not focusing Have seen my primary, rheumatologist- received injection of steroid and put on oral steroids, chiropractor nerve stimulation, adjustment. Waiting to see a neurologist
59 2021-03-29 taste impairment Immediate metallic taste in mouth that lasted about 72 hours. This happened with both doses.
59 2021-03-29 sensitivity to light Sharp headache up the middle of my head that got progressively worse as the day went on. By early ev... Read more
Sharp headache up the middle of my head that got progressively worse as the day went on. By early evening was more like a migraine, with slight nausea and aversion to lights. Extra strength Tylenol didn't really help. Also joint aches and slight chills, but no fever. Was better by the next day, but still a mild headache and some joint aches.
59 2021-03-29 swollen tongue Pt reporting tongue swelling, which also occurred after Pzifer vaccine #1. She took antihistamine p... Read more
Pt reporting tongue swelling, which also occurred after Pzifer vaccine #1. She took antihistamine prior to first dose. Reports she frequently has tongue swelling after her allergy shots as well. Denies any mouth swelling, oral itching, changes in respiration. Pt appears alert, oriented, no facial swelling, no respiratory distress or no respiratory effort. Benadryl dispensed by RN Clinical Lead at 1135. She is now resting in obs chair. -------------- TIME:1145 Pt reporting swelling of tongue has almost completely resolved. Denies any mouth swelling, oral itching, changes in respiration -------------- TIME: 1205 Pt reports tongue swelling has resolved. Denies any mouth swelling, oral itching, changes in respiration. Will be transported home by husband. ED precautions reviewed. Will notify PCP.
59 2021-03-29 ringing in ears Ringing in ears, headache behind eyes, weak.
59 2021-03-30 ear pain, ear discomfort coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild alle... Read more
coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild allergic reaction; a lot of pressure and pain and tightness in my ears; a lot of pressure and pain and tightness in my ears; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 at 04:15 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 03Mar2021 at 17:00 (reported as 05:00PM), the patient experienced mild allergic reaction. The patient waited for 15 minutes before leaving. On the way home, the patient experienced a lot of pressure and pain and tightness in her ears. She stated that she felt "not so good in her chest". The patient took 2 Benadryl to help. At 18:00 (reported as 06:00PM), the patient developed pain in her chest and was coughing with a "wheezy sounding cough". Her doctor instructed her to go to the emergency room where she was told she was having a mild to moderate reaction and was administered Albuterol. She states that the next day she was still coughing, but by the day after that, she felt fine. She states she already spoke with her doctor who recommended she not get the second shot. At the emergency room, they checked her pulse oximetry for the blood oxygen level. She had an albuterol treatment for her breathing. They listened to her chest with a stethoscope. The outcome of the event coughing, she felt "not so good in my chest", and pain in chest was recovered on 05Mar2021 while the outcome of the other events was recovered on an unspecified date. Information on the lot/batch number has been requested.
59 2021-03-30 eye swelling, swollen tongue, mouth swelling Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of ... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: swelling in mouth - tongue/throat. white spots on lip/mouth. vaccine given 11:07, sx started ~11:17, benadryl given 11:20, EMS arrived 11:34. Patient was fine and stable, left with husband a few minutes later. counseled on what to do if symptoms reemerge.
59 2021-03-30 eye swelling When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen;... Read more
When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events. Information on the lot/batch number has been requested.
59 2021-03-30 drooping eyelid, swelling of eyelid sore right eyelid; eyelid more swollen/right eyelid is much more swollen, red, and droopy; right eye... Read more
sore right eyelid; eyelid more swollen/right eyelid is much more swollen, red, and droopy; right eyelid is much more swollen, red, and droopy; right eyelid is much more swollen, red, and droopy; This is a spontaneous report received from a contactable consumer (patient herself). A 59-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9265), via an unspecified route of administration on arm Left on 05Feb2021 15:15 at single dose for COVID-19 immunisation at workplace clinic. Medical history included Chronic reactivated Epstein Barr Virus and Cytomegalovirus. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, the patient woke up Saturday on 06Feb2021 with sore right eyelid. Looked for evidence of stye but could not identify. Sunday, on 07Feb2021 eyelid more swollen, still no evidence of stye. Monday, on 08Feb2021, right eyelid was much more swollen, red, and droopy. Cannot locate a stye. Patient was treating with hot compresses. All the events were occurred on 06Feb2021 at 07:00 AM. The patient not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The events were assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.
59 2021-03-30 mouth itchiness 11:00 pt reports "mild oral itching, breathing feels different , not asthma related" 11:05 pt brough... Read more
11:00 pt reports "mild oral itching, breathing feels different , not asthma related" 11:05 pt brought to Triage 1 reports "throat feels tight" 11:06 MD consult, HR 78, 02 98%, RA 11:20 pt given Benadryl PO 50mg.
59 2021-03-31 bloodshot eyes, vision blurred 59 y/o female, c/o headache, mild nose bleed, blurry vision on both eyes and left eye redness. Pt. S... Read more
59 y/o female, c/o headache, mild nose bleed, blurry vision on both eyes and left eye redness. Pt. Stated her blood sugar this am was 200?s, did not take am meds and insulin, stated ?because I am scared I will be taking the vaccine.? last insulin taken evening of 3/31/21 Lantus 50units. Paramedics came to check VSS, blood sugar above 400?s. Advised further eval, sent to Hospital via ambulance.
59 2021-03-31 ringing in ears Severe Tinnitus constant ringing in ears, getting worse
59 2021-03-31 ringing in ears Tinnitus and dizziness, muscle cramps
59 2021-04-01 mouth discomfort 3 days later, when I woke up, my body felt like it was ran over by a dump truck. I had excruciating ... Read more
3 days later, when I woke up, my body felt like it was ran over by a dump truck. I had excruciating back pain for 3 days. My tongue is red, and it burns when I eat. My teeth are very sensitive, very difficult to brush them. It is now 1 week later, and I feel lethargic. I took aspirin and it helped alleviate the pain in my back.
59 2021-04-01 mouth tingling Tingling to forehead and top of mouth 15 min after receiving vaccine. VS 128/88, HR 100, O2 Sat 100... Read more
Tingling to forehead and top of mouth 15 min after receiving vaccine. VS 128/88, HR 100, O2 Sat 100.
59 2021-04-01 swollen tongue, lip swelling Tightness in throat, difficulty breathing and speaking. Swelling of tongue and lips.
59 2021-04-01 ringing in ears, deafness Hearing loss with tinnitus to right ear; Hearing loss with tinnitus to right ear; This is a spontane... Read more
Hearing loss with tinnitus to right ear; Hearing loss with tinnitus to right ear; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:30 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included DM (diabetes mellitus) and HTN (hypertension) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Jan2021 11:30, the patient experienced hearing loss with tinnitus to right ear. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The events was treated with hyperbaric oxygen therapy. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the event hearing loss with tinnitus cannot be completely excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
59 2021-04-02 deafness, ringing in ears Severe Tinnitus, slight hearing loss, accompanying severe headache - tinnitus has persisted for thr... Read more
Severe Tinnitus, slight hearing loss, accompanying severe headache - tinnitus has persisted for three weeks, unabated.
59 2021-04-02 deafness, ringing in ears Tinnitus and severe hearing loss in right ear. Scheduled for an MRI by ENT doctor to rule out anythi... Read more
Tinnitus and severe hearing loss in right ear. Scheduled for an MRI by ENT doctor to rule out anything else. Audiologist checked hearing. Normal on left ear , severe hearing loss and tinnitus right ear. Scheduled for 2nd dose on April 6, 2021. Probably going to at least delay second dose as I am now terrified hearing loss will get worse! Just to note, I have NEVER had anything wrong with my hearing ever until I got this shot!
59 2021-04-02 eye pain fatigue body ache headache chills nightsweats hands ache eyes ache
59 2021-04-03 loss of taste Nauseous, Migraine and loss of taste
59 2021-04-03 dry mouth Migraine Nausea Vomiting Diarrhea Headache Dizzy Heart palpitations In a fog Extreme fatigue Muscle ... Read more
Migraine Nausea Vomiting Diarrhea Headache Dizzy Heart palpitations In a fog Extreme fatigue Muscle & joint pain Loss of appetite Dry mouth Started 4/3/2021 @ 11:00 am Still continuing
59 2021-04-03 taste impairment Pfizer Covid 19 the patient presented at the end of her Observation time with a complaint of a metal... Read more
Pfizer Covid 19 the patient presented at the end of her Observation time with a complaint of a metalic taste in her mouth. Heartland was contacted and created incident # 2021-00020461. The patient denied treatment or transport, and her husband said they would take her to the ED if necessary.
59 2021-04-03 thirst Soreness in vaccine spot, chills, thirst, on the first night. Lack of appetite, pain, and dizziness ... Read more
Soreness in vaccine spot, chills, thirst, on the first night. Lack of appetite, pain, and dizziness on the second day, and soreness spreading to the left breast and side, dizziness, thirst, on the third day.
59 2021-04-03 ringing in ears, inability to speak, eye itchiness, mouth tingling eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; li... Read more
eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown. Information on the lot/batch number has been requested.
59 2021-04-04 loss of taste Woke up morning after receiving vaccine injection and my tongue felt scalded, as if I had burned it ... Read more
Woke up morning after receiving vaccine injection and my tongue felt scalded, as if I had burned it drinking a too-hot beverage. My sense of taste was seriously diminished - everything I ate tasted bland. The scalded sensation lasted about 12-14 days before it began to abate. Gradually improved sense of taste after 12-14 days. Sensation nearly gone completely by about day 19 or 20.
59 2021-04-04 permanent deafness, ear discomfort, ringing in ears Worsening of mild, intermittent tinniutus to constant high-pitched loud tinnitus. Pressure in head a... Read more
Worsening of mild, intermittent tinniutus to constant high-pitched loud tinnitus. Pressure in head and ears that comes and goes (varies from day to day), waves of pins and needles through head and face (intermittent, daily), flushes of heat through body (intermittent, most days of week). Queasiness (most of the time), reduced appetite. The tinnitus manifested as a screech that sounds like it is in the head rather than the ears, with lower frequencies that change in intensity in both ears.
59 2021-04-04 oropharyngeal discomfort, eye swelling, eye itchiness 25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something... Read more
25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something was in it or irritating it. It kept driving me to check if something was in it. I put in renu eye drops and did not think any more of it. 40 minutes post injection: both feet red and swollen left foot about half of the top, the whole right foot looked like a giant hive or welted area across the whole top of foot. The injection site began being quite sore, and it also looked welted and felt hot to the touch. I kept checking my left rib cage and my left thumb as I was sure there was going to be hives, because I could not stop rubbing or scratching them as they itched so badly. I continued itching and feeling weird tingly sensations and either rubbed or scratched these areas to no avail. Even my head itched terribly by the second day. 45 minutes post injection: Tightness and scratchiness in throat appeared and my throat was sore, my voice began going out and my voice got hoarse. There was about a two inch area of my throat in which I felt I needed to keep trying to clear something that was stuck. (This made no sense to me as I was able to drink water without any issues.) I had a slight cough every time I stopped drinking, so I continually drank water while I was not trying to sleep. My chest was tight, but because I have asthma I took albuterol and thought nothing of it. (This really did not help, but I did not get worse either.) About an hour after the shot, I constantly felt on the verge of shaking, much like when you have a fever, but I did not think to check my temperature until the following morning when I was extremely tired, felt like I had a sinus headache and possibly did have a fever. My temperature was 99.4 degrees farenheight. At this point, I felt very flu-ish and achy. My armpit area hurt a lot and I chewed two aspirin. I experienced wheeziness, chest tightness, and hoarseness the second and third day as well. I had the morning congestion and stuffiness as well as the need to keep clearing my voice still as of this morning but to much less degree as the initial onset. The skin itchiness is still ongoing, but to a much lesser degree than previously had.
59 2021-04-04 swollen tongue RED, SWOLLEN, RIPPLED TONGUE . HEADACHE LEFT-SIDE , FATIGUE
59 2021-04-04 ringing in ears, ear discomfort Telephone call received from client who reports she received vaccine yesterday and is now having a ... Read more
Telephone call received from client who reports she received vaccine yesterday and is now having a sore arm and pressure in her ears. Also stated she had sinus infection for a month. Having buzzing in her ears but not sure if buzzing or "shot:. Stated at work at time of this report and just wanted to report.
59 2021-04-05 eye bleeding Malaise with some chills and low grade fever. Not sure if this is related but on Monday, morning, Ma... Read more
Malaise with some chills and low grade fever. Not sure if this is related but on Monday, morning, March 29 I woke up to burst blood vessel in left eye.
59 2021-04-05 eye swelling anaphylaxis response Swelling of neck/face/eyes, difficulty in breathing
59 2021-04-05 mouth itchiness, eye itchiness Injection at 9:55 am. Itchy eyes and root of mouth started 15 minutes after injection. I waited for... Read more
Injection at 9:55 am. Itchy eyes and root of mouth started 15 minutes after injection. I waited for an additional 15 minutes at facility and the symptoms went away on their own. At 12 noon at home malaise set in. I rested off and on for the remainder of the day. At 4 pm, pain and swelling in right arm. No treatment. Also, at the same time pain in vaginal area started. Pain remained for remainder of the evening and night. The next morning the pain had lessened some, however not totally. I can not think of any cause for the vaginal pain, just that it started several hours after vaccine was administered.
59 2021-04-05 oropharyngeal discomfort Patient was experiencing her throat feeling funny and she stated she feared her throat would close. ... Read more
Patient was experiencing her throat feeling funny and she stated she feared her throat would close. Started about 5-10 minutes after administration. We gave the patient a water and sat and talked to her for the next 25 minutes. Nothing else occurred and the patient was fine to leave.
59 2021-04-06 dry eye, mouth numbness, dry mouth Bell's Palsy on left side of face: eyebrow, eye lid, nostril, cheek, and mouth droop; can not blink ... Read more
Bell's Palsy on left side of face: eyebrow, eye lid, nostril, cheek, and mouth droop; can not blink eyelid; eye and mouth do not close all the way; numbness in mouth, tongue, cheek, and forehead; pain behind left ear; dry eye, and mouth; and fatigue. It all started when I awoke on Wednesday, March 17, 2021 at 9:27 am.
59 2021-04-06 ear pain, deafness unilateral, burning mouth syndrome, hearing loss, ringing in ears Received Covid vaccination/injection in right arm on 2/2/21. For the 1st four days, had occasional h... Read more
Received Covid vaccination/injection in right arm on 2/2/21. For the 1st four days, had occasional heart palpitations that lasted first 4 days then stopped--heart returned to normal with no more episodes. On 2/4/21, that night when I went to bed, I noticed a ringing in my left ear that became louder & louder as the next several days went by. I then noticed substantial hearing loss in my left ear. Also 2 days later, I started having a dull ache around my left ear along with the loud, high pitched ringing. I kept thinking it would get better but a week before my next vaccine, I called my ENT who monitors a small lesion & hearing in my left middle ear. I already had slight conductive hearing loss from this lesion and my last appointment/check up with her was in September 2020. Dr. had me come to the hospital on 3/11/21 and a hearing test was performed and my left ear hearing had declined 15 decibels since my last hearing test in Sept 2020. I was prescribed a Medrol Pak (steroids) for 1 week and returned on 3/23 for a 2nd hearing test with no improvement in my hearing or the loud ringing (tinnitus). The Dr. told me that my hearing test showed damage to the left ear nerve. I had also developed an inflamed, painful large sore under the left side of my tongue & was prescribed Triamcinolone Acetonide Dental Paste to use 2 x daily on the sore. The Dr. ordered an MRI of my brain & left ear to make sure the lesion in my ear had not grown. I had the MRI on 3/29/21 and returned to my Dr. on 3/30/21 for results. The lesion was stable, no growth. I made my own decision and did not return for my 2nd Covid vaccine because it appears the 1st vaccine either inflamed the nerve in my ear or caused an auto immune response.
59 2021-04-06 mouth tingling Started to feel little light headed they gave me ice water about 12 minutes after shot, at 30 went t... Read more
Started to feel little light headed they gave me ice water about 12 minutes after shot, at 30 went to car .when took off mask my cheeks where fire engine red and quite swollen, mouth was feeling tingly, went back to facility, nurse said to take my Benadryl and if gets worse call doctor,. My face stayed swollen and sides of neck got red and pills felt stuck deep in back of my throat. Started taking Zyrtec,Allegra,Benadryl in a rotation every 2-3 hours in between, could take up to 4 doses of each anti histime in a day. nurse practitioner 4/2 11:30am, she added 2 doses of Pe I?d to the rotation. I continue to have face/mouth swelling intermittently and pills still feel stuck in my throat. Arm swelled day for at injection site with a sand dollar size red rash:pain ful. On 4/2-4/4 had horrible headache..
59 2021-04-06 sensitivity to light shortly after vaccine admin, patient states felt weakness all over, feeling like needing to lie down... Read more
shortly after vaccine admin, patient states felt weakness all over, feeling like needing to lie down, light sensitivity, "gel legs". arrived to obs 1122, bp 155/83, hr 54, rr 18, sao2 97% on ra. continued to c/o lightheadedness lying, sitting and standing, ortho bp/hr 167/82 52 lying, 163/76 54 sitting, 154/82 54 standing. states has low hr, n propanolol. 1230p ems called due to unrelieved dizziness/lightheadedness for transport to hospital, report provided to ems.
59 2021-04-06 ringing in ears Bad Tinnitus
59 2021-04-06 visual impairment 10-15 minutes after the vaccine was administered that patient c/o "feeling dizzy and eyes were swirl... Read more
10-15 minutes after the vaccine was administered that patient c/o "feeling dizzy and eyes were swirling" Some mild shortness of breath and patient was sweating. Rapid response was called and responded. Pt was taking to Urgent care In facility for further evaluation.
59 2021-04-07 mouth numbness, taste impairment, oropharyngeal discomfort 30 min after, bad taste in mouth.; throat felt odd; couldnt swallow; roof of mouth, back of throat a... Read more
30 min after, bad taste in mouth.; throat felt odd; couldnt swallow; roof of mouth, back of throat and back of tongue was numb like had novacaine.; roof of mouth, back of throat and back of tongue was numb like had novacaine.; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 09:30 (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, High Blood Pressure, High Cholesterol, known allergies, covid-19 prior vaccination. Concomitant medication included dulaglutide (TRULICITY); insulin lispro (HUMALOG); insulin detemir (LEVEMIR); canagliflozin, metformin hydrochloride (INVOKAMET); eicosapentaenoic acid ethyl ester (VASCEPA) all for unspecified indication. It was reported that on 12Feb2021, 10:15 AM 30 min after vaccination, bad taste in mouth. Then throat felt odd, couldnt swallow, had to really concentrate to swallow, roof of mouth, back of throat and back of tongue was numb like had novacaine. Outcome of the events was recovered on unspecified date in 2021.
59 2021-04-07 ringing in ears Loud and constant tinnitus of a high pitched frequency started less than 12 hours following the inj... Read more
Loud and constant tinnitus of a high pitched frequency started less than 12 hours following the injection and has continued unabated for 3 weeks. 5 days ago I experienced a very sharp pain in my head on the left side that lasted about one second but occurred at least a half dozen times that day. This was very frightening to me as the pain, if it persisted for more than that brief snippet of time, would be intolerable and I also associated it with a potentially life ending event. I returned home as soon as expedient but there were no further incidents of this nature. 3 days ago I also started to experience pulsatile tinnitus that seems to be getting louder.
59 2021-04-08 ear pain Muscle Aches, Joint Pain, Sore Throat, Ears Hurt, Temperature/fever, left side of head has constant ... Read more
Muscle Aches, Joint Pain, Sore Throat, Ears Hurt, Temperature/fever, left side of head has constant sharp pain, the rest of my head feels like a sinus headache, congestion in my head and nose, chest hurts. Went to ER. They gave me fluid IV and Tylenol. My body and joint pain felt better for about 4 or 5 hours, but now it?s bad again. Nothing else improved. It has been 39 hours now
59 2021-04-08 lacrimation increased Extreme itching all over my body, watery eyes, constant sneezing
59 2021-04-08 mouth tingling Pt. received her 2nd dose of the vaccine and while waiting in the pod she complained the left side ... Read more
Pt. received her 2nd dose of the vaccine and while waiting in the pod she complained the left side of her tongue was tingling. She was given some water to sip. Then stated that she felt her left cheek droop and her left eye is not focusing as well as before. Stated she did not have a reaction after her first dose. A droop was not noted on her face. Pt. initially refused (thought it would take too long) but then agreed to be taken to the E.D. and ambulated instead of using a w/c. Upon arrival, she stated that her tingling seemed to have worsened and it was now on her buttocks, she reported to an RN who came to triage her.
59 2021-04-08 swollen tongue, lip swelling Ears filled with fluid, tongue swelling, lips swelling, face and neck swelling, rash all over body, ... Read more
Ears filled with fluid, tongue swelling, lips swelling, face and neck swelling, rash all over body, itch all over body, burning skin after 1 week. Multiple episodes (at least 10) over the course of 3 weeks - resulted in 3 trips to the ER. Received injected or oral steroids at the ER. This caused loss of work and a great deal of stress. Was put on a course of oral steroids and antihistamines by allergist following ER visits. Had a prior reaction to the flu shot in October 2020. Everything above but the rash and itching. also resulted in a trip to the ER
59 2021-04-10 deafness Loss of hearing in right ear and some in left ear.
59 2021-04-10 taste impairment Could taste the injection in the back of my throat and nasal cavities soon after the injection. Neck... Read more
Could taste the injection in the back of my throat and nasal cavities soon after the injection. Neck felt swollen as I was getting in my car to leave Mild headache early evening and into the following day Developed Itchy Rash by bedtime: upper chest and back and base of neck - which is the reason that I am submitting this form. The rash is still itchy. Have used OTC allergy meds and calamine spray
59 2021-04-10 mouth numbness nerve problems behind left eye; nerve problems in face; lips had nerve problems; tongue was numb; th... Read more
nerve problems behind left eye; nerve problems in face; lips had nerve problems; tongue was numb; throat felt swollen; Bell's palsy; lightheaded and dizzy; This is a spontaneous report received from a contactable consumer (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in the left arm, on 11Mar2021 15:30, as single dose, for covid-19 immunisation. Medical history included known allergies to antihistamine (unspecified) and sulfur drugs. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior the vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); omeprazole; and anastrozole, all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) received at age 59 years, via an unspecified route of administration in the left arm, on 18Feb2021 15:45, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 11Mar2021 at 15:45, 15 minutes after the second dose, the patient got lightheaded and dizzy. On the same day at 16:15, 45 minutes after the second dose, the patient experienced nerve problems behind left eye, then nerve problems in face, then lips had nerve problems, then tongue was numb, and throat felt swollen. The patient reported the side effects on the hotline, and she was transferred to a nurse who told her to go to the emergency room immediately as she could be getting Bell's palsy from the vaccine. The events resulted to emergency room visit and hospitalization (unspecified date in Mar2021). Treatment for the events included unspecified IV. The patient was hooked up to an EKG and her blood was drawn for checking in Mar2021 (results were unknown). The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.
59 2021-04-10 taste disorder Within 2 minutes I had a horrific taste in my mouth followed by light headedness/dizziness. I almos... Read more
Within 2 minutes I had a horrific taste in my mouth followed by light headedness/dizziness. I almost passed out & had to be caught by a nurse & put into a wheelchair. They administered EpiPen, 50 mg of liquid benadryl & 2 puffs of a rescue inhaler.
59 2021-04-10 ringing in ears Woke up with loud ringing in left ear. Makes it difficult to concentrate. Had permanent tinnitus al... Read more
Woke up with loud ringing in left ear. Makes it difficult to concentrate. Had permanent tinnitus already in right ear. This is new and started the day after recieving the injection.
59 2021-04-10 ringing in ears I received my vaccine at 3 PM on 4/8/21. The next morning I was awakened at about 5 AM by a very lou... Read more
I received my vaccine at 3 PM on 4/8/21. The next morning I was awakened at about 5 AM by a very loud pulsating in my left ear. I was unable to continue sleep. This pulsating in left ear has continued non stop since then. Today is 4/11/21. I have reported this by email to my primary care physician , but still waiting for response.
59 2021-04-10 ringing in ears Dizziness, fatigue, worsened tinnitus. Dizziness and fatigue lasted continuously for about 5 days ... Read more
Dizziness, fatigue, worsened tinnitus. Dizziness and fatigue lasted continuously for about 5 days then lessened but still recurs occasionally. Pre-existing tinnitus has become more pronounced after receiving vaccine.
59 2021-04-11 ringing in ears Ringing in both ears
59 2021-04-11 tongue itchiness, ear itchiness, mouth itchiness Itching began in left arm, moved across torso to right arm, itching also in mouth, tongue, throat an... Read more
Itching began in left arm, moved across torso to right arm, itching also in mouth, tongue, throat and ear. Took 2 Benadryl and itching subsided after approximately two hours.
59 2021-04-11 eye floaters, visual impairment, vision blurred Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had ... Read more
Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had severe weakness of the right arm starting the day after the immunization, headaches across the whole head, severe fatigue, confusion (brain fog), worsening depression, body aches, and these all progressed and got worse for at least 14 days. She was unable to work any of those days due to weakness, confusion, and body aches. She saw me in the clinic on March 2 as she was still feeling weak, tired, confused. The clinic notes that day record: "On the next day, the 26th, she had severe pain and couldn't do much. Then she got super depressed and could not get out of bed for 2 weeks, had a lot of fatigue, body aches, and felt down. She tried going to the store one day and by the time she got done she could not get into her truck because she was in so much pain. That would have been about 2 weeks ago. She went back to work last week and was at work the whole week. She was told she does have leave time and that it did not cover the absence of work. She now needs new leave time forms completed. Currently she is in a lot of pain. She has her endocrine appointment on March 15th. The pain is getting worse. The cold is really hard on her. She is barely able to move her right arm at the end of the day, and that is the arm where she had the COVID shot. She is having a lot more weakness. She can not even take one flight of stairs now because everything hurts her. This is a huge difference than before. She used to be able to do several flights, and she can't do that anymore. She has also had vision changes. She has floaters but she is having a harder time focusing. She feels like no one would believe her, but she feels like this is all part of the reaction to COVID. She has a hard time focusing. She feels like she is going insane."
59 2021-04-12 blindness in both eyes, sensitivity to light, vision blurred I woke up the morning after dose #1 unable to see out of my right eye. It was tho someone had placed... Read more
I woke up the morning after dose #1 unable to see out of my right eye. It was tho someone had placed a large amount of vaseline in my right ee. My left eye was blurred and extremely sensitive to light. The right eye began to clear up but took many days. Opthamalogist appoint was made. Now seeing a Retinal specialist. Vitreous Hemmorhage in the right eye and an Aneurysm sitting on the optic nerve in the left eye.
59 2021-04-12 feeling of choking PATIENT STATES FACE FEELS TIGHT AND FLUSHED. ALSO STATED THROAT FEELS TINGLY. AFTER 5 MINTUES ALMOS... Read more
PATIENT STATES FACE FEELS TIGHT AND FLUSHED. ALSO STATED THROAT FEELS TINGLY. AFTER 5 MINTUES ALMOST ALL SYMPTOMS ARE GONE. BP 156/82 SAT 97%
59 2021-04-12 ringing in ears Ringing in ears (tinnitus) No treatment Still ringing after dose 2 of Pfizer Covid 19 vaccine Have b... Read more
Ringing in ears (tinnitus) No treatment Still ringing after dose 2 of Pfizer Covid 19 vaccine Have been told there is no treatment, no cure for tinnitus.
59 2021-04-12 ringing in ears Tinnitus Sounds like I?m in a teeny tiny room with 1 million crickets
59 2021-04-12 visual impairment Dizziness lasting 4 weeks (and still ongoing). Visual tracking connected to dizziness. Lightheaded.... Read more
Dizziness lasting 4 weeks (and still ongoing). Visual tracking connected to dizziness. Lightheaded. Pain in neck (on side of injection) lasting 4 weeks past injection.
59 2021-04-13 loss of smell, loss of taste In addition to having a headache on and off since my second dose, I have now lost my sense of taste ... Read more
In addition to having a headache on and off since my second dose, I have now lost my sense of taste and smell.
59 2021-04-13 taste impairment, mouth tingling 15 days after the 1st dose of Pfizer Covid19 vaccine developed measle like rash on back, backs of le... Read more
15 days after the 1st dose of Pfizer Covid19 vaccine developed measle like rash on back, backs of legs, and buttocks. By the afternoon on day 15th, rash had spread to other parts of legs and stomach. Tongue also felt funny. Metallic tasting and felt like rash was inside of mouth. On day 16, rash erupted on arms, inside of ear, tops of feet- full body. Extremely extremely itchy. Top of both arms rash is very red and more prounounced. Arms in those areas are warm to the touch and hurt. Taking Claritin (brand name) and Benadryl (brand name) - only taking an edge off. Today 4/14, day 7 of rash, it is still extremely itchy especially at night.
59 2021-04-13 oropharyngeal discomfort, taste disorder Patient reports funny taste in mouth, cough, lightheaded, facial numbness, hoarseness, and states "f... Read more
Patient reports funny taste in mouth, cough, lightheaded, facial numbness, hoarseness, and states "feels like cardboard in throat" Epi pen and Benadryl given
59 2021-04-13 taste disorder, smell distorsion Fever 101º/ Extreme Chills (3 days) Stomach ache (5 days) Strange/adverse sense of smell (3 days) S... Read more
Fever 101º/ Extreme Chills (3 days) Stomach ache (5 days) Strange/adverse sense of smell (3 days) Strange/adverse sense of taste (3 days) EXTREME lethargy /sleepiness (10 days) Aggravation of arthritis in left knee (could not walk normally for 8 day, but the condition still persists and now includes swelling) Loss of use of left arm - no range of motion, pain, etc. (ONGOING) Numbness of left leg in various stages (ONGOING) Complete numbness of left leg with sudden loss of use of left leg, resulting in a fall (March 27, 2021) Shoulder swelling in muscle at the front of left shoulder, resulting in pain with use of arm (ONGOING).
59 2021-04-13 ringing in ears, mouth tingling *Tingling left side of face, and lips and tongue 2 pm on 4/12 to present Extreme fatigue, dizziness,... Read more
*Tingling left side of face, and lips and tongue 2 pm on 4/12 to present Extreme fatigue, dizziness, buzzing of head, tinnitus, increase in head ache, stomach pain, 4/13/21 starting at 11 am and worsening throughout the day
59 2021-04-15 eye pain, pain in jaw Symptoms within a few minutes of vaccine administration: body aches and headaches (although these tw... Read more
Symptoms within a few minutes of vaccine administration: body aches and headaches (although these two specifically are not uncommon for pt), jaw pain, left arm shaking until bedtime that night, twitching (also not uncommon for pt per seizure disorder). Symptoms resolved by next morning at 7am, but within 2 hours, symptoms returned, including swollen face that is painful to the touch, intense fatigue, burning/throbbing/tingling sensation in arms and legs, worsening of arthritic pain, jaw pain, chills/hot flash-like episodes, decreased appetite, stinging sensation in the eye, home measurement had pulse ox 98% and HR at 93 bpm (pt endorsed). Note that pt was COVID positive on Dec 1st, 2020
59 2021-04-15 lip itchiness, swelling of eyelid, lip swelling Started with headache about 20 minutes after shot, then gradually over the next 45 minutes itchy & ... Read more
Started with headache about 20 minutes after shot, then gradually over the next 45 minutes itchy & puffy upper lip, cheeks, eyelids, tightness at back of mouth. all cleared up about 45 minutes after onset so all lasted about 1.5 hours
59 2021-04-15 oropharyngeal discomfort Feel throat difficulty swallowing. Recommended by EMS to contact primary care or call 911. Underst... Read more
Feel throat difficulty swallowing. Recommended by EMS to contact primary care or call 911. Understanding verbalized. 176/96, HR 76, BS 187, O2Sat 98%, 183/102, P 70. 197/93 11:10am Refusing transport, prefers to go home and will call 911 from home. Accompanied by husband.
59 2021-04-15 mouth tingling Patient received first dose and developed a rash that was treated with Benadryl. After receiving se... Read more
Patient received first dose and developed a rash that was treated with Benadryl. After receiving second dose, patient was not feeling well and reported her lips tingling and her throat feeling like it was swelling resulting in trouble swallowing. No issues reported with trouble breathing. Patient received 50 mg IM Benadryl in right arm and 911 was called. Patient left store with paramedics
59 2021-04-15 swollen tongue A few minutes after receiving the vaccine, I got dizzy, then my tongue and back of my throat started... Read more
A few minutes after receiving the vaccine, I got dizzy, then my tongue and back of my throat started to swell. I could breathe, and that was great. Swallowing was a bit difficult at first. My throat stopped swelling and we left the vaccination site. Later that night, very tired and my scalp itched. Next day very tired, nauseous, headache, scalp itched very badly, a little dizzy and felt very "off". All resolved by the 2nd day.
59 2021-04-15 vision blurred After taking the first Pfizer shot there was nothing remarkable that followed. Following the 2d dos... Read more
After taking the first Pfizer shot there was nothing remarkable that followed. Following the 2d dose on 25 Mar, patient was feeling tired, and described mental capacity as being foggy. Lost apatite and wanted to sleep. Described vision as blurry and couldn't focus.
59 2021-04-16 eye swelling, swollen tongue, mouth swelling Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient waited in the observation area after getting vaccinated for 15 minutes, went home and started feeling anaphylactic symptoms around 30 minutes after and drove back to the pharmacy to seek medical attention. She was panicked and hyperventilating upon arrival and I had the patient sit down and to take deep breaths. I was about to give her benadryl but she complained of swollen throat and having a hard time breathing. I injected her with epi-pen and within 5 minutes she was better.
59 2021-04-16 ringing in ears significant increase in perceived loudness of existing tinnitus
59 2021-04-16 tongue discomfort, mouth numbness, mouth itchiness 59 yo female with h/o HTN and allergy (shellfish and chorine) who received the Pfizer vaccine. About... Read more
59 yo female with h/o HTN and allergy (shellfish and chorine) who received the Pfizer vaccine. About 10 minutes later, she c/o lips and nose numbness. Several minutes later she c/o hands itching followed by soft palate itching, followed by face( B/L maxillary region)- itching/numb. At this point she had been with us for 30 mins so we gave Benadryl IN 50mg. She told us that she had chest tightness and racing heart with her lips/nose became numb. She maintained no SOB or DIB. BP 142/92 HR 80. One hour later she again c/o chest tightness and left side of tongue burning. Other symptoms had resolved. EMS called. EMS checked BP 124/82. EKG NSR and O2 sat 100%. She was taken to Hopsital. She was in no apparent distress.
59 2021-04-17 loss of smell Caller stated that she received the second dose of the pfizer covid 19 on 4Feb2021. Caller stated th... Read more
Caller stated that she received the second dose of the pfizer covid 19 on 4Feb2021. Caller stated that she tested positive for covid 19 yesterday, 28Mar2021; Patient contracted COVID; head cold, one nostril she can't smell out of, it is a sinus inflammatory; head cold, one nostril she can't smell out of, it is a sinus inflammatory; head cold, one nostril she can't smell out of, it is a sinus inflammatory; Her nose is not running as much; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose BNT162B2 (Solution for injection, lot number: EL9264) via an unspecified route of administration on 04Feb2021 at 15:30 at single dose for COVID-19 immunisation. Patient medical history included ongoing Sinus pain (Sudafed sinus maximum strength. LOT PLC017, expiration date May2021) and ongoing Mild Hypertension. Historical vaccine included first dose BNT162B2 (Solution for injection, lot number: EL3302) via an unspecified route of administration in left arm on 14Jan2021 at 15:30 at single dose for COVID-19 immunisation. Concomitant medications included losartan potassium started at 50 mg, once a day for mild hypertension nearly a year ago, stopped as she did not really have hypertension, she was healthy, she exercises, she goes to the doctor but she gets white coat syndrome (AS REPORTED) , paracetamol, pseudoephedrine hydrochloride (SUDAFED SINUS, lot number: PLC017, expiry date: May2021) for sinus pain. She stated that she received the second dose of Pfizer Covid-19 vaccine on 04Feb2021. On 25Mar2021, she stated that she was tested positive for Covid 19 on 28Mar2021. She stated her son had Covid and she thought she would be protected. She wanted to know how this could happen and if there was something in the vaccine incorrect. She contacted her state to let them know she contracted Covid 19 after two doses. She wanted to know if the vaccine would prevent her symptoms if she would get worse. Symptoms started on March 25th. She got tested on Saturday and got the results on Sunday (AS REPORTED). She says it has not been not serious so far, it has been 5 days, her son was fine it was just a head cold. On 25Mar2021, she says one nostril she can't smell out of, it was a sinus inflammatory. On 25Mar2021, her nose was not running as much, it was a right nostril sinus problem, she still can't smell out of it. She can smell and taste because the other nostril was open. She asked if she should call the center, they said to call Pfizer. She says she was not obese. She had stress. She was walking for 7 hours on her feet, her blood pressure was low at home. She went to doctors and it was a little elevated at 150, when she gets procedures it elevates. She has white coat syndrome. She used saline spray up her right nostril yesterday. Spray lot number HT920788, expiration date on 26Jun2021. She also took a Sudafed yesterday for some sinus pain. LOT PLC017, she says its hard to tell with these labels, expiration date in May2021. She took one Sudafed sinus maximum strength. Patient contracted COVID 19: lack of efficacy. Reporter considered events as non-serious. Outcome of events was not recovered. Causality not provided. Information on the lot/batch number has been requested.
59 2021-04-17 swollen tongue, lip swelling, ear pain she was in distress with her throat starting to swell, her tongue started to swell and she was cover... Read more
she was in distress with her throat starting to swell, her tongue started to swell and she was covered with the hives and rash from head to toe.; her lips and tongue began to swell; her lips and tongue began to swell; rash on her palms, hands, elbows, and left hip/rash all over her body; elbows were red; hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy; developed hives/rash on her palms, hands, elbows, and left hip; WBC count was high; liver was not doing great; post COVID vaccine delayed allergic reaction; pain in her right ear; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:15 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included arrhythmia, ear infection. Concomitant medication(s) included propranolol (PROPANOLOL [PROPRANOLOL]) taken for arrhythmia from Apr2020 to an unspecified stop date. The patient previously took augmentin [amoxicillin;clavulanic acid] for ear pain and experienced rash on her elbows and palm and arm. Caller stated on Friday 05Mar2021, which was the 11th day after getting the Pfizer COVID Vaccine although she noticed symptoms on the 10th day 04Mar2021 after receiving the vaccine, states she noticed she had a hive rash on her palm and hand and elbows/rash on her palms, hands, elbows, and left hip and it was strange and her elbows were red and were itchy on the palms like red and itchy and she could see the rash starting on the left inside forearm; from there as the day wore on into the next day the rash became worse and more areas of the body were covered with the rash. States she made an appointment on that Monday morning with her HCP and had gone into the HCP office at that time; states on 08Mar2021, she was in distress with her throat starting to swell, her tongue started to swell/ her lips and tongue began to swell and she was covered with the hives and rash from head to toe. Caller states she was started on Prednisone at her HCP office and it was one of those dose packs; states she has no lot numbers to provide. Later on that evening she needed to go to the emergency room and she had become more severe and had a big dose of Prednisone at the emergency room and at that time the HCP there did believe she was having what is considered a post COVID vaccine delayed allergic reaction and hives; states she was in the emergency room early and was there past midnight and thinks she presented to the emergency room on 09Mar2021 and then most recent results she has of her paperwork were from 09Mar2021 to 10Mar2021; no further details provided by the caller. Caller states she was in the emergency room rolled over to the next day on the 09Mar in the evening around 10:30pm and concluded her ER visit on the 10Mar after 12:30. Caller states the HCP gave her the 40mg dose of Prednisone by injection and she has no lot number; states then at the ER, they gave her Prednisone 125mg IV and she has no lot number; they gave her hydroxyzine which is Atarax by IV and gave her Pepcid for her stomach at the same time; no lots for the Pepcid or Hydroxyzine. States the reason for her visit was allergic reaction, allergy hives, post covid delayed reaction. States she let them know at the site that before the vaccine she felt like she might have had an ear infection and was not taking anything no vitamins or anything like that and no Tylenol or anything for a week or so prior because she wanted nothing to be in her system other than the vaccine should anything happen. Had the vaccine that day, later on that afternoon contacted her HCP felt like she had ear infection, no fever but had fullness and some pain in her right ear. Saw her HCP at that time and took a look inside her ear and felt that she did have an ear infection without fever but was painful to the touch around her ear underneath her ear; prescribed Augmentin which she has taken before. Started taking one Augmentin pill on the 23rd in evening which would be Tues 23Feb2021 for the 1st dose, 500mg and dose supposed to take following the next day was to take two tablets one tablet twice per day which she did finish up around 10 days of that on 04Mar. The day before all this started with the rash she finished Augmentin, went to the HCP and two things happened; she was taking Augmentin and had the Pfizer COVID Vaccine. States she had the rash on her elbows and palm and arm and she was like that coincides with the Pfizer vaccine but also was on Augmentin and had been on that before with no problems; thought it was either the vaccine or being on the Augmentin as the reason for the rash but narrowed it to the vaccine. States she ended up in the hospital that evening on Monday evening of 09Mar and it was something they had not seen but were prepared to see could happen and concluded the rash was from the vaccine. Caller states she went to see her immunologist at the conclusion of this event and she was still covered in hives and rash and did step her down on the Prednisone and prescribed her hydroxyzine and topical itch stuff. Caller states she has no lot numbers to provide for the topical stuff or the hydroxyzine or Prednisone. States the HCP concluded she could not receive the 2nd dose of the Pfizer COVID Vaccine or any other vaccine that comes forward and she is not a candidate because of this reaction he can't safely say it would be ok to get a 2nd dose of the vaccine; states she can't receive a 2nd dose of any covid vaccine and it worried her because she has to be ok with having had the 1st dose of the vaccine and wants to know where she stands with that and what to do and she just doesn't know. States it is not she herself saying she can't get the 2nd dose of the covid vaccine but under her HCP advice and two ER visits and many doses of Prednisone and she presented how she looked and that prompted the HCP to say no 2nd dose for her. States she was taking Prednisone started two days of 50mg then 2 days of 40mg, then 30mg, then 20mg, then 10mg and that brought down the amount in her system; states she was given Hydroxyzine 1-2 tablets every 4 hours of 25mg and has no lot numbers for the Prednisone or Hydroxyzine. Caller states instead of taking Benadryl she was taking the topical stuff because Benadryl was not really working and she took Benadryl 25mg tablets in the beginning to try to get the itching out of her system and she felt really really tired and was so tired from taking the Benadryl; caller states she has no lot numbers to provide for the Benadryl. She was given a prescription for Hydroxyzine and the thinks it tended to work better and she did not take a drastic amount of it but it could cause drowsiness and she did feel a lot better from taking it but did not have a really bad feeling of feeling really dopey and sleepy with it because she felt bad enough and did not want to feel bad. States she kept on this for the 10 days or more of a 14 day course and was feeling like until it started to subside. On an unspecified date it was reported that Her WBC count was high and her "liver was not doing great" but recent bloodwork shows it has returned to normal. The patient was hospitalized for the events developed hives/rash on her palms, hands, elbows, and left hip, elbows were red, hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy, her lips and tongue began to swell, WBC count was high, liver was not doing great, post COVID vaccine delayed allergic reaction. The patient underwent lab tests and procedures which included white blood cell count: returned to normal on an unspecified date, white blood cell count: high on Mar2021. Therapeutic measures were taken as a result of the events except for WBC count high and liver was not doing great. The outcome of the events was unknown.
59 2021-04-17 taste disorder, taste impairment, loss of taste Day after vaccine, began to experience metallic and bitter taste. By the next day (2 days after vac... Read more
Day after vaccine, began to experience metallic and bitter taste. By the next day (2 days after vaccination) I lost all sense of taste. My sense of smell is only slightly off. Even a glass of water tastes horrible. Acidic foods are worst. But everything tastes slightly soapy, bitter and metallic to the point where I am having difficulty eating anything (now on day 6 after vaccination).
59 2021-04-18 mouth numbness, pain in jaw, ear discomfort 4/14-vaccine. Stiff neck, sore left base of skull, beginning w/in 1 hour. Painful arm barely lift-a... Read more
4/14-vaccine. Stiff neck, sore left base of skull, beginning w/in 1 hour. Painful arm barely lift-able by 9 PM, largely resolved w/ 48 hrs. 4/16, AM awoke w/intense pain in buttock and down leg to knee when trying to walk or crawl. Right and left low back pains. 2 days in bed with ice, Tylenol, CBD balm, diclofenac. By 4/18, able to shuffle. Right buttock soreness. 4/19 cautious walking. Burning in right buttock, off and on. 4/19-Very sore base of skull both sides, stiff and sore right jaw, ear fullness, numb teeth, headache. Anxiety treated w/ herbs, Tylenol for pains, herbal balm for pain.
59 2021-04-18 ringing in ears blood in urine, three days, tinnitus is continual
59 2021-04-19 loss of taste, loss of smell Dose 1-No smell/ no taste 24 hours Dose 2-No smell/No taste-today is day 11
59 2021-04-19 mouth numbness face turned red tongue felt numb Benadryl 50 mg IM with resolution of symptoms
59 2021-04-19 swelling of eyelid Client received Dose 1 of Pfizer Covid Vaccine Lot # EN6200 on 3/25/2021 as well as Pfizer Dose 2 L... Read more
Client received Dose 1 of Pfizer Covid Vaccine Lot # EN6200 on 3/25/2021 as well as Pfizer Dose 2 Lot # ER 8732 on 4/15/2021. Client stated had mild eyelid swelling after both dose 1 and dose 2, but did not keep a journal of the exact days the swelling occurred. Client stated was unsure whether to report the reaction as she gets the same swelling after taking various medications. She stated she has been tested for allergies and does not have any. She reported the eyelid swelling was mild and came and went the weeks following the first dose of vaccine. She also had some swelling after the second but nothing that would keep her from getting future doses of the vaccine if they become necessary.
59 2021-04-19 ringing in ears After receiving the Pfizer 1st vaccine on March 17 and next appt to take the second one is on April... Read more
After receiving the Pfizer 1st vaccine on March 17 and next appt to take the second one is on April 7th but missed it due to I'm out of town and I will take it after coming back home. On the 9th of April starting to have an pulse tile feeling in my left ear so I made an appt to see my ear doctor to see if something connected to my ear infection and had surgery last year but my Dr said everything is good my hearing test is much better. Mention to my Dr that what's going and about the vaccine I had. He said possibly that is one of the side effect of the vaccine and heard some people who's got the same situation.
59 2021-04-21 ear pain Arm got real sore by evening. During the night I came down with the chills, extreme headache and bo... Read more
Arm got real sore by evening. During the night I came down with the chills, extreme headache and body aches all over. Some nausia, had a mild earache and sore throat along with fever. Had a little bit of an appitite. Earlier today (11:30 AM) I took two dayquil which took approx 1-1/2 hours b4 body aches, etc subsided a bit. Felt ok for a couple of hours. Its now 5:00PM and I'm feeling at my worst.
59 2021-04-21 lacrimation increased, dry mouth, swollen tongue, eye swelling Chief Complaint: ? Care Coordination ? Immunization/Vaccine Administration ? Tongue Swelling a 59 y.... Read more
Chief Complaint: ? Care Coordination ? Immunization/Vaccine Administration ? Tongue Swelling a 59 y.o. female with PMHx of HTN, Anxiety, well controlled T2DM and obesity who presented today to receive her first COVID Vaccine. Denies hx of anaphylaxis due to any cause. First COVID Vaccine administered in RD at 9:53 AM 13 min after the vaccine was administered she informed my CMA that she was having throat thickness, tongue swelling and watery eyes. I immediately completed vitals: BP: 178/100 Pulse: 76 RR 16 SpO2: 97% 10:13 am I moved her into my exam room. She stated that within 2-3 min of receiving the vaccine she began experiencing "throat thickness", dry mouth and tongue "thickness" but the symptoms had not progressed. She also c/o postnasal drip and a horse voice. She also c/o watery eyes and swelling around eye but states she had the watery eyes this morning prior to the vaccine. She also c/o numbness of a small area of her left wrist. She has significant environmental seasonal allergies for which she takes Claritin each morning and uses Flonase and montelukast each evening. She ran out of Claritin so she did not take one this morning. All of her symptoms are consistent with her normal environmental allergy symptoms she has been having off and on the last few weeks. She states they just all flared up about 2 min after the vaccine was given. She also states she did not take her BP medication this morning. She states she was very stressed out getting her today because she got lost and thought she would be late. Admits to feeling anxious. Denies hives, itching, difficulty swallowing, throat closing sensation, shortness of breath, chest pain, difficulty breathing, lightheadedness, dizziness, n/v/d, abdominal pain, wheezing, headache. 10:22 am States she has a slight headache but otherwise symptoms are stable Completed physical exam - unremarkable. No stridor, no lip/tongue/posterior pharynx swelling I reviewed her medication list 10:27 am Repeat vitals: BP: 178/102 Pulse: 72 RR 16 SpO2: 99% 10:36 am I continued to monitor her, I completed serial vitals and physical exams as well as continuously asked how she was feeling and doing. She denied difficulty breathing, wheezing, worsening of symptoms, chest pain, lightheadedness, palpitations. I advised giving her liquid benadryl only if she could have someone come pick her up. She declined stating that she did not have someone that could drive her home. She lives 20 min away 10:40 am She states that the eye swelling has resolved and the throat thickness was improving. Her slight headache has resolved. I advised we monitor for another 30 min here in the clinic. 11:10 am She states she is feeling much better. She reports her tongue and throat feel back to normal. Headache has resolved. She denies any difficulty breathing, wheezing, lightheadedness, dizziness, n/v/d, hives, itching, palpitations, throat/tongue itching. Rechecked vitals and physical exam. Vitals (75 min after vaccination) BP: 176/98 Pulse: 78 RR 12 SpO2: 98% ROS: Constitutional: Negative for fatigue, diaphoresis and weakness. Eyes: Negative for blurred vision, eye pain and photophobia. Watery eyes E/N/T: Positive for congestion and hoarseness. Negative for rhinorrhea, odynophagia, stridor and tinnitus. Throat and tongue thickness Cardiovascular: Negative for chest pain, palpitations, tachycardia, edema, dyspnea on exertion, irregular heartbeat and near-syncope. Respiratory: Negative for cough, shortness of breath, wheezing and sputum production. Gastrointestinal: Negative for abdominal pain, diarrhea, stool changes, nausea and vomiting. Integumentary: Negative for dry skin, pruritus, rashes, dry skin and flushing. Neurological: Positive for headaches. Negative for dizziness, weakness, focal weakness, light-headedness and vertigo. Allergic/Immunologic: Positive for environmental allergies. Negative for frequent illnesses, urticaria, hives and persistent infections. PMH: Diagnosis Date ? Abnormal mammogram ? Anxiety ? Essential hypertension, benign ? High cholesterol I reviewed the following historical information during this visit: Tobacco | Meds | Problems | Med Hx | Surg Hx | Fam Hx | Soc Hx OBJECTIVE: Vitals (75 min after vaccination): BP: 176/98 Pulse: 78 RR 12 SpO2: 98% Temp: 97.1 PHYSICAL EXAM CONSTITUTIONAL Vitals reviewed. GENERAL APPEARANCE: Well-developed and obese. GROOMING: Well groomed. LEVEL OF DISTRESS: The patient is nervous/anxious. The patient is not distressed or diaphoretic. She appears to be well. The patient is not lethargic or toxic. The patient does not appear tired. EYES: LIDS/CONJUCTIVA:Positive for Bilat/clear eye drainage.Negative for eye lid edema. No lid edema, no surrounding facial edema Conjunctiva are minimally pink, no erythema PUPILS/IRIS: extraocular movement intact. ENT EXTERNAL EARS/NOSE: External ears and nose are normal. SEPTUM/MUCOSA: Turbinates are mildly swollen. Negative for edematous mucosa, sinus tenderness and pale, boggy nasal mucosa. LIPS/TEETH/GUMS: Normal lips, teeth and gums. No lip edema. OROPHARYNX: Oropharynx normal. Mucosa: Mucosa appears normal. No tongue edema, erythema or rash noted No oropharynx or posterior pharynx swelling noted She is swallowing and breathing normally No stridor NECK: Neck normal. RESPIRATORY EFFORT AND PATTERN: Effort normal. No tachypnea, intercostal retractions, accessory muscle usage, hypopnea and irregular rate. AUSCULTATION: Normal breath sounds with no rales, rhonchi, wheezes or rubs. No inspiratory wheezes, expiratory wheezes or stridor. CARDIOVASCULAR AUSCULTATION: Rate: Is normal. Rhythm: regular. Heart sounds: S1 is normal. S2 is normal. S3/S4 not present. With no murmurs heard. EDEMA/VARICOSITIES: No edema or varicosities. RADIAL: radial pulses normal bilaterally PEDAL PULSE: Normal bilateral posterior tibal pulses. LYMPHATIC OTHER NODES: No neck adenopathy. No supraclavicular or submandibular nodes.Supraclavicular INTEGUMENTARY SKIN INSPECTION: Normal. ECZEMA/PRURITIC CONDITIONS: Negative for urticaria. Skin temp and color normal, no flushing, no diaphoresis, no urticaria Injection site is unremarkable NEUROLOGICAL CRANIAL NERVES: Cranial nerves normal. CN grossly normal GAIT, COORDINATION, REFLEXES Gait: normal PSYCHIATRIC ORIENTATION: She is alert and oriented to person, place and time. MOOD/AFFECT: Appears anxious. Does not appear agitated or depressed. She is not argumentative. She does not act disrepectful, act distrustful or have a flat affect. INSIGHT/JUDGEMENT: Normal insight/judgement. The patient has good insight with good judgment. ASSESSMENT/PLAN: Environmental allergies - Symptoms were consistent with her normal environmental allergy flare ups. - She did not take claritin this morning as usual so this may be why the allergies flared up - Symptoms resolved within 70 min of giving the vaccine without any therapy - I recommended giving liquid benadryl and having someone come pick her up and monitor her at home. She declined stating that she did not have someone who could pick her up and stated that she would rather take benadryl at home. - She stated she felt safe to drive home. I gave strict warnings that if any sx recurred or if any new or concerning symptoms developed that she should call 911. Reviewed signs and symptoms of anaphylaxis. - I advised she take liquid benadryl when she got home and have someone monitor her for the next 4 hours. Essential hypertension - elevated today likely due to increased stress/anxiety and not taking BP medication this morning - I advised that she monitor her BP closely at home. I advised she take her BP medication when she got home if her throat felt normal. - recommended f/u with PCP Encounter for administration of vaccine First Pfizer COVID Vaccine given today I recommended she consult with her PCP about the second vaccine. She expressed understanding and all questions answered. ----------------------------------- Called patient at 2:10 pm to check up on her. She states that she took liquid benadryl about 40 min ago and that all of her symptoms have completely resolved. She states that she is feeling great now. She denies difficulty breathing, throat swelling/tighntess/thickness, tongue swelling, wheezing, headache, n/v/d, lightheadedness, hives, itching, palpitations or chest pain. She states she took her BP medications but has not checked her BP at home yet. I recommended she continue taking benadryl as needed and recommended she follow up with her PCP in 1-2 days. --------------------------------- Patient's PCP) I wanted you to be aware that your patient had a mild reaction vs flare up of her environmental allergies after her first COVID Vaccine today. I called her 4 hours after the vaccine. She had taken benadryl at home and her symptoms had resolved. I was hoping to consult with you about her receiving her second vaccine. Her BP was elevated. She had not taken her BP medication this AM. I recommended she also f/u with you on that as well. --------------------------------- Dr's response "People react to making antibodies. The serious anaphylaxis is rare. Most are having general side affects and flu-like symptoms I would like you to administer the 2nd vaccine. Notes seen on morning of April 20. Responded."
59 2021-04-21 ringing in ears Ringing and buzzing in my ears.
59 2021-04-22 dry mouth, loss of taste 3 days after first dose - headache, dry mouth, loss of taste, fatigue, stomach pains, bloating, belc... Read more
3 days after first dose - headache, dry mouth, loss of taste, fatigue, stomach pains, bloating, belching, reflux, diarrhea, brain fog, no appetite. Saw healthcare provider. Given restricted diet, ordered abdominal ultrasound. Symptoms lasted 13 days. 2 days after second dose - same symptoms, but more intense/extreme. Healthcare provider has ordered abdominal MRI. Still experiencing symptoms.
59 2021-04-22 mouth numbness Patient reported a low grade fever and face/tongue numbness beginning 1 hour post-vaccination. She r... Read more
Patient reported a low grade fever and face/tongue numbness beginning 1 hour post-vaccination. She reported no difficulty breathing, but noted that eating and drinking was bothersome. No swelling/redness. Referred to the local urgent care for follow up.
59 2021-04-22 bloodshot eyes, eye disorder Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure ... Read more
Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; Anxiety; Eye felt red; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: E10142), dose 1 via an unspecified route of administration, administered in left arm on 14jan2021 at 09:00 as single dose for covid-19 immunisation. Medical history included vitamin supplementation, supplementation therapy, cataract (Mother had cataracts; problems with her heart; had a couple of strokes before she died at 59 years of age), cardiac disorder, cerebrovascular accident, pain (Before she had the first dose of Pfizer COVID-19 Vaccine she was not so concerned because she figured she would probably get body aches or headaches, normal side effects), headache, normal side effects. Concomitant medications included ergocalciferol (vitamin d [ergocalciferol), krill oil (megared omega 3 krill oil), vitamin c [ascorbic acid], nigella sativa seed (black seed [nigella sativa seed]), betacarotene, calcium carbonate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, sodium ascorbate, thiamine hydrochloride, tocopheryl acetate (one-a-day vitamin), cyanocobalamin (vitamin b12 [cyanocobalamin]), acetylsalicylic acid (baby aspirin), calcium, magnesium, zinc (magnesium/calcium/zinc) taken for vitamin supplementation and probiotics taken for supplementation therapy. No any other vaccinations within 4 weeks Prior to the first administration. No AE(s) following prior vaccinations: although she did get unknown Shingles vaccine in Sep2020, no AEs associated. She has not gone to get the second Shingles vaccine because she does not want to overlap vaccines while getting Pfizer COVID-19 Vaccine. The patient Was concerned for her 2nd dose which she was scheduled to take tomorrow on 02Feb2021 at 14:30, because of the side effects from her 1st dose. On 15Jan2020, a day after the 1st dose, her heart started pumping really hard and she had a fast heartbeat/ heart fluttering a lot. She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye. She it was strange because this has never happened to her before up until she got the vaccine. She consulted her eye doctor and mentioned that she will be monitored for the pressure in her right eye. She is also getting anxiety because of this. She was asking if she can go tomorrow to take the 2nd shot. The outcome of events her heart started pumping really hard, she also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye, anxiety and eye felt red was unknow where the outcome of events fast heartbeat/heart fluttering a lot was not recovered. Follow-up attempts are completed. No further information is expected.
59 2021-04-22 pain in jaw Upon going to bed, I experienced severe chills and shaking for 5 hours. Also severe headache, jaw, ... Read more
Upon going to bed, I experienced severe chills and shaking for 5 hours. Also severe headache, jaw, body and neck pain. Lymphnodes were swollen. Body aches; fever and nausea and fatigue. This lasted until 8 pm the next day (4/22). I am still experiences chills, fever, nausea, fatigue and general malaise as of 4/23/2021
59 2021-04-22 mouth tingling Headache, tingling of lips, chills,joint pain, muscle pain, fatigue sore and swollen site
59 2021-04-22 ringing in ears Severe tinnitus 2 days after first injection. Continued and made worse by second injection. Absolute... Read more
Severe tinnitus 2 days after first injection. Continued and made worse by second injection. Absolutely no improvement.
59 2021-04-22 vision blurred wheezing, dizziness, lightheadedness, fatigue, GI distress, hoarseness, Stridor, muscle/joint aches,... Read more
wheezing, dizziness, lightheadedness, fatigue, GI distress, hoarseness, Stridor, muscle/joint aches, skin redness/rash, nausea, vomiting, flushed skin, blurred vision
59 2021-04-23 mouth numbness Intense face and neck flush; Skin was red, very warm and tingly; Skin was red, very warm and tingly;... Read more
Intense face and neck flush; Skin was red, very warm and tingly; Skin was red, very warm and tingly; Began to have numbness in my lips and tongue; My BP was on the elevated side; skin very warm; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ELI283 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 03:00 PM, as single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism and hypertension. The concomitant medication included toprol, pravastatin, levothyroxine, fish oil, CoQ10. Patient did not take any other vaccine in four weeks. No COVID prior vaccination and no covid tested post vaccination. On 09Feb2021 at 15:15 At about 18 minutes after the vaccine was administered, patient had a sudden and intense face and neck flush, skin was red, very warm and tingly. Patient took benadryl 25 mg tablet and after about 5-10 minutes began to have numbness in lips and tongue. At this point, patient returned to the vaccination site to report this and wait for resolution. Patient was immediately seen by a nurse and EMS and her vitals were taken and was advised to take another 25mg of Benadryl. Patient underwent lab test and procedure which included BP was on the elevated side, O2 sat was normal. Her symptoms improved and by 45 mins after the vaccination she was comfortable returning to home no additional symptoms. The outcome of the patient's events was recovered.
59 2021-04-23 lip swelling Patient reported adverse effect of covid vaccine dose one during her second dose appointment. Patie... Read more
Patient reported adverse effect of covid vaccine dose one during her second dose appointment. Patient self reported that 12 hours after she received dose 1 of her covid vaccine she woke up with her cheek swollen on her right side. Also part oher her lip and the inside of her ight cheek was swollen. Patient reported she spoke with her oncologist, who recommended she take benadryl. She took Benadryl a few times a day for a couple days, which helped her symptoms. Her symptoms lasted for 1-2 days. Patient reported per d/w her oncologist she took Benadryl as a pre-medication for dose 2 of the covid vaccine.
59 2021-04-23 eye discomfort On 4-9-2021, pt (community member) came in to receive a covid vaccine. Pt answered health questio... Read more
On 4-9-2021, pt (community member) came in to receive a covid vaccine. Pt answered health questionnaire and was unremarkable, thus vaccine was given after all consents were signed and identity was confirmed with 2 sources. Pt arm was prepared as per policy and procedure. Pt asked, "are you a nurse and what method of vaccination are you going to use?" I told the patient that I am a nurse and that I was going to use the z track method to administer vaccine and then described it. After cleaning the site the patient stated, "wait let it dry and began wafting the site." The patient was told not to do this as waving air toward the site would bring germs to it. The patient's deltoid was then prepared again. The vaccine was administered as per policy and procedure. About 10 minutes after receiving vaccine pt stated she was having eye discomfort but denied other symptoms. The patient was offered oral Benadryl as an anaphylactic response was not apparent. The patient refused the clinic's Benadryl and stated I have my own. The patient was given water and took 25mg of Benadryl by mouth. The patient was also asked to stay 15 to 30 minutes longer for observation as it appeared she was having a mild reaction. Patient was agreeable. Blood pressure was 178/80, heart rate was 78, and oxygen saturation was 95 on room air with a respiratory rate of 18. No signs or symptoms of distress were noted. At 11:00, patient was asked if she felt better. The patient stated yes, but stated having numbness in arm that vaccine was given in. The arm was assessed, patient was able to move arm in full range of motion, capillary refill was less than 3 seconds, and no swelling or redness was observed. The patient then stated, "oh it just must be my muscle." The patient was educated that a sore arm was to be expected and was a common side effect, but if the numbness worsened or diminished function was observed she should go to the Emergency Room. Pt stated understanding. The patient stated, that at this times she needed to go because her daughter had to go to work. The patient was encouraged to stay for more observation, but refused and stated she was feeling better. The patient was told to go to the emergency room if symptoms worsened. Patient was also educated on her blood pressure, as it was noted to be elevated. The patient stated she took her blood pressure medications that morning. The patient was asked to take blood pressure at least 2 more times ( at lunch and dinner time) and if blood pressure remained higher than 170 systolic (on the top number), that she needed to go to the emergency room and consult with her primary doctor. Patient stated understanding. Clinic phone number was provided to patient, in case she had any question or concerns. Patient was able to exit clinic with a steady gain, alert and oriented x3, and with no signs or symptoms of distress noted
59 2021-04-23 mouth tingling Just after having the shot 20 mins, lips started having tingling, 10 mins later face on the left sid... Read more
Just after having the shot 20 mins, lips started having tingling, 10 mins later face on the left side started been numb and it lasted for about an hour.
59 2021-04-23 ringing in ears Tinnitus followed by smelling smoke issues
59 2021-04-24 deafness unilateral, ringing in ears, ear discomfort Right ear started popping; patient started to feel fullness in her right ear; right ear started high... Read more
Right ear started popping; patient started to feel fullness in her right ear; right ear started high pitched ringing ( tinnitus); She then lost hearing in her right ear; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 15Mar2021 15:00 (lot number: EN6207) at the age of 59 years old, as single dose for COVID-19 immunization. Medical history reported as none. The patient was not pregnant at the time of vaccination. Concomitant medications included hydrochlorothiazide, metoprolol tartrate (METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE); losartan; levothyroxine sodium (LEVOTHYROXINE); all taken for an unspecified indication, start and stop date were not reported. 2 days after 1st dose (17Mar2021 04:00), the patient started to feel fullness in her right ear. She thought at first perhaps it was water, but feeling continued. Right ear started popping a few days later. She called her primary care physician and made appointment to come in. Primary care could see nothing wrong, no inflammation in ear or fluid. That following weekend (Mar2021) after primary care visit, her right ear started high pitched ringing (tinnitus). She then lost hearing in her right ear. She went to urgent care who also saw nothing but referred her to ENT doctor. 2 days later at ENT audiologist reported significant hearing loss in her right ear. She is currently prescribed prednisone with no change. She never had a reaction to any shot ever previously. She also have never had any hearing issues or tinnitus ever in her life. The only time she had anything is from the Pfizer shot. She has been advised by her doctor to hold off on second dose. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. The patient was not diagnosed with COVID prior and after vaccination. The patient has no known allergies. No other vaccines received four weeks prior to COVID vaccine. The patient has not recovered from the events.
59 2021-04-24 ringing in ears Beginning the evening of my second shot I have developed, with no prior history, tinnitus in both ea... Read more
Beginning the evening of my second shot I have developed, with no prior history, tinnitus in both ears. The sound is not terribly loud unless my house is silent - it is more like crickets or tree frog sounds rather than just a high pitch. I plan to call my family dr if the sound persists into this next week.
59 2021-04-24 vision blurred The evening of my vaccine, my vision became blurry. My hands began to tingle with pins and needles s... Read more
The evening of my vaccine, my vision became blurry. My hands began to tingle with pins and needles sensation. Concerned, I looked up side effects online but all I could find was possible fainting. I did not feel faint, so I continued to monitor myself. I finally fell asleep around midnight. I woke up around 8 still with pins and needles sensation; however, in my left big toe it had subsided. My blurred vision seemed better. Still concerned I called the doctor's office.
59 2021-04-25 dry throat Patient exhibits rash on inside of R arm after receiving 1st dose Pfizer vaccine in R deltoid. Patie... Read more
Patient exhibits rash on inside of R arm after receiving 1st dose Pfizer vaccine in R deltoid. Patient also notes "dry throat". At 0953, RN administered 25mg oral liquid benadryl. 2nd dose 25mg benadryl liquid oral administered at 1015am. Patient rash diminished. Patient states "feeling great" and ready to go home after benadryl administration. Patient instructed to stay hydrated.
59 2021-04-25 eye bleeding Broken blood vessel at the corner On the lid of my right thigh starting from the corner up on the to... Read more
Broken blood vessel at the corner On the lid of my right thigh starting from the corner up on the top eyelid. I had to strange dizzy spells about a week out from having my second shot and again about a week and a half another dizzy spell. Today is 23 days out from getting my second shot. There?s no soreness at the eye area and my eye ball is totally unaffected. No redness in the eye at all.
59 2021-04-25 eye pain Initially just a sore arm and itching and then each day progressively worse dizziness headache eye p... Read more
Initially just a sore arm and itching and then each day progressively worse dizziness headache eye pain nauseated swollen lymph glands difficulty breathing now 2 weeks!
59 2021-04-25 lip swelling mild upper lip and facial swelling over course of one hour; normal vital signs. no progression to a... Read more
mild upper lip and facial swelling over course of one hour; normal vital signs. no progression to anaphylaxis treated with cetirizine 10 mg x 1
59 2021-04-25 swollen tongue Swollen Tongue and Throat and Nausea.
59 2021-04-26 dry mouth, loss of taste pt says she when she woke up she was dry heaving and severe headache. She had chills, diarhea, naus... Read more
pt says she when she woke up she was dry heaving and severe headache. She had chills, diarhea, nausea, skin was slightly red and peeling. She had vertigo, sore throat, dry mouth, loss of taste, fatigue, muscle aches and pains. Her right arm hurt more than the left arm where she had the arm that was injected. She had major hair loss and trouble focusing and feels like she has a sinus infection. Patient is taking cold and flu meds. She does feel some better but still has a headache and feels like she has a cold.
59 2021-04-26 taste impairment A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficul... Read more
A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficulty breathing; had a horrific taste in my mouth; A nurse saw me in distress & caught me before I hit the floor; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 11Apr2021 at 11:15 (batch/lot number: EP7533) as a single dose for COVID-19 immunisation. Medical history included cancer history, back injury, right shoulder injury; and known allergies to sulfa, IVP dye, latex, bee stings and mushrooms. The patient was not pregnant. Facility type vaccine was health clinic. No other vaccine in four weeks. No Covid prior to vaccination and not Covid tested post vaccination. Concomitant medications in two weeks included gabapentin, valaciclovir, tramadol, doxycycline and vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine, morphine and hydromorphone hcl (DILAUDID) and experienced known allergies to all drugs. On 11Apr2021 at 11:30, also reported as within 2 minutes of getting the vaccine, the patient had a horrific taste in her mouth followed by dizziness & lightheadedness. A nurse saw her in distress & caught her before she hit the floor. She then had difficulty breathing. They administered EpiPen, 50 mg liquid Benadryl & 2 puffs of Ventolin. She was transported to the ER by ambulance. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
59 2021-04-26 taste impairment Metallic taste in my mouth. Arm very sore like someone punched me.
59 2021-04-26 mouth numbness 11:44am Numbness to upper section of lip. Patient voiced that she is feeling much better. 156/88, ... Read more
11:44am Numbness to upper section of lip. Patient voiced that she is feeling much better. 156/88, HR 86, O2Sat 96%
59 2021-04-26 mouth pain My mouth got sore and I had a headache. Now I have several sores in my mouth and my right cheek is ... Read more
My mouth got sore and I had a headache. Now I have several sores in my mouth and my right cheek is sore. It is uncomfortable to eat.
59 2021-04-27 loss of smell strong headache; a lot of shortness of breath; lungs full of fluids; stomach sickness; lost of smell... Read more
strong headache; a lot of shortness of breath; lungs full of fluids; stomach sickness; lost of smell; This is a spontaneous report from a contactable Nurse (patient). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 14:00 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, asthma, diabetes. Known allergies: ranitidine/metformin. No pregnant. The patient's concomitant medications were not reported. No covid prior vaccination.No other vaccine in four weeks. Historical Vaccine included first dose bnt162b2 at 58 year old for covid-19 immunisation, first dose lot number=EN6199, administration date=10Mar2021, administration time=02:00 PM, vaccine location=Left arm and experienced headache, shortness of breath and body pain. The patient experienced strong headache, a lot of shortness of breath, lungs full of fluids, stomach sickness, lost of smell on 05Apr2021 with outcome of recovering. The event was serious due to life threatening. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Betamethasone 6mg/ml=3ml/ predinisone 40mg x 4. No covid tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021444473 Same patient, different shot/event
59 2021-04-27 lip swelling LIP SWELLING
59 2021-04-27 mouth swelling, mouth discomfort Patient called the pharmacy complaining of swelling inside of mouth, having spicy feeling, red in ap... Read more
Patient called the pharmacy complaining of swelling inside of mouth, having spicy feeling, red in apperance. It's not painful but uncomfortable according to the patient, can still taste, chew or eat normally. No ulcer or bleeding. Recommended the patient to start Benadryl right away at night to avoid drowsiness.
59 2021-04-27 ringing in ears tennitis and possible hearing loss
59 2021-04-28 ear pain Two weeks after first Covid Pfizer shot, I started with fatique, then painful left ear ache, which w... Read more
Two weeks after first Covid Pfizer shot, I started with fatique, then painful left ear ache, which was pulse like in nature. Painful and kept coming and going. Dr. appt and said ear was good, might be a lymphnode but no infection. Thought maybe a tooth issue. Dentist said no. Fatigue progressed, with irritability and a dull pain started in left chest muscle but I thought it was from lifting weights. Then extreme itching in center of back, thought a spider bite? Couldn't see it. 24 hrs before my 2nd shot appt, asked son to look at my back. Small rash size of a quarter. Changing my shirt, I noticed two more quarter size rashes on side of left breast. Never any fever. Uploaded photos and telemed dr confirmed shingles. Prescribed Valacyclovir for 7 days. Was told it looked like a mild case. First symptoms started 4/10/21, rash discovered 4/16/21 but probably started 4/13/21. No blisters developed. Back only itched but left breast pain grew worse to under arm and entire breast. But rash did not spread. Rash just starting to fade April 28, but pain still persists. Dr. advised not to get 2nd shot until after antiviral med finished, but I am still waiting 2 more weeks and hope to get 2nd shot May 7th, before the 42 day window closes even if I still have pain. I flew to get first shot as I was eligible there. I needed vaccine asap due to childcare and my Medicare business seeing over 65 population. I will probably try to get the 2nd shot now only because it is slowly but finally opening up with some vaccine availability. Hope this helps.
59 2021-04-28 eye disorder, eye pain Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side;... Read more
Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side; she was about to faint; seizure; Diarrhea; chills; head hurting; eyes hurting; Muscle soreness; joint pain; Nausea; temperature of 99.3; This is a spontaneous report from a contactable consumer (daughter of patient) and another consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:21 (Lot Number: EW0164; Expiration Date: Aug2021) at vaccination age of 59 years old as single dose for covid-19 immunisation. Medical history included vertigo, antacid therapy. Concomitant medication included esomeprazole magnesium (NEXIUM 24HR) taken for antacid therapy from an unspecified start date and ongoing. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7533), on 23Mar2021 at 17:38 PM at age of 59 years old in the right arm as single dose for covid-19 immunisation and only had a little bit of muscle soreness on her right arm on 23Mar2021 after the first dose and it went away the day after (24Mar2021). The patient took Tetanus shot about two weeks before the first dose of the Pfizer COVID 19 vaccine. Then received the second dose on 13Apr2021 16:21PM in the left arm. After the second dose she had chills; her head was hurting; her eyes were hurting; she had muscle soreness; she had joint pain all yesterday 14Apr2021. Then this morning 15Apr2021, after taking a Tylenol and getting a shower she felt dizzy like she was about to faint. Her mother had vertigo but this was not like her usual vertigo. Her mother sat on the bed and started to have what looked like a seizure with twitching and shaking; then she lost consciousness. Her mother's eyes were open and they saw her mother's eyes twisted, went to one side, and she fell back on the bed. They called at 05:30 AM and the ambulance arrived quickly but by the time they arrived she had regained consciousness. They recommended she follow up with HCP. They called the doctor who advised her to rest, and make an appointment to see the doctor tomorrow. Reporter clarified her mother had the chills from 10:00 AM today (15Apr2021) and had them day with a lot of headache, eyes hurting goes along with the headache, and she had a temperature of 99.3. The chills and temperature resolved last night then the eyes hurting ended this morning (15Apr2021) with the headache. All of the other symptoms resolved yesterday (14Apr2021). She also had nausea that started yesterday (14Apr2021) and she started to have diarrhea once today (15Apr2021)and felt like it had stopped. The nausea was coming and going from time to time. The events did not require a visit to emergency room or physician office. The outcome of events chills, muscle soreness, joint pain, temperature of 99.3 was recovered on 14Apr2021. The outcome of events Lost consciousness, head hurting, eyes hurting, felt dizzy, twitching and shaking, eyes went to one side, Diarrhea was recovered on 15Apr2021. The outcome of event seizure, she was about to faint was unknown. The outcome of event nausea was recovering.
59 2021-04-28 swollen tongue Swelling tongue, throat, ankles, hands, headache, stuffed nose
59 2021-04-29 oropharyngeal discomfort Just under 48 hours after the vaccine on 4/10/2021, I experienced a large swelling on either side of... Read more
Just under 48 hours after the vaccine on 4/10/2021, I experienced a large swelling on either side of my neck, up and down the neck. I assume it was my lymph nodes. I felt as if someone was pushing my Adam's apple. Unpleasant and scary as I though it might get worse and I would choke. This lasted most of the day Saturday. The same swelling and pressure in my throat occurred after the second Pfizer shot on 4/29/2021 (Lot Number: EW0153 ; 7/21/2021). This time it happened more quickly. Five hours after I received the shot. (Vaccine received at 11:30 am). The pressure in my throat lasted throughout the afternoon. I also felt burning and tingling at the site of the FIRST vaccine at this time.
59 2021-04-29 pain in jaw 59 y/o woman with hx Graves disease, htn, OSA, HLD, obesity who presented to OSH with 3-4 days of wo... Read more
59 y/o woman with hx Graves disease, htn, OSA, HLD, obesity who presented to OSH with 3-4 days of work finding difficulty, leg weakness, headaches, jaw pain and poor po intake. At outside hospital she was found to have left posterior frontal centrum semiovale infarct (MRI), lab work revealed thrombocytopenia with significant schistocytes on blood smear. She had a mild troponin leak with normal ECG. She had hematology input from advising Plex for suspected TTP. She was transferred to hospital on 4/30/21.
59 2021-05-04 taste impairment, mouth numbness Immediately had strong metallic taste, accompanied by mild nausea. Began drinking lots of water, wh... Read more
Immediately had strong metallic taste, accompanied by mild nausea. Began drinking lots of water, which did help. Lips became numb, but did not swell, no difficulty breathing or tightness in chest. Symptoms were mild, so no treatment was needed., so I went home to rest and hydrate. Continued to drink lots of water. Felt very fatigued and lips were numb for 4-5 hours post vaccine.
59 2021-05-05 mouth tingling, lip swelling Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine ra... Read more
Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine rash on cheeks/chin and face swelling, roof of mouth felt slightly swollen and lips tingly feeling slightly swollen, pills felt stuck in back of throat. went back in facility they told me to take Benadryl and go to doctor or ER if it gets worse, took Benadryl and Zyrtec and started past allergic reactions protocol, up to 4 Zyrtec and 4 Allegra in a day and Benadryl as needed. QNasl. Saw nurse practitioner who added Pepcid 2times a day. Did this for 3 weeks pills still feel stuck at back of throat on and off in a day.
59 2021-05-07 deafness, ear discomfort, ringing in ears head pressure (specifically left ear area, also mild hearing loss left ear); Headache; head pressure... Read more
head pressure (specifically left ear area, also mild hearing loss left ear); Headache; head pressure (specifically left ear area, also mild hearing loss left ear); Tinnitus; loss of appetite; insomnia (still have tinnitus and ear pressure as well as insomnia); insomnia (still have tinnitus and ear pressure as well as insomnia); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration (at the age of 59-years-old), administered in Arm Left on 23Mar2021 12:45 (Lot Number: ER8730) as single dose for COVID-19 immunization. Medical history included known allergy to penicillin. The patient was not pregnant. Not diagnosed with COVID prior vaccination. No concomitant medications received. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 59-years-old), administered in Arm Left on 02Mar2021 08:15 AM (Lot Number: EN6202) as single dose for COVID-19 immunization. The patient experienced headache, head pressure (specifically left ear area, also mild hearing loss left ear), tinnitus, loss of appetite, insomnia (still have tinnitus and ear pressure as well as insomnia) on 28Mar2021 12:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 30Mar2021. No treatment received for the events. The outcome of the events was not recovered. The event mild hearing loss left ear was considered as serious (medically significant). Facility type vaccine was Hospital. No other vaccine in four weeks.
59 2021-05-09 ear pain, taste disorder, swollen tongue Tingling in hands and feet,slight swelling of tongue,funny taste in mouth,pain in right ear,Benadryl... Read more
Tingling in hands and feet,slight swelling of tongue,funny taste in mouth,pain in right ear,Benadryl taken at home for 2 days after also tired , lightheaded and slight headache. Now Zyrtec daily .... itching and tingling occurs in various areas and continues today.
59 2021-05-09 pupils dilated o ED Course Medical decision making arrival to ED 5:54 am on 5/10/21 Patient with altered mental s... Read more
o ED Course Medical decision making arrival to ED 5:54 am on 5/10/21 Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic ED COURSE: o ED Course Medical decision making Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic CRITICAL CARE: o Critical Care Indication patient was critically ill... o Critical Care Indication Patient was critically ill with a high probability of imminent or life threatening deterioration. o Critical Care Time Spent 75-104 minutes (1 hour 15 minutes-1 hour 44 minutes) 2 hours and 50 minutes ED WORKING DIAGNOSIS: Perforated abdominal viscus (R19.8): Status: Active Septic shock (A41.9): Status: Active DISCHARGE/ADMISSION/TRANSFER DISPOSITION: o Disposition admitted o Admit To To OR CONDITION ON DISCHARGE/ADMISSION/TRANSFER: o Condition Critical Date of OR Procedure o Date of Procedure 05/10/2021 10:01 Pre Op Dx, Post Op Dx, Procedure o Pre Operative Diagnosis: Perforated viscus o Post Operative Diagnosis: Ischemic bowel, most likely from shower emboli. Most of the small intestine and large intestine was affected. o Procedure: Exploratory laparotomy, ICG injection for evaluation of perfusion Indication and Consent Findings: . Findings: Even after the ICG injection. There was spotty tissue necrosis from mid jejunum all the way through sigmoid colon. Most areas were blackened with a foul smell. There was some highlighted areas secondary to the ICG but not a significant amount that would lend for an anastomosis. Black ascites was present throughout the abdomen. Unfortunately after much contemplation there was no surgical intervention. Procedure Procedure: Patient was placed in supine position. Was intubated in the emergency room so, we were able to proceed with resuscitation through our anesthesia team. Patient's abdomen was prepped and draped in usual fashion. Proceeded to make a midline incision. The blood supply in the subcutaneous tissues did not even bleed. Appeared to be darkened and almost coagulated. As we entered through the fascia we were able to open the peritoneum between 2 hemostats. The large rush of free air through from the abdomen. We then proceeded to open the abdomen for the length of her incision. This was done with electrocautery. From here there was a black ascites present within the abdomen. There was a large amount of dead intestine that we could immediately see. I worked my way to the ligament of Treitz. There was no adhesions so this was easily found. That intestine did appear to be pink. It lasted for about a foot. After that area everything was either black or purple in color with a few pink spots in between. This went all the way down to the terminal ileum where pneumatosis was visualized. We then looked at the colon from cecum through rectum. It appeared to be blackened as well. Not knowing whether all of this intestine was dead or not especially with patient being hypotensive I injected ICG dye approximately 2 cc. This was to evaluate perfusion. Unfortunately perfusion was no better than what I could visualize. I could not even find enough room of the colon or small intestine to make an anastomosis. Was very hard decision, however, we did not resect any bowel. I closed the patient's abdomen. Patient will be taken to ICU on ventilator. Discussed with daughter with pastor present.
59 2021-05-09 toothache, pain in jaw Day of shot within 1 hour Felt like my arm was dislocated for several days. Still feeling discomfort... Read more
Day of shot within 1 hour Felt like my arm was dislocated for several days. Still feeling discomfort. Day 3 Extreme burning in lower jaw with pain also similar to toothache and all teeth and lower jaw. Eventually extended throughout my neck and lower part of my head. Inhaling felt like stabbing in lower neck and a three and four.
59 2021-05-11 ringing in ears arm started burning, hives on roof of mouth, developed ringing in the ears that wont go away. Pro... Read more
arm started burning, hives on roof of mouth, developed ringing in the ears that wont go away. Provider only said to take Benydral.
59 2021-05-19 swelling around the eyes Increasing the itchiness. now in my legs too/itchiness in my skin; Rash in my left side of my face, ... Read more
Increasing the itchiness. now in my legs too/itchiness in my skin; Rash in my left side of my face, neck , ears, arms and chest; My under left eye was swollen & redness; My under left eye was swollen & redness; It's very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 22Apr2021 12:15 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, depression and known allergies: yes from an unknown date and unknown if ongoing. Concomitant medications included losartan; escitalopram oxalate (LEXAPRO); bupropion; hydrochlorothiazide all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old, via an unspecified routed of administration administered in left arm on 01Apr2021 12:15 (lot number was not reported) for covid-19 immunization. The patient reported 2 days after her second vaccine, she was with rash in the left side of her face, neck , ears, arms and chest. Her under left eye was swollen & redness. Increasing the itchiness now in her legs too. It's very uncomfortable. The events occurred on 24Apr2021 06:00. She have been using several products over the counter such as Zyrtec, Benadryl cream, Caladryl, Hydrocortisone, Aveeno body wash and Curel lotion. But still suffering of the itchiness in her skin. The patient did not recover from the events. Information on the lot/batch number has been requested.
59 2021-05-19 feeling of choking Immediately after administration, patient stated tingling in throat, sweating and shakiness. Asked ... Read more
Immediately after administration, patient stated tingling in throat, sweating and shakiness. Asked if patient is diabetic ( she did say no to all chronic health conditions on question form). stated she could be hypoglycemic and nervous. We monitored for 5 minutes and she complained of difficulty breathing upon which I asked if she wants me to administer EpiPen and she said "yes". I administered EpiPen 0.3mg in right tight. After EpiPen she seamed to calm dowm. 911 was called as the EpiPen was administered. After EMS came, patient walked on her own to get her vitals checked. Shortly after leaving, pharmacy received call from patient her self that she is home and feel normal. Followed up with patient an hour later and she is still doing well.
59 2021-05-19 ringing in ears Developed tinnitus shortly after2nd vaccine/ Within 2 days of 2 bf vaccine on 20Feb2021 o developed... Read more
Developed tinnitus shortly after2nd vaccine/ Within 2 days of 2 bf vaccine on 20Feb2021 o developed tinnitus in my left ear and fullness; I have had a constant hissing sound in my head since with little relief; This is a spontaneous report from a contactable other health care professional. A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 20Feb2021 (Batch/Lot number was not reported; 59-years age at time of vaccination) as single dose for covid-19 immunisation. The patient medical history was not reported. The concomitant medications includes Statin. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in Left arm on 30Jan2021 12:00 for COVID-19 immunisation. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination includes Statin. On 21Feb2021 13:00, patient developed tinnitus shortly after2nd vaccine within 2 days or so. have now had it for 6 weeks. Also reported "Within 2 days of vaccine on 20Feb2021, developed tinnitus in my left ear and fullness. I have had a constant hissing sound in my head since with little relief. I have never had tendinitis or experienced anything like this it has been debilitating I am furious and expect a response from Pfizer". treatment received with Vitamins, treated with steroid. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The events outcome was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Tinnitus and Fuzzy head. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
59 2021-05-19 visual impairment stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Na... Read more
stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Nausea; Believes it effected her memory; stroke like symptoms; similar to migraines; mini-strokes; This is a spontaneous report received from a contactable consumer. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Apr2021 (Lot Number: EW0153; Expiration Date: 31Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 59 years). Medical history included ongoing strokes, ongoing third and fourth Nerve Palsy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) taken for blood thinner; metoprolol for Stroke, Heart regulation; lovastatin taken for Stroke, Heart regulation. The patient states that she went to the Emergency Room on 17Apr2021 and then went again on either 18Apr2021 or 19Apr2021. The patient states she does not know if she was admitted or not. States that she thinks she just was in the emergency room the time that she was there. Says that after the Covid Vaccine she was having stroke like symptoms; similar to migraines; mini-strokes. She was passing out, had nausea, blind spots in her vision, and she believes it effected her memory. The events occurred on 17Apr2021. Also, she said on her first emergency room visit they did a CT Scan and on her second emergency room visit they did a MRI and both was not reported. States they told her there was no issues. The patient underwent lab tests and procedures which included CT Scan: and MRI: not reported on Apr2021. Outcome of the event vision impairment was not recovered while outcome of the event nausea was recovered on Apr2021. Outcome of the event memory impairment was recovering while outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-05-24 lacrimation increased constant runny nose; Mild fatigue; constant watering eye; This is a spontaneous report received from... Read more
constant runny nose; Mild fatigue; constant watering eye; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female non-pregnant patient received at workplace clinic BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via unspecified route of administration in right arm on 18Feb2021 10:00 AM (at the age of 59-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included that patient was healthy at present she had cancer (ovarian) with chemotherapy on 2013 (also reported as 7 years before the present report) and she had cancer (breast) with radiation 6 years before the present report on 2015. No COVID prior vaccination was reported. The patient's concomitant medications administered in two weeks included anastrozole (ARIMIDEX), calcium carbonate (CALTRATE) and centrum multivitamin, all from unspecified date. No other vaccine administered in four weeks. As per known allergies it was reported that the patient previously received penicillin, sulfa drugs and she experienced rash with both, vancomycin and she experienced intolerance, codeine and she experienced vomiting. On 18Feb2021 04:45 PM (as reported) the patient experienced constant runny nose and constant watering eye, both over the course of about 6 hours in the evening after the vaccination (as reported) and mild fatigue. No treatment was received due to events. Patient was not tested for COVID post-vaccination. The outcome of the events was resolved. No follow-up attempts are needed. No further information is expected.
59 2021-05-25 ear itchiness 45 minutes after the first vaccine of the Pfizer had a reaction that consisted of ears itching and g... Read more
45 minutes after the first vaccine of the Pfizer had a reaction that consisted of ears itching and getting hot. Patient took prednisone and better within hours.
59 2021-05-25 eye itchiness, lip swelling, swollen tongue, ringing in ears Within 2 minutes and her heart rate was over 112 beats per minute. Alsolso felt dizziness, lighthead... Read more
Within 2 minutes and her heart rate was over 112 beats per minute. Alsolso felt dizziness, lightheaded, vertigo, brain fog, tinnitus, rash on upper back, puffy red lips, white spots on the soles of the feet, stomach cramps, had problems forming sentences,had a hard tine even trying to call husband, itchy eyes, felt itchy and hot on her injection arm, had difficulty breathing, had to to take deep breaths, chills, freezing, headache, tongue started to swell, neck started to swell in the thyroid area, started to feel tired and sleepy, had to get assisted to the bathroom, the walls started to move in. The patient took Claritin 1 hour and a half i because they didn't want to give her her epi pen because her heart rate was too high and she is allergic to Benadryl. Stayed at the site for 2 hours, drank a lot of water, couldn't walk and she had to stay in a wheelchair. She said it took around 2 weeks to feel normal. She had spells of feeling dizzy and confused with brain fog for 2 weeks. Felt tinnitus for around 10 days after the vaccine. tinitis lasted 10 days brain fog 2 weeks: didn't know how to figure out how to turn car on. fatigue lasted about 4 weeks white spot on feet went away 2 weeks.
59 2021-05-25 tunnel vision, eye disorder 1. 3/21 leading up to 3/31 I had a low grade fever that would not go away. 2. 3/31 at 2am, hit wi... Read more
1. 3/21 leading up to 3/31 I had a low grade fever that would not go away. 2. 3/31 at 2am, hit with bout of intense nausea which continued through 4/-3. The most intense was 3/31-4/1. 3. 4/3-4/4 my right side under rib cage was screaming in pain Treatment -- went to doctor's office on 4/2 to make sure not covid (tested negative), given a perscription for nausea. Called Dr.'s office and advised to go to Primary Care Physician. Also, advised hot water bottle on organs that hurt. The hot water bottle soothed the intense pain. Had soup when could tolerate it. 4. Went to doctor's office on 4/5 regarding the intense pain on right side. An abdominal Ultrasound was ordered. April 25, 4am, my eye sight went to seeing 1/2 of objects and words, then went to tunnel vision. 1. I saw Primary Physician who referred me to an opthamalogist. 2. Opthamalogist saw nothing wrong with eye -- suggested taking baby asprin and that there had been a TIA, referred me back to Primary Physician for a referral to Cardiologist / Vascular physician
59 2021-05-25 vision blurred Tingling pins and needles on my hands; Blurred vision; This is a spontaneous report from a contactab... Read more
Tingling pins and needles on my hands; Blurred vision; This is a spontaneous report from a contactable consumer (patient) from COVAES. This 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8733) via an unspecified route of administration in the left arm on 23Apr2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin and shellfish allergies, both from unknown dates and unknown if ongoing. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included prednisone from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number not reported) on 02Apr2021 at 11:30 (at the age of 59-years-old) for COVID-19 immunisation. The patient reported the evening of her vaccination she noticed some blurred vision and tingling pins and needles on her hands on 23Apr2021 at 18:00. She reported that because she was concerned about it, she kept watch of it until she fell asleep and in the morning she called her doctor's office who suggested she go to the emergency room for possible neurological effects. The events required an emergency room and physician office visit. The clinical outcomes of blurred vision and tingling pins and needles on her hands were recovering. It was also reported that the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are needed. No further information is expected.
59 2021-05-26 lip swelling Lip swelling, hives
59 2021-05-28 hearing loss, ringing in ears crackling in right ear, slight hollow type sound when moving jaw, slight muffling, noticeable on a... Read more
crackling in right ear, slight hollow type sound when moving jaw, slight muffling, noticeable on and off... has not subsided as yet, have not ever had this type of issue with hearing..
59 2021-05-28 mouth swelling, swollen tongue, eye swelling Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of ... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
59 2021-05-28 ringing in ears, ear pain On 05/18/21at 6pm I started hearing a loud hissing noise in both ears, tinnitus; left ear pain on a... Read more
On 05/18/21at 6pm I started hearing a loud hissing noise in both ears, tinnitus; left ear pain on and off; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8732), via an unspecified route of administration, administered in left arm on 11May2021 (age at the vaccination 59-year-old) as first dose single for covid-19 immunisation. Medical history included migraine and COVID-19. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date vaccine location left arm. On 18May2021 at 6pm patient started hearing a loud hissing noise in both ears, tinnitus, it subsided after about 15 minutes but returned at about 9 pm, it subsided after a few minutes, it has continued to come and go since. Also left ear pain on and off since vaccine. Patient did not received treatment for the adverse events. The outcome of the events was not recovered.
59 2021-05-31 lip swelling, mouth tingling 35 minutes after injection, tingling and swelling of bottom lip; tingling felt on tongue but no swel... Read more
35 minutes after injection, tingling and swelling of bottom lip; tingling felt on tongue but no swelling. Tingling lasted for 10 minutes and swelling lasted for about 12 hours. No hives, shortness of breath.
59 2021-06-01 taste impairment She had Covid 19 virus symptoms; shortness of breath; heart is racing; chills; she feels her mouth a... Read more
She had Covid 19 virus symptoms; shortness of breath; heart is racing; chills; she feels her mouth as if she had eaten too much salt; diarrhea; Feet pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0170), via an unspecified route of administration, administered on Left Arm on 14May2021 09:00 at single dose for covid-19 immunization (to protect herself from the virus). The patient's Medical history and concomitant medications were not reported. The Family Medical History Relevant to events was reported as none. The patient has not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172) via unspecified route of administration administered on Left Arm on 23Apr2021 for COVID-19 immunization. On 14May2021 14:00 the patient experienced shortness of breath, heart is racing, chills, she feels her mouth as if she had eaten too much salt, diarrhea, feet pain. Upon received follow-up information on 20May2021, it was reported that On 18May2021 the patient experienced She was told she had Covid 19 virus symptoms and if her symptoms persisted to keep treating herself at home. The doctor did not perform a Covid 19 virus test. It was reported that About 5 hours after receiving her second Covid 19 vaccine, the patient experienced the events. The events resulted in physician visit. The relevant tests was reported as none. The outcome of event she had covid 19 virus symptoms was unknown, while rest of events was not recovered. Follow up(20May2021): New Information received from the Pfizer colleague includes new adverse event details, anatomical location of both doses details. Follow up(20May2021): Upon follow up, no new information has been included. Information about Lot/Batch number is available. Further information is expected.
59 2021-06-01 ear pain 5/16/21 Pt presented to a free standing ED with complaints of cough, body aches, nasal congestion an... Read more
5/16/21 Pt presented to a free standing ED with complaints of cough, body aches, nasal congestion and otalgia that started around 5/11/21. In the ED she had audible wheezing, mild tachypnea (RR19) and her RA pulse ox was 88-943%. She was placed on oxygen and found to be positive for SARS-CoV-2. CXR showed possible pneumonia and she was transferred to a tertiary care facility for admission. She was discharged on 5/21/21 Acute hypoxic respiratory failure, resolved Covid-19 Virus Infection Date of onset of symptoms: Approximately 7 days prior (5/15/2021) Symptoms present on admission: Nasal congestion, myalgias, productive cough of yellow-green sputum, diarrhea Date of covid positive test: 5/16 Vaccination status: vaccinated, received only first dose Imaging: CXR with lobar pneumonia Oxygen requirements on admission: 2 L Current oxygen requirements: None Medical therapy: Oral prednisone, not a candidate for remdesivir Inflammatory markers: CRP 18.1, ferritin 111, D-dimer 0.62, LDH 174 Community-acquired pneumonia Given lobar appearance on CXR and productive cough of green/yellow sputum I do feel it prudent to cover the patient for community-acquired pneumonia Treated with Azithromycin, Augmentin Acute on chronic kidney disease Baseline serum creatinine approximately 1.1-1.2, presenting serum creatinine 1.94 Prerenal versus intrinsic renal 2/2 infection Creatinine trending down to 1.24 at time of discharge COPD with acute exacerbation IV Solu-Medrol initially, transition to oral prednisone Schedule bronchodilators Started Symbicort per hospital formulary, and held home Flovent while hospitalized Antibiotic coverage as above
59 2021-06-01 mouth numbness Facial numbness middle to left side of chin and over to check, including lower lip and tip of tongue... Read more
Facial numbness middle to left side of chin and over to check, including lower lip and tip of tongue. First spoke with dentist and he took xrays to see if there was anything related he did not see anything, suggested I see my doctor. Had appt. with my family doctor and she did bloodwork, only issue with bloodwork was very low B12, began a daily supplement. Family suggested I see a neurologist to figure out this numbness. Went to neurologist, had more bloodwork and an MRI.. MRI was negative and bloodwork showed low albumin. I did document this on my weekly check-in post vaccine and in May received a call from CDC to report this adverse event. I had not correlated this to the vaccine, but once the CDC called, I did investigate and it seems that this could very well be a side effect. I am hoping someone can help me find a doctor that can help correct this numbness, thank you~
59 2021-06-01 toothache One day after 2nd dose, (Apr 13) pt woke up with symptoms resembling a sinus infection. On Apr 14, p... Read more
One day after 2nd dose, (Apr 13) pt woke up with symptoms resembling a sinus infection. On Apr 14, pt woke up with sore tooth and thought she'd been grinding her teeth through the night. Apr 15, pt had a severe tooth ache in tooth 4 involving gum tissue and into bone. Apr 16, she went to an endodontist and was diagnosed with a severe infection on a tooth with a prior root canal. Dr put her on antibiotics for a week. Pain and swelling reduced somewhat during antibiotic course. On Apr 26 pt had an apicoectomy. Apr 27 Pt started having pain in tooth 19 (that also had a prior root canal.) Apr 29 pt had the sutures of first surgery removed, and pt had dr take an xray of tooth 19, which showed an infection in tooth 19, despite the ongoing antibiotics course. May 7 pt had a root canal on tooth 19. May 19 tooth 21 started hurting . May 27, pt went to an new endodontist. He said pt need an apicoectomy on tooth 21 or simply pull the tooth. Summary: after years of no problems with root canals (or even decay), within 1 day of 2nd Pfizer dose and over the next 7 weeks, 3 prior root canal teeth became problematic.
59 2021-06-02 feeling of choking Patient stated she had second Pfizer on 5/28/21, and after 5 minutes her throat felt like it was tin... Read more
Patient stated she had second Pfizer on 5/28/21, and after 5 minutes her throat felt like it was tingling for a minute or two. She stated the next day she felt tired, achy and soreness at injection site. She stated she still feels tired, but not as much as on the weekend.
59 2021-06-02 ringing in ears nausea added to all the symptoms above; Dizziness; chills; fever; severe ringing in ears; Burning un... Read more
nausea added to all the symptoms above; Dizziness; chills; fever; severe ringing in ears; Burning under skin above both elbows throughoutback shoulders and down back torsobut not along spinal bones; overall weakness and tiredness throughout body/unable to get out of bed; overall weakness and tiredness throughout body; Slight headache begins; feeling unwell; pain in left and moving up arm from injection site, across backshoulders, and down right are above elbow; shaky; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246), an unspecified route of administration, administered in arm left on 04Mar2021 (at the age of 59-year-old) as a single dose for covid-19 immunisation at CDR. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient previously took compazine [prochlorperazine maleate] and Zoloft and experienced drug allergies. The patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246) via unspecified route of administration in right arm on 11Feb2021at 02:00 PM as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccine in four week and not received any other medications in two weeks. On 04Mar2021 at 6:00 PM, patient experienced pain in left and moving up arm from injection site, across back shoulders, and down right are above elbow. 05Mar2021 at 10:00 AM, patient experienced burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones, overall weakness and tiredness throughout body, slight headache begins and feeling unwell. On 06Mar2021 at 8:00 AM, patient had dizziness and weakness, tiredness, severe/excruciating headache, muscle pain, chills, fever, feeling unwell, severe ringing in ears, unable to get out of bed. 06Mar2021 at 5:00 PM, nausea added to all symptoms above last 2 hours. 07Mar2021 at 8:00 AM, patient was able to get out of bed. On an unspecified date in Mar2021, patient was shaky. No relief from Advil pain reliever. Headache was manageable, dizziness persists, weakness/minimal energy, shaky, burning under skin remained. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
59 2021-06-03 taste disorder I have had a "chemical" taste and smell since my second vaccine even though I had Covid in Oct2020 a... Read more
I have had a "chemical" taste and smell since my second vaccine even though I had Covid in Oct2020 and did not have taste or smell alterations; This is a spontaneous report received from a contactable other Health Care Professional. A 59-years-old non pregnancy female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EK 923, Expiration date: Unknown) via an unspecified route of administration, in Arm Left on 07Jan2021 (at the age of 59-years-old) as single dose for Covid-19 immunisation. The patient medical history included Covid-19 on Oct2020. The patient had no known allergies. Patient had a historical vaccine of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EK 5730, Expiration date: Unknown), via an unspecified route of administration, in Arm right on 16Dec2020 (at the age of 59-years-old) as single dose for Covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received the medications within 2 weeks included calcium; linum usitatissimum seed oil; curcuma longa; cyanocobalamin; colecalciferol taken all for an unspecified indication, start and stop date were not reported. The patient was diagnosed for COVID, prior vaccination. The patient was not tested for COVID, post vaccination. The patient had experienced a "chemical" taste and smell since her second vaccine even though she had covid in Oct2020 and did not have taste or smell alterations on 08Jan2021. The patient did not received treatment for the events. The clinical outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
59 2021-06-04 eye itchiness, lacrimation increased, bloodshot eyes headache; red and teary eyes; red and teary eyes; felt like she had the flu afterward; Eyes Red, Tea... Read more
headache; red and teary eyes; red and teary eyes; felt like she had the flu afterward; Eyes Red, Teary and Itchy; her allergy's haven gotten worst.; she felt sick; Bruise to left arm at injection site; This is a spontaneous report from a contactable consumer (patient) reported herself. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 at 13:30 (Batch/Lot Number: EP6955) as a Single dose for covid-19 immunization. The patient past Medical history included high blood Pressure and seasonal allergy. The patient took flu vaccine in sep or oct in 2020 and experienced felt sick for a day after flu vaccine.The Concomitant medication included Amlodipine for blood pressure. On 18Mar2021, 2-3 hours after the administration of vaccine the patient experienced headache, red and teary eyes and her eyes is not red but was still itching. The patient felt like she had the flu afterward, bruise on her left arm where she received the vaccine for 3 weeks, but it was now fading, her allergy's haven gotten worst, her bruise took 3 weeks to go away and she felt sick. She states she has had to take an antihistamine every day.Says her eyes got red and teary, says the redness lasted about 3 days. Her eyes were also itchy, she states they still are at times. Thought maybe it was just her allergies but that her allergies aren't normally as bad as this particular event was.Says she put some drops in and took some antihistamine like she does for seasonal allergies.States she also had a headache. Said it wasn't her whole head that hurt but it felt like it was hurting in different spots at different times.Says she was told that after her first shot it was normal to feel sick. Was told the medication needed to work its way through her body.She says she was also told that the injection spot would have a bruise on it for three weeks. States that it was lighter, but the bruise was still there on her left arm.Denies any pain, just a bruise.Caller states that the symptoms with her eyes and her headache started 2-3 hours after receiving the vaccine on 18Mar2021.she was scheduled tomorrow to get her second dose of the vaccine. The patient inquired was it ok to take the next vaccine. The patient also asked what medication she can take, what about the day before, What about taking it the night before and can't take it after the vaccination.The patient enquired whether it was normal, but it was stronger because it is a booster shot. she is scared because when she got the first one, she noticed some reactions. She wants to know what to expect from second dose. she fears vaccines and medications and does not take medication unless she has to.Says her friends told her she should take Tylenol before the vaccine but she did not.The event outcome was recovered for red and teary eyes and Bruise to left arm at injection site, Unknown for Headache, Flu like symptoms, feeling sick and Allergy aggravated and for and Itchy eyes not recovered .The reporter assessed the case as non serious. No follow-up attempts are needed. No further information is expected.
59 2021-06-07 loss of taste, loss of smell Patient received 2 doses of Pfizer covid vaccine on 3/19/2021 and 4/16/2021. She tested positive for... Read more
Patient received 2 doses of Pfizer covid vaccine on 3/19/2021 and 4/16/2021. She tested positive for covid on 6/8/2021. Her symptoms started on 6/3/2021 and included fever, cough, chills, loss of taste/smell, diarrhea, headache, and congestion/runny nose.
59 2021-06-07 ear pain, swollen tongue couldn't read or write; couldn't read or write; inflammation in the tongue; cannot turn from her nec... Read more
couldn't read or write; couldn't read or write; inflammation in the tongue; cannot turn from her neck because it was swollen; couldn't sleep and toss and turn; Sweating; sharp pain in her head; pain from her neck; sharp pain coming from her ear; feeling the pain/feeling the pain when laying down and she cannot handle the pain; It hurt, even when eating her throat hurt and it hurt to swallow and pass food; gaining weight; cheek and tongue swollen, it was swollen; cheek and tongue swollen, it was swollen; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Jan2021 (at age of 59-year-old) as single dose for covid-19 immunisation. Medical history included ongoing human immunodeficiency virus (HIV). The patient's concomitant medications were not reported. Patient received the first dose of Covid vaccine on 28Jan2021. Patient had inflammation in the tongue and she cannot turn from her neck because it was swollen. It was been 3 months since she received the vaccine (Apr2021). She went to the emergency room and also to her primary care provider and they just cannot find anything. She has had it, the vaccine, and it was good and she had good health when she got the first dose. Mentioned she couldn't read or write. On unspecified date in 2021, she would like to file a safety report because at night she couldn't sleep and it felt like a sharp pain in her head and she started sweating. Feels the pain from her neck and sharp pain coming from her ear. She couldn't sleep and toss and turn. Told the doctor and was informed to buy pills to sleep and even with the pills the pain still wakes her up. Clarified pills as Melatonin. Mentioned she had called before to this number (Pfizer), but they just do not answer. Has tried this number a couple days ago. Had not spoken to safety. Wanted to know what to do because she was feeling the pain. What was she going to do during the day when feeling the pain when laying down and she cannot handle the pain. She went 3 times to the emergency room and 3 times to the primary care provider and they cannot recommend anything because this was from the shot she was given. Wanted to know if the doctor couldn't give her any medicine, why did they give vaccine to her. Said if she took this to the tv or media and said she got the vaccine and it was not working and cannot get any good advice for a doctor what was she to do. Not sure if it was because she does not understand because she does not read or write. Has been gaining weight even though she did not eat. The inflammation of the tongue was noticed since the first vaccine. She had called the doctor and he told her to take allergy pills. So she went to the pharmacy, got it and nothing it did help her. She still felt like that with the cheek and tongue swollen, it was swollen. Clarifies pilled as Benadryl. Issues, pain with neck have all been since the first vaccine and it got worse after the second dose. It hurt, even when eating her throat hurt and it hurt to swallow and pass food. Went to the emergency room 15 days after the second dose because she could not handle the pain. The sharp pains, sweating, pain in ear came and gone and really felt it when laying down she felt the sharp pain in the head. Had to be upside down in order to feel better. The pain waked her up from sleep. No other vaccines given the same day and no problems with vaccines in past. At clinic there were tests ordered and exams, x-ray for the neck and on Tuesday they took 5 bottles of blood to see what the labs look like. When she was at the emergency room, they took x-rays and the doctor ordered those exams and all came out fine. They gave her the shot (covid) so soon because she has HIV. She was perfectly fine for 19 years and was fine with all her medicines and treatments. All exams came out fine and everything. Clarified HIV (human immunodeficiency virus) diagnosed and treatment/medications were before she received the Covid vaccines. The outcome of the events "feeling the pain/feeling the pain when laying down and she cannot handle the pain", "gaining weight", "cheek and tongue swollen, it was swollen" was unknown, for other events was not recovered. Information about lot/batch number has been requested.
59 2021-06-07 oropharyngeal discomfort PT. c/o "feeling like throat is swelling", "feels funny", Benadryl 25mg. PO given per PA verbal ord... Read more
PT. c/o "feeling like throat is swelling", "feels funny", Benadryl 25mg. PO given per PA verbal order no rash/hives noted @ this time, VS stable, 166/78, 99% oxygen sat, 66 heart rate pt. speaking in full sentences
59 2021-06-07 ringing in ears Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I ... Read more
Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I had not previously had diabetes-level blood sugar. Constant high pitched ringing in ears X 6 weeks a; Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I had not previously had diabetes-level blood sugar. Constant high pitched ringing in ears X 6 weeks a; headache X 3 days after 1st and 2nd vaccines; Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I had not previously had diabetes-level blood sugar. Constant high pitched ringing in ears X 6 weeks a; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female non- pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at the age of 59-year-old on 01Apr2021 16:00 (Lot Number: EN6202) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included perennial allergies. Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC); fluticasone propionate (FLONASE ALLERGY RELIEF); amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3), multi- vitamin, all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration administered in arm left at the age of 59-year-old on 04Mar2021 16:00 for covid-19 immunisation and experienced ringing in ears and headache; seldane and experienced drug hypersensitivity, horseradish and experienced drug hypersensitivity. The patient experienced higher blood sugar levels noted within one week of vaccine indicated type ii diabetes levels when the patient had not previously had diabetes-level blood sugar (on an unknown date); constant high pitched ringing in ears for 6 weeks and headache for 3 days after 1st and 2nd vaccines, both occurred on 01Apr2021 16:00. Events all resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 10May2021. Therapeutic measures were taken as a result of all events. It is reported as high blood sugar noted routine check, 3 months recheck. The outcome of the events was unknown.
59 2021-06-08 mouth discomfort, hearing loss I developed Belle Palsy after receiving the vaccine. I had very similar symptoms to having a stroke... Read more
I developed Belle Palsy after receiving the vaccine. I had very similar symptoms to having a stroke. I have a droopy mouth, slurred speech, I couldn't blink my eye. I had a reaction to the steroid that was given to treat my Belle Palsy diagnosis from the ER visit. I also experience horrible headaches. And hearing issues in the effect side.
59 2021-06-08 ringing in ears ringing in left ear, same side as inoculation; ringing in left ear, Same side as inoculation; This i... Read more
ringing in left ear, same side as inoculation; ringing in left ear, Same side as inoculation; This is a spontaneous report from a contactable consumer (patient) reporting about herself. A 59-year-old non pregnant female patient (at 59-year-old) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: eP6955, Expiration date: not reported), via an unspecified route of administration, in left arm on 09Mar2021 at 14:15 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The medical history and concomitant medications were not reported. She had no history of known allergies. Prior to vaccination, she did not receive any other vaccine (in four weeks) and other medications (in two weeks). The patient experienced ringing in left ear and same side as inoculation on 09Mar2021 at 21:00. No treatment was received. Covid prior and post vaccination was No. The clinical outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.
59 2021-06-09 eye strain After receiving the shot my arm was tad bit red. I felt okay at fine and 1:00am I woke up and my hea... Read more
After receiving the shot my arm was tad bit red. I felt okay at fine and 1:00am I woke up and my head was hurting terribly. I took Tylenol thinking it would help my headache. I checked my blood pressure and it was 182/118. My eyes were very heavy. When I got to work I felt so nauseous.
59 2021-06-09 ringing in ears developed tinnitus in both ears